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IRB # Pro00010812
Consent to Participate in a Research Study
Adult Subjects, SEARCH 3 Cohort Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
SEARCH Carolina Site Principal Investigators:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD
(919-966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Funding Source and/or Sponsor: Centers for Disease Control and Prevention and National
Institutes of Health/NIDDK
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
_________________________________________________________________
What are some general things you should know about research studies?
You are being asked to take part in a research study. To join the study is voluntary.
You may refuse to join, or you may withdraw your consent to be in the study, for any reason.
Research studies are designed to obtain new knowledge that may help other people in the
future. You may not receive any direct benefit from being in the research study. There also
may be risks to being in research studies.
Deciding not to be in the study or leaving the study before it is done will not affect your
relationship with the researcher or your health care provider. If you are a patient with an
illness, you do not have to be in the research study in order to receive health care.
Details about this study are discussed below. It is important that you understand this
information so that you can make an informed choice about being in this research study. You
will be given a copy of this consent form. You should ask the researchers named above, or
staff members who may assist them, any questions you have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about diabetes in children and young adults.
Diabetes is the third most common life-long disease in people under 20 years of age. The total
number of cases of diabetes in this age group is increasing. Also, types of diabetes that have
not been seen in young people are now being seen. Specifically, this project is interested in
studying the following questions:
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a.
How common are long-term complications related to diabetes, including: retinopathy
(damage to back of the eye), nephropathy (kidney damage), neuropathy (nerve damage),
and damage to the heart and blood vessels?
b. How common are short-term complications, including hypoglycemia (low blood sugar) and
diabetic ketoacidosis (DKA)?
c. What type of medical care are young people with diabetes receiving and how does diabetes
affect the lives of these individuals?
You are being asked to be in the study because you have diabetes, previously did an in-person
visit with the SEARCH study and have had diabetes for at least five years.
Are there any reasons you should not be in this study?
You should not complete a study visit if you are currently pregnant. You may take part in the
study visit when it has been at least four months after the end of your pregnancy.
How many people will take part in this study?
A total of approximately 3900 people at five sites across the US will take part in the Cohort
Study visit, including approximately 821 people from the Carolina SEARCH site.
How long will your part in this study last?
The Cohort Study visit will take about 3 ½ hours. We may contact you every year to be sure
we have your correct contact information. If you agree to have a sample of your blood, urine or
DNA stored following the Cohort Study visit, it will be saved for 10 years after the end of
funding for follow- up of SEARCH participants. After this time, stored samples will be
destroyed.
What will happen if you take part in the study?
A research team member will set up an appointment for you in the early morning. You will
come to the appointment after not having anything to eat or drink other than water for 8-12
hours. You will not take your usual diabetes medicines until after you have been given
breakfast during the appointment.
Laboratory Tests
Blood draw: When you arrive, blood will be taken from your arm to measure blood sugar,
hemoglobin A1c (a measure of long-term blood sugar control), different types of cholesterol
(fat), c-peptide (a measure of your own insulin production), islet cell antibodies (markers in the
blood for type 1 diabetes), cystatin-C and serum creatinine (measures of kidney function), and
several new blood markers associated with risk for developing heart disease or stroke
(apolipoprotein B, C-reactive protein, interleukin-6, leptin, and adiponectin).
The total amount of blood drawn will be based on weight tables and will not exceed 3
tablespoons. The blood draw takes about 10 minutes. If you need numbing medicine for the
blood draw, SEARCH staff can provide that for you. If you agree, results commonly used in
clinical practice (hemoglobin A1c, cholesterol, c-peptide, and urine albumin/creatinine) will be
shared with your doctor.
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Mark the line that best matches your choice:
_____ OK to share results of the tests with my doctor
_____ Not OK to share results of the test with my doctor
Urine Collection: Before your scheduled appointment, you will be mailed a container with
detailed instructions to collect your first morning urine the day of your study visit. You will be
asked to bring this urine container with you to your visit.
A urine sample will also be collected during the study visit. .
Your urine will be tested for albumin and creatinine (small particles of protein) to see how well
your kidneys are working.
A sample of your blood, urine, and DNA may be saved after the visit, if you agree.
After the blood and urine samples are obtained, you will be given a snack.
Physical Exam
The physical exam will include height, weight, waist measurement, blood pressure, and
examination of the skin of the neck. This will be done by trained study staff. The time to
complete this part of the visit is approximately 30 minutes.
Questionnaires
The questionnaires can be completed either at home before the visit or at the visit. If you prefer,
a separate visit may be scheduled to complete the forms. You will be asked questions about
your diabetes, medical care, current medications, family history of diabetes, education, family
income level, food access and security, health insurance, and the effect diabetes has had on
your life.
You will also be asked to answer some questions dealing with the following health issues –
physical activity, smoking, eating and sleeping patterns, depression, and whether you have ever
been pregnant. You will also be asked what might be done to prevent low blood sugars, what
worries you might have in relation to low blood sugars, and practices that are consistent with
eating problems.
The estimated time to complete these questions is 80-120 minutes.
Nerve and Heart Function Tests
Nerve Tests: Diabetic neuropathy is a complication of diabetes that results from damage to the
nerves. We will be looking for signs of early nerve damage by asking you to complete a short
questionnaire, doing an examination of your feet, and doing an electrocardiogram (ECG) test of
your heart.
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We will ask you to answer 15 questions about foot sensation including pain, numbness, and
temperature sensitivity. We will examine your feet to measure the ability to feel vibrations,
reflexes, and the ability to feel light touches to the feet. The examiner will test the vibration
sense by placing a vibrating instrument on the big toe. The examiner will use a rubber
“hammer” to test the reflexes in the ankle. To test your sense of touch, the examiner will touch
your toe several times with a thin piece of plastic. Doing the foot nerve tests will take about 10
minutes. The results of the tests will be sent to the University of Michigan for analysis.
In order to check the accuracy of our measurements, the foot test will be repeated for
approximately 5% (1 in 20) of participants. Participants will be randomly selected to receive
the repeat measurements. If you are selected for repeat measurements of the feet and you agree
to have the measurements performed, the visit will last about 10 minutes longer. You may
refuse to have the repeat measures, but still complete the foot examination.
____ You have been selected for the repeat measurements of the feet.
____ You have not been selected for repeat measurements of the feet.
Heart Rate Variability: Heart Rate Variability (HRV) is a measurement to assess the health of
nerves in the heart. The test uses an ECG, or electrocardiogram. This is a test that doctors
routinely use to study the heart; your doctor may have used it with you before. The examiner
will place an EKG lead on each of your arms and on the left leg or two EKG leads on the chest
and one on the stomach. It is important for the EKG leads to pick up a good signal of the
heartbeats. In some cases it may be necessary for us to shave hair from a small area of skin to
improve the heart signal. You will be asked to lie down and rest for 5 minutes before the test
begins. We will then record the pattern of your heart beats for 10 minutes.
Blood Vessel Test: We will perform a test to measure how your blood vessels function. The
test is called an arterial stiffness test. You will be asked to wear loose shorts or to put on a
patient gown. A trained member of the research team will measure the pulse in the groin area,
but will not expose your private parts. At your request a chaperone will be present during these
procedures.
The following test will then be performed:
A staff member will measure the distance from your neck to the top of your sternum (breast
bone), from the neck to your wrist, from the sternum to the your belly button, from your belly
button to your groin, and from the groin to your foot. The electrodes (sticky pads) used for the
HRV test will be left in place for the blood vessel test.
Your wrist will be touched with a small instrument shaped like a pen and the stiffness of your
blood vessels will be measured. The pen instrument detects pressure changes with a tiny,
highly-sensitive pressure sensor in the flat end of the device that is shaped like a pencil eraser.
It does not use radiation (X-rays), sound waves (ultrasound), or needles. This test is painless
and will be repeated 3 times.
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Then the same pen-shaped instrument will be touched on the side of your neck, the top of your
thigh, and your foot to measure the speed at which blood travels from the heart to that area of
the body. This test will be repeated 3 times. The blood vessel tests will take about one hour.
This test is designed to be short, simple, and painless. This is a test that doctors use every day,
and it is not dangerous. But if you feel uncomfortable at any time during any of these tests, just
tell the examiner and he/she will immediately stop the tests.
In order to check the accuracy of our measurements, the blood vessel tests will be repeated for
approximately 5% (1 in 20) of participants. Participants will be randomly selected to receive
repeat measurements. If you are selected for repeat measurements of the blood vessel tests and
you agree to have the measurements performed, your visit will last about 15 minutes longer.
You may refuse to have the repeat measures, but still complete the blood vessel testing. You
will receive additional compensation for your time if you have the repeat measures done.
____ You have been selected for repeat measurements of the blood vessels.
____ You have not been selected for repeat measurements of the blood vessels.
Eye Photographs
Diabetic retinopathy is a complication of diabetes that results from damage to the blood vessels
at the back of the eye (retina). We will be taking 2 pictures of each of your eyes. These
pictures will be sent to the Ocular Epidemiology Reading Center in Madison, Wisconsin to be
read by trained eye specialists who will study the blood vessels and look for possible problems.
You will be asked to sit in a darkened room before a special camera with your chin in a chin
rest. After your pupils have dilated (opened) naturally, we will take 2 photographs of the back
of each of your eyes (retinas). No drops will be put in the eyes; and the camera will not touch
the eyes. After each picture is taken, you may see a white or colored spot, which will disappear
within a few minutes and cause no damage to the eye. We will pause for a few minutes
between photographs to allow your eyes time to re-adjust to the darkened room so the pupils
will dilate once again.
You will also be asked for the name and phone number of your eye doctor, and whether or not
you have ever had eye injections or laser treatments on the back of your eyes. Doing the eye
photographs will take about 20 minutes. We will send you the results of your eye photographs.
If you agree, results will be shared with your doctor.
Mark the line that best matches your choice:
_____ OK to share results of the tests with my doctor
_____ Not OK to share results of the test with my doctor
Medical Record Review
A medical record review will be conducted for a small number (~25 people) who give us
permission to check that the information you gave us regarding key medical events and markers
of healthcare quality were remembered correctly.
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Mark the line that best matches your choice:
__OK to review my medical records to check that the information I remembered was correct
__Not OK to review my medical records to check that the information I remembered was
correct
Contact in the Future
The researchers will call you as new studies are developed in the future to let you know about
new studies and ask you to take part in these studies. As with this study, taking part in any
future study is voluntary. Taking part in the present study does not mean that you are agreeing
to take part in any future study.
Mark the line that best matches your choice:
_____ OK to contact me in the future to tell me about other studies
_____ Not OK to contact me in the future to tell me about other studies
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. You will not benefit
personally from being in this research study.
What are the possible risks or discomforts involved with being in this study?
The risks from drawing blood from a vein in the lower arm include mild pain, bruising at the
site of the blood draw, and occasionally fainting. To lower the possibility of these risks, blood
will be drawn by experienced staff and a local numbing medicine may be placed on the skin
before the blood is drawn to decrease any pain. The total amount of blood that will be obtained
will be no more than 3 tablespoons (45cc) depending on your age and body size. When
drawing your blood, our research staff will follow all necessary safety precautions. In the
highly unlikely event that our research staff is accidentally exposed to your bodily fluids (blood
or urine), we will abide by the South Carolina law that provides for testing of blood to
minimize threats to the health of the staff. You will be notified should this testing be necessary
and the results will be reported as required by law.
The blood tests require that you not eat any food overnight. In order to limit low or high blood
sugars, your blood sugar will be checked and your diabetes medication or a fast-acting
carbohydrate will be given as needed.
There are no known risks associated with the nerve tests. There are no known risks associated
with taking photographs of the eye. Although you will see a flash of light when the picture is
taken, this flash is not harmful. People who are light sensitive may experience some minor
discomfort from the camera flash, but the discomfort will not last. When the pen-shaped blood
vessel device is placed on your skin you may feel some pressure for a few seconds.
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Some of the tests will look for the presence or risk of developing of the complications of
diabetes. If these tests identify complications of diabetes or risk of developing the
complications, the results may make you anxious. If this happens, you will be referred to your
diabetes care provider or a local mental health professional.
Other possible risks include loss of privacy or confidentiality. Loss of privacy might happen if
someone could overhear or see you taking part in the study. To limit this, we will do the study
visit in a private location. Information collected will be stored in a locked filing cabinet or in a
password-protected electronic file.
In addition, there may be uncommon or previously unknown risks that might occur. You
should report any problems to the researchers.
If you choose not to be in the study, how does this affect your medical care?
You can still receive evaluation and treatment for your condition if you do not participate in
this study. Discuss any alternative treatments with your regular doctor and/or the study doctor
before you decide to participate in the study. Your decision is entirely up to you. If you decide
not to participate in the study, you will not be penalized or lose any benefits and your decision
will not affect your relationship with your doctor or hospital.
What if we learn about new findings or information during the study?
You will be given any new information gained during the course of the study that might affect
your willingness to continue your participation.
How will your privacy be protected?
SEARCH staff will keep the information collected, tests done, and samples stored strictly
private. This is so because the study has been given a Certificate of Confidentiality. This
means anything you tell us will not have to be given out to anyone, even if a court orders us to
do so, unless you say it’s okay. But under the law, we must report to the state suspected cases
of child abuse or if you tell us you are planning to cause serious harm to yourself or others.
When you enter the study, a special number will be given to you. The number will be used to
identify the information and laboratory tests that will be done during this study. The special
number and the information collected during this study will be sent to Wake Forest University
in order to study the information. Blood and urine specimens will be sent to the University of
Washington for testing or storage. The nerve test results and your special number will be sent
to the University of Michigan and Wake Forest University. The eye test results and your
special number will be sent to the Ocular Epidemiology Reading Center (OERC) at the
University of Wisconsin-Madison and Wake Forest University. The list containing the special
number assigned to you will be kept in a password-protected database at the Carolina SEARCH
site. Thus, no one other than the study investigators (Dr. Mayer-Davis at the University of
North Carolina (UNC), Dr. Nelson at Greenville Health System (GHS), Dr. Bowlby at the
Medical University of South Carolina (MUSC), Dr. Merchant at the University of South
Carolina (USC)) and the SEARCH Carolina research team will be able to link any of the
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information collected in the study to you. Paper forms collected during the study will be stored
in a locked filing cabinet.
No subjects will be identified in any report or publication about this study. Although every
effort will be made to keep research records private, there may be times when federal or state
law requires the disclosure of such records, including personal information. This is very
unlikely, but if disclosure is ever required, UNC-Chapel Hill and your local data collection site
(GHS, MUSC, or USC) will take steps allowable by law to protect the privacy of personal
information. In some cases, your information in this research study could be reviewed by
representatives of UNC-Chapel Hill or your local data collection site (GHS, MUSC, or USC),
research sponsors, or government agencies (for example, the FDA) for purposes such as quality
control or safety.
What will happen if you are injured by this research?
All research involves a chance that something bad might happen to you. This may include the
risk of personal injury. In spite of all safety measures, you might develop a reaction or injury
from being in this study. If such problems occur, the researchers will help you get medical care,
but any costs for the medical care will be billed to you and/or your insurance company. The
University of North Carolina at Chapel Hill and your local data collection site (GHS, MUSC,
or USC) have not set aside funds to pay you for any such reactions or injuries, or for the related
medical care. However, by signing this form, you do not give up any of your legal rights.
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, without penalty.
Will you receive anything for being in this study?
You will be receiving $120 in VISA gift cards for completing a full study visit. If you
complete a partial study visit due to refusal of the blood draw, you will only receive $80 in gift
cards. You will get an additional $10 gift card if you are selected and complete the repeat
measure of the blood vessel test. In the rare circumstance that a blood redraw is necessary; you
would receive an additional $20 gift card.
If you traveled a significant distance to complete this study visit, you will be provided
additional incentive to assist with travel costs. This additional incentive will be: two $20 gift
cards if you traveled 70-100 miles round trip, three $20 gift cards if you traveled 101-150 miles
round trip, or four $20 gift cards if you traveled more than 151 miles round trip. Travel
distance will be determined based on your current home address and the location of the
SEARCH visit.
Will it cost you anything to be in this study?
There will be no costs for being in the study
What if you are a student at UNC, MUSC or USC?
You may choose not to be in the study or to stop being in the study before it is over at any time.
This will not affect your class standing or grades. You will not be offered or receive any
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special consideration if you take part in this research.
What if you are an employee at MUSC, GHS, or USC?
Taking part in this research is not a part of your job duties, and refusing will not affect your
job. You will not be offered or receive any special job-related consideration if you take part in
this research.
Who is sponsoring this study?
This research is funded by the Centers for Disease Control and Prevention and the National
Institutes of Health. This means that the research team is being paid by the sponsor for doing
the study. The researchers do not, however, have a direct financial interest with the sponsor or
in the final results of the study.
What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research.
If you have questions, complaints, concerns, or if a research-related injury occurs, you should
contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you have questions or concerns about your rights as a research subject, or if you
would like to obtain information or offer input, you may contact the Institutional Review Board
at Greenville Health System (864-522-2097; email [email protected]) or at UNC-Chapel Hill
(919-966-3113; email: [email protected]).
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a
paper copy of this survey, please tell your doctor.
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------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating
Site); Bryce Nelson, MD (GHS data collection site), Deborah Bowlby, MD (MUSC data
collection site); Anwar Merchant, ScD (USC data collection site)
Subject’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily agree to participate in this research study.
_________________________________________________
Signature of Research Subject
__________________
Date
_________________________________________________
Printed Name of Research Subject
_________________________________________________
Signature of Research Team Member Obtaining Consent
_________________________________________________
Printed Name of Research Team Member Obtaining Consent
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Date
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Assent to Participate in a Research Study
Adolescent Subjects age 15-17, Cohort Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Assent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
SEARCH Carolina Site Principal Investigators:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD (919966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Funding Source and/or Sponsor: Centers for Disease Control and Prevention and National
Institutes of Health/NIDDK
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
_______________________________________________________________________
What are some general things you should know about research studies?
You are being asked to take part in a research study. Your parent, or guardian, needs to give
permission for you to be in this study. You do not have to be in this study if you don’t want to,
even if your parent has already given permission. To join the study is voluntary. You may refuse
to join, or you may withdraw your consent to be in the study, for any reason.
Research studies are designed to obtain new knowledge that may help other people in the future.
You may not receive any direct benefit from being in the research study. There also may be risks
to being in research studies.
Deciding not to be in the study or leaving the study before it is done will not affect your
relationship with the researcher or your health care provider. If you are a patient with an illness,
you do not have to be in the research study in order to receive health care.
Details about this study are discussed below. It is important that you understand this information
so that you can make an informed choice about being in this research study. You will be given a
copy of this consent form. You should ask the researchers named above, or staff members who
may assist them, any questions you have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about diabetes in children and young adults.
Diabetes is the third most common life-long disease in people under 20 years of age. The total
number of cases of diabetes in this age group is going up. Also, types of diabetes that have not
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been seen in young people are now being seen. Specifically, this project is interested in studying
the following questions:
a. How common are long-term problems related to diabetes, including: retinopathy (damage to
back of the eye), nephropathy (kidney damage), neuropathy (nerve damage), and damage to
the heart and blood vessels?
b. How common are short-term problems, including hypoglycemia (low blood sugar) and
diabetic ketoacidosis (DKA)?
c. What type of medical care are young people with diabetes receiving and how does diabetes
affect the lives of these individuals?
You are being asked to be in the study because you have diabetes, already did an in-person visit
with SEARCH and have had diabetes for at least five years.
Are there any reasons you should not be in this study?
You should not do a study visit if you are pregnant. You may take part in the study visit when it
has been at least four months after the end of your pregnancy.
How many people will take part in this study?
A total of approximately 3900 people at five sites across the US will take part in the Cohort
Study visit, including approximately 821 people from the Carolina SEARCH site.
How long will your part in this study last?
The Cohort Study visit will take about 3 ½ hours. We may contact your parent every year to be
sure we have your correct contact information. If you agree to have a sample of your blood,
urine or DNA stored after the Cohort Study visit, it will be saved for 10 years after the end of
funding for follow-up of SEARCH participants. After this time, stored samples will be
destroyed.
What will happen if you take part in the study?
A study team member will set up a time for your study visit in the morning. You will be asked
to not have anything to eat or drink other than water for 8-12 hours before your visit. You will
not take your usual diabetes medicines until after you have been given breakfast after your blood
draw.
Laboratory Tests
Blood draw: When you arrive, blood will be taken from your arm to test blood sugar,
hemoglobin A1c (a measure of long-term blood sugar control), different types of fat, c-peptide (a
measure of your own insulin production), islet cell antibodies (markers in the blood for type 1
diabetes), cystatin-C and serum creatinine (measures of kidney function), and several new blood
markers associated with risk for developing heart disease or stroke (apolipoprotein B, C-reactive
protein, interleukin-6, leptin, and adiponectin).
The total amount of blood drawn will be based on weight tables and will not exceed 3
tablespoons. The blood draw takes about 10 minutes. If you need numbing medicine for the
blood draw, SEARCH staff can provide that for you. If you agree, results commonly used in
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clinical practice (hemoglobin A1c, cholesterol, c-peptide, and urine albumin/creatinine will be
shared with your doctor.
Mark the line that best matches your choice:
_____ OK to share results of the tests with my doctor
_____ Not OK to share results of the test with my doctor
Urine Collection: Before your scheduled appointment, you will be mailed a container with
detailed instructions to collect your first morning urine the day of your study visit. You will be
asked to bring this urine container with you to your visit.
A urine sample will also be collected during the study visit. We will mark the time that you give
this urine sample on a sheet of paper.
Your urine will be tested for albumin and creatinine (small particles of protein) to see how well
your kidneys are working.
A sample of your blood, urine, and DNA may be saved after the visit, if you agree.
After the blood and urine samples are obtained, you will be given a snack.
Physical Exam
The physical exam will include height, weight, waist measurement, blood pressure, and
examination of the skin of the neck. This will be done by trained study staff. The time to
complete this part of the visit is approximately 30 minutes.
Questionnaires
The questionnaires can be completed either at home before the visit or at the visit. If you prefer,
a separate visit may be scheduled to complete the forms. You and your parent will be asked
questions about your diabetes, medical care, current medications, family history of diabetes,
education, family income level, the food you eat, health insurance, and the effect diabetes has
had on your life.
If you are 8-17 years of age, you will also be asked about stage of sexual development. If you
are 10-17 years of age, you will be asked about diabetes-related topics that might be a source of
fighting between you and your parent. The estimated time to complete these questionnaires is
40-60 minutes.
Additional questions for children 10 years or older
If you are 10 years of age or older, you will also be asked to answer a separate written
series of questions dealing with the following health issues – physical activity, smoking,
eating and sleeping patterns, depression, and whether you have ever been pregnant. You
will also be asked what might be done to prevent low blood sugars, what worries you
might have in relation to low blood sugars, and practices that are consistent with eating
problems. This will take about 40 minutes to do. This information will not be shared
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with your parent/guardian unless health issues are identified that need to be treated. The
reason for this is to increase the likelihood that you will answer the questions more
accurately.
Nerve and Heart Function Tests
Nerve Tests: Diabetic neuropathy is a complication of diabetes that results from damage to the
nerves. We will be looking for signs of early nerve damage by asking you to complete a short
questionnaire, doing an examination of your feet, and doing an electrocardiogram (ECG) test of
your heart.
We will ask you to answer 15 questions about foot sensation including pain, numbness, and
temperature sensitivity. We will examine your feet to measure the ability to feel vibrations,
reflexes, and the ability to feel light touches to the feet. The examiner will test the vibration
sense by placing a vibrating instrument on the big toe. The examiner will use a rubber
“hammer” to test the reflexes in the ankle. To test your sense of touch, the examiner will touch
your toe several times with a thin piece of plastic. Doing the foot nerve tests will take about 10
minutes. The results of the tests will be sent to the University of Michigan for analysis.
In order to check the accuracy of our measurements, the foot test will be repeated for
approximately 5% (1 in 20) of participants. Participants will be randomly selected to receive the
repeat measurements. If you are selected for repeat measurements of the feet and you agree to
have the measurements performed, the visit will last about 10 minutes longer. You may refuse to
have the repeat measures, but still complete the foot examination.
____ You have been selected for the repeat measurements of the feet.
____ You have not been selected for repeat measurements of the feet.
Heart Rate Variability: Heart Rate Variability (HRV) is a measurement to assess the health of
nerves in the heart. The test uses an ECG, or electrocardiogram. This is a test that doctors
routinely use to study the heart; your doctor may have used it with you before. The examiner will
place an EKG lead on each of your arms and on the left leg or two EKG leads on the chest and
one on the stomach. It is important for the EKG leads to pick up a good signal of the heartbeats.
In some cases it may be necessary for us to shave hair from a small area of skin to improve the
heart signal. You will be asked to lie down and rest for 5 minutes before the test begins. We
will then record the pattern of your heart beats for 10 minutes.
Blood Vessel Test: We will perform a test to measure how your blood vessels function. The test
is called an arterial stiffness test. You will be asked to wear loose shorts or to put on a patient
gown. A trained member of the research team will measure the pulse in the groin area, but will
not expose your private parts. At your request a chaperone will be present during these
procedures.
The following test will then be performed:
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A staff member will measure the distance from your neck to the top of your sternum (breast
bone), from the neck to your wrist, from the sternum to the your belly button, from your belly
button to your groin, and from the groin to your foot. The electrodes (sticky pads) used for the
HRV test will be left in place for the blood vessel test.
Your wrist will be touched with a small instrument shaped like a pen and the stiffness of your
blood vessels will be measured. The pen instrument detects pressure changes with a tiny, highlysensitive pressure sensor in the flat end of the device that is shaped like a pencil eraser. It does
not use radiation (X-rays), sound waves (ultrasound), or needles. This test is painless and will be
repeated 3 times.
Then the same pen-shaped instrument will be touched on the side of your neck, the top of your
thigh, and your foot to measure the speed at which blood travels from the heart to that area of the
body. This test will be repeated 3 times. The blood vessel tests will take about one hour.
This test is designed to be short, simple, and painless. This is a test that doctors use every day,
and it is not dangerous. But if you feel uncomfortable at any time during any of these tests, just
tell the examiner and he/she will immediately stop the tests.
In order to check the accuracy of our measurements, the blood vessel tests will be repeated for
approximately 5% (1 in 20) of participants. Participants will be randomly selected to receive
repeat measurements. If you are selected for repeat measurements of the blood vessel tests and
you agree to have the measurements performed, your visit will last about 15 minutes longer. You
may refuse to have the repeat measures, but still complete the blood vessel testing. You will
receive additional compensation for your time if you have the repeat measures done.
____ You have been selected for repeat measurements of the blood vessels.
____ You have not been selected for repeat measurements of the blood vessels.
Eye Photographs
Diabetic retinopathy is a complication of diabetes that results from damage to the blood vessels
at the back of the eye (retina). We will be taking 2 pictures of each of your eyes. These pictures
will be sent to the Ocular Epidemiology Reading Center in Madison, Wisconsin to be read by
trained eye specialists who will study the blood vessels and look for possible problems.
You will be asked to sit in a darkened room before a special camera with your chin in a chin rest.
After your pupils have dilated (opened) naturally, we will take 2 photographs of the back of each
of your eyes (retinas). No drops will be put in the eyes; and the camera will not touch the eyes.
After each picture is taken, you may see a white or colored spot, which will disappear within a
few minutes and cause no damage to the eye. We will pause for a few minutes between
photographs to allow your eyes time to re-adjust to the darkened room so the pupils will dilate
once again.
You will also be asked for the name and phone number of your eye doctor, and whether or not
you have ever had eye injections or laser treatments on the back of your eyes. Doing the eye
photographs will take about 20 minutes. We will send you the results of your eye photographs.
If you agree, results will be shared with your doctor.
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Mark the line that best matches your choice:
_____ OK to share results of the tests with my doctor
_____ Not OK to share results of the test with my doctor
Medical Record Review
A medical record review will be conducted for a small number (~25 people) who give us
permission to check that the information you gave us regarding key medical events and markers
of healthcare quality were remembered correctly.
Mark the line that best matches your choice:
__OK to review my medical records to check that the information I remembered was correct
__Not OK to review my medical records to check that the information I remembered was correct
Contact in the Future
The researchers will call your parent as new studies are developed in the future to let you know
about new studies and ask you to take part in these studies. As with this study, taking part in any
future study is voluntary. Taking part in the present study does not mean that you are agreeing to
take part in any future study.
Mark the line that best matches your choice:
_____ OK to contact me in the future to tell me about other studies
_____ Not OK to contact me in the future to tell me about other studies
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. You will not benefit
personally from being in this research study.
What are the possible risks or discomforts involved with being in this study?
The risks from drawing blood include mild pain, bruising at the site of the blood draw, and
occasionally fainting. To lower the chance of these risks, blood will be drawn by experienced
staff and a local numbing medicine may be used before the blood is drawn to decrease any pain.
The total amount of blood that will be drawn will be no more than 3 tablespoons (45cc)
depending on your age and body size. When drawing your blood, our research staff will follow
all necessary safety precautions. In the highly unlikely event that our study staff is accidentally
exposed to your bodily fluids (blood or urine), we will abide by the South Carolina law that
provides for testing of blood to minimize threats to the health of the staff. You will be notified
should this testing be necessary and the results will be reported as required by law.
You need to not eat any food overnight before you have the blood tests. In order to limit low or
high blood sugars, your blood sugar will be checked and your diabetes medicine or a fast-acting
carbohydrate will be given as needed.
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There are no known risks associated with the nerve tests. There are no known risks related to
taking photographs of the eye. Although you will see a flash of light when the picture is taken,
this flash is not harmful. People who are light sensitive may experience some minor discomfort
from the camera flash, but the discomfort will not last. When the pen-shaped blood vessel device
is placed on your skin you may feel some pressure for a few seconds.
Some of the tests will look for the presence or risk of getting problems related to diabetes. If
these tests identify problems from diabetes or risk of getting these problems, the results may
make you worried. If this happens, you will be referred to your diabetes care provider or a local
mental health professional.
Other possible risks include loss of privacy or confidentiality. Loss of privacy might happen if
someone could overhear or see you taking part in the study. To limit this, we will do the study
visit in a private location. Information collected will be stored in a locked filing cabinet or in a
password-protected electronic file.
In addition, there may be uncommon or previously unknown risks that might occur. You should
report any problems to the researchers.
If you choose not to be in the study, how does this affect your medical care?
Whether you decide to take part or decline to take part in this study, your decision will not affect
your medical care.
What if we learn about new findings or information during the study?
You will be given any new information gained during the study that might affect your
willingness to continue to take part.
How will your privacy be protected?
SEARCH staff will keep the information collected, tests done, and samples stored strictly
private. This is so because the study has been given a Certificate of Confidentiality. This means
anything you tell us will not have to be given out to anyone, even if a court orders us to do so,
unless you say it’s okay. But under the law, we must report to the state suspected cases of child
abuse or if you tell us you are planning to cause serious harm to yourself or others.
When you enter the study, a special number will be given to you. The number will be used to
identify the information and laboratory tests that will be done during this study. The special
number and the information collected during this study will be sent to Wake Forest University in
order to study the information. Blood and urine specimens will be sent to the University of
Washington for testing or storage. The nerve test results and your special number will be sent to
the University of Michigan and Wake Forest University. The eye test results and your special
number will be sent to the Ocular Epidemiology Reading Center (OERC) at the University of
Wisconsin-Madison and Wake Forest University. The list containing the special number
assigned to you will be kept in a password-protected database at the Carolina SEARCH site. So,
no one other than the study investigators (Dr. Mayer-Davis at the University of North Carolina at
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Chapel Hill (UNC), Dr. Nelson at Greenville Health System (GHS), Dr. Bowlby at the Medical
University of South Carolina (MUSC), Dr. Merchant at the University of South Carolina (USC))
and the SEARCH Carolina research team will be able to link any of the information collected in
the study to you. Paper forms collected during the study will be stored in a locked filing cabinet.
No subjects will be identified in any report or publication about this study. Although every effort
will be made to keep research records private, there may be times when federal or state law
requires the disclosure of such records, including personal information. This is very unlikely,
but if disclosure is ever required, UNC-Chapel Hill and your local data collection site (GHS,
MUSC, or USC) will take steps allowable by law to protect the privacy of personal information.
In some cases, your information in this research study could be reviewed by representatives of
UNC-Chapel Hill or your local data collection site (GHS, MUSC or USC) , research sponsors, or
government agencies (for example, the FDA) for purposes such as quality control or safety.
What will happen if you are injured by this research?
All research involves a chance that something bad might happen to you. This may include the
risk of personal injury. In spite of all safety measures, you might develop a reaction or injury
from being in this study. If such problems occur, the researchers will help you get medical care.
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, or your parents can withdraw you, without
penalty.
Will you receive anything for being in this study?
You will get $80 in VISA gift cards for completing a full study visit. If you complete a partial
study visit due to refusal of the blood draw, you will only receive $40 in gift cards. Your parents
will also get $40 in gift cards at the end of the visit. You will get an additional $10 gift card if
you are selected and do the repeat measure of the blood vessel test. In the rare circumstance that
a blood redraw is necessary; you would receive an additional $20gift card.
Your parents will also get additional incentive to assist with travel costs, if you and your parent
traveled a significant distance to do the study visit. This additional incentive will be: two $20
gift cards if you traveled 70-100 miles round trip, three $20 gift cards if you traveled 101-150
miles round trip, or four $20 gift cards if you traveled more than 151 miles round trip. Travel
distance will be determined based on your current home address and the location of the
SEARCH visit.
Who is sponsoring this study?
This research is funded by the Centers for Disease Control and Prevention and the National
Institutes of Health. This means that the research team is being paid by the sponsor for doing the
study. The researchers do not, however, have a direct financial interest with the sponsor or in the
final results of the study.
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What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If
you have questions, complaints, concerns, or if a research-related injury occurs, you should
contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you have questions or concerns about your rights as a research subject, or if you
would like to obtain information or offer input, you may contact the Institutional Review Board
at Greenville Health System (864-522-2097; email [email protected]) or at UNC-Chapel Hill
(919-966-3113; email: [email protected]).
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a paper
copy of this survey, please tell your doctor.
-------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site), Deborah Bowlby, MD (MUSC data collection
site); Anwar Merchant, ScD (USC data collection site)
Subject’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily agree to participate in this research study.
________________________________________________
Your signature if you agree to be in the study
_________________
Date
________________________________________________
Printed name if you agree to be in the study
________________________________________________
Signature of Research Team Member Obtaining Assent
________________________________________________
Printed Name of Research Team Member Obtaining Assent
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Consent to Participate in a Research Study
Adult Subjects, SEARCH 3 Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
People in charge of the study:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD
(919-966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
What are some general things you should know about research studies?
You are being asked to take part in a research study. To join the study is voluntary.
You may refuse to join, or you may withdraw your consent to be in the study, for any reason.
Research studies are designed to obtain new knowledge that may help other people in the
future. You may not receive any direct benefit from being in the research study. There also
may be risks to being in research studies.
Deciding not to be in the study or leaving the study before it is done will not affect your
relationship with the researcher or your health care provider. If you are a patient with an
illness, you do not have to be in the research study in order to receive health care.
Details about this study are discussed below. It is important that you understand this
information so that you can make an informed choice about being in this research study. You
will be given a copy of this consent form. You should ask the researchers named above, or
staff members who may assist them, any questions you have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about diabetes in children and young adults.
Diabetes is the third most common life-long disease in people under 20 years of age. The total
number of cases of diabetes in this age group is increasing. Also, types of diabetes that have
not been seen in young people are now being seen. These changes have resulted in gaps in
knowledge about the total number of cases and types of diabetes in the United States, the type
of care young people with diabetes receive, and the effect diabetes has on their lives. This
research study will gather information to answer these questions.
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You are being asked to be in the study because you have diabetes and were under age 20 and
living in South Carolina around the time you developed diabetes.
Are there any reasons you should not be in this study?
You should not complete a study visit if you are currently pregnant. You may take part in the
study visit when it has been at least four months after the end of your pregnancy.
How many people will take part in this study?
A total of approximately 900 people at five sites across the US will take part in the Registry
Study visit, including approximately 211 people from the Carolina SEARCH site.
How long will your part in this study last?
The Registry Study visit will take about 40 minutes. We may contact you every year to be sure
we have your correct contact information. If you agree to have a sample of your blood, urine or
DNA stored following the Registry Study visit, it will be saved for 10 years after the end of
funding for follow-up of SEARCH participants. After this time, stored samples will be
destroyed.
What will happen if you take part in the study?
A research team member will set up an appointment for you in the early morning. You will
come to the appointment after not having anything to eat or drink other than water for 8-12
hours. You will not take your usual diabetes medicines until after you have been given
breakfast during the appointment.
Laboratory Tests
When you arrive, blood will be taken from your arm to measure blood sugar, hemoglobin A1c
(a measure of long-term blood sugar control), different types of cholesterol (fat), c-peptide (a
measure of your own insulin production), and islet cell antibodies (markers in the blood for
type 1 diabetes). A genetic marker for diabetes risk (HLA genes) will also be tested. The total
amount of blood drawn will be based on weight tables and will not exceed 3 tablespoons. If
you agree, results commonly used in clinical practice (hemoglobin A1c, cholesterol, c-peptide,
islet cell antibodies, and urine albumin/creatinine) will be shared with your doctor.
Mark the line that best matches your choice:
_____ OK to share results of the tests with my doctor
_____ Not OK to share results of the test with my doctor
Urine Collection: Before your scheduled appointment, you will be mailed a container with
detailed instructions to collect your first morning urine the day of your study visit. You will be
asked to bring this urine container with you to your visit.
A urine sample will also be collected during the study visit.
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Your urine will be tested for albumin and creatinine (small particles of protein) to see how well
your kidneys are working.
A sample of your blood, urine, and DNA may be saved after the visit, if you agree.
After the blood and urine samples are obtained, you can take your pills or insulin and you will
be given a snack.
.
Physical Exam and Questionnaires
After eating, we will ask you some questions about the medicines you use and the food you eat.
A physical examination will be done by trained study staff. The physical examination will
include height, weight, waist measurement, blood pressure, and examination of the skin on the
neck. Then you will do a brief form to update your contact information. We will also ask you
some questions about the types of providers you see for your diabetes care.
Contact in the Future
The researchers will call you as new studies are developed in the future to let you know about
new studies and ask you to take part in these studies. As with this study, taking part in any
future study is voluntary. Taking part in the present study does not mean that you are agreeing
to take part in any future study.
Mark the line that best matches your choice:
_____ OK to contact me in the future to tell me about other studies
_____ Not OK to contact me in the future to tell me about other studies
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. You will not benefit
personally from being in this research study.
What are the possible risks or discomforts involved with being in this study?
The risks from drawing blood from a vein in the lower arm include mild pain, bruising at the
site of the blood draw, and occasionally fainting. To lower the chance of these risks, blood will
be drawn by experienced staff and a local numbing medicine may be placed on the skin before
the blood is drawn to decrease any pain. The total amount of blood that will be obtained will
be no more than 3 tablespoons (45cc) depending on your age and body size. When drawing
your blood, our research staff will follow all necessary safety precautions. In the highly
unlikely event that our research staff is accidentally exposed to your bodily fluids (blood or
urine), we will abide by the South Carolina law that provides for testing of blood to minimize
threats to the health of the staff. You will be notified should this testing be necessary and the
results will be reported as required by law.
The blood tests require that you not eat any food overnight. In order to limit low or high blood
sugars, your blood sugar will be checked and your diabetes medication or a fast-acting
carbohydrate will be given as needed.
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Some of the tests will look for the presence or risk of developing of the complications of
diabetes. If these tests identify complications of diabetes or risk of developing the
complications, the results may make you anxious. If this happens, you will be referred to your
diabetes care provider or a local mental health professional.
Other possible risks include loss of privacy or confidentiality. Loss of privacy might happen if
someone could overhear or see you taking part in the study. To limit this, we will do the study
visit in a private location. Information collected will be stored in a locked filing cabinet or in a
password-protected electronic file.
In addition, there may be uncommon or previously unknown risks that might occur. You
should report any problems to the researchers.
If you choose not to be in the study, how does this affect your medical care?
You can still receive evaluation and treatment for your condition if you do not participate in
this study. Discuss any alternative treatments with your regular doctor and/or the study doctor
before you decide to participate in the study. Your decision is entirely up to you. If you decide
not to participate in the study, you will not be penalized or lose any benefits and your decision
will not affect your relationship with your doctor or hospital.
What if we learn about new findings or information during the study?
You will be given any new information gained during the course of the study that might affect
your willingness to continue your participation.
How will your privacy be protected?
SEARCH staff will keep the information collected, tests done, and samples stored strictly
private. This is so because the study has been given a Certificate of Confidentiality. This
means anything you tell us will not have to be given out to anyone, even if a court orders us to
do so, unless you say it’s okay. But under the law, we must report to the state suspected cases
of child abuse or if you tell us you are planning to cause serious harm to yourself or others.
When you enter the study, a special number will be given to you. The number will be used to
identify the information and laboratory tests that will be done during this study. The special
number and the information collected during this study will be sent to Wake Forest University
in order to study the information. Blood and urine specimens will be sent to the University of
Washington for testing or storage. The list containing the special number assigned to you will
be kept in a password-protected database at the Carolina SEARCH site. Thus, no one other
than the study investigators (Dr. Mayer-Davis at the University of North Carolina (UNC), Dr.
Nelson at Greenville Health System (GHS), Dr. Bowlby at the Medical University of South
Carolina (MUSC), Dr. Merchant at the University of South Carolina (USC)) and the SEARCH
Carolina research team will be able to link any of the information collected in the study to you.
Paper forms collected during the study will be stored in a locked filing cabinet.
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No subjects will be identified in any report or publication about this study. Although every
effort will be made to keep research records private, there may be times when federal or state
law requires the disclosure of such records, including personal information. This is very
unlikely, but if disclosure is ever required, UNC-Chapel Hill and your local data collection site
(GHS, MUSC, or USC) will take steps allowable by law to protect the privacy of personal
information. In some cases, your information in this research study could be reviewed by
representatives of the UNC-Chapel Hill or your local data collection site (GHS, MUSC, or
USC), research sponsors, or government agencies (for example, the FDA) for purposes such as
quality control or safety.
What will happen if you are injured by this research?
All research involves a chance that something bad might happen to you. This may include the
risk of personal injury. In spite of all safety measures, you might develop a reaction or injury
from being in this study. If such problems occur, the researchers will help you get medical care,
but any costs for the medical care will be billed to you and/or your insurance company. The
University of North Carolina at Chapel Hill and your local data collection site (GHS, MUSC or
USC) have not set aside funds to pay you for any such reactions or injuries, or for the related
medical care. However, by signing this form, you do not give up any of your legal rights.
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, without penalty.
Will you receive anything for being in this study?
You will be receiving $80 in store gift cards for taking part in this study. In the rare
circumstance that a blood redraw is necessary; you would receive an additional $20 gift card.
If you traveled a significant distance to complete this study visit, you will be provided
additional incentive to assist with travel costs. This additional incentive will be: two $20 gift
cards if you traveled 70-100 miles round trip, three $20 gift cards if you traveled 101-150 miles
round trip, or four $20 gift cards if you traveled more than 151 miles round trip. Travel
distance will be determined based on your current home address and the location of the
SEARCH visit.
Will it cost you anything to be in this study?
There will be no costs for being in the study
What if you are a student at UNC, MUSC or USC?
You may choose not to be in the study or to stop being in the study before it is over at any time.
This will not affect your class standing or grades. You will not be offered or receive any
special consideration if you take part in this research.
What if you are an employee at MUSC, GHS, or USC?
Taking part in this research is not a part of your job duties, and refusing will not affect your
job. You will not be offered or receive any special job-related consideration if you take part in
this research.
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Who is sponsoring this study?
This research is funded by the Centers for Disease Control and Prevention and the National
Institutes of Health. This means that the research team is being paid by the sponsor for doing
the study. The researchers do not, however, have a direct financial interest with the sponsor or
in the final results of the study.
What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research.
If you have questions, complaints, concerns, or if a research-related injury occurs, you should
contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you have questions or concerns about your rights as a research subject, or if you
would like to obtain information or offer input, you may contact the Institutional Review Board
at Greenville Health System (864-522-2097; email: [email protected]) or at UNC-Chapel Hill
(919-966-3113; email: [email protected].
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a
paper copy of this survey, please tell your doctor.
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------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site);
Deborah Bowlby, MD (MUSC data collection site);
Anwar Merchant, ScD (USC data collection site)
Subject’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily agree to participate in this research study.
_________________________________________________
Signature of Research Subject
__________________
Date
_________________________________________________
Printed Name of Research Subject
_________________________________________________
Signature of Research Team Member Obtaining Consent
_________________________________________________
Printed Name of Research Team Member Obtaining Consent
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Assent to Participate in a Research Study
Adolescent Subjects age 15-17, Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Assent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
SEARCH Carolina Site Principal Investigators:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD (919966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Funding Source and/or Sponsor: Centers for Disease Control and Prevention and National
Institutes of Health/NIDDK
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
_______________________________________________________________________
What are some general things you should know about research studies?
You are being asked to take part in a research study. Your parent, or guardian, needs to give
permission for you to be in this study. You do not have to be in this study if you don’t want to,
even if your parent has already given permission. To join the study is voluntary. You may refuse
to join, or you may withdraw your consent to be in the study, for any reason.
Research studies are designed to obtain new knowledge that may help other people in the future.
You may not receive any direct benefit from being in the research study. There also may be risks
to being in research studies.
Deciding not to be in the study or leaving the study before it is done will not affect your
relationship with the researcher or your health care provider. If you are a patient with an illness,
you do not have to be in the research study in order to receive health care.
Details about this study are discussed below. It is important that you understand this information
so that you can make an informed choice about being in this research study. You will be given a
copy of this consent form. You should ask the researchers named above, or staff members who
may assist them, any questions you have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about diabetes in children and young adults.
Diabetes is the third most common life-long disease in people under 20 years of age. The total
number of cases of diabetes in this age group is increasing. Also, types of diabetes that have not
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been seen in young people are now being seen. These changes have resulted in gaps in
knowledge about the total number of cases and types of diabetes in the United States, the type of
care young people with diabetes receive, and the effect diabetes has on their lives. This research
study will gather information to answer these questions.
You are being asked to be in the study because you have diabetes and were under age 20 and
living in South Carolina around the time you developed diabetes.
Are there any reasons you should not be in this study?
You should not do a study visit if you are pregnant. You may take part in the study visit when it
has been at least four months after the end of your pregnancy.
How many people will take part in this study?
A total of about 900 people at five sites across the US will take part in the Registry Study visit,
including about 211 people from the Carolina SEARCH site.
How long will your part in this study last?
The Registry Study visit will take about 40 minutes. We may contact your parent every year to
be sure we have your correct contact information. If you agree to have a sample of your blood,
urine or DNA stored after the Registry Study visit, it will be saved for 10 years after the end of
funding for follow-up of SEARCH participants. After this time, stored samples will be
destroyed.
What will happen if you take part in the study?
A study team member will set up a time for your study visit in the morning. You will be asked
to not have anything to eat or drink other than water for 8-12 hours before your visit. You will
not take your usual diabetes medicines until after you have been given breakfast after your blood
draw.
Laboratory Tests
When you arrive, blood will be taken from your arm to test blood sugar, hemoglobin A1c (a
measure of long-term blood sugar control), different types of fat, c-peptide (a measure of your
own insulin production), and islet cell antibodies (markers in the blood for type 1 diabetes). A
genetic marker for diabetes risk (HLA genes) will also be tested. The total amount of blood
drawn will be based on weight tables and will not exceed 3 tablespoons. If you agree, results
commonly used in clinical practice (hemoglobin A1c, cholesterol, c-peptide, islet cell antibodies,
and urine albumin/creatinine) will be shared with your doctor.
Mark the line that best matches your choice:
_____ OK to share results of the tests with my doctor
_____ Not OK to share results of the test with my doctor
Urine Collection: Before your scheduled appointment, you will be mailed a container with
detailed instructions to collect your first morning urine the day of your study visit. You will be
asked to bring this urine container with you to your visit.
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A urine sample will also be collected during the study visit.
Your urine will be tested for albumin and creatinine (small particles of protein) to see how well
your kidneys are working.
A sample of your blood, urine, and DNA may be saved after the visit, if you agree.
After the blood and urine samples are obtained, you can take your pills or insulin and you will be
given a snack.
Physical Exam and Questionnaires
After eating, we will ask you about the medicines you use and the food you eat. A physical
examination will be done by trained study staff. The physical exam will include height, weight,
waist measurement, blood pressure, and examination of the skin on the neck. Then you or your
parent will do a brief form to update your contact information. We will also ask you or your
parent about the types of providers you see for your diabetes care.
Contact in the Future
The researchers will call your parent as new studies are developed in the future to let you know
about new studies and ask you to take part in these studies. As with this study, taking part in any
future study is voluntary. Taking part in the present study does not mean that you are agreeing to
take part in any future study.
Mark the line that best matches your choice:
_____ OK to contact me in the future to tell me about other studies
_____ Not OK to contact me in the future to tell me about other studies
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. You will not benefit
personally from being in this research study.
What are the possible risks or discomforts involved with being in this study?
The risks from drawing blood include mild pain, bruising at the site of the blood draw, and
occasionally fainting. To lower the chance of these risks, blood will be drawn by experienced
staff and a local numbing medicine may be used before the blood is drawn to decrease any pain.
The total amount of blood that will be drawn will be no more than 3 tablespoons (45cc)
depending on your age and body size. When drawing your blood, our research staff will follow
all necessary safety precautions. In the highly unlikely event that our study staff is accidentally
exposed to your bodily fluids (blood or urine), we will abide by the South Carolina law that
provides for testing of blood to minimize threats to the health of the staff. You will be notified
should this testing be necessary and the results will be reported as required by law.
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You need to not eat any food overnight before you have the blood tests. In order to limit low or
high blood sugars, your blood sugar will be checked and your diabetes medicine or a fast-acting
carbohydrate will be given as needed.
Some of the tests will look for the presence or risk of getting problems from diabetes. If these
tests identify problems from diabetes or risk of getting these problems, the results may make you
worried. If this happens, you will be referred to your diabetes care provider or a local mental
health professional.
Other possible risks include loss of privacy or confidentiality. Loss of privacy might happen if
someone could overhear or see you taking part in the study. To limit this, we will do the study
visit in a private location. Information collected will be stored in a locked filing cabinet or in a
password-protected electronic file.
In addition, there may be uncommon or previously unknown risks that might occur. You should
report any problems to the researchers.
If you choose not to be in the study, how does this affect your medical care?
Whether you decide to take part or decline to take part in this study, your decision will not affect
your medical care.
What if we learn about new findings or information during the study?
You will be given any new information gained during the study that might affect your
willingness to continue to take part.
How will your privacy be protected?
SEARCH staff will keep the information collected, tests done, and samples stored strictly
private. This is so because the study has been given a Certificate of Confidentiality. This means
anything you tell us will not have to be given out to anyone, even if a court orders us to do so,
unless you say it’s okay. But under the law, we must report to the state suspected cases of child
abuse or if you tell us you are planning to cause serious harm to yourself or others.
When you enter the study, a special number will be given to you. The number will be used to
identify the information and laboratory tests that will be done during this study. The special
number and the information collected during this study will be sent to Wake Forest University in
order to study the information. Blood and urine specimens will be sent to the University of
Washington for testing or storage. The list containing the special number assigned to you will be
kept in a password-protected database at the Carolina SEARCH site. So, no one other than the
study investigators (Dr. Mayer-Davis at the University of North Carolina (UNC), Dr. Nelson at
Greenville Health System (GHS), Dr. Bowlby at the Medical University of South Carolina
(MUSC), Dr. Merchant at the University of South Carolina (USC)) and the SEARCH Carolina
research team will be able to link any of the information collected in the study to you. Paper
forms collected during the study will be stored in a locked filing cabinet.
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No subjects will be identified in any report or publication about this study. Although every effort
will be made to keep research records private, there may be times when federal or state law
requires the disclosure of such records, including personal information. This is very unlikely,
but if disclosure is ever required, UNC-Chapel Hill and your local data collection site (GHS,
MUSC, or USC) will take steps allowable by law to protect the privacy of personal information.
In some cases, your information in this research study could be reviewed by representatives of
UNC-Chapel Hill or your local data collection site (GHS, MUSC, or USC), research sponsors, or
government agencies (for example, the FDA) for purposes such as quality control or safety.
What will happen if you are injured by this research?
All research involves a chance that something bad might happen to you. This may include the
risk of personal injury. In spite of all safety measures, you might develop a reaction or injury
from being in this study. If such problems occur, the researchers will help you get medical care.
What if you want to stop before your part in the study is complete?
You can withdraw from this study at any time, or your parents can withdraw you, without
penalty.
Will you receive anything for being in this study?
You will get $40 in store gift cards for taking part in this study. Your parents will also get $40 in
gift cards at the end of the visit. In the rare circumstance that a blood redraw is necessary; you
would receive an additional $20 gift card.
Your parents will also get additional incentive to assist with travel costs, if you and your parent
traveled a significant distance to do the study visit. This additional incentive will be: two $20
gift cards if you traveled 70-100 miles round trip, three $20 gift cards if you traveled 101-150
miles round trip, or four $20 gift cards if you traveled more than 151 miles round trip. Travel
distance will be determined based on your current home address and the location of the
SEARCH visit.
Who is sponsoring this study?
This research is funded by the Centers for Disease Control and Prevention and the National
Institutes of Health. This means that the research team is being paid by the sponsor for doing the
study. The researchers do not, however, have a direct financial interest with the sponsor or in the
final results of the study.
What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If
you have questions, complaints, concerns, or if a research-related injury occurs, you should
contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you have questions or concerns about your rights as a research subject, or if you
would like to obtain information or offer input, you may contact the Institutional Review Board
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at Greenville Health System (864-522-2097;email [email protected]) or at UNC-Chapel Hill (919966-3113; email: [email protected]).
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a paper
copy of this survey, please tell your doctor.
-------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site);
Deborah Bowlby, MD (MUSC data collection site);
Anwar Merchant, ScD (USC data collection site)
Subject’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily agree to participate in this research study.
________________________________________________
Your signature if you agree to be in the study
_________________
Date
________________________________________________
Printed name if you agree to be in the study
________________________________________________
Signature of Research Team Member Obtaining Assent
________________________________________________
Printed Name of Research Team Member Obtaining Assent
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Parental Permission for a Minor Child to Participate in a Research Study
SEARCH 3 Cohort Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
SEARCH Carolina Site Principal Investigators:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD (919966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Funding Source and/or Sponsor: Centers for Disease Control and Prevention and National
Institutes of Health/NIDDK
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
_________________________________________________________________
What are some general things you and your child should know about research studies?
You are being asked to allow your child to take part in a research study. To join the study is
voluntary. You may refuse to give permission, or you may withdraw your permission for your
child to be in the study, for any reason. Even if you give your permission, your child can decide
not to be in the study or to leave the study early.
Research studies are designed to obtain new knowledge that may help other people in the future.
Your child may not receive any direct benefit from being in the research study. There also may
be risks to being in research studies.
Deciding not to be in the study or leaving the study before it is done will not affect your or your
child’s relationship with the researcher or with the health care provider. If your child is a patient
with an illness, your child does not have to be in the research study in order to receive health
care.
Details about this study are discussed below. It is important that you and your child understand
this information so that you and your child can make an informed choice about being in this
research study. You will be given a copy of this permission form. You and your child should
ask the researchers named above, or staff members who may assist them, any questions you or
your child have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about diabetes in children and young adults.
Diabetes is the third most common life-long disease in people under 20 years of age. The total
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number of cases of diabetes in this age group is increasing. Also, types of diabetes that have not
been seen in young people are now being seen. Specifically, this project is interested in studying
the following questions:
a. How common are long-term complications related to diabetes, including: retinopathy
(damage to back of the eye), nephropathy (kidney damage), neuropathy (nerve damage), and
damage to the heart and blood vessels?
b. How common are short-term complications, including hypoglycemia (low blood sugar) and
diabetic ketoacidosis (DKA)?
c. What type of medical care are young people with diabetes receiving and how does diabetes
affect the lives of these individuals?
Your child is being asked to be in the study because he/she has diabetes, previously did an inperson visit with the SEARCH study and has had diabetes for at least five years.
Are there any reasons your child should not be in this study?
Your child should not complete a study visit if currently pregnant. She may take part in the
study visit when it has been at least four months after the end of the pregnancy.
How many people will take part in this study?
A total of approximately 3900 people at five sites across the US will take part in the Cohort
Study visit, including approximately 821 people from the Carolina SEARCH site.
How long will your child’s part in this study last?
The Cohort Study visit will take about 3 ½ hours. We may contact you every year to be sure we
have your correct contact information. If you and your child agree to have a sample of blood,
urine or DNA stored following the Cohort Study visit, it will be saved for 10 years after the end
of funding for follow-up of SEARCH participants. After this time, stored samples will be
destroyed.
What will happen if your child takes part in the study?
A research team member will set up an appointment for your child in the early morning. Your
child will come to the appointment after not having anything to eat or drink other than water for
8-12 hours. Your child will not take your usual diabetes medicines until after he/she has been
given breakfast during the appointment.
Laboratory Tests
Blood draw: When you arrive, blood will be taken from your child’s arm to measure blood
sugar, hemoglobin A1c (a measure of long-term blood sugar control), different types of
cholesterol (fat), c-peptide (a measure of your child’s own insulin production), islet cell
antibodies (markers in the blood for type 1 diabetes), cystatin-C and serum creatinine (measures
of kidney function), and several new blood markers associated with risk for developing heart
disease or stroke (apolipoprotein B, C-reactive protein, interleukin-6, leptin, and adiponectin).
The total amount of blood drawn will be based on weight tables and will not exceed 3
tablespoons. The blood draw takes about 10 minutes. If your child needs numbing medicine for
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the blood draw, SEARCH staff can provide that. If you agree, results commonly used in clinical
practice (hemoglobin A1c, cholesterol, c-peptide, and urine albumin/creatinine) will be shared
with your child’s doctor.
Mark the line that best matches your choice:
_____ OK to share results of the tests with my child’s doctor
_____ Not OK to share results of the test with my child’s doctor
Urine Collection: Before your child’s scheduled appointment, you will be mailed a container
with detailed instructions to collect the first morning urine the day of the study visit. You will
be asked to bring this urine container with you to your child’s visit.
A urine sample will also be collected during the study visit.
Your child’s urine will be tested for albumin and creatinine (small particles of protein) to see
how well your kidneys are working.
A sample of your child’s blood, urine, and DNA may be saved after the visit, if you and your
child agree.
After the blood and urine samples are obtained, your child can take his/her diabetes pills or
insulin and will be given a snack.
Physical Exam
The physical exam will include height, weight, waist measurement, blood pressure, and
examination of the skin of the neck. This will be done by trained study staff. The time to
complete this part of the visit is approximately 30 minutes.
Questionnaires:
The questionnaires can be completed either at home before the visit or at the visit. If you prefer,
a separate visit may be scheduled to complete the forms. You and your child will be asked
questions about your child’s diabetes, medical care, current medications, family history of
diabetes, education, family income level, the food your child eats, health insurance, and the
effect diabetes has had on your life.
If your child is 8-17 years of age, he/she will also be asked about stage of sexual development.
If your child is 10-17 years of age, he/she will be asked about diabetes-related topics that might
be a source of conflict between you and your child. The estimated time to complete these
questionnaires is 40-60 minutes.
Additional questions for children 10 years or older
If your child is 10 years of age or older, your child will be asked to answer a separate
written series of questions dealing with the following health issues – physical activity,
smoking, eating and sleeping patterns, depression, and whether your child has ever been
pregnant. Your child will also be asked what might be done to prevent low blood sugars,
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what worries he/she might have in relation to low blood sugars, and practices that are
consistent with eating problems. This will take about 40 minutes to do. As a
parent/guardian, this information will not be shared with you unless health issues are
identified that need to be treated. The reason for this is to increase the likelihood that
your child will answer the questions more accurately.
Nerve and Heart Function Tests
Nerve Tests: Diabetic neuropathy is a complication of diabetes that results from damage to the
nerves. We will be looking for signs of early nerve damage by asking your child to complete a
short questionnaire, doing an examination of your child’s feet, and doing an electrocardiogram
(ECG) test of your child’s heart.
We will ask your child to answer 15 questions about foot sensation including pain, numbness,
and temperature sensitivity. We will examine your child’s feet to measure the ability to feel
vibrations, reflexes, and the ability to feel light touches to the feet. The examiner will test the
vibration sense by placing a vibrating instrument on the big toe. The examiner will use a rubber
“hammer” to test the reflexes in the ankle. To test your child’s sense of touch, the examiner will
touch your child’s toe several times with a thin piece of plastic. Doing the foot nerve tests will
take about 10 minutes. The results of the tests will be sent to the University of Michigan for
analysis.
In order to check the accuracy of our measurements, the foot test will be repeated for
approximately 5% (1 in 20) of participants. Participants will be randomly selected to receive the
repeat measurements. If your child is selected for repeat measurements of the feet and you agree
to have the measurements performed, the visit will last about 10 minutes longer. You child may
refuse to have the repeat measures, but still complete the foot examination.
____ Your child has been selected for the repeat measurements of the feet.
____ Your child has not been selected for repeat measurements of the feet.
Heart Rate Variability: Heart Rate Variability (HRV) is a measurement to assess the health of
nerves in the heart. The test uses an ECG, or electrocardiogram. This is a test that doctors
routinely use to study the heart; your doctor may have used it with you or your child before. The
examiner will place an EKG lead on each of your child’s arms and on the left leg or two EKG
leads on the chest and one on the stomach. It is important for the EKG leads to pick up a good
signal of the heartbeats. In some cases it may be necessary for us to shave hair from a small area
of skin to improve the heart signal. Your child will be asked to lie down and rest for 5 minutes
before the test begins. We will then record the pattern of your child’s heartbeats for 10 minutes.
Blood Vessel Test: We will perform a test to measure how your child’s blood vessels function.
The test is called an arterial stiffness test. Your child will be asked to wear loose shorts or to put
on a patient gown. A trained member of the research team will measure the pulse in the groin
area, but will not expose your child’s private parts. At your or your child’s request a chaperone
will be present during these procedures.
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The following test will then be performed:
A staff member will measure the distance from your child’s neck to the top of your child’s
sternum (breast bone), from the neck to your child’s wrist, from the sternum to the belly button,
from the belly button to your child’s groin, and from your child’s groin to your child’s foot. The
electrodes (sticky pads) used for the HRV test will be left in place for the blood vessel test.
Your child’s wrist will be touched with a small instrument shaped like a pen and the stiffness of
your child’s blood vessels will be measured. The pen instrument detects pressure changes with a
tiny, highly-sensitive pressure sensor in the flat end of the device that is shaped like a pencil
eraser. It does not use radiation (X-rays), sound waves (ultrasound), or needles. This test is
painless and will be repeated 3 times.
Then the same pen-shaped instrument will be touched on the side of your child’s neck, the top of
your child’s thigh, and your child’s foot to measure the speed at which blood travels from the
heart to that area of the body. This test will be repeated 3 times. The blood vessel tests will take
about one hour.
This test is designed to be short, simple, and painless. This is a test that doctors use every day,
and it is not dangerous. But if your child feels uncomfortable at any time during any of these
tests, just tell the examiner and he/she will immediately stop the tests.
In order to check the accuracy of our measurements, the blood vessel tests will be repeated for
approximately 5% (1 in 20) of participants. Participants will be randomly selected to receive
repeat measurements. If your child is selected for repeat measurements of the blood vessel tests
and you/your child agree to have the measurements performed, your child’s visit will last about
15 minutes longer. You/your child may refuse to have the repeat measures, but still complete the
blood vessel testing. Your child will receive additional compensation for your time if you have
the repeat measures done.
____ Your child has been selected for repeat measurements of the blood vessels.
____ Your child has not been selected for repeat measurements of the blood vessels.
Eye Photographs
Diabetic retinopathy is a complication of diabetes that results from damage to the blood vessels
at the back of the eye (retina). We will be taking 2 pictures of each of your child’s eyes. These
pictures will be sent to the Ocular Epidemiology Reading Center in Madison, Wisconsin to be
read by trained eye specialists who will study the blood vessels and look for possible problems.
Your child will be asked to sit in a darkened room before a special camera with your child’s chin
in a chin rest. After your child’s pupils have dilated (opened) naturally, we will take 2
photographs of the back of each of your child’s eyes (retinas). No drops will be put in the eyes;
and the camera will not touch the eyes. After each picture is taken, your child may see a white or
colored spot, which will disappear within a few minutes and cause no damage to the eye. We
will pause for a few minutes between photographs to allow your child’s eyes time to re-adjust to
the darkened room so the pupils will dilate once again.
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You will also be asked for the name and phone number of your child’s eye doctor, and whether
or not your child has ever had eye injections or laser treatments on the back of the eyes. Doing
the eye photographs will take about 20 minutes. We will send you the results of your child’s eye
photographs. If you agree, results will be shared with your child’s doctor.
Mark the line that best matches your choice:
_____ OK to share results of the tests with my child’s doctor
_____ Not OK to share results of the test with my child’s doctor
Medical Record Review
A medical record review will be conducted for a small number (~25 people) who give us
permission to check that the information you gave us regarding key medical events and markers
of healthcare quality were remembered correctly.
Mark the line that best matches your choice:
__OK to review my child’s medical records to check that the information I remembered was
correct
__Not OK to review my child’s medical records to check that the information I remembered was
correct
Contact in the Future
The researchers will call you as new studies are developed in the future to let you know about
new studies and ask you/your child to take part in these studies. As with this study, taking part
in any future study is voluntary. Taking part in the present study does not mean that you are
agreeing to take part in any future study.
Mark the line that best matches your choice:
_____ OK to contact me/my child in the future to tell me about other studies
_____ Not OK to contact me/my child in the future to tell me about other studies
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. Your child will not benefit
personally from being in this research study.
What are the possible risks or discomforts involved with being in this study?
The risks from drawing blood from a vein in the lower arm include mild pain, bruising at the site
of the blood draw, and occasionally fainting. To lower the possibility of these risks, blood will
be drawn by experienced staff and a local numbing medicine may be placed on the skin before
the blood is drawn to decrease any pain. The total amount of blood that will be obtained will be
no more than 3 tablespoons (45cc) depending on your child’s age and body size. When drawing
your child’s blood, our research staff will follow all necessary safety precautions. In the highly
unlikely event that our research staff is accidentally exposed to your child’s bodily fluids (blood
or urine), we will abide by the South Carolina law that provides for testing of blood to minimize
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threats to the health of the staff. You will be notified should this testing be necessary and the
results will be reported as required by law.
The blood tests require that your child not eat any food overnight. In order to limit low or high
blood sugars, your child’s blood sugar will be checked and his/her diabetes medication or a fastacting carbohydrate will be given as needed.
There are no known risks associated with the nerve tests. There are no known risks associated
with taking photographs of the eye. Although your child will see a flash of light when the picture
is taken, this flash is not harmful. People who are light sensitive may experience some minor
discomfort from the camera flash, but the discomfort will not last. When the pen-shaped blood
vessel device is placed on your child’s skin he/she may feel some pressure for a few seconds.
Some of the tests will look for the presence or risk of developing of the complications of
diabetes. If these tests identify complications of diabetes or risk of developing the
complications, the results may make you or your child anxious. If this happens, you will be
referred to your child’s diabetes care provider or a local mental health professional.
Other possible risks include loss of privacy or confidentiality. Loss of privacy might happen if
someone could overhear or see you taking part in the study. To limit this, we will do the study
visit in a private location. Information collected will be stored in a locked filing cabinet or in a
password-protected electronic file.
In addition, there may be uncommon or previously unknown risks that might occur. You should
report any problems to the researchers.
If you choose not to give permission for your child to be in the study, how does this affect
your child’s medical care?
You can still receive evaluation and treatment for your condition if you do not participate in this
study. Discuss any alternative treatments with your regular doctor and/or the study doctor before
you decide to participate in the study. Your decision is entirely up to you. If you decide not to
participate in the study, you will not be penalized or lose any benefits and your decision will not
affect your relationship with your doctor or hospital.
What if we learn about new findings or information during the study?
You and your child will be given any new information gained during the course of the study that
might affect your willingness to continue your child’s participation in the study.
How will your child’s privacy be protected?
SEARCH staff will keep the information collected, tests done, and samples stored strictly
private. This is so because the study has been given a Certificate of Confidentiality. This means
anything you or your child tells us will not have to be given out to anyone, even if a court orders
us to do so, unless you say it’s okay. But under the law, we must report to the state suspected
cases of child abuse or if you tell us you are planning to cause serious harm to yourself or others.
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When you enter the study, a special number will be given to your child. The number will be
used to identify the information and laboratory tests that will be done during this study. The
special number and the information collected during this study will be sent to Wake Forest
University in order to study the information. Blood and urine specimens will be sent to the
University of Washington for testing or storage. The nerve test results and your child’s special
number will be sent to the University of Michigan and Wake Forest University. The eye test
results and your child’s special number will be sent to the Ocular Epidemiology Reading Center
(OERC) at the University of Wisconsin-Madison and Wake Forest University. The list
containing the special number assigned to your child will be kept in a password-protected
database at the Carolina SEARCH site. Thus, no one other than the study investigators (Dr.
Mayer-Davis at the University of North Carolina (UNC), Dr. Nelson at Greenville Health
System (GHS), Dr. Bowlby at the Medical University of South Carolina (MUSC), Dr. Merchant
at the University of South Carolina (USC)) and the SEARCH Carolina research team will be able
to link any of the information collected in the study to your child. Paper forms collected during
the study will be stored in a locked filing cabinet.
No subjects will be identified in any report or publication about this study. Although every effort
will be made to keep research records private, there may be times when federal or state law
requires the disclosure of such records, including personal information. This is very unlikely,
but if disclosure is ever required, UNC-Chapel Hill and your local data collection site (GHS,
MUSC, or USC) will take steps allowable by law to protect the privacy of personal information.
In some cases, your child’s information in this research study could be reviewed by
representatives of UNC-Chapel Hill or your local data collection site (GHS, MUSC, or USC),
research sponsors, or government agencies (for example, the FDA) for purposes such as quality
control or safety.
What will happen if your child is injured by this research?
All research involves a chance that something bad might happen. This may include the risk of
personal injury. In spite of all safety measures, your child might develop a reaction or injury
from being in this study. If such problems occur, the researchers will help your child get medical
care, but any costs for the medical care will be billed to you and/or your insurance company. The
University of North Carolina at Chapel Hill and your local data collection site (GHS, MUSC, or
USC) have not set aside funds to pay you for any such reactions or injuries, or for the related
medical care. However, by signing this form, you and your child do not give up any of your legal
rights.
What if you or your child wants to stop before your child’s part in the study is complete?
You can withdraw your child from this study at any time, without penalty.
Will you or your child receive anything for being in this study?
You will get $40 in VISA gift cards at the end of the Cohort Study Visit. Your child will get $80
in gift cards if he/she completes a full study visit. If your child completes a partial study visit
due to refusal of the blood draw, he/she will only receive $40 in gift cards. Your child will get
an additional $10 gift card if he/she is selected and completes the repeat measure of the blood
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vessel test. In the rare circumstance that a blood redraw is necessary; your child would receive
an additional $20 gift card.
If you traveled a significant distance to complete this study visit, you will be provided additional
incentive to assist with travel costs. This additional incentive will be: two $20 gift cards if you
traveled 70-100 miles round trip, three $20 gift cards if you traveled 101-150 miles round trip, or
four $20 gift cards if you traveled more than 151 miles round trip. Travel distance will be
determined based on your current home address and the location of the SEARCH visit.
Will it cost you anything for your child to be in this study?
There will be no costs for being in the study
What if you are a student at MUSC or USC?
You may choose not to give permission for your child to be in the study or to stop being in the
study before it is over at any time. This will not affect your class standing or grades. You will
not be offered or receive any special consideration if your child takes part in this research.
What if you are an employee at MUSC, GHS, or USC?
Your child’s taking part in this research is not a part of your job duties, and refusing to give
permission will not affect your job. You will not be offered or receive any special job-related
consideration if your child takes part in this research.
Who is sponsoring this study?
This research is funded by the Centers for Disease Control and Prevention and the National
Institutes of Health. This means that the research team is being paid by the sponsor for doing the
study. The researchers do not, however, have a direct financial interest with the sponsor or in the
final results of the study.
What if you or your child has questions about this study?
You and your child have the right to ask, and have answered, any questions you may have about
this research. If there are questions, complaints, concerns, or if a research-related injury occurs,
you should contact the researchers listed on the first page of this form.
What if you or your child has questions about his/her rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you or your child has questions or concerns about your child’s rights as a
research subject, or if you would like to obtain information or offer input, you may contact the
Institutional Review Board at Greenville Health System (864-522-2097; email [email protected])
or at UNC-Chapel Hill (919-966-3113;email: [email protected]).
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
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Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a paper
copy of this survey, please tell your doctor.
-------------------------------------------------------------Title of Study:
SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site);
Deborah Bowlby, MD (MUSC data collection site);
Anwar Merchant, ScD (USC data collection site)
Parent’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily give permission to allow my child to participate in this research study.
_________________________________________________
Printed Name of Research Subject (Child)
_________________________________________________
Signature of Parent
_________________
Date
_________________________________________________
Printed Name of Parent
___________________________________________________
Signature of Research Team Member Obtaining Permission
___________________________________________________
Printed Name of Research Team Member Obtaining Permission
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Assent to Participate in a Research Study
Minor Subjects (7-14 yrs), SEARCH 3 Cohort Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
People in charge of the study:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD (919966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
The people named above are doing a research study.
These are some things we want you to know about research studies:
Your parent needs to say it is okay for you to be in this study. You do not have to be in this
study if you don’t want to, even if your parent says it is okay for you to be in the study.
You may stop being in the study at any time. If you decide to stop, no one will be angry or upset
with you.
Sometimes good things happen to people who take part in studies, and sometimes things we may
not like happen. We will tell you more about these things below.
Why are they doing this research study?
The reason for doing this study is to learn about diabetes in children and young adults. Diabetes
is the third most common life-long disease in people under 20 years of age. The total number of
cases of diabetes in this age group is going up. Also, types of diabetes that have not been seen in
young people are now being seen. Specifically, this project is interested in studying the following
questions:
a. How common are long-term problems from having diabetes, like problems with the eyes,
nerves, or other parts of the body?
b. How common are short-term problems from having diabetes, like low blood sugar?
c. What type of medical care are young people with diabetes getting and how does diabetes
affect them?
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Why are you being asked to be in this research study?
You are being asked to be in this study because you have diabetes, you already did a visit with
SEARCH, and you have had diabetes for at least five years.
How many people will take part in this study?
A total of about 3900 people at five sites in the U.S. will take part in this study, including about
821 people from South Carolina.
What will happen during this study?
During this study we will ask to:
Measure you and check your blood pressure. This will be a lot like when they
measure you at your doctor’s office.
Take some blood from your arm with a needle and do some special tests that tell us
about your diabetes.
Take some blood from your arm with a needle and look at some of the genes that we
know have something to do with diabetes. A sample from this blood will be kept in
a freezer until we do tests on it.
Test some of your urine to see if diabetes is changing the way your kidneys work.
Have you and your parent answer some questions about having diabetes and how you
take care of your diabetes
Have you (if you are 10 or older) answer some questions about what you eat, your
physical activity, when you sleep, what you do when your blood sugar is low, and
things related to diabetes that might cause fighting between you and your parents
Take pictures of the back of your eyes
Look at your feet and ask you some questions about your feet. Some people may be
asked to do this two times. If you are asked to do this twice, you can say no.
Use a small machine to test your heart, blood vessels, and nerves. Some people may
be asked to do parts of this two times. If you are asked to do this twice, you can say
no.
Get your parent/guardian's permission to review some of your medical records.
This study visit will last about 3 ½ hours.
Who will be told the things we learn about you in this study?
SEARCH staff will keep the things we learn private, but we must report to the state if we feel
you are being hurt or if you tell us you are planning to hurt yourself or others. If you tell us you
are planning to hurt yourself or others, we will also tell your parents.
When you start in SEARCH, a special number is given to you. The number is used to mark all
the forms and blood tests we do with you. The special number and the forms will be sent to
Wake Forest University. Blood and urine will be sent to the University of Washington to test or
store. The nerve test results and your special number will be sent to the University of Michigan
and Wake Forest University. The eye test results and your special number will be sent to the
reading center at the University of Wisconsin-Madison and Wake Forest University. The list
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showing the special number given to you will be kept in a file and saved with a password. Only
the people listed on the first page or others working with the Carolina study site will be able to
see this list.
What are the good things that might happen?
People may have good things happen to them because they are in research studies. These are
called “benefits.” You will not benefit from being in this research study.
What are the bad things that might happen?
Sometimes things happen to people in research studies that may make them feel bad. These are
called “risks.” These are the risks of this study:
It may hurt when you have your blood drawn and you may get a bruise. We can put
some medicine on your skin to make it hurt less.
You need to come to the visit without eating anything the night before your visit. This
may affect your blood sugar. We will test your blood sugar and you may take your
diabetes medicine or eat a snack to help your blood sugar.
When you have the picture of your eye done, it will not hurt, but you will see a bright
flash and this may bother you for a minute or two.
When we use the machine to test your blood vessels, you will feel a little pushing on your
skin. This will not hurt.
Not all of these things may happen to you. None of them may happen or things may happen that
the researchers don’t know about. You should report any problems to the researcher
What if you or your parents don’t want you to be in this study?
It is okay if you or your parents don’t want to be in this study. This will not affect the care you
get.
Will you get any money or gifts for being in this research study?
You will get $80 in VISA gift cards for doing a full study visit. If you do a partial study visit
due to refusing the blood draw, you will only receive $40 in gift cards. You will also get another
$10 gift card if you are asked to do the blood vessel test two times. If we are not able to get your
blood and you return for a 2nd blood draw, you will get another $20 gift card.
Your parents will get $40 in gift cards for being in the study.
Who should you ask if you have any questions?
If you have questions you should ask the people listed on the first page of this form. If you have
other questions, complaints or concerns about your rights while you are in this research study
you may contact the Institutional Review Board at Greenville Health System (864-522-2097;
email: [email protected]) or at UNC-Chapel Hill (919-966-3113;email: [email protected]).
A survey about your experience with this informed consent process is located at the following
website:
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http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a paper
copy of this survey, please tell your doctor.
------------------------------------------------------------------------------------------------------------------
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Cohort Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site);
Deborah Bowlby, MD (MUSC data collection site);
Anwar Merchant, ScD (USC data collection site)
If you sign your name below, it means that you agree to take part in this research study.
________________________________________________
Sign your name here if you want to be in the study
_______________
Date
________________________________________________
Print your name here if you want to be in the study
________________________________________________
Signature of Research Team Member Obtaining Assent
________________________________________________
Printed Name of Research Team Member Obtaining Assent
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Date
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Parental Permission for a Minor Child to Participate in a Research Study
SEARCH 3 Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
SEARCH Carolina Site Principal Investigators:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD (919966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Funding Source and/or Sponsor: Centers for Disease Control and Prevention and National
Institutes of Health/NIDDK
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
_________________________________________________________________
What are some general things you and your child should know about research studies?
You are being asked to allow your child to take part in a research study. To join the study is
voluntary. You may refuse to give permission, or you may withdraw your permission for your
child to be in the study, for any reason. Even if you give your permission, your child can decide
not to be in the study or to leave the study early.
Research studies are designed to obtain new knowledge that may help other people in the future.
Your child may not receive any direct benefit from being in the research study. There also may
be risks to being in research studies.
Deciding not to be in the study or leaving the study before it is done will not affect your or your
child’s relationship with the researcher or with the health care provider. If your child is a patient
with an illness, your child does not have to be in the research study in order to receive health
care.
Details about this study are discussed below. It is important that you and your child understand
this information so that you and your child can make an informed choice about being in this
research study. You will be given a copy of this permission form. You and your child should
ask the researchers named above, or staff members who may assist them, any questions you or
your child have about this study at any time.
What is the purpose of this study?
The purpose of this research study is to learn about diabetes in children and young adults.
Diabetes is the third most common life-long disease in people under 20 years of age. The total
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number of cases of diabetes in this age group is increasing. Also, types of diabetes that have not
been seen in young people are now being seen. These changes have resulted in gaps in
knowledge about the total number of cases and types of diabetes in the United States, the type of
care young people with diabetes receive, and the effect diabetes has on their lives. This research
study will gather information to answer these questions.
Your child is being asked to be in the study because he/she has diabetes and was under age 20
and living in South Carolina around the time the diabetes started.
Are there any reasons your child should not be in this study?
Your child should not complete a study visit if currently pregnant. She may take part in the
study visit when it has been at least four months after the end of the pregnancy.
How many people will take part in this study?
A total of approximately 900 people at five sites across the US will take part in the Registry
Study visit, including approximately 211 people from the Carolina SEARCH site.
How long will your child’s part in this study last?
The Registry Study visit will take about 40 minutes. We may contact you every year to be sure
we have your correct contact information. If you and your child agree to have a sample of blood,
urine or DNA stored following the Registry Study visit, it will be saved for 10 years after the end
of funding for follow-up of SEARCH participants. After this time, stored samples will be
destroyed.
What will happen if your child takes part in the study?
A research team member will set up an appointment for your child in the early morning. Your
child will come to the appointment after not having anything to eat or drink other than water for
8-12 hours. Your child will not take your usual diabetes medicines until after he/she has been
given breakfast during the appointment.
Laboratory Tests
When you arrive, blood will be taken from your child’s arm to measure blood sugar, hemoglobin
A1c (a measure of long-term blood sugar control), different types of cholesterol (fat), c-peptide
(a measure of your child’s own insulin production), and islet cell antibodies (markers in the
blood for type 1 diabetes). A genetic marker for diabetes risk (HLA genes) will also be tested.
The total amount of blood drawn will be based on weight tables and will not exceed 3
tablespoons. . If you agree, results commonly used in clinical practice (hemoglobin A1c,
cholesterol, c-peptide, islet cell antibodies, and urine albumin/creatinine) will be shared with
your child’s doctor.
Mark the line that best matches your choice:
_____ OK to share results of the tests with my child’s doctor
_____ Not OK to share results of the test with my child’s doctor
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Urine Collection: Before your scheduled appointment, you will be mailed a container with
detailed instructions to collect your first morning urine the day of your study visit. You will be
asked to bring this urine container with you to your visit.
A urine sample will also be collected during the study visit.
The urine will be tested for albumin and creatinine (small particles of protein) to see how well
your child’s kidneys are working.
A sample of your child’s blood, urine, and DNA may be saved after the visit, if you agree.
After the blood and urine samples are obtained, your child can take his/her pills or insulin and
will be given a snack.
Physical Exam and Questionnaires
After eating, we will ask you some questions about the medicines your child uses and the food
your child eats. A physical examination will be done on your child by trained study staff. The
physical examination will include height, weight, waist measurement, blood pressure, and
examination of the skin on the neck. Then you will do a brief form to update your contact
information. We will also ask you about the type of providers your child sees for his/her
diabetes care.
Contact in the Future
The researchers will call you as new studies are developed in the future to let you know about
new studies and ask your child to take part in these studies. As with this study, taking part in any
future study is voluntary. Taking part in the present study does not mean that you are agreeing to
take part in any future study.
Mark the line that best matches your choice:
_____ OK to contact me/my child in the future to tell me about other studies
_____ Not OK to contact me/my child in the future to tell me about other studies
What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. Your child will not benefit
personally from being in this research study.
What are the possible risks or discomforts involved with being in this study?
The risks from drawing blood from a vein in the lower arm include mild pain, bruising at the site
of the blood draw, and occasionally fainting. To lower the possibility of these risks, blood will
be drawn by experienced staff and a local numbing medicine may be placed on the skin before
the blood is drawn to decrease any pain. The total amount of blood that will be obtained will be
no more than 3 tablespoons (45cc) depending on your child’s age and body size. When drawing
your child’s blood, our research staff will follow all necessary safety precautions. In the highly
unlikely event that our research staff is accidentally exposed to your child’s bodily fluids (blood
or urine), we will abide by the South Carolina law that provides for testing of blood to minimize
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threats to the health of the staff. You will be notified should this testing be necessary and the
results will be reported as required by law.
The blood tests require that your child not eat any food overnight. In order to limit low or high
blood sugars, your child’s blood sugar will be checked and his/her diabetes medication or a fastacting carbohydrate will be given as needed.
Some of the tests will look for the presence or risk of developing of the complications of
diabetes. If these tests identify complications of diabetes or risk of developing the
complications, the results may make you or your child anxious. If this happens, you will be
referred to your child’s diabetes care provider or a local mental health professional.
Other possible risks include loss of privacy or confidentiality. Loss of privacy might happen if
someone could overhear or see you taking part in the study. To limit this, we will do the study
visit in a private location. Information collected will be stored in a locked filing cabinet or in a
password-protected electronic file.
In addition, there may be uncommon or previously unknown risks that might occur. You should
report any problems to the researchers.
If you choose not to give permission for your child to be in the study, how does this affect
your child’s medical care?
You can still receive evaluation and treatment for your condition if you do not participate in this
study. Discuss any alternative treatments with your regular doctor and/or the study doctor before
you decide to participate in the study. Your decision is entirely up to you. If you decide not to
participate in the study, you will not be penalized or lose any benefits and your decision will not
affect your relationship with your doctor or hospital.
What if we learn about new findings or information during the study?
You and your child will be given any new information gained during the course of the study that
might affect your willingness to continue your child’s participation in the study.
How will your child’s privacy be protected?
SEARCH staff will keep the information collected, tests done, and samples stored strictly
private. This is so because the study has been given a Certificate of Confidentiality. This means
anything you or your child tells us will not have to be given out to anyone, even if a court orders
us to do so, unless you say it’s okay. But under the law, we must report to the state suspected
cases of child abuse or if you tell us you are planning to cause serious harm to yourself or others.
When you enter the study, a special number will be given to your child. The number will be
used to identify the information and laboratory tests that will be done during this study. The
special number and the information collected during this study will be sent to Wake Forest
University in order to study the information. Blood and urine specimens will be sent to the
University of Washington for testing or storage. The list containing the special number assigned
to your child will be kept in a password-protected database at the Carolina SEARCH site. Thus,
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no one other than the study investigators (Dr. Mayer-Davis at the University of North Carolina
(UNC), Dr. Nelson at Greenville Health System (GHS), Dr. Bowlby at the Medical University of
South Carolina (MUSC), Dr. Merchant at the University of South Carolina (USC)) and the
SEARCH Carolina research team will be able to link any of the information collected in the
study to your child. Paper forms collected during the study will be stored in a locked filing
cabinet.
No subjects will be identified in any report or publication about this study. Although every effort
will be made to keep research records private, there may be times when federal or state law
requires the disclosure of such records, including personal information. This is very unlikely,
but if disclosure is ever required, UNC-Chapel Hill and your local data collection site (GHS,
MUSC, or USC) will take steps allowable by law to protect the privacy of personal information.
In some cases, your child’s information in this research study could be reviewed by
representatives of UNC-Chapel Hill or your local data collection site (GHS, MUSC, or USC),
research sponsors, or government agencies (for example, the FDA) for purposes such as quality
control or safety.
What will happen if your child is injured by this research?
All research involves a chance that something bad might happen. This may include the risk of
personal injury. In spite of all safety measures, your child might develop a reaction or injury
from being in this study. If such problems occur, the researchers will help your child get medical
care, but any costs for the medical care will be billed to you and/or your insurance company. The
University of North Carolina at Chapel Hill and your local data collection site (GHS, MUSC, or
USC) have not set aside funds to pay you for any such reactions or injuries, or for the related
medical care. However, by signing this form, you and your child do not give up any of your legal
rights.
What if you or your child wants to stop before your child’s part in the study is complete?
You can withdraw your child from this study at any time, without penalty.
Will you or your child receive anything for being in this study?
You and your child will both get $40 in store gift cards at the end of the Registry Study Visit. In
the rare circumstance that a blood redraw is necessary, your child would receive an additional
$20 gift card.
If you traveled a significant distance to complete this study visit, you will be provided additional
incentive to assist with travel costs. This additional incentive will be: two $20 gift cards if you
traveled 70-100 miles round trip, three $20 gift cards if you traveled 101-150 miles round trip, or
four $20 gift cards if you traveled more than 151 miles round trip. Travel distance will be
determined based on your current home address and the location of the SEARCH visit.
Will it cost you anything for your child to be in this study?
There will be no costs for being in the study
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What if you are a student at MUSC or USC?
You may choose not to give permission for your child to be in the study or to stop being in the
study before it is over at any time. This will not affect your class standing or grades. You will
not be offered or receive any special consideration if your child takes part in this research.
What if you are an employee at MUSC, GHS, or USC?
Your child’s taking part in this research is not a part of your job duties, and refusing to give
permission will not affect your job. You will not be offered or receive any special job-related
consideration if your child takes part in this research.
Who is sponsoring this study?
This research is funded by the Centers for Disease Control and Prevention and the National
Institutes of Health. This means that the research team is being paid by the sponsor for doing the
study. The researchers do not, however, have a direct financial interest with the sponsor or in the
final results of the study.
What if you or your child has questions about this study?
You and your child have the right to ask, and have answered, any questions you may have about
this research. If there are questions, complaints, concerns, or if a research-related injury occurs,
you should contact the researchers listed on the first page of this form.
What if you or your child has questions about his/her rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you or your child has questions or concerns about your child’s rights as a
research subject, or if you would like to obtain information or offer input, you may contact the
Institutional Review Board at Greenville Health System (864-522-2097; email [email protected]
or UNC-Chapel Hill (919-966-3113 or by email to [email protected]).
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a paper
copy of this survey, please tell your doctor.
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-------------------------------------------------------------Title of Study:
SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site);
Deborah Bowlby, MD (MUSC data collection site);
Anwar Merchant, ScD (USC data collection site)
Parent’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily give permission to allow my child to participate in this research study.
_________________________________________________
Printed Name of Research Subject (Child)
_________________________________________________
Signature of Parent
_________________
Date
_________________________________________________
Printed Name of Parent
___________________________________________________
Signature of Research Team Member Obtaining Permission
___________________________________________________
Printed Name of Research Team Member Obtaining Permission
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Assent to Participate in a Research Study
Minor Subjects (7-14 yrs), SEARCH 3 Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
People in charge of the study:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD (919966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
The people named above are doing a research study.
These are some things we want you to know about research studies:
Your parent needs to say it is okay for you to be in this study. You do not have to be in this
study if you don’t want to, even if your parent says it is okay for you to be in the study.
You may stop being in the study at any time. If you decide to stop, no one will be angry or upset
with you.
Sometimes good things happen to people who take part in studies, and sometimes things we may
not like happen. We will tell you more about these things below.
Why are they doing this research study?
The reason for doing this study is to find out how many young people have diabetes in your area.
We want to learn more about the types of diabetes young people have. We want to learn more
about your health, and how diabetes affects you and your family.
Why are you being asked to be in this research study?
You are being asked to be in this study because you have diabetes and you found out you had
diabetes when you were a child.
How many people will take part in this study?
A total of about 900 people at five sites in the U.S. will take part in this study, including about
211 people from South Carolina.
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What will happen during this study?
During this study we will ask to:
Measure you and check your blood pressure. This will be a lot like when they
measure you at your doctor’s office.
Take some blood from your arm with a needle and do some special tests that tell us
about your diabetes.
Take some blood from your arm with a needle and look at some of the genes that we
know have something to do with diabetes. A sample from this blood will be kept in
a freezer until we do tests on it.
Test some of your urine to see if diabetes is changing the way your kidneys work.
Have your parent/guardian fill in some forms about how to best contact you and also
about who you see for your diabetes care.
Answer some questions about the food you eat.
This study visit will last about 40 minutes.
Who will be told the things we learn about you in this study?
SEARCH staff will keep the things we learn private, but we must report to the state if we feel
you are being hurt or if you tell us you are planning to hurt yourself or others. If you tell us you
are planning to hurt yourself or others, we will also tell your parents.
When you start in SEARCH, a special number is given to you. The number is used to mark all
the forms and blood tests we do with you. The special number and the forms will be sent to
Wake Forest University. Blood and urine will be sent to the University of Washington to test or
store. The list showing the special number given to you will be kept in a file and saved with a
password. Only the people listed on the first page or others working with the Carolina study site
will be able to see this list.
What are the good things that might happen?
People may have good things happen to them because they are in research studies. These are
called “benefits.” You will not benefit from being in this research study.
What are the bad things that might happen?
Sometimes things happen to people in research studies that may make them feel bad. These are
called “risks.” These are the risks of this study:
It may hurt when you have your blood drawn and you may get a bruise. We can put
some medicine on your skin to make it hurt less.
You need to come to the visit without eating anything the night before your visit. This
may affect your blood sugar. We will test your blood sugar and you may take your
diabetes medicine or eat a snack to help your blood sugar.
Not all of these things may happen to you. None of them may happen or things may happen that
the researchers don’t know about. You should report any problems to the researcher
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What if you or your parents don’t want you to be in this study?
It is okay if you or your parents don’t want to be in this study. This will not affect the care you
get.
Will you get any money or gifts for being in this research study?
You will receive $40 in store gift cards for being in this study. If we are not able to get your
blood and you return for a 2nd blood draw, you will get another $20 gift card.
Your parents will get $40 in gift cards for being in the study.
Who should you ask if you have any questions?
If you have questions you should ask the people listed on the first page of this form. If you have
other questions, complaints or concerns about your rights while you are in this research study
you may contact the Institutional Review Board at Greenville Health System (864-522-2097;
email: [email protected]) or at UNC-Chapel Hill (919-966-3113; email:[email protected]).
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a paper
copy of this survey, please tell your doctor.
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-----------------------------------------------------------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site);
Deborah Bowlby, MD (MUSC data collection site);
Anwar Merchant, ScD (USC data collection site)
If you sign your name below, it means that you agree to take part in this research study.
________________________________________________
Sign your name here if you want to be in the study
_______________
Date
________________________________________________
Print your name here if you want to be in the study
________________________________________________
Signature of Research Team Member Obtaining Assent
________________________________________________
Printed Name of Research Team Member Obtaining Assent
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Date
IRB # Pro00010812
SEARCH for Diabetes in Youth, Carolina Site
Consent for Storing Biological Specimens With Identifying Information
_______________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: January 2014
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3), Registry Study Visit
SEARCH Carolina Site Principal Investigators:
University of North Carolina-Chapel Hill, Coordinating Site: Elizabeth Mayer-Davis, PhD (919966-1991)
Greenville Health System, Data Collection Site: Bryce Nelson, MD (864-454-5100)
Medical University of South Carolina, Data Collection Site: Deborah Bowlby, MD (843-7926807)
University of South Carolina, Data Collection Site: Anwar Merchant, ScD (803-777-6095)
Funding Source and/or Sponsor: Centers for Disease Control and Prevention and National
Institutes of Health/NIDDK
Study Contact telephone number: local numbers given above or studywide toll-free at 866595-2397
Study Contact email: [email protected]
______________________________________________________________________________
What are some general things you should know about research?
Research is designed to gain scientific information that may help other people in the future. You
may not receive any direct benefit from taking part. There also may be risks.
You may refuse to take part in research. If you are a patient with an illness, you do not have to
be in research in order to receive treatment.
Details are discussed below. It is important that you understand this information so that you can
make an informed choice. You will be given a copy of this consent form. You should ask the
researchers named above, or staff members who may assist them, any questions you have about
this study at any time.
What is the purpose of this specimen repository or “biobank?”
Research with blood or body fluids (specimens) can help researchers understand how the human
body works. Research can also answer other questions by using specimens. Researchers may
develop new tests to find diseases, or new ways to treat diseases. In the future, research may
help to develop new products, such as drugs. Specimens are commonly used for genetic
research. Sometimes researchers collect and store many specimens together and use them for
different kinds of research, or share them with other scientists; this is called a specimen
repository or “biobank.”
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The purpose of this particular repository or biobank is to aid in our understanding of causes of
diabetes and related conditions. It may also help in the development of new diagnoses, treatment
and cures, as well as a better overall scientific understanding of diabetes and related conditions.
Specimens to be stored following the SEARCH visit include blood, DNA, and urine.
How will the specimens be collected?
Blood and DNA will be collected during the blood draw for your SEARCH study visit. Urine
will also be collected during the study visit.
What will happen to the specimens?
The blood, DNA, and urine will be sent to the study’s central laboratory at the University of
Washington, Northwest Lipid Research Laboratories for storage. These samples will be labeled
with your unique study number. The laboratory will not be able to link the number to you. The
list linking the number to you is kept at the SEARCH Carolina site in a password-protected file.
SEARCH will plan to keep your specimens until 10 years after the end of funding for follow-up
of SEARCH participants. After this time, stored samples will be destroyed.
SEARCH may share your stored specimens with other investigators to be used for testing related
to diabetes or associated complications. This would only be done after the investigators have
submitted a proposal to use these specimens to the SEARCH Ancillary Studies Committee. The
committee will review the proposal to ensure the proposed testing adequately relates to the goals
of SEARCH.
____ I agree to have blood stored to be used in the future for new tests as they are developed to
learn more about diabetes and related conditions.
____ I do not agree to have blood stored to be used in the future.
_____ I agree to have DNA stored to be used in the future for new tests as they are developed to
learn more about diabetes and related conditions.
_____ I do not agree to have DNA stored to be used in the future.
___
I agree to have urine stored to be used in the future for new tests as they are developed to
learn more about diabetes and related conditions.
____ I do not agree to have urine stored to be used in the future.
What are Genome Wide Association Studies (GWAS)?
Usually researchers study just a few areas of your genetic material (DNA) that is linked to a
single disease or condition. However, in a whole genome analysis (GWAS), all (or most) of
your genes are analyzed and used by researchers to study links to multiple diseases or conditions.
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At this time, SEARCH has no plans to complete GWAS on your stored sample, but it could be
done in the future. If GWAS is done, the results are saved in the form of a data report and will
be stored in a data bank at the National Institutes of Health (NIH), where the report could be
shared with other investigators for research. The report would not include name, address or
other information that could be traced back to you.
____ I agree to allow GWAS to be done on my stored DNA and to share the data with the NIH
data bank.
_____ I do not agree to allow GWAS to be done on my stored DNA.
What are the possible benefits to you?
Benefits to you are unlikely. Studies that use specimens from this repository may provide
additional information that will be helpful in understanding diabetes and related conditions.
What are the possible risks or discomforts involved with the use of your specimens?
The risks from drawing blood from a vein in the lower arm include mild pain, bruising at the site
of the blood draw, and occasionally fainting. To lower the chance of these risks, blood will be
drawn by experienced staff and a local numbing medicine may be placed on the skin before the
blood is drawn to decrease any pain.
The blood tests require that you not eat any food overnight. In order to limit low or high blood
sugars, your blood sugar will be checked and your diabetes medication or a fast-acting
carbohydrate will be given as needed.
Other possible risks include loss of privacy and breach of confidentiality. If this research
involves genetics, there is also a potential risk for some of your relatives and other members of
your ethnic group, since they share some of your genetic makeup.
In addition, there may be uncommon or previously unknown risks that might occur.
Will there be any cost to you for storage of the specimens?
There will be no cost to you for the storage and use of the specimens for research purposes.
Will you receive anything for the use of your specimens?
You will receive gift cards after you finish your SEARCH study visit (as noted on the visit
consent form), but you will not get additional gift cards for giving your specimens for storage.
Who owns the specimens?
Any blood, body fluids, or tissue specimens obtained for this purpose become the exclusive
property of the University of North Carolina at Chapel Hill and your local data collection site
(GHS, MUSC, or USC). These organizations may retain, preserve or dispose of these specimens
and may use these specimens for research related to diabetes and its complications. The research
may result in commercial applications. There are no plans to compensate you for any future
commercial use of these specimens.
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How will your privacy be protected?
SEARCH staff will keep the information collected, tests done, and samples stored strictly
private. This is so because the study has been given a Certificate of Confidentiality. This means
anything you tell us will not have to be given out to anyone, even if a court orders us to do so,
unless you say it’s okay. But under the law, we must report to the state suspected cases of child
abuse or if you tell us you are planning to cause serious harm to yourself or others.
When you enter the study, a special number will be given to you. The number will be used to
identify the information and laboratory tests that will be done during this study. Blood and urine
specimens will be sent to the University of Washington for testing or storage. Results from
testing will be sent to Wake Forest University in order to study the information. The list
containing the special number assigned to you will be kept in a password-protected database at
the Carolina SEARCH site. Thus, no one other than the study investigators (Dr. Mayer-Davis at
the University of North Carolina (UNC), Dr. Nelson at Greenville Health System (GHS), Dr.
Bowlby at the Medical University of South Carolina (MUSC), Dr. Merchant at the University of
South Carolina (USC)) and the SEARCH Carolina research team will be able to link any of the
information collected in the study to you. Paper forms collected during the study will be stored
in a locked filing cabinet.
You will not be identified in any report or publication about research using your specimens.
Although every effort will be made to keep research records private, there may be times when
federal or state law requires the disclosure of such records, including personal information. This
is very unlikely, but if disclosure is ever required, UNC-Chapel Hill and your local data
collection site (GHS, MUSC, or USC) will take steps allowable by law to protect the privacy of
personal information. In some cases, your information in this research could be reviewed by
representatives of UNC-Chapel Hill or your local data collection site (GHS, MUSC, or USC) ,
research sponsors, or government agencies for purposes such as quality control or safety.
A Federal law called the Genetic Information Nondiscrimination Act (GINA) generally makes it
illegal for health insurance companies, group health plans, and most employers to discriminate
against you based on your genetic information. GINA does not protect you against genetic
discrimination by companies that sell life insurance, disability insurance, or long-term care
insurance. GINA also does not protect you against discrimination based on an already-diagnosed
genetic condition or disease.
Will researchers seek approval from you to do future studies involving the specimens?
By signing this consent form, you are giving your permission for researchers to use your
specimens as described above. Current and future research is overseen by a committee called the
Institutional Review Board (IRB). The role of the IRB is to protect the rights and welfare of
research participants. In some cases, the IRB may require that you be re-contacted and asked for
your consent to use your specimens in a specific research study. You have the right, at that
future time, not to participate in any research study for which your consent is sought. Refusal to
participate will not affect your medical care or result in loss of benefits to which you are entitled.
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Will you receive results from research involving your specimens?
Most research with your specimens is not expected to yield new information that would be
meaningful to share with you personally. There are no plans to re-contact you or other subjects
with information about research results.
Can you withdraw the specimens from the research repository?
If you decide that you no longer wish for the specimens to be stored, you should contact the
researchers on the front page of this form. It is best to make your request in writing.
Any analysis in progress at the time of your request or already performed prior to your request
being received by the researcher will continue to be used as part of the research study. Once the
researchers have been notified, your remaining specimens would be destroyed. If you do not
make such a request, the specimens may be stored forever. The researchers may choose to
destroy the specimens at any time.
What will happen if you are injured by this research?
All research involves a chance that something bad might happen to you. This may include the
risk of personal injury. In spite of all safety measures, you might develop a reaction or injury
from having your specimen collected. If such problems occur, the researchers will help you get
medical care, but any costs for the medical care will be billed to you and/or your insurance
company. The University of North Carolina at Chapel Hill and your local data collection site
(GHS, MUSC, USC) have not set aside funds to pay you for any such reactions or injuries, or for
the related medical care. However, by signing this form, you do not give up any of your legal
rights.
Who is sponsoring this research?
This research is funded by the Centers for Disease Control and Prevention and the National
Institutes of Health. This means that the research team is being paid by the sponsor for doing the
study. The researchers do not, however, have a direct financial interest with the sponsor or in the
final results of the study.
What if you have questions about this research?
You have the right to ask, and have answered, any questions you may have about this research. If
you have questions, you should contact the researchers listed on the first page of this form.
What if you have questions about your rights as a research subject?
All research on human volunteers is reviewed by a committee that works to protect your rights
and welfare. If you have questions or concerns about your rights as a research subject you may
contact, anonymously if you wish, the Institutional Review Board at Greenville Health System
(864-522-2097; email: [email protected]) or at UNC Chapel Hill (919-966-3113; e-mail:
[email protected].
Greenville Hospital System
IRB Number: Pro00010812
Date Approved 1/21/2014
Version Valid Until: 5/21/2014
IRB # Pro00010812
A survey about your experience with this informed consent process is located at the following
website:
http://www.ghs.org/Research-and-Clinical-Trials
Participation in the survey is completely anonymous and voluntary and will not affect your
relationship with your doctor or the Greenville Health System. If you would like to have a paper
copy of this survey, please tell your doctor.
Title of Study: SEARCH for Diabetes in Youth 3 (SEARCH 3)
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD (GHS data collection site);
Deborah Bowlby, MD (MUSC data collection site);
Anwar Merchant, ScD (USC data collection site)
Subject’s Agreement:
I have read the information provided above. I have asked all the questions I have at this time. I
voluntarily agree to participate. I agree to my specimen(s) being stored with the identifying
code(s).
_________________________________________________
Signature of Research Subject
_________________
Date
_________________________________________________
Printed Name of Research Subject
_________________________________________________
Signature of Parent (if subject is under 18)
_________________
Date
_________________________________________________
Printed Name of Parent (if subject is under 18)
_________________________________________________
Signature of Research Team Member Obtaining Consent
_________________________________________________
Printed Name of Research Team Member Obtaining Consent
Greenville Hospital System
IRB Number: Pro00010812
Date Approved 1/21/2014
Version Valid Until: 5/21/2014
_________________
Date
Colorado
Consents
Ohio
Consents
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
STUDY TITLE: SEARCH FOR DIABETES IN YOUTH
(STUDY VISIT: 2002-06 & 2008 COHORT)
STUDY NUMBER: 2011-0407
FUNDING ORGANIZATION: Centers for Disease Control and Prevention;
National Institutes of Health
Lawrence Dolan, MD
Name of Principal Investigator
513-636-2444
Telephone Number
INTRODUCTION
We are asking you to be in a research study so we can learn new information
that may help others. If you decide not to be in this study, we will still take good
care of you. If you decide to be in this study, you may change your mind at
any time during the study and you can stop being in the study. Take all the
time you need to make your choice. Ask us any questions you have. It is also
okay to ask more questions after you decide to be in the study. You can ask
questions at any time.
WHY ARE WE DOING THIS RESEARCH?
In this research study we want to learn more about diabetes in children, teens,
and young adults.
We are asking you and others with diabetes to be in the research, because we
want to learn more about how diabetes is affecting the lives of young people
with diabetes, what type of medical care they receive, and what type of
complications are beginning to develop.
WHO IS IN CHARGE OF THE RESEARCH?
Dr. Lawrence Dolan is the researcher at Cincinnati Children’s Hospital Medical
Center (CCHMC) who is in charge of this study.
CCHMC is being paid by the CDC (Centers for Disease Control and
Prevention) and the NIH (National Institutes of Health) to do this study.
Adult Consent Version 5
Page 1 of 9
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
WHO SHOULD NOT BE IN THE STUDY
You cannot be in this study if you do not have diabetes.
• If you are pregnant, you will not be able to take part in the study visit
until 4 months after delivery or end of the pregnancy.
WHAT WILL HAPPEN IN THE STUDY?
The research staff will explain the visit to you. You will be able to ask
questions to make sure you understand what will happen to you.
If you qualify and you decide you want to be in the study, you will come to
CCHMC one time. Your visit will last about 3½ - 4 hours. You may be
contacted once a year by mail to update any changes in your address or phone
number. If your address/phone number has changed, we may attempt to
update your contact information through a public database, such as
LexisNexis.
These are the things that will happen to you while in the study:
Physical Exam and Blood and Urine Samples
•
•
•
•
•
•
Fast for 8-10 hours before the visit (no food or drinks, except water)
Bring in a urine sample to be tested for albumin and creatinine to see
how well your kidneys are working
Measure height, weight, waist, and blood pressure. Each will be done
2-3 times.
Look at skin on back of neck
Another urine sample will be collected during your visit. It will also be
tested for albumin and creatinine.
Blood will be taken from your arm or hand to measure blood sugar,
hemoglobin A1c (measures average blood sugar over past 3 months),
c-peptide (measures your own insulin production), creatinine (measures
kidney function), different types of cholesterol (fat), adiponectin and
leptin (hormones made by fat cells), diabetes antibodies (markers in the
blood for type 1 diabetes), hsCRP and IL-6 (measures of inflammation),
fibrinogen (involved in blood clotting), and creatinine and cystatin C
(measures of how well the kidneys are functioning). The amount of
blood needed for these tests is about 4 teaspoons.
If you agree, extra blood will be collected and saved for the duration of the
study. This blood may be used in the future as new tests are developed to
tell your type of diabetes and your risk of developing the complications of
diabetes, insulin resistance (insulin is not working as well as it should), and
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being overweight. The amount of blood needed is about 3¾ teaspoons.
I agree to have my blood and urine stored.
__________initials
I do not agree to have my blood and urine stored.
__________initials
If you agree, extra blood will be collected for DNA. This blood sample may
be tested to identify your genetic makeup. This blood sample or the test
results may be sent to a national storage center to help researchers better
understand how genes affect the risk of developing diseases such as
asthma, cancer, diabetes, and heart disease. When your blood or test
results and clinical information are sent to the storage center, no personal
information, such as your name, date of birth, or address will be included.
Thus, researchers will not be able to link this information back to you. The
amount of blood needed is about 1¾ teaspoons.
I agree to have my blood stored and tested for DNA. __________initials
I do not agree to have my blood stored and tested
for DNA.
•
__________initials
After the blood test is done, you will be given a snack. You may take
your diabetes medicine at that time. When the heart function tests have
been completed, you will be given breakfast.
Questions
• You will be asked questions about your diabetes, medical care, current
medications, family history of diabetes, education, family income level,
health insurance, and the effect diabetes has had on your life. You will
be asked to answer questions dealing with the following health issues;
physical activity, smoking, alcohol use, eating and sleeping patterns,
and depression. You will also be asked what you might do to prevent
low blood sugars, what worries you might have in relation to low blood
sugars, and practices that are consistent with eating problems.
Nerve Tests
Diabetic neuropathy is a complication of diabetes that results from damage to
the nerves. We will be looking for signs of early nerve damage by asking you
to complete a short questionnaire and doing an examination of your feet.
Doing the nerve tests will take about 10 minutes. The results of your foot exam
and questionnaire will be sent to the University of Michigan for analysis.
•
•
We will ask you to answer 15 questions about foot sensation including
pain, numbness, and temperature sensitivity.
We will examine your feet to measure your ability to feel vibrations, your
reflexes, and the ability to feel light touches to your feet. To test the
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sense of touch, the examiner will touch your big toe several times with a
thin piece of plastic and place a vibrating instrument on the toe. The
examiner will use a rubber “hammer” to test the reflexes in the ankle.
We may ask you to repeat the foot exam with a different examiner.
Eye Photographs
Diabetic retinopathy is a complication of diabetes that results from damage to
the blood vessels at the back of the eye (retina). We will be taking 2 pictures
of each of your eyes. These pictures will be sent to the Ocular Epidemiology
Reading Center in Madison, Wisconsin to be read by trained eye specialists
who will study the blood vessels and look for possible problems.
• You will be asked to sit in a darkened room in front of a special camera
with your chin in a chin rest. After the pupils have dilated, we will take 2
photographs of the back of each eye. No drops will be put in your eyes;
and the camera will not touch your eyes. After each picture is taken,
you may see a white or colored spot, which will disappear within a few
minutes and cause no damage to the eye. We will pause for a few
minutes between photographs to allow the eyes time to re-adjust to the
darkened room so the pupils will dilate once again.
• You will also be asked for the name and phone number of your eye
doctor, and whether or not you have ever had eye injections or laser
treatments on the back of the eyes. We will send you the results of your
eye photographs.
Heart Function Tests
We will be monitoring blood vessel changes to see if the changes that are
commonly related to other risk factors for heart disease are present in children,
adolescents and young adults. These tests will not hurt.
• The examiner will place an EKG lead on each of your arms and on the
left leg or two EKG leads on your chest and one on the stomach. It is
important for the EKG leads to pick up a good signal of your heart beats.
In some cases it may be necessary for us to shave the hair from a small
area of skin to improve the heart signal. You will be asked to lie down
and rest for 5 minutes before the test begins. We will then record the
pattern of heart beats for 10 minutes.
• We will check your pulse on the upper, inner thigh, but will not expose
private parts. You may be asked to remove outer clothing and to put on
a patient gown. At your request a chaperone will be present during
these procedures.
The following tests will then be performed:
• A staff member will measure the distance from your sternum (breast
bone) to the umbilicus (belly button), from the umbilicus to the top of the
leg, from the top of the leg to the foot, from the sternum to the wrist, and
from the neck to the sternum. These measurements will be repeated 3
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times.
A small instrument shaped like a pen will be touched on the side of your
neck, the top of the leg, and the top of the foot to measure the speed of
your pulse. This test will be repeated 3 times.
Your wrist will be touched with the pen-shaped instrument to measure
the stiffness of the blood vessels. This instrument detects pressure
changes with a tiny, highly-sensitive pressure sensor in the flat end of
the device that is shaped like a pencil eraser. It does not use radiation
(X-rays), sound waves (ultrasound), or needles. This test will be
repeated 3 times.
In order to check the accuracy of our measurements, some of the blood vessel
tests will be repeated for about 32 CCHMC participants. Participants will be
randomly selected to receive repeat measurements. Your chance of being
selected for these repeat measurements is 5% (1 out of every 20 participants).
If you are selected for repeat measurements and you agree to have the
measurements performed, your visit will last about 30 minutes longer; and you
will receive an extra payment of $10 for your time.
You have been selected for these repeat measurements.
You have not been selected for these repeat measurements.
WHAT ARE THE GOOD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
Being in this research may not help you right now. When we finish the study,
we hope that we will know more about diabetes. This may help others with
diabetes later on.
As part of this research you will receive blood and urine test results at no
charge. At your request, we will send copies of your test results to your
healthcare provider. This may allow the provider to change, if indicated, how
they take care of your diabetes and to treat any complications that may be
present.
If you agree, your results will be shared with your provider(s).
I agree to have my results shared with my
healthcare provider.
__________initials
I do not agree to have my results shared with
my healthcare provider.
__________initials
WHAT ARE THE BAD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
The risks of drawing blood from a vein in the lower arm include mild pain,
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bruising at the site of the blood draw, and occasionally fainting. To lower the
possibility of these risks, experienced medical staff will draw blood. A local
numbing medicine may be placed on the skin before the blood is drawn to
decrease any pain.
You will be fasting for 8-10 hours before your appointment. To help prevent
and treat low or high blood sugars, your blood sugar will be checked; and you
may take diabetes medicine or a fast-acting carbohydrate as needed to control
the blood sugar level.
Some of the tests will look for the presence or risk of developing the
complications of diabetes. If these tests identify complications of diabetes or
risk of developing the complications, the results may make you anxious. If this
happens, you will be referred to a local mental health professional for
evaluation and treatment.
There are no known risks associated with the nerve tests. There are no known
risks associated with taking photographs of the eye. Although you will see a
flash of light when the picture is taken, this flash is not harmful. People who
are light sensitive may experience some minor discomfort from the camera
flash, but the discomfort will not last. When the pen-shaped blood vessel
device is placed on your skin you may feel some pressure for a few seconds.
There may be other risks that we do not know about yet.
WHAT OTHER CHOICES ARE THERE?
Instead of being in this study, you can choose not to be in it.
HOW WILL INFORMATION ABOUT YOU BE KEPT PRIVATE?
Making sure that information about you remains private is important to us. To
protect your privacy in this research study, we will assign a special number to
you. This number will be used instead of your name to identify the information
and laboratory tests collected during the study. The list containing the special
number assigned to you is kept in a password-protected database at CCHMC.
Thus, no one other than Dr. Dolan and his research team at CCHMC will be
able to link any of the information collected in the study to you.
WILL IT COST YOU ANYTHING EXTRA FOR YOU TO BE IN THE
RESEARCH STUDY?
Your time is valuable and, therefore, would be the most costly part of your
involvement in the study. The only other cost to you would be for transportation
to and from the study site.
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WILL YOU BE PAID TO BE IN THIS RESEARCH STUDY?
You will be reimbursed for your time, effort and travel while you are in this
research study.
You will be paid $100 for completing the study visit and an extra $20 for
bringing in a 1st morning urine sample.
If you are able to complete only a portion of the study visit, you will be asked to
schedule a second visit to complete the remainder of the study procedures.
Based on the time spent at the visit, your payment will be pro-rated accordingly
for each visit.
We may ask you to repeat one or both urine samples. You will be paid an
extra $20 for providing these urine samples.
WHAT HAPPENS IF YOU ARE INJURED FROM BEING IN THIS STUDY?
If you believe you have been injured as a result of this research you should
contact Dr. Dolan as soon as possible to discuss the concerns. Treatment for
injuries is available at CCHMC. If you go to the Emergency Room or to
another hospital or doctor, it is important that you tell them that you are in a
research study. If possible, you should give them a copy of this consent form.
CCHMC follows a policy of making all decisions about compensation for the
medical treatment of physical injuries that happened during or were caused by
research on an individual basis.
WHO DO YOU CALL IF YOU HAVE QUESTIONS OR PROBLEMS?
For questions, concerns, or complaints about this research study you can
contact the study person listed on page 1 of this document. If you would like to
talk to someone that is not part of the research staff or if you have general
questions about your research study rights or questions, concerns, or
complaints about the research, you can call the CCHMC Institutional Review
Board at 513-636-8039.
AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION
FOR RESEARCH
To be in this research study you must also give your permission (or
authorization) to use and disclose (or share) your “protected health
information” (called PHI for short).
What protected health information will be used and shared during this
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study?
CCHMC will need to use and share your PHI as part of this study. This PHI
will come from:
Your CCHMC medical records
Your research records
The types of information that will be used and shared from these records
include:
Laboratory test results, diagnosis, and medications
Reports and notes from clinical and research observations
Imaging (like CT scans, MRI scans, x-rays, etc.) studies and reports
If applicable, information concerning HIV testing or the treatment of AIDS or
AIDS-related conditions, drug or alcohol abuse, drug-related conditions,
alcoholism, and/or psychiatric/psychological conditions (but not
psychotherapy notes).
Who will share, receive and/or use your protected health information in
this study?
Staff at all the research study sites (including CCHMC)
Personnel who provide services to you as part of this study
Other individuals and organizations that need to use your PHI in connection
with the research, including people at the sponsor and organizations that
the sponsor may use to oversee or conduct the study.
The members of the CCHMC Institutional Review Board and staff of the
Office of Research Compliance and Regulatory Affairs.
How will you know that your PHI is not misused?
People that receive your PHI as part of the research are generally limited in
how they can use your PHI. In addition, most people who receive your PHI are
also required by federal privacy laws to protect your PHI. However, some
people that may receive your PHI may not be required to protect it and may
share the information with others without your permission, if permitted by the
laws that apply to them.
Can you change your mind?
You may choose to withdraw your permission at any time. A withdrawal of
your permission to use and share your PHI would also include a withdrawal
from participation in the research study. If you wish to withdraw your
permission to use and share your PHI you need to notify the study doctor,
listed on the first page of this document, in writing. Your request will be
effective immediately and no new PHI about you will be used or shared. The
only exceptions are (1) any use or sharing of PHI that has already occurred or
was in process prior to you withdrawing your permission and (2) any use or
sharing that is needed to maintain the integrity of the research.
Will this permission expire?
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Your permission will expire at the end of the study. If the study involves the
creation or maintenance of a research database repository, this authorization
will not expire.
Will your other medical care be impacted?
By signing this document you agree to participate in this research study and
give permission to CCHMC to use and share your PHI for the purpose of this
research study. If you refuse to sign this document you will not be able to
participate in the study. However, your rights concerning treatment not related
to this study, payment for services, enrollment in a health plan or eligibility of
benefits will not be affected.
SIGNATURES
The research team has discussed this study with you and answered all of your
questions. Like any research, the researchers cannot predict exactly what will
happen. Once you have had enough time to consider whether you should
participate in this research you will document your permission by signature
below.
You will receive a copy of this signed document for your records.
_____________________________________
Printed Name of Research Participant
_____________________________________
Signature of Research Participant
Indicating Consent
____________
Date
____________________________________
Signature of Legally Authorized
Representative*
____________
Date
_______________________________________________________________
* If signed by a legally authorized representative, a description of such
representative’s authority must be provided
_____________________________________
Signature of Individual Obtaining Consent
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____________
Date
IRB #: 2011-0407
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Do Not Use After:
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STUDY TITLE: SEARCH FOR DIABETES IN YOUTH
(STUDY VISIT: 2002-06 & 2008 COHORT)
STUDY NUMBER: 2011-0407
FUNDING ORGANIZATION: Centers for Disease Control and Prevention;
National Institutes of Health
Lawrence Dolan, MD
Name of Principal Investigator
513-636-2444
Telephone Number
INTRODUCTION
We are asking for your permission for your child to be in a research study so
we can learn new information that may help others. If you decide not to give
your permission for your child to be in this study, we will still take good care of
him/her. If you decide to allow your child to be in this study, you may change
your mind at any time during the study and your child can stop being in the
study. Take all the time you need to make your choice. Ask us any questions
you have. It is also okay to ask more questions after you decide to allow your
child to be in the study. You can ask questions at any time.
WHY ARE WE DOING THIS RESEARCH?
In this research study we want to learn more about diabetes in children, teens,
and young adults.
We are asking your child and other children with diabetes to be in the research,
because we want to learn more about how diabetes is affecting the lives of
young people with diabetes, what type of medical care they receive, and what
type of complications are beginning to develop.
WHO IS IN CHARGE OF THE RESEARCH?
Dr. Lawrence Dolan is the researcher at Cincinnati Children’s Hospital Medical
Center (CCHMC) who is in charge of this study.
CCHMC is being paid by the CDC (Centers for Disease Control and
Prevention) and the NIH (National Institutes of Health) to do this study.
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WHO SHOULD NOT BE IN THE STUDY
Your child cannot be in this study if your child does not have diabetes.
• If your child is pregnant, she will not be able to take part in the study
visit until 4 months after delivery or end of the pregnancy.
WHAT WILL HAPPEN IN THE STUDY?
The research staff will explain the visit to you. You will be able to ask
questions to make sure you understand what will happen to your child.
If your child qualifies and you decide you want your child to be in the study,
your child will come to CCHMC one time. If your child is less than 10 years of
age, the study visit will last about 3 hours. If your child is 10 years of age or
older, visits will take about 3½ - 4 hours. You may be contacted once a year
by mail to update any changes in your address or phone number. If your
address/phone number has changed, we may attempt to update your contact
information through a public database, such as LexisNexis.
These are the things that will happen to your child while in the study:
Physical Exam and Blood and Urine Samples
•
•
•
•
•
•
Fast for 8-10 hours before the visit (no food or drinks, except water)
Bring in a urine sample to be tested for albumin and creatinine to see
how well your child’s kidneys are working
Measure height, weight, waist, and blood pressure. Each will be done
2-3 times.
Look at skin on back of neck
Another urine sample will be collected during your visit. It will also be
tested for albumin and creatinine.
Blood will be taken from your child’s arm or hand to measure blood
sugar, hemoglobin A1c (measures average blood sugar over past 3
months), c-peptide (measures your child’s own insulin production),
creatinine (measures kidney function), different types of cholesterol (fat),
adiponectin and leptin (hormones made by fat cells), diabetes
antibodies (markers in the blood for type 1 diabetes), hsCRP and IL-6
(measures of inflammation), fibrinogen (involved in blood clotting), and
creatinine and cystatin C (measures of how well the kidneys are
functioning). The amount of blood needed for these tests is between 1
and 4 teaspoons. Smaller amounts will be used for very young children.
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If you agree, extra blood will be collected and saved for the duration of the
study. This blood may be used in the future as new tests are developed to
tell your child’s type of diabetes and your child’s risk of developing the
complications of diabetes, insulin resistance (insulin is not working as well
as it should), and being overweight. The amount of blood needed is about
3¾ teaspoons.
I agree to have my child’s blood and urine stored.
__________initials
I do not agree to have my child’s blood and urine
stored.
__________initials
If you agree, extra blood will be collected for DNA. This blood sample may
be tested to identify your child’s genetic makeup. This blood sample or the
test results may be sent to a national storage center to help researchers
better understand how genes affect the risk of developing diseases such as
asthma, cancer, diabetes, and heart disease. When your child’s blood or
test results and clinical information are sent to the storage center, no
personal information, such as your child’s name, date of birth, or address
will be included. Thus, researchers will not be able to link this information
back to your child. The amount of blood needed is about 1¾ teaspoons.
•
I agree to have my child’s blood stored and tested
for DNA.
__________initials
I do not agree to have my child’s blood stored and
tested for DNA.
__________initials
After the blood test is done, your child will be given a snack. Your child
may take his/her diabetes medicine at that time. When the heart
function tests have been completed, your child will be given breakfast.
Questions
•
•
•
Your child will be asked questions about the effect diabetes has had on
his/her life.
If your child is 8 years of age or older, your child will also be asked
about his/her stage of sexual development.
Young people 10 years of age or older will be asked to answer
questions dealing with the following health issues; physical activity,
smoking, alcohol use, eating and sleeping patterns, and depression.
They will also be asked what they might do to prevent low blood sugars,
what worries they might have in relation to low blood sugars, practices
that are consistent with eating problems, and diabetes-related topics
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that might be a source of conflict between you and your child. This
information will not be shared with you unless health issues are
identified that need to be treated. The reason why the information will
not be shared is to increase the likelihood that your child will answer the
questions honestly.
You will be asked questions about your child’s diabetes, medical care,
current medications, family history of diabetes, education, family income
level, health insurance, and the effect diabetes has had on your life.
Nerve Tests
Diabetic neuropathy is a complication of diabetes that results from damage to
the nerves. We will be looking for signs of early nerve damage by asking your
child to complete a short questionnaire and doing an examination of your
child’s feet. Doing the nerve tests will take about 10 minutes. The results of
your child’s foot exam and questionnaire will be sent to the University of
Michigan for analysis.
•
•
We will ask your child to answer 15 questions about foot sensation
including pain, numbness, and temperature sensitivity.
We will examine your child’s feet to measure your child’s ability to feel
vibrations, your child’s reflexes, and the ability to feel light touches to
your child’s feet. To test the sense of touch, the examiner will touch
your child’s big toe several times with a thin piece of plastic and place a
vibrating instrument on the toe. The examiner will use a rubber
“hammer” to test the reflexes in the ankle. We may ask your child to
repeat the foot exam with a different examiner.
Eye Photographs
Diabetic retinopathy is a complication of diabetes that results from damage to
the blood vessels at the back of the eye (retina). We will be taking 2 pictures
of each of your child’s eyes. These pictures will be sent to the Ocular
Epidemiology Reading Center in Madison, Wisconsin to be read by trained eye
specialists who will study the blood vessels and look for possible problems.
•
Your child will be asked to sit in a darkened room in front of a special
camera with the chin in a chin rest. After the pupils have dilated, we will
take 2 photographs of the back of each eye. No drops will be put in the
eyes; and the camera will not touch your child’s eyes. After each picture
is taken, your child may see a white or colored spot, which will
disappear within a few minutes and cause no damage to the eye. We
will pause for a few minutes between photographs to allow the eyes
time to re-adjust to the darkened room so the pupils will dilate once
again.
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You will also be asked for the name and phone number of your child’s
eye doctor, and whether or not your child has ever had eye injections or
laser treatments on the back of the eyes. We will send you the results
of your child’s eye photographs.
Heart Function Tests
We will be monitoring blood vessel changes to see if the changes that are
commonly related to other risk factors for heart disease are present in children,
adolescents and young adults. These tests will not hurt.
•
•
The examiner will place an EKG lead on each of your child’s arms and
on the left leg or two EKG leads on your child’s chest and one on the
stomach. It is important for the EKG leads to pick up a good signal of
your child’s heart beats. In some cases it may be necessary for us to
shave the hair from a small area of skin to improve the heart signal.
Your child will be asked to lie down and rest for 5 minutes before the
test begins. We will then record the pattern of heart beats for 10
minutes.
We will check your child’s pulse on the upper, inner thigh, but will not
expose private parts. Your child may be asked to remove outer clothing
and to put on a patient gown. At your request a chaperone will be
present during these procedures.
The following tests will then be performed:
•
•
•
A staff member will measure the distance from your child’s sternum
(breast bone) to the umbilicus (belly button), from the umbilicus to the
top of the leg, from the top of the leg to the foot, from the sternum to the
wrist, and from the neck to the sternum. These measurements will be
repeated 3 times.
A small instrument shaped like a pen will be touched on the side of your
child’s neck, the top of the leg, and the top of the foot to measure the
speed of your child’s pulse. This test will be repeated 3 times.
Your child’s wrist will be touched with the pen-shaped instrument to
measure the stiffness of the blood vessels. This instrument detects
pressure changes with a tiny, highly-sensitive pressure sensor in the flat
end of the device that is shaped like a pencil eraser. It does not use
radiation (X-rays), sound waves (ultrasound), or needles. This test will
be repeated 3 times.
In order to check the accuracy of our measurements, some of the blood vessel
tests will be repeated for about 32 CCHMC participants. Participants will be
randomly selected to receive repeat measurements. Your chance of being
selected for these repeat measurements is 5% (1 out of every 20 participants).
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If your child is selected for repeat measurements and you agree to have the
measurements performed, your visit will last about 30 minutes longer; and your
child will receive an extra payment of $10 for their time.
Your child has been selected for these repeat measurements.
Your child has not been selected for these repeat measurements.
WHAT ARE THE GOOD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
Being in this research may not help your child right now. When we finish the
study, we hope that we will know more about diabetes. This may help other
children with diabetes later on.
As part of this research you will receive blood and urine test results at no
charge. At your request, we will send copies of your child’s test results to your
child’s healthcare provider. This may allow the provider to change, if indicated,
how they take care of your child’s diabetes and to treat any complications that
may be present.
If you agree, your child’s results will be shared with your child’s provider(s).
I agree to have my child’s results shared with my
child’s healthcare provider.
__________initials
I do not agree to have my child’s results shared
with my child’s healthcare provider.
__________initials
WHAT ARE THE BAD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
The risks of drawing blood from a vein in the lower arm include mild pain,
bruising at the site of the blood draw, and occasionally fainting. To lower the
possibility of these risks, experienced medical staff will draw blood. A local
numbing medicine may be placed on the skin before the blood is drawn to
decrease any pain.
Your child will be fasting for 8-10 hours before your appointment. To help
prevent and treat low or high blood sugars, your child’s blood sugar will be
checked; and your child may take diabetes medicine or a fast-acting
carbohydrate as needed to control the blood sugar level.
Some of the tests will look for the presence or risk of developing the
complications of diabetes. If these tests identify complications of diabetes or
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risk of developing the complications, the results may make you or your child
anxious. If this happens, you or your child will be referred to local mental
health professionals for evaluation and treatment.
There are no known risks associated with the nerve tests. There are no known
risks associated with taking photographs of the eye. Although your child will
see a flash of light when the picture is taken, this flash is not harmful. People
who are light sensitive may experience some minor discomfort from the
camera flash, but the discomfort will not last. When the pen-shaped blood
vessel device is placed on your child’s skin your child may feel some pressure
for a few seconds.
There may be other risks that we do not know about yet.
WHAT OTHER CHOICES ARE THERE?
Instead of being in this study, you can choose not to have your child be in it.
HOW WILL INFORMATION ABOUT YOUR CHILD BE KEPT PRIVATE?
Making sure that information about your child remains private is important to
us. To protect your child’s privacy in this research study, we will assign a
special number to your child. This number will be used instead of your child’s
name to identify the information and laboratory tests collected during the study.
The list containing the special number assigned to your child is kept in a
password-protected database at CCHMC. Thus, no one other than Dr. Dolan
and his research team at CCHMC will be able to link any of the information
collected in the study to your child.
WILL IT COST YOU ANYTHING EXTRA FOR YOUR CHILD TO BE IN THE
RESEARCH STUDY?
Your time is valuable and, therefore, would be the most costly part of your
involvement in the study. The only other cost to you would be for transportation
to and from the study site.
WILL YOU/YOUR CHILD BE PAID TO BE IN THIS RESEARCH STUDY?
You and your child will be reimbursed for your time, effort and travel while you
are in this research study.
Your child will be paid $60 for completing the study visit and an extra $20 for
bringing in a 1st morning urine sample.
Parental Permission Version 5
Page 7 of 10
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
You will receive $40 for completing the study visit.
If you are able to complete only a portion of the study visit, you will be asked to
schedule a second visit to complete the remainder of the study procedures.
Based on the time spent at the visit, your payment will be pro-rated accordingly
for each visit.
We may ask your child to repeat one or both urine samples. Your child will be
paid an extra $20 for providing these urine samples.
WHAT HAPPENS IF YOUR CHILD IS INJURED FROM BEING IN THIS
STUDY?
If you believe that your child has been injured as a result of this research you
should contact Dr. Dolan as soon as possible to discuss the concerns.
Treatment for injuries is available at CCHMC. If your child goes to the
Emergency Room or to another hospital or doctor, it is important that you tell
them that your child is in a research study. If possible, you should give them a
copy of this parental permission form.
CCHMC follows a policy of making all decisions about compensation for the
medical treatment of physical injuries that happened during or were caused by
research on an individual basis.
WHO DO YOU CALL IF YOU HAVE QUESTIONS OR PROBLEMS?
For questions, concerns, or complaints about this research study you can
contact the study person listed on page 1 of this document. If you would like to
talk to someone that is not part of the research staff or if you have general
questions about your research study rights or questions, concerns, or
complaints about the research, you can call the CCHMC Institutional Review
Board at 513-636-8039.
AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION
FOR RESEARCH
To be in this research study you must also give your permission (or
authorization) to use and disclose (or share) your child’s “protected health
information” (called PHI for short).
What protected health information will be used and shared during this
study?
CCHMC will need to use and share your child’s PHI as part of this study. This
PHI will come from:
Parental Permission Version 5
Page 8 of 10
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
Your child’s CCHMC medical records
Your child’s research records
The types of information that will be used and shared from these records
include:
Laboratory test results, diagnosis, and medications
Reports and notes from clinical and research observations
Imaging (like CT scans, MRI scans, x-rays, etc.) studies and reports
If applicable, information concerning HIV testing or the treatment of AIDS or
AIDS-related conditions, drug or alcohol abuse, drug-related conditions,
alcoholism, and/or psychiatric/psychological conditions (but not
psychotherapy notes).
Who will share, receive and/or use your child’s protected health
information in this study?
Staff at all the research study sites (including CCHMC)
Personnel who provide services to your child as part of this study
Other individuals and organizations that need to use your child’s PHI in
connection with the research, including people at the sponsor and
organizations that the sponsor may use to oversee or conduct the study.
The members of the CCHMC Institutional Review Board and staff of the
Office of Research Compliance and Regulatory Affairs.
How will you know that your child’s PHI is not misused?
People that receive your child’s PHI as part of the research are generally
limited in how they can use your child’s PHI. In addition, most people who
receive your child’s PHI are also required by federal privacy laws to protect
your child’s PHI. However, some people that may receive your child’s PHI may
not be required to protect it and may share the information with others without
your permission, if permitted by the laws that apply to them.
Can you change your mind?
You may choose to withdraw your permission at any time. A withdrawal of
your permission to use and share your child’s PHI would also include a
withdrawal from participation in the research study. If you wish to withdraw
your permission to use and share your child’s PHI you need to notify the study
doctor, listed on the first page of this document, in writing. Your request will be
effective immediately and no new PHI about your child will be used or shared.
The only exceptions are (1) any use or sharing of PHI that has already
occurred or was in process prior to you withdrawing your permission and (2)
any use or sharing that is needed to maintain the integrity of the research.
Will this permission expire?
Your permission will expire at the end of the study. If the study involves the
creation or maintenance of a research database repository, this authorization
will not expire.
Parental Permission Version 5
Page 9 of 10
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
Will your child’s other medical care be impacted?
By signing this document you agree for child to participate in this research
study and give permission to CCHMC to use and share your child’s PHI for the
purpose of this research study. If you refuse to sign this document your child
will not be able to participate in the study. However, your child’s rights
concerning treatment not related to this study, payment for services, enrollment
in a health plan or eligibility of benefits will not be affected.
SIGNATURES
The research team has discussed this study with you and answered all of your
questions. Like any research, the researchers cannot predict exactly what will
happen. Once you have had enough time to consider whether your child
should participate in this research you will document your permission by
signature below.
You will receive a copy of this signed document for your records.
_____________________________________
Printed Name of Research Participant
_____________________________________
Signature of Research Participant
Indicating Consent or Assent
____________
Date
____________________________________
Signature of Parent or Legally Authorized
Representative*
____________
Date
_______________________________________________________________
* If signed by a legally authorized representative, a description of such
representative’s authority must be provided
_____________________________________
Signature of Individual Obtaining Consent
Parental Permission Version 5
Page 10 of 10
____________
Date
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
STUDY TITLE: SEARCH FOR DIABETES IN YOUTH
(STUDY VISIT: 2012 REGISTRY)
STUDY NUMBER: 2011-0407
FUNDING ORGANIZATION: Centers for Disease Control and Prevention;
National Institutes of Health
Lawrence Dolan, MD
Name of Principal Investigator
513-636-2444
Telephone Number
INTRODUCTION
We are asking you to be in a research study so we can learn new information
that may help others. If you decide not to be in this study, we will still take good
care of you. If you decide to be in this study, you may change your mind at
any time during the study and you can stop being in the study. Take all the
time you need to make your choice. Ask us any questions you have. It is also
okay to ask more questions after you decide to be in the study. You can ask
questions at any time.
WHY ARE WE DOING THIS RESEARCH?
In this research study we want to learn more about diabetes in people less
than 20 years of age.
We are asking you and others with diabetes to be in the research, because we
want to count the number of children and teens with diabetes. We also want to
learn more about all the types of diabetes that affect children and teens.
WHO IS IN CHARGE OF THE RESEARCH?
Dr. Lawrence Dolan is the researcher at Cincinnati Children’s Hospital Medical
Center (CCHMC) who is in charge of this study.
CCHMC is being paid by the CDC (Centers for Disease Control and
Prevention) and the NIH (National Institutes of Health) to do this study.
Adult Consent Version 4
Page 1 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
WHO SHOULD NOT BE IN THE STUDY
You cannot be in this study if you do not have diabetes.
• If you are pregnant, you will not be able to take part in the study visit
until 4 months after delivery or end of the pregnancy.
WHAT WILL HAPPEN IN THE STUDY?
The research staff will explain the visit to you. You will be able to ask
questions to make sure you understand what will happen to you.
If you qualify and you decide you want to be in the study, you will come to
CCHMC one time. This visit will last about one hour. You may be contacted
once a year by mail to update any changes in your address or phone number.
If your address/phone number has changed, we may attempt to update your
contact information through a public database, such as LexisNexis.
These are the things that will happen to you while in the study:
•
•
•
•
•
•
Fast for 8-10 hours before the visit (no food or drinks, except water)
Bring in a urine sample to be tested for albumin and creatinine to see
how well your kidneys are working
Measure height, weight, waist, and blood pressure. Each will be done
2-3 times.
Look at skin on back of neck
Another urine sample will be collected during your visit. It will also be
tested for albumin and creatinine.
Blood will be taken from your arm or hand to measure blood sugar,
hemoglobin A1c (measures average blood sugar over past 3 months),
c-peptide (measures your own insulin production), creatinine (measures
kidney function), different types of cholesterol (fat), and diabetes
antibodies (markers in the blood for type 1 diabetes). The amount of
blood needed for these tests is about 4 teaspoons.
If you agree, extra blood will be collected and saved for the duration of the
study. This blood may be used in the future as new tests are developed to
tell your type of diabetes and your risk of developing the complications of
diabetes, insulin resistance (insulin is not working as well as it should), and
being overweight. The amount of blood needed is about 3¾ teaspoons.
I agree to have my blood and urine stored.
__________initials
I do not agree to have my blood and urine stored.
__________initials
Adult Consent Version 4
Page 2 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
If you agree, extra blood will be collected for DNA. This blood sample may
be tested to identify your genetic makeup. This blood sample or the test
results may be sent to a national storage center to help researchers better
understand how genes affect the risk of developing diseases such as
asthma, cancer, diabetes, and heart disease. When your blood or test
results and clinical information are sent to the storage center, no personal
information, such as your name, date of birth, or address will be included.
Thus, researchers will not be able to link this information back to you. The
amount of blood needed is about 1¾ teaspoons.
I agree to have my blood stored and tested for DNA. __________initials
I do not agree to have my blood stored and tested
for DNA.
•
•
__________initials
After the blood test is done, you will be given breakfast. You may take
your diabetes medicine at that time.
You will be asked questions about your diabetes, medical care, current
medications, family history of diabetes, education, family income level,
and health insurance.
WHAT ARE THE GOOD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
Being in this research may not help you right now. When we finish the study,
we hope that we will know more about diabetes. This may help others with
diabetes later on.
As part of this research you will receive blood and urine test results at no
charge. At your request, we will send copies of your test results to your
healthcare provider. This may allow the provider to change, if indicated, how
they take care of your diabetes and to treat any complications that may be
present.
If you agree, your results will be shared with your provider(s).
I agree to have my results shared with my
healthcare provider.
__________initials
I do not agree to have my results shared with my
healthcare provider.
__________initials
WHAT ARE THE BAD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
The risks of drawing blood from a vein in the lower arm include mild pain,
Adult Consent Version 4
Page 3 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
bruising at the site of the blood draw, and occasionally fainting. To lower the
possibility of these risks, experienced medical staff will draw blood. A local
numbing medicine may be placed on the skin before the blood is drawn to
decrease any pain.
You will be fasting for 8-10 hours before your appointment. To help prevent
and treat low or high blood sugars, your blood sugar will be checked; and you
may take diabetes medicine or a fast-acting carbohydrate as needed to control
the blood sugar level.
Some of the tests will look for the presence or risk of developing the
complications of diabetes. If these tests identify complications of diabetes or
risk of developing the complications, the results may make you anxious. If this
happens, you will be referred to a local mental health professional for
evaluation and treatment.
There may be other risks that we do not know about yet.
WHAT OTHER CHOICES ARE THERE?
Instead of being in this study, you can choose not to be in it.
HOW WILL INFORMATION ABOUT YOU BE KEPT PRIVATE?
Making sure that information about you remains private is important to us. To
protect your privacy in this research study, we will assign a special number to
you. This number will be used instead of your name to identify the information
and laboratory tests collected during the study. The list containing the special
number assigned to you is kept in a password-protected database at CCHMC.
Thus, no one other than Dr. Dolan and his research team at CCHMC will be
able to link any of the information collected in the study to you.
WILL IT COST YOU ANYTHING EXTRA FOR YOU TO BE IN THE
RESEARCH STUDY?
Your time is valuable and, therefore, would be the most costly part of your
involvement in the study. The only other cost to you would be for transportation
to and from the study site.
WILL YOU BE PAID TO BE IN THIS RESEARCH STUDY?
You will be reimbursed for your time, effort and travel while you are in this
research study.
Adult Consent Version 4
Page 4 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
You will be paid $60 for completing the study visit and an extra $20 for bringing
in a 1st morning urine sample.
We may ask you to repeat one or both urine samples. You will be paid an
extra $20 for providing these urine samples.
WHAT HAPPENS IF YOU ARE INJURED FROM BEING IN THIS STUDY?
If you believe you have been injured as a result of this research you should
contact Dr. Dolan as soon as possible to discuss the concerns. Treatment for
injuries is available at CCHMC. If you go to the Emergency Room or to
another hospital or doctor, it is important that you tell them that you are in a
research study. If possible, you should give them a copy of this consent form.
CCHMC follows a policy of making all decisions about compensation for the
medical treatment of physical injuries that happened during or were caused by
research on an individual basis.
WHO DO YOU CALL IF YOU HAVE QUESTIONS OR PROBLEMS?
For questions, concerns, or complaints about this research study you can
contact the study person listed on page 1 of this document. If you would like to
talk to someone that is not part of the research staff or if you have general
questions about your research study rights or questions, concerns, or
complaints about the research, you can call the CCHMC Institutional Review
Board at 513-636-8039.
AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION
FOR RESEARCH
To be in this research study you must also give your permission (or
authorization) to use and disclose (or share) your “protected health
information” (called PHI for short).
What protected health information will be used and shared during this
study?
CCHMC will need to use and share your PHI as part of this study. This PHI
will come from:
Your CCHMC medical records
Your research records
The types of information that will be used and shared from these records
include:
Laboratory test results, diagnosis, and medications
Adult Consent Version 4
Page 5 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
Reports and notes from clinical and research observations
Imaging (like CT scans, MRI scans, x-rays, etc.) studies and reports
If applicable, information concerning HIV testing or the treatment of AIDS or
AIDS-related conditions, drug or alcohol abuse, drug-related conditions,
alcoholism, and/or psychiatric/psychological conditions (but not
psychotherapy notes).
Who will share, receive and/or use your protected health information in
this study?
Staff at all the research study sites (including CCHMC)
Personnel who provide services to you as part of this study
Other individuals and organizations that need to use your PHI in connection
with the research, including people at the sponsor and organizations that
the sponsor may use to oversee or conduct the study.
The members of the CCHMC Institutional Review Board and staff of the
Office of Research Compliance and Regulatory Affairs.
How will you know that your PHI is not misused?
People that receive your PHI as part of the research are generally limited in
how they can use your PHI. In addition, most people who receive your PHI are
also required by federal privacy laws to protect your PHI. However, some
people that may receive your PHI may not be required to protect it and may
share the information with others without your permission, if permitted by the
laws that apply to them.
Can you change your mind?
You may choose to withdraw your permission at any time. A withdrawal of
your permission to use and share your PHI would also include a withdrawal
from participation in the research study. If you wish to withdraw your
permission to use and share your PHI you need to notify the study doctor,
listed on the first page of this document, in writing. Your request will be
effective immediately and no new PHI about you will be used or shared. The
only exceptions are (1) any use or sharing of PHI that has already occurred or
was in process prior to you withdrawing your permission and (2) any use or
sharing that is needed to maintain the integrity of the research.
Will this permission expire?
Your permission will expire at the end of the study. If the study involves the
creation or maintenance of a research database repository, this authorization
will not expire.
Will your other medical care be impacted?
By signing this document you agree to participate in this research study and
give permission to CCHMC to use and share your PHI for the purpose of this
research study. If you refuse to sign this document you will not be able to
participate in the study. However, your rights concerning treatment not related
Adult Consent Version 4
Page 6 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
to this study, payment for services, enrollment in a health plan or eligibility of
benefits will not be affected.
SIGNATURES
The research team has discussed this study with you and answered all of your
questions. Like any research, the researchers cannot predict exactly what will
happen. Once you have had enough time to consider whether you should
participate in this research you will document your permission by signature
below.
You will receive a copy of this signed document for your records.
_____________________________________
Printed Name of Research Participant
_____________________________________
Signature of Research Participant
Indicating Consent
____________
Date
____________________________________
Signature of Legally Authorized
Representative*
____________
Date
_______________________________________________________________
* If signed by a legally authorized representative, a description of such
representative’s authority must be provided
_____________________________________
Signature of Individual Obtaining Consent
Adult Consent Version 4
Page 7 of 7
____________
Date
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
STUDY TITLE: SEARCH FOR DIABETES IN YOUTH
(STUDY VISIT: 2012 REGISTRY)
STUDY NUMBER: 2011-0407
FUNDING ORGANIZATION: Centers for Disease Control and Prevention;
National Institutes of Health
Lawrence Dolan, MD
Name of Principal Investigator
513-636-2444
Telephone Number
INTRODUCTION
We are asking for your permission for your child to be in a research study so
we can learn new information that may help others. If you decide not to give
your permission for your child to be in this study, we will still take good care of
him/her. If you decide to allow your child to be in this study, you may change
your mind at any time during the study and your child can stop being in the
study. Take all the time you need to make your choice. Ask us any questions
you have. It is also okay to ask more questions after you decide to allow your
child to be in the study. You can ask questions at any time.
WHY ARE WE DOING THIS RESEARCH?
In this research study we want to learn more about diabetes in people less
than 20 years of age.
We are asking your child and other children with diabetes to be in the research,
because we want to count the number of children and teens with diabetes. We
also want to learn more about all the types of diabetes that affect children and
teens.
WHO IS IN CHARGE OF THE RESEARCH?
Dr. Lawrence Dolan is the researcher at Cincinnati Children’s Hospital Medical
Center (CCHMC) who is in charge of this study.
CCHMC is being paid by the CDC (Centers for Disease Control and
Prevention) and the NIH (National Institutes of Health) to do this study.
Parental Permission Version 4
Page 1 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
WHO SHOULD NOT BE IN THE STUDY
Your child cannot be in this study if your child does not have diabetes.
• If your child is pregnant, she will not be able to take part in the study
visit until 4 months after delivery or end of the pregnancy.
WHAT WILL HAPPEN IN THE STUDY?
The research staff will explain the visit to you. You will be able to ask
questions to make sure you understand what will happen to your child.
If your child qualifies and you decide you want your child to be in the study,
your child will come to CCHMC one time. This visit will last about one hour.
You may be contacted once a year by mail to update any changes in your
address or phone number. If your address/phone number has changed, we
may attempt to update your contact information through a public database,
such as LexisNexis.
These are the things that will happen to your child while in the study:
•
•
•
•
•
•
Fast for 8-10 hours before the visit (no food or drinks, except water)
Bring in a urine sample to be tested for albumin and creatinine to see
how well your child’s kidneys are working
Measure height, weight, waist, and blood pressure. Each will be done
2-3 times.
Look at skin on back of neck
Another urine sample will be collected during your visit. It will also be
tested for albumin and creatinine.
Blood will be taken from your child’s arm or hand to measure blood
sugar, hemoglobin A1c (measures average blood sugar over past 3
months), c-peptide (measures your child’s own insulin production),
creatinine (measures kidney function), different types of cholesterol (fat),
and diabetes antibodies (markers in the blood for type 1 diabetes). The
amount of blood needed for these tests is between ½ and 3½
teaspoons. Smaller amounts will be used for very young children.
If you agree, extra blood will be collected and saved for the duration of the
study. This blood may be used in the future as new tests are developed to
tell your child’s type of diabetes and your child’s risk of developing the
complications of diabetes, insulin resistance (insulin is not working as well
as it should), and being overweight. The amount of blood needed is about
3¾ teaspoons.
Parental Permission Version 4
Page 2 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
I agree to have my child’s blood and urine stored.
__________initials
I do not agree to have my child’s blood and urine
stored.
__________initials
If you agree, extra blood will be collected for DNA. This blood sample may
be tested to identify your child’s genetic makeup. This blood sample or the
test results may be sent to a national storage center to help researchers
better understand how genes affect the risk of developing diseases such as
asthma, cancer, diabetes, and heart disease. When your child’s blood or
test results and clinical information are sent to the storage center, no
personal information, such as your child’s name, date of birth, or address
will be included. Thus, researchers will not be able to link this information
back to your child. The amount of blood needed is about 1¾ teaspoons.
•
•
I agree to have my child’s blood stored and tested
for DNA.
__________initials
I do not agree to have my blood stored and tested
for DNA.
__________initials
After the blood test is done, your child will be given breakfast. Your
child may take his/her diabetes medicine at that time.
You will be asked questions about your child’s diabetes, medical care,
current medications, family history of diabetes, education, family income
level, and health insurance.
WHAT ARE THE GOOD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
Being in this research may not help your child right now. When we finish the
study, we hope that we will know more about diabetes. This may help other
children with diabetes later on.
As part of this research you will receive blood and urine test results at no
charge. At your request, we will send copies of your child’s test results to your
child’s healthcare provider. This may allow the provider to change, if indicated,
how they take care of your child’s diabetes and to treat any complications that
may be present.
If you agree, your child’s results will be shared with your child’s provider(s).
I agree to have my child’s results shared with my
child’s healthcare provider.
__________initials
I do not agree to have my child’s results shared
with my child’s healthcare provider.
__________initials
Parental Permission Version 4
Page 3 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
WHAT ARE THE BAD THINGS THAT CAN HAPPEN FROM THIS
RESEARCH?
The risks of drawing blood from a vein in the lower arm include mild pain,
bruising at the site of the blood draw, and occasionally fainting. To lower the
possibility of these risks, experienced medical staff will draw blood. A local
numbing medicine may be placed on the skin before the blood is drawn to
decrease any pain.
Your child will be fasting for 8-10 hours before your appointment. To help
prevent and treat low or high blood sugars, your child’s blood sugar will be
checked; and your child may take diabetes medicine or a fast-acting
carbohydrate as needed to control the blood sugar level.
Some of the tests will look for the presence or risk of developing the
complications of diabetes. If these tests identify complications of diabetes or
risk of developing the complications, the results may make you or your child
anxious. If this happens, you or your child will be referred to local mental
health professionals for evaluation and treatment.
There may be other risks that we do not know about yet.
WHAT OTHER CHOICES ARE THERE?
Instead of being in this study, you can choose not to have your child be in it.
HOW WILL INFORMATION ABOUT YOUR CHILD BE KEPT PRIVATE?
Making sure that information about your child remains private is important to
us. To protect your child’s privacy in this research study, we will assign a
special number to your child. This number will be used instead of your child’s
name to identify the information and laboratory tests collected during the study.
The list containing the special number assigned to your child is kept in a
password-protected database at CCHMC. Thus, no one other than Dr. Dolan
and his research team at CCHMC will be able to link any of the information
collected in the study to your child.
WILL IT COST YOU ANYTHING EXTRA FOR YOUR CHILD TO BE IN THE
RESEARCH STUDY?
Your time is valuable and, therefore, would be the most costly part of your
involvement in the study. The only other cost to you would be for transportation
to and from the study site.
Parental Permission Version 4
Page 4 of 7
IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
WILL YOU/YOUR CHILD BE PAID TO BE IN THIS RESEARCH STUDY?
You and your child will be reimbursed for your time, effort and travel while you
are in this research study.
Your child will be paid $40 for completing the study visit and an extra $20 for
bringing in a 1st morning urine sample.
You will receive $20 for completing the study visit.
We may ask your child to repeat one or both urine samples. Your child will be
paid an extra $20 for providing these urine samples.
WHAT HAPPENS IF YOUR CHILD IS INJURED FROM BEING IN THIS
STUDY?
If you believe that your child has been injured as a result of this research you
should contact Dr. Dolan as soon as possible to discuss the concerns.
Treatment for injuries is available at CCHMC. If your child goes to the
Emergency Room or to another hospital or doctor, it is important that you tell
them that your child is in a research study. If possible, you should give them a
copy of this parental permission form.
CCHMC follows a policy of making all decisions about compensation for the
medical treatment of physical injuries that happened during or were caused by
research on an individual basis.
WHO DO YOU CALL IF YOU HAVE QUESTIONS OR PROBLEMS?
For questions, concerns, or complaints about this research study you can
contact the study person listed on page 1 of this document. If you would like to
talk to someone that is not part of the research staff or if you have general
questions about your research study rights or questions, concerns, or
complaints about the research, you can call the CCHMC Institutional Review
Board at 513-636-8039.
AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION
FOR RESEARCH
To be in this research study you must also give your permission (or
authorization) to use and disclose (or share) your child’s “protected health
information” (called PHI for short).
What protected health information will be used and shared during this
study?
Parental Permission Version 4
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IRB #: 2011-0407
Approved:
1/23/2014
Do Not Use After:
1/22/2015
CCHMC will need to use and share your child’s PHI as part of this study. This
PHI will come from:
Your child’s CCHMC medical records
Your child’s research records
The types of information that will be used and shared from these records
include:
Laboratory test results, diagnosis, and medications
Reports and notes from clinical and research observations
Imaging (like CT scans, MRI scans, x-rays, etc.) studies and reports
If applicable, information concerning HIV testing or the treatment of AIDS or
AIDS-related conditions, drug or alcohol abuse, drug-related conditions,
alcoholism, and/or psychiatric/psychological conditions (but not
psychotherapy notes).
Who will share, receive and/or use your child’s protected health
information in this study?
Staff at all the research study sites (including CCHMC)
Personnel who provide services to your child as part of this study
Other individuals and organizations that need to use your child’s PHI in
connection with the research, including people at the sponsor and
organizations that the sponsor may use to oversee or conduct the study.
The members of the CCHMC Institutional Review Board and staff of the
Office of Research Compliance and Regulatory Affairs.
How will you know that your child’s PHI is not misused?
People that receive your child’s PHI as part of the research are generally
limited in how they can use your child’s PHI. In addition, most people who
receive your child’s PHI are also required by federal privacy laws to protect
your child’s PHI. However, some people that may receive your child’s PHI may
not be required to protect it and may share the information with others without
your permission, if permitted by the laws that apply to them.
Can you change your mind?
You may choose to withdraw your permission at any time. A withdrawal of
your permission to use and share your child’s PHI would also include a
withdrawal from participation in the research study. If you wish to withdraw
your permission to use and share your child’s PHI you need to notify the study
doctor, listed on the first page of this document, in writing. Your request will be
effective immediately and no new PHI about your child will be used or shared.
The only exceptions are (1) any use or sharing of PHI that has already
occurred or was in process prior to you withdrawing your permission and (2)
any use or sharing that is needed to maintain the integrity of the research.
Will this permission expire?
Your permission will expire at the end of the study. If the study involves the
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IRB #: 2011-0407
Approved:
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Do Not Use After:
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creation or maintenance of a research database repository, this authorization
will not expire.
Will your child’s other medical care be impacted?
By signing this document you agree for child to participate in this research
study and give permission to CCHMC to use and share your child’s PHI for the
purpose of this research study. If you refuse to sign this document your child
will not be able to participate in the study. However, your child’s rights
concerning treatment not related to this study, payment for services, enrollment
in a health plan or eligibility of benefits will not be affected.
SIGNATURES
The research team has discussed this study with you and answered all of your
questions. Like any research, the researchers cannot predict exactly what will
happen. Once you have had enough time to consider whether your child
should participate in this research you will document your permission by
signature below.
You will receive a copy of this signed document for your records.
_____________________________________
Printed Name of Research Participant
_____________________________________
Signature of Research Participant
Indicating Consent or Assent
____________
Date
____________________________________
Signature of Parent or Legally Authorized
Representative*
____________
Date
_______________________________________________________________
* If signed by a legally authorized representative, a description of such
representative’s authority must be provided
_____________________________________
Signature of Individual Obtaining Consent
Parental Permission Version 4
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____________
Date
Washington
Consents
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
PARENTAL PERMISSION FORM
CONSENT FORM: Ages 18 and up
ASSENT FORM: Ages 14-17
COHORT VISIT
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
The Research Team:
Name/Degree
Title
Department
Catherine Pihoker, MD
Lenna Liu, MD MPH
Maryam Afkarian, MD
Irl Hirsch, MD
Joyce Yi-Frazier, PhD
Carla Greenbaum, MD
Martin Goldsmith, MD
Beth Babler, ARNP
Patricia Fechner, MD
Christian Roth, MD
Ildi Koves, MD
Craig Taplin, MD
Kate Ness, MD
Carolina DiBlasi, MD
Jason Mendoza, MD MPH
Erin Alving, ARNP
Karen Aitken, ARNP
Sara Benitez, PA
Gwyn Recupero, PA
Beth Loots, MPH MSW
Sue Kearns, RN
Mary Klingsheim, RN BSN
Principal Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Research Manager
Study Coordinator
Study Coordinator
Endocrinology
Pediatrics
Nephrology
Medicine
Endocrinology
Benaroya Res Instit
Peds Northwest
Mary Bridge
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
CHBD
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Phone
Number
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 884-1261
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206-987-2540
206 987-2540
206 987-2540
Template Version: 6/10/2014
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Name/Degree
Title
Department
Jessica Fosse, MPH RN
BSN
Study Coordinator
Endocrinology
Phone
Number
206 987-2540
Clinical Research
Associate
Clinical Research
Associate
Clinical Research
Associate
Clinical Research
Associate
Clinical Research
Associate
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Katherine Cochrane, BS
Patricia D’Alessandro, MA
Michael Pascual, BA
Connor Mitrovich, BA
Natalie Beauregard, BA
If you have questions about your rights as a research study participant, you can call the
Multicare Health System Institutional Review Board (IRB) at 253-403-3844.
24 hour Emergency Contact Number: 206 987-2000 Ask for the Endocrinologist on call
1. Researchers’ Statement:
You have the option to take part in a research study. The goals of this form are to give
you information about what would happen in the study if you choose to take part and to
help you decide if you want to be in the study.
Feel free to take notes, write questions or highlight any part of this form.
Potential Participants 18 years and older: This is a consent form. It provides a summary of
the information the research team will discuss with you. If you decide that you would like to take
part in this research study, you would sign this form to confirm your decision. If you sign this
form, you will receive a signed copy of this form for your records.
Potential Teen Participants: This form also serves as an assent form. That means that if you
choose to take part in this research study, you would sign this form to confirm your choice. Your
parent or guardian would also need to give their permission and sign this form for you to join the
study.
Parents/Guardians: You have the option of having your child or teen join a research study.
This is a parental permission form. It provides a summary of the information the research team
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
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Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
will discuss with you. If you decide that your child can take part in this study, you would sign
this form to confirm your decision. If you sign this form, you will receive a signed copy for your
records.
The word “you” in this form refers to your child/teen.
Joining the study as a parent:
Parents also have the option to take part in this research study. There is a page at the end of
this form explaining what it would mean to participate as a parent.
2. What you should know about this study:
•
•
•
•
•
•
•
•
This form explains what would happen if you join this research study.
Please read it carefully. Take as much time as you need.
Please ask the research team questions about anything that is not clear.
You can ask questions about the study any time.
If you choose not to be in the study, it will not affect your care at Seattle Children’s.
If you say ‘Yes’ now, you can still change your mind later.
You can quit the study at anytime.
You would not lose benefits or be penalized if you decide not to take part in the study or to
quit the study later.
3. What is the goal of this study?
Diabetes is the third most common chronic or ongoing disease in individuals under 20 years of
age. The total number of cases of diabetes in this age group is increasing, and types of
diabetes that have not been seen in young people are now being seen. These changes have
resulted in gaps in our knowledge about the total number of cases and types of diabetes in the
United States, the type of care young people with diabetes receive, the complications they
experience, and the effect diabetes has on their lives.
The goal of any research study is to answer questions. We (the research team listed on the
front of this form and our staff) are doing this research study to answer the following questions:
•
•
•
How common are long-term complications related to diabetes, including: retinopathy
(damage to back of the eye), nephropathy (kidney damage), neuropathy (nerve
damage), and damage to the heart and blood vessels?
How common are short-term complications, including hypoglycemia (low blood sugar)
and diabetic ketoacidosis (DKA)?
What type of medical care are young people with diabetes receiving, and how does
diabetes affect the lives of these individuals?
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
4. Why do I have the option of joining the study?
You have the option to take part in this research study because you have completed a SEARCH
baseline in-person visit and have had diabetes for (about) 5 years or more.
5. How many people will take part in the study?
We think that about 610 people will take part in the SEARCH cohort visit at Seattle Children’s.
A total of about 3,900 people will take part in the cohort visit at hospitals and clinics around the
country.
6. If I agree to join this study, what would I need to do?
The cohort study visit includes:
• Blood draw
• Urine collections
• Brief physical exam
• Questionnaires
• Nerve tests
• Blood vessel test
• Eye test
• Medical record review
• Follow up contact
Blood Draw and Urine Collection
You/your child would be scheduled for an in-person study visit(s) at the Clinical Research
Center at Seattle Children’s or at another SEARCH outreach clinic. We would work with you to
schedule 1 or 2 visits to complete the cohort study measurements at time(s) that are convenient
for you. At least one of these visits would be a "fasting" visit, which means that no food or
fluids, other than water, could be consumed for at least 8 hours before coming to your visit.
You/your child would be asked not to take insulin or other diabetes medications the morning
before the test, except for basal insulin, which should be taken as usual. If you come to the visit
nonfasting, we might ask you to return another day to redraw all or part of the blood sample.
Before your scheduled appointment, you would receive a container with detailed instructions to
collect one urine sample at home the morning of your visit. We will ask that you collect the urine
from the first time you urinate in the morning. You would be asked to bring this urine sample
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
with you to your visit. Your urine would be tested for microalbumin (small particles of protein) to
see how well your kidneys are working.
When you arrive at your appointment, we would review the consent/assent form(s). This would
take about 20 – 30 minutes. If you/your child would like a numbing agent for the blood draw,
this part may take about an additional 30 minutes.
A blood sample would be drawn from your/your child's arm to measure blood sugar, hemoglobin
A1c (a test measuring your/your child’s average blood glucose level over the past 3 months), Cpeptide (a measure of your/your child's own insulin production), different types of cholesterol
(fat), islet cell antibodies (markers in the blood for type 1 diabetes), and several blood markers
associated with risk for developing heart disease or stroke. Based on age and size, the amount
of blood that would be needed for this would be between 1 teaspoon and 3 tablespoons.
If possible, we would collect all blood samples at the same time that a routine blood draw would
be done. If you/your child take part in more than one research study at the same visit, we would
try to combine tests and results when we can.
A urine sample would also be obtained during the visit and tested for several markers
associated with the risk of diabetes complications, such as heart disease and stroke.
The SEARCH study would like to keep some of the blood and urine that would be collected
during the study but is not used for other tests. Should we have questions about some of tests,
the storage sample would allow us to repeat the tests without needing to ask for a second blood
draw from you/your child. In addition, we would like to collect another sample of blood for
storage for future research.
We will also ask your permission to obtain and store a sample of blood to look at DNA, the
genetic material that is found in all of your cells. Researchers may look at specific genes, or
they may look at all of your genes together. If researchers were to look at specific genes, you
have the option of receiving the results of this testing if it would effect your clinical care.
However, if they were to look at all of your genes together, you would not receive the results.
The information researchers find out about your DNA would be sent to a national storage center
called dbGaP (part of the National Institutes of Health) to help researchers better understand
how genes affect the risk of developing diseases such as asthma, cancer, diabetes, and heart
disease. When your DNA and clinical information would be sent to the storage center, no
personal information would be included, such as your name, date of birth, or address. Thus,
researchers would not be able to link this information back to you. The research that would be
done with your blood and urine samples would not be designed to specifically help you. It might
help people who have diabetes and other diseases in the future.
The total amount of blood that would be needed for the storage sample would be 1 teaspoon for
young children and up to 2 tablespoons for older children, dependent on age and weight. This
part of the visit would take 10 – 20 minutes.
The total volume of blood for this visit would be up to approximately 3 tablespoons.
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
After the fasting blood and urine samples are collected, a free snack and/or meal or meal
voucher would be provided and you/your child would also take your routine medication.
Physical Exam
A trained member of the research team would perform a brief physical examination including:
height, weight, waist measurements, blood pressure, and examination of the skin of the neck.
The time to complete this exam would be about 20 minutes.
Nerve Tests
The purpose of these tests is to learn more about nerve damage in people with diabetes. We
would ask you not to exercise heavily the day before the tests. If you get sick or get very upset
in the day or two before the tests, or you eat or drink things that may affect the tests, we may
ask you to reschedule these tests.
These are the nerve tests:
1) MNSI, or Michigan Neuropathy Screening Instrument, is a 1-page survey and a brief foot
exam.
You would fill out the survey yourself; it has 15 “yes or no” questions about pain, numbness, and
temperature sensitivity in your legs and feet.
The foot exam is short and tests for your vibration sense, your reflexes, and your sensitivity to
monofilaments. Monofilaments are just small pieces of lightweight plastic, much like fishing
lines. The study coordinator would first test your vibration sense by placing a vibrating
instrument on your big toe. They would then use a rubber “hammer” to test the reflexes in your
ankle. These tests are not painful, and your regular doctor has probably used them with you
before. Finally, the study coordinator would place a monofilament on your toe to test your
sense of touch. These small pieces of plastic are not painful. The study coordinator would just
ask you if you could feel them on your toe or not.
The MNSI would take about 10 minutes to complete.
2) HRV, or Heart Rate Variability, would find out the health of your heart nerves. The test uses
an ECG, or electrocardiogram. This is a test that doctors regularly use to study the heart, and
your doctor may have used it with you before. The study coordinator would apply three
electrode stickers (special stickers that help transmit information) on your wrists and left
ankle/leg. These pads would be attached to wires and would record your heartbeat. During the
test, you would simply breathe normally for ten minutes while the ECG records your heartbeat.
The Heart Rate Variability test would take about 20 minutes to complete.
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
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Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Blood Vessel Test
We would perform a test to measure how your blood vessels function. This test is called an
arterial stiffness test. You/your child would be asked to remove your outer clothing and to put
on a patient gown if you are not wearing loose-fitting shorts. A trained study coordinator would
check your pulse on your upper, inner thigh (groin), but would not expose private parts. A
chaperone would be present during these procedures.
The following test would then be performed:
The study coordinator would measure the distance from your neck to the top of your sternum
(breast bone), from your neck to your wrist, from your sternum to your belly button, from your
belly button to your groin, and from your groin to your foot. The electrode pads would be left in
place on your wrists and leg during this part of the test.
Your wrist would be touched with a small instrument shaped like a pen; and the stiffness of your
blood vessels would be measured. This instrument detects pressure changes with a tiny,
highly-sensitive pressure sensor in the flat end of the device that is shaped like a pencil eraser.
It does not use radiation (X-rays), sound waves (ultrasound), or needles. This test would be
repeated 3 times.
Then the same pen-shaped instrument would be touched on the side of your neck, your groin,
and your foot to measure the speed of your pulse. This test would be repeated 3 times.
The blood vessel test would take about one hour. After the test you would receive a meal or
meal voucher.
Eye Test
You/your child would be asked about your eyes and your eye doctor if you have one.
We would take 2 pictures of each of your/your child’s eyes. You/your child would be asked to sit
in front of a special camera and place your chin in a chin rest. The study coordinator would
darken the room so that your pupils would dilate (open) and we could align and focus the
camera on your retina (the back of your eye). No drops would be put in your eyes, and the
camera would not touch your eye. The study coordinator would sit on the other side of the
camera to record information into a computer and prepare the camera. While we do this, you
would see some small red bars and a multi-colored “x” in the camera lens. We would ask you to
look at the “x”. Just before we take the pictures, we would ask you to blink your eyes and then
open them really wide. The camera would flash a light from within the camera lens as the
picture is taken. This flash does not hurt the eye. Just after the picture is taken, you may see a
blue or red circular spot in front of your eye. This spot would not harm you and would go away
in about 5 to 7 minutes. We would wait a little while until your eyes dilate (open) again, and
then we would take another picture of this eye. We would then take 2 pictures of your other
eye. We might need to take extra pictures if the first ones don’t come out OK.
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
These pictures would be sent to the Ocular Epidemiology Reading Center in Madison,
Wisconsin to be read by trained eye specialists who would study the blood vessels and look for
any unusual changes.
Doing the eye test would take about 30 minutes.
Questionnaires
You/your child would answer questions about the effects of diabetes on your/your child's lives,
including current medications, personal and family medical history, financial information, the
type of diabetes education available, health insurance, diabetes self-care habits, diet and
household food availability and food assistance, your/your child’s self-report on stage of
puberty, and information about your/your child's medical care. If you are 18 years old or older,
we would also ask about your employment and income. If it looks like it is difficult for you to
access food, we may refer you to a social worker to help you find available resources.
If you are 10 years of age or older, you would be asked to answer additional questions about
physical activity, smoking, alcohol, eating, and depression. You would also be asked about the
food that is available to eat and how it makes you feel. Some of the questions may be sensitive,
for example, there are questions about mood, how well you/your child get along in school, how
you/your child gets along with family, friends, and others.
You/your child are free to not answer any questions you don't want to answer, and may stop the
interview at any time. If you/your child decide not to answer any of the questions, you can still
take part in the rest of the research study.
One of the questionnaires assesses risk for depression, and it would be scored while you are at
your/your child’s appointment. If you/your child scores in a range at risk for depression that
result would be shared with your parent/you and a referral list would be shared with you if you
need it.
These questionnaires would take 55 – 65 minutes to complete.
Medical Records Review
We ask your permission for the researchers involved in this study to review your/your child's
medical record. Any information obtained from the medical charts is for use in this research
study only. It may be necessary to review your diabetes-related inpatient and outpatient
medical records. These records may include, but are not limited to visit notes, progress notes,
discharge summaries, consultation notes, medication records, history and physical, emergency
room records, and lab and other test reports.
Follow up
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
We will send you requests to update your contact information about every year. Part of this
update includes a question about your/your child’s social security number, which we will use to
track mortality among SEARCH study participants. If this study is expanded, or if other diabetes
studies are developed, we may contact you/your child in the future to ask if you/your child want
to participate further. As with this study, taking part in any future study is voluntary.
7. How long would I be in the study?
The study is currently funded through September 2015.
The total time to complete the cohort visit would be about 3 ½ to 4 hours. You may complete
the visit on one or two days, based on your preference and the research staff’s availability. You
may be able to complete some of the questionnaires at home or over the phone to shorten the
length of the in-person visit.
If you join the study, you can decide to stop at any time for any reason. Please discuss your
decision to stop with Dr. Pihoker or the research team.
If you would like your/your child’s stored samples removed from storage, we would send a
request to the central laboratory. They would then destroy the sample, and send us a letter
certifying that the sample has been destroyed. We would send you a copy of this letter.
The research study doctor could also decide to take you out of this study. This might happen if
we find out that it is not safe for you to stay in the study. Or it might happen if you cannot
complete to enough of the study elements. If we ask you to leave the study, we would always
explain why.
8. What are the potential harms or risks if I join this study?
If you feel uncomfortable at any time during any of these tests, just tell the study coordinator and
they would immediately stop the tests. All reasonable precautions would be taken to reduce
risks.
Some of the questions we ask may be sensitive in nature and may make you feel embarrassed
or upset. You are free to not answer any questions you don't want to answer, and you may stop
taking any survey at any time. If you decide not to answer any of the questions, you can still
take part in the rest of the research study.
When taking a blood sample, there may be brief discomfort, and a bruise may form where the
needle poke occurs. To reduce the possibility of these risks, a local anesthetic (numbing cream
or liquid) may be applied to the skin before blood is taken.
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
The blood tests require that you/your child not have any food or fluids overnight, other than
water. In order to prevent low or high blood sugars, you/your child’s blood sugar would be
checked by finger-stick and your diabetes medication would be given as needed to control
your/your child’s blood sugar.
Some of the tests would look for the presence of health problems associated with diabetes,
such as high cholesterol. If researchers find signs of these health problems, it may cause
you/your child some anxiety or concern. If this happens, you/your child would be referred to the
appropriate local health professionals for evaluation and treatment.
There are no majors risks associated with the MNSI foot exam. All of the devices used (a reflex
hammer, a tuning fork, and a monofilament) are used daily in doctors’ offices; your doctor has
probably used them with you before. The tests are not painful, but some people may be slightly
anxious or uncomfortable when these instruments are used.
There are no major risks associated with the Heart Rate Variability nerve test. ECGs are used
daily in hospitals; you may have had one before. No electrical current is sent through the body,
so there is no risk of electrical shock. Application of the patches may feel cold, and in very rare
cases, a patient may develop a skin rash or irritation where the patches were applied. Some
people become slightly anxious when this test is done.
You may feel some pressure for a few seconds when the arterial stiffness blood vessel device is
placed on your skin.
There are no known risks associated with taking these pictures of the eye. People who are
light-sensitive may see a blue or red spot after the camera flashes, but this would not hurt the
eye, and it would go away within a few minutes.
If you find out that you have eye damage it could make you worried. We would share the
results with your provider, and would refer you to your provider or another doctor for appropriate
treatment. We would also be available to explain the results to you to help reduce your worry.
There could be harms associated with sharing your genetic information despite our safety
measures to protect your genetic information. They include:
• Someone could break into the computer system. They could then find the code that links
your genetic and medical information to you. This is very unlikely, but is possible.
• Find a way to link your genetic or medical information in a database back to you. Your
genetic information is unique to you. But you do share some genetic information with
your children, parents, brothers, sisters and other blood relatives. So it might be possible
for someone to use genetic information from your relatives to help figure out who you
are. That person would need to be able to access the database. They would also need
genetic information from you or one of your relatives. Again, it is unlikely this would
happen.
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 10 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
•
•
•
Since some genetic information may predict health problems you or your relatives could
have in the future. This information might be of interest to health providers, life insurance
companies and others. There are state and federal laws that protect against genetic
discrimination. There is a new federal law called the Genetic Information
Nondiscrimination Act (GINA). This law makes it illegal for health insurance companies,
group health plans and most employers to discriminate against you based on your
genetic information. However, it does not completely protect you from discrimination.
Genetic information could also be used by law enforcement agencies to identify a person
or his/her blood relatives.
There could be privacy risks we don’t know about.
As with any research study, there may be additional risks that are unknown or unexpected.
9. What are the potential benefits if I join this study?
Potential Benefits for You:
You/your child may not directly benefit from participating in this research study. However, this
study may more clearly tell us about your/your child’s type of diabetes and whether you/your
child has any of the complication of diabetes.
You would receive results of your/your child’s blood and urine tests usually within 6-8 weeks of
the study visit. These results would include the Hemoglobin A1C, lipid profile (cholesterol), and
urine microalbumin (urine protein). These are standard tests. The report you receive would
explain the results to you. Your/your child’s doctor would also receive these standard test
results, plus results of the research laboratory tests that are being studied to determine the type
of diabetes.
You/your child and your/your child’s diabetes provider may receive the results of genetic tests
done for research purposes while taking part in this research study if it is determined that the
results of such tests could impact clinical care.
We would give you information about any eye problems that we find. If something is found that
needs urgent attention, we would phone/contact you and your health care provider as soon as
we receive these results (usually within 2 – 3 days). This eye test does not take the place of a
visit to your own personal doctor nor does it replace your regular dilated comprehensive eye
examinations. It is not a test of your/your child’s vision.
You would not receive any results or feedback on the nerve tests or blood vessel test as part of
this study. These tests are for research purposes only and do not replace the normal care
provided to you by your regular health care provider.
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 11 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Potential Benefits for Others:
We hope that the information learned in this research study will benefit young people with
diabetes in the future. This is a large research study being carried out at five major medical
centers across the United States. The information we learn in this research study will improve
our understanding of how education, diagnosis, and the costs of having diabetes can affect the
people who live with this disease every day. The tests we do may help us better understand the
short and long term effects of diabetes. This may help improve diabetes-related care in the
future.
10. What other options do I have?
Taking part in research is voluntary. You/your child may choose not to take part in this study or
in parts of the study.
11. How would you keep my information confidential?
All information gathered during this study would be held in strict confidence. Any publication
resulting from participation in this study would not identify you/your child by name. A one of a
kind number, called a research study number, would be assigned to you/your child. No other
identifying information would be used. The research study number would be used to identify
only the test and interview information that was collected during the research study. The
research number assigned to you/your child, and not your child’s name, would be sent to the
study Coordinating Center at Wake Forest University in order to study the information. The list
containing the research study number assigned to you/your child would be kept in a locked file
in the research office of Dr. Pihoker, the research study's Principal Investigator. No one other
than Dr. Pihoker and her research team would be able to connect any of research study
information to you/your child.
Any stored samples would be kept in a central laboratory and stored for upcoming studies of
diabetes. The central laboratory is at the University of Washington. The samples would be
banked with a code, with no information at the laboratory that could link the samples to you/your
child. Dr. Pihoker and the study coordinators on this project would be the only people with
access to the code. The banked samples would be stored indefinitely, although would likely be
used within 7 years. When there is another researcher who wants to do a diabetes study and
use the stored samples, he/she would need to talk to Dr. Pihoker. If the study seems to be
important and reasonable, an Institutional Review Board (IRB) would review the study, and
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 12 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
samples can be used only after the study is approved. The IRB is a committee responsible for
protecting the rights of persons taking part in research.
The nerve test results would be sent to the University of Michigan and the SEARCH
Coordinating Center. The eye test results would be sent to the Ocular Epidemiology Reading
Center (OERC) at the University of Wisconsin – Madison and the SEARCH Coordinating center.
Investigators would analyze these results along with other data collected in the SEARCH study.
All answers that you/your child give and other information gathered about you/your child during
this study would be kept private. This is so because this study has been given a Certificate of
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child would not have to be given out to anyone, even if a court orders us to do so,
unless you say it’s OK. But under the law, we must report to the state suspected cases of child
abuse or if you/your child tell us he/she is planning to cause serious harm to self or others.
If you take part, we would make every effort to keep your information confidential.
If you join this study, we may put information about this study in your medical record. We do
this because the research study involves patient care.
Information collected about you during the study would be kept until all information has been
studied and results have been published. Future funding may allow the study to continue for a
longer period of time, however, the information about you would be destroyed as soon as it is no
longer necessary for the conduct of the research study.
12. Would it cost me money to be in the study?
If you take part in this study, there would be no cost to you and no cost to your
insurance company.
13. What if I were injured because I joined the study?
If you were injured as the direct result of this research study, Seattle Children's Hospital
would provide treatment. We would refer you for treatment if needed.
You would NOT need to pay for this treatment and neither would your insurance
company. This is the only compensation offered for study-related injuries. It is
important that you tell the Principal Researcher Catherine Pihoker, if you think that you
have been injured as a result of taking part in this study. You can call her at 206-9875037.
14. Would I be paid if I join this study?
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 13 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
If needed, we may be able to offer some assistance with travel costs, dependent on availability
of study funds. Important: You would need to give us receipts that clearly show your costs.
Once you complete all of the study procedures, we would give you/your child $120 in gift cards.
You would be paid a smaller amount if you complete only part of the study procedures. In the
rare circumstance that a blood redraw is necessary, you would receive an additional $20 gift
card.
We will be asking a small number of study participants to repeat the Heart Rate Variability and
Blood Vessel tests in order to assess the research team’s quality control. If you were asked to
participate in these repeat measurements and you agree to participate, you would be given
either an additional $10 or an additional $20 gift card, depending on the number of
measurements completed. The Study coordinator would let you know ahead of time what
measurements you would be asked to complete, and the dollar amount of the gift card that you
would receive.
If you are fasting for the visit, we will provide a snack after you complete the blood draw and/or
a $6 meal or meal voucher after the blood vessel tests.
The IRS has certain rules about paying people who take part in research studies. If you
took part in this study, we would ask you to provide your name, mailing address, and
social security number so we could pay you.
You can be in this study even if you do not give us this information. If you decide not to
give us this information, you could receive a gift card or no payment.
The payments you would receive for being in this study might be taxable. Seattle
Children’s is required to report to the IRS study payments of $600 or more made to
anyone in any year.
Your samples could be used to make new products, tests or findings. These may have value
and may be developed and owned by the research team and/or others. If this happens, there
are no plans to provide any money to you.
15. Who do I call if I have problems or questions?
If I have questions or
would like to know about …
• Emergencies
• General study
You can call …
Catherine Pihoker, MD or
Endocrinologist on call
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
At …
Phone: 206-987-2000
Template Version: 6/10/2014
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
If I have questions or
would like to know about …
questions
• Research-related
injuries
• Any research concerns
or complaints
• Emergencies
• General study
questions
• Research-related
injuries
• Any research concerns
or complaints
•
Your rights as a
research participant
•
Assistance with figuring
out what questions to
ask the research team
Help understanding the
research process
•
You can call …
At …
Diabetes Research Team
Phone: 206-987-2540
Multicare Health System
Institutional Review Board
This is a group of scientists
and community members
who make sure research
meet legal and ethical
standards.
Research and Family
Liaison
A person who works with
families to ensure they
receive the information they
need to make an informed
decision about taking part in
a research study.
Phone: (253) 403-3844
Phone: (206) 884-7858
Pager: (206) 469-3983
16. If I join the study, can I stop?
Yes. Taking part in research is always a choice. If you decide to be in the study, you can
change your mind at any time. We ask that you tell the study team. You can contact this
person by calling 206-987-2540.
If you choose to leave the study, it will not affect your care at Seattle Children’s. You will
not lose any benefits or be penalized if you choose to leave the study.
17. What would my signature on this form mean?
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 15 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Your signature on this form would mean:
• The research study was explained to you.
• You had a chance to ask all the questions you have at this time. All your questions have
been answered in a way that is clear.
• You understand that the persons listed on this form will answer any other questions you
may have about the study or your rights as a research study participant.
• You have rights as a research participant. We will tell you about new information or
changes to the study that may affect your health or your willingness to stay in the
study.
• By signing this consent form, you do not give up any of your legal rights. The
researcher(s) or sponsor(s) are not relieved of any liability they may have.
o You agree to take part in the research study.
o If the person reading this form is a parent/guardian, you agree to have your child take
part in this research study.
Please Note: If the person taking part in this research study is a foster child or a ward of the
state, then please tell the researcher or their staff.
___________________________________
Printed Name of Research Participant
______________________________________
Signature of Research Participant (required if 14 years or older)
Date/Time
______________________________________
Printed Name of Parent or Legal Guardian
______________________________________
Signature of Parent or Legal Guardian
Date/Time
Permissions:
Storage of Blood and Urine Samples
Do you give permission to have your/your child’s blood and urine samples saved and used in
current and future research studies?
Yes, I give my permission
No, I do not give permission
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 16 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Storage of DNA Samples (looking at specific genes)
Do you give permission to have your/your child’s DNA saved and used in current and future
research studies?
Yes, I give my permission
No, I do not give permission
Genetic Test Results (looking at specific genes)
If researchers determine that genetic results could impact clinical care, would you like to have
the results of genetic tests sent to you and your/your child’s diabetes provider?
Yes, I give my permission
No, I do not give permission
Full Gene Analysis (looking at all of your genes) and the National Storage Center
(NIH/dbGaP)
Do you give permission to have your/your child’s DNA analyzed to identify a complete picture of
your genetic makeup? This information would be sent to a national storage center to help
researchers better understand how genes affect the risk of developing diseases. When your
DNA and clinical information is sent to the storage center, no personal information would be
included, such as your name, date of birth, or address. Thus, researchers would not be able to
link this information back to you.
Yes, I give my permission
No, I do not give permission
Medical Record Review
Do you give permission to have your/your child’s medical chart, reviewed by research study
members, as described above?
Yes, I give my permission
No, I do not give permission
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 17 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Future contact
Do you give permission for researchers to contact you/your child in the future, to ask if you/your
child are interested in participating in new research studies that are developed? As with this
research study, taking part in any future studies is voluntary. Participation in this present study
does not mean that you/your child are automatically volunteering to take part in any future
studies. You/your child would be asked to sign a consent form for any future research studies in
which you/your child agree to participate.
Yes, I give my permission
No, I do not give permission
18. Researcher’s Signature
I have fully explained the research study described by this form. I have answered the
participant and/or parent/guardians questions and will answer any future questions to the best of
my ability. I will tell the family and/or the person taking part in this research of any changes in
the procedures or in the possible harms/possible benefits of the study that may affect their
health or their willingness to stay in the study.
_________________________________
Printed Name of Researcher Obtaining Parental Permission or Consent
_______________________________
Signature of Researcher Obtaining Parental Permission or Consent
Date/Time
19. Interpreter Information
_____________________________________
Printed Name of Interpreter during initial presentation of study
Date/Time
______________________________________
Printed Name of Interpreter when translated form is presented (if applicable)
Date/Time
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
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Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
PARENT PARTICIPANT ADDENDUM
Parent Participants
Why do parents have the option of taking part?
As a part of this research study, we would like to ask you to complete a brief survey on the
amount of food that is available in your household and any assistance you may receive to
provide enough food for your family. If it looks like it is hard for you to access food, we may
refer you to a social worker to help you find available resources. This study will look at how
difficult it is for families of youth with diabetes to access food and how that may affect youth with
diabetes. Completing this questionnaire should take about 5 minutes.
Do parents have to take part?
Taking part in research is optional. If you decide not to join you will not be penalized or lose any
benefits that you are otherwise entitled to.
What are the possible risks?
The main risk of participating as a parent participating in this study would be breach of
confidentiality. Some of the questions may be sensitive in nature and may make you feel
embarrassed or upset. You are free not to answer any questions you don't want to answer, and
you may stop taking the survey at any time. If you decide not to answer any of the questions,
your child can still take part in the rest of the research study.
What are the possible benefits?
We do not expect you to benefit directly from participating in this research study. We hope that
the information learned in this research study will benefit young people with diabetes in the
future.
How will you protect my information?
The same procedures that are in place to protect your child’s medical information are also in
place to protect your confidentiality. You can find these in the form under the section “How
would you keep my or my child’s information confidential?”
Can I change my mind?
You can decide to take part and change your mind at anytime. Taking part in research is
voluntary.
If you have questions about the study, your rights, or feel you have been harmed by the study,
please contact the study team members listed on the front of this form.
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
Template Version: 6/10/2014
Page 19 of 20
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
What would my signature mean?
• You agree to take part in the research study.
• You keep all your legal rights. The researcher(s) or sponsor(s) are not relieved of any
liability they may have.
___________________________________
Printed Name of Parent or Legal Guardian
______________________________________
Signature of Parent or Legal Guardian
___________
Date
_____________
Time
___________________________________
Printed Name of Parent or Legal Guardian
______________________________________
Signature of Parent or Legal Guardian
___________
Date
_____________
Time
Original form to:
Research Team File
Copies to:
Participant
Parents/Guardians (if applicable)
Medical Records (if applicable)
Consent, Assent and Parental Permission Form
Participant Initials _______
Institutional Review Board
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
PARENTAL PERMISSION FORM
CONSENT FORM: Ages 18 and up
ASSENT FORM: Ages 14-17
REGISTRY VISIT (2012 cohort)
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
The Research Team:
Name/Degree
Catherine Pihoker, MD
Lenna Liu, MD MPH
Maryam Afkarian, MD
Irl Hirsch, MD
Joyce Yi-Frazier, PhD
Carla Greenbaum, MD
Martin Goldsmith, MD
Beth Babler, ARNP
Patricia Fechner, MD
Christian Roth, MD
Ildi Koves, MD
Craig Taplin, MD
Kate Ness, MD
Carolina DiBlasi, MD
Jason Mendoza, MD MPH
Erin Alving, ARNP
Karen Aitken, ARNP
Sara Benitez, PA
Gwyn Recupero, PA
Beth Loots, MPH MSW
Sue Kearns, RN
Mary Klingsheim, RN BSN
Jessica Fosse, MPH RN
BSN
Title
Department
Principal Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator
Research Manager
Study Coordinator
Study Coordinator
Study Coordinator
Endocrinology
Pediatrics
Nephrology
Medicine
Endocrinology
Benaroya Res Instit
Peds Northwest
Mary Bridge
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
CHBD
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Endocrinology
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Phone
Number
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206-884-1261
206 987-5037
206 987-5037
206 987-5037
206 987-5037
206-987-2540
206 987-2540
206 987-2540
206 987-2540
Template Version: 6/10/2014
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Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Katherine Cochrane, BS
Patricia D’Alessandro, MA
Michael Pascual, BA
Connor Mitrovich, BA
Natalie Beauregard, BA
Clinical Research
Associate
Clinical Research
Associate
Clinical Research
Associate
Clinical Research
Associate
Clinical Research
Associate
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Endocrinology
206 987-2540
Endocrinology
206 987-2540
If you have questions about your rights as a research study participant, you can call the
Multicare Health System Institutional Review Board (IRB) at 253-403-3844.
24 hour Emergency Contact Number(s): 206 987-2000 Ask for the Endocrinologist on call
1. Researchers’ Statement:
You have the option to take part in a research study. The goals of this form are to give
you information about what would happen in the study if you choose to take part and to
help you decide if you want to be in the study.
Feel free to take notes, write questions or highlight any part of this form.
Potential Participants 18 years and older: This is a consent form. It provides a summary of
the information the research team will discuss with you. If you decide that you would like to take
part in this research study, you would sign this form to confirm your decision. If you sign this
form, you will receive a signed copy of this form for your records.
Potential Teen Participants: This form also serves as an assent form. That means that if you
choose to take part in this research study, you would sign this form to confirm your choice. Your
parent or guardian would also need to give their permission and sign this form for you to join the
study.
Parents/Guardians: You have the option of having your child or teen join a research study.
This is a parental permission form. It provides a summary of the information the research team
will discuss with you. If you decide that your child can take part in this study, you would sign
this form to confirm your decision. If you sign this form, you will receive a signed copy for your
records.
The word “you” in this form refers to your child/teen.
Joining the study as a parent:
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 2 of 16
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IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Parents also have the option to take part in this research study. There is a page at the end of
this form explaining what it would mean to participate as a parent.
2. What you should know about this study:
•
•
•
•
•
•
•
•
This form explains what would happen if you join this research study.
Please read it carefully. Take as much time as you need.
Please ask the research team questions about anything that is not clear.
You can ask questions about the study any time.
If you choose not to be in the study, it will not affect your care at Seattle Children’s.
If you say ‘Yes’ now, you can still change your mind later.
You can quit the study at anytime.
You would not lose benefits or be penalized if you decide not to take part in the study or to
quit the study later.
3. What is the goal of this study?
Diabetes is the third most common chronic or ongoing disease in individuals under 20 years of
age. The total number of cases of diabetes in this age group is increasing, and types of
diabetes that have not been seen in young people are now being seen. These changes have
resulted in gaps in our knowledge about the total number of cases and types of diabetes in the
United States, the type of care young people with diabetes receive, the complications they
experience, and the effect diabetes has on their lives.
The goal of any research study is to answer questions. We (the research team listed on the
front of this form and our staff) are doing this research study to answer the following questions:
•
•
•
•
How many cases of diabetes there are in the United States among youth;
What are the characteristics of each type of diabetes;
What medical care is being given to young people who have different forms of diabetes;
How is diabetes affecting the lives of young people with diabetes.
4. Why do I have the option of joining the study?
You have the option to take part in this research study because you have any type of diabetes,
were diagnosed under the age of 20 in 2012, and lived in King, Kitsap, Pierce, Snohomish, or
Thurston county in 2012.
5. How many people will take part in the study?
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 3 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
We think that about 1,220 people will take part in the SEARCH registry study at Seattle
Children’s. About 225 people at this site will complete a registry visit. A total of about 6,440
people will take part in the registry study at hospitals and clinics around the country.
6. If I agree to join this study, what would I need to do?
The registry study includes:
• Written questionnaires
• Blood draw
• Urine collections
• Brief physical exam
• Medical record review
• Follow up contact
Written Questionnaires
Prior to your visit, you/your child will have been asked to answer a short series of questions – in
person, via mail, online, or on the telephone – about the effects of diabetes on your/your child's
lives, your family’s education and income level, and general medical care. If you are 10 years of
age or older, you would also be asked to answer questions about the food that is available to
eat and how this makes you feel. If you are 18 years old or older, we would also ask you about
any food assistance that you may receive; and we would ask you about your employment and
income. If it looks like it is difficult for you to access food, we may refer you to a social worker to
help you find available resources. We would ask your parents similar questions.
These surveys will have taken about 25 minutes. During your visit, we will ask you to complete
an additional brief survey about the medications that you/your child takes.
Blood Draw and Urine Collection
You/your child would be scheduled for an in-person study visit at the Clinical Research Center
at Seattle Children’s or at another SEARCH outreach clinic that is convenient to you. This
would be a "fasting" visit, which means that no food or fluids, other than water, could be
consumed for at least 8 hours before coming to your visit. You/your child would be asked not to
take insulin or other diabetes medications the morning before the test, except for basal insulin,
which should be taken as usual. If you come to the visit nonfasting, we might ask you to return
another day to redraw all or part of the blood sample.
Before your scheduled appointment, you would receive a container with detailed instructions to
collect one urine sample at home the morning of your visit. We will ask that you collect the urine
from the first time you urinate in the morning. You would be asked to bring this urine sample
with you to your visit. Your urine would be tested for microalbumin (small particles of protein) to
see how well your kidneys are working.
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 4 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
When you arrive at your appointment, we would review the consent/assent form(s). This would
take about 20 – 30 minutes. If you/your child would like a numbing agent for the blood draw,
this part may take about an additional 30 minutes.
A blood sample would be drawn from your/your child's arm to measure blood sugar, hemoglobin
A1c (a test measuring your/your child’s average blood glucose level over the past 3 months), Cpeptide (a measure of your/your child's own insulin production), different types of cholesterol
(fat), islet cell antibodies (markers in the blood for type 1 diabetes), and genetic markers for
diabetes. Based on age and size, the total amount of blood that would be needed would be
between 1 teaspoon and 3 tablespoons.
If possible, we would collect all blood samples at the same time that a routine blood draw would
be done. If you/your child take part in more than one research study at the same visit, we would
try to combine tests and results when we can.
A urine samples would also be obtained during the visit and tested for several markers
associated with the risk of diabetes complications, such as heart disease and stroke.
The SEARCH study would like to keep some of the blood and urine that would be collected
during the study but is not used for other tests. Should we have questions about some of tests,
the storage sample would allow us to repeat the tests without needing to ask for a second blood
draw from you/your child. In addition, we would like to collect another sample of blood for
storage for future research.
We will also ask your permission to obtain and store a sample of blood to look at DNA, the
genetic material that is found in all of your cells. Researchers may look at specific genes, or
they may look at all of your genes together. If researchers were to look at specific genes, you
have the option of receiving the results of this testing if it would effect your clinical care.
However, if they were to look at all of your genes together, you would not receive the results.
The information researchers find out about your DNA would be sent to a national storage center
called dbGaP (part of the National Institutes of Health) to help researchers better understand
how genes affect the risk of developing diseases such as asthma, cancer, diabetes, and heart
disease. When your DNA and clinical information would be sent to the storage center, no
personal information would be included, such as your name, date of birth, or address. Thus,
researchers would not be able to link this information back to you. The research that would be
done with your blood and urine samples would not be designed to specifically help you. It might
help people who have diabetes and other diseases in the future.
The total amount of blood that would be needed for the storage sample would be 1 teaspoon for
young children and up to 2 tablespoons for older children, dependent on age and weight. This
part of the visit would take 10 – 20 minutes.
The total volume of blood for this visit would be up to approximately 3 tablespoons.
After the fasting blood and urine samples are collected, a free breakfast or meal voucher would
be provided and you/your child would take your routine medication.
Physical Exam
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 5 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
A trained member of the research team would perform a brief physical examination including:
height, weight, waist measurements, blood pressure, and examination of the skin of the neck.
The time to complete this exam would be about 20 minutes.
Follow up
We will send you requests to update your contact information about every year. Part of this
update includes a question about your/your child’s social security number, which we will use to
track mortality among SEARCH study participants. If this study is expanded, or if other diabetes
studies are developed, we may contact you/your child in the future to ask if you/your child want
to participate further. As with this study, taking part in any future study is voluntary.
7. How long would I be in the study?
The study is currently funded through September 2015.
The time to complete the registry visit would be about 1 hour.
If you join the study, you can decide to stop at anytime for any reason. Please discuss your
decision to stop with Dr. Pihoker or the research team.
If you would like your/your child’s stored samples removed from storage, we would send a
request to the central laboratory. They would then destroy the sample, and send us a letter
certifying that the sample has been destroyed. We would send you a copy of this letter.
The research study doctor could also decide to take you out of this study. This might happen if
we find out that it is not safe for you to stay in the study. Or it might happen if you cannot
complete to enough of the study elements. If we ask you to leave the study, we would always
explain why.
8. What are the potential harms or risks if I join this study?
If you feel uncomfortable at any time during any of these tests, just tell the study coordinator and
they would immediately stop the tests. All reasonable precautions would be taken to reduce
risks.
Some of the questions we ask may be sensitive in nature and may make you feel embarrassed
or upset. You are free to not answer any questions you don't want to answer, and you may stop
taking any survey at any time. If you decide not to answer any of the questions, you can still
take part in the rest of the research study.
When taking a blood sample, there may be brief discomfort, and a bruise may form where the
needle poke occurs. To reduce the possibility of these risks, a local anesthetic (numbing cream
or liquid) may be applied to the skin before blood is taken.
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 6 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
The blood tests require that you/your child not have any food or fluids overnight, other than
water. In order to prevent low or high blood sugars, you/your child’s blood sugar would be
checked by finger-stick and your diabetes medication would be given as needed to control
your/your child’s blood sugar.
Some of the tests would look for the presence of health problems associated with diabetes,
such as high cholesterol. If researchers find signs of these health problems, it may cause
you/your child some anxiety or concern. If this happens, you/your child would be referred to the
appropriate local health professionals for evaluation and treatment.
There could be harms associated with sharing your genetic information despite our safety
measures to protect your genetic information. They include:
• Someone could break into the computer system. They could then find the code that links
your genetic and medical information to you. This is very unlikely, but is possible.
• Find a way to link your genetic or medical information in a database back to you. Your
genetic information is unique to you. But you do share some genetic information with
your children, parents, brothers, sisters and other blood relatives. So it might be possible
for someone to use genetic information from your relatives to help figure out who you
are. That person would need to be able to access the database. They would also need
genetic information from you or one of your relatives. Again, it is unlikely this would
happen.
• Since some genetic information may predict health problems you or your relatives could
have in the future. This information might be of interest to health providers, life insurance
companies and others. There are state and federal laws that protect against genetic
discrimination. There is a new federal law called the Genetic Information
Nondiscrimination Act (GINA). This law makes it illegal for health insurance companies,
group health plans and most employers to discriminate against you based on your
genetic information. However, it does not completely protect you from discrimination.
• Genetic information could also be used by law enforcement agencies to identify a person
or his/her blood relatives.
• There could be privacy risks we don’t know about.
As with any research study, there may be additional risks that are unknown or unexpected.
9. What are the potential benefits if I join this study?
Potential Benefits for You:
You/your child may not directly benefit from participating in this research study. However, this
study may more clearly tell us about your/your child’s type of diabetes and whether you/your
child has complication of diabetes.
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 7 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
You would receive results of your/your child’s blood and urine tests usually within 6-8 weeks of
the study visit. These results would include Hemoglobin A1C, lipid profile (cholesterol), and
urine microalbumin (urine protein). These are standard tests. The report you receive would
explain the results to you. Your/your child’s doctor would also receive these standard test
results, plus results of the research laboratory tests that are being studied to determine the type
of diabetes.
You/your child and your/your child’s diabetes provider may receive the results of genetic tests
done for research purposes while taking part in this research study if it is determined that the
results of such tests could impact clinical care.
Potential Benefits for Others:
We hope that the information learned in this research study will benefit young people with
diabetes in the future. This is a large research study being carried out at five major medical
centers across the United States. The information we learn in this research study will improve
our understanding of how education, diagnosis, and the costs of having diabetes can affect the
people who live with this disease every day.
10. What other options do I have?
Taking part in research is voluntary. You/your child may choose not to take part in this study or
in parts of the study.
11. How would you keep my information confidential?
All information gathered during this study would be held in strict confidence. Any publication
resulting from participation in this study would not identify you/your child by name. A one of a
kind number, called a research study number, would be assigned to you/your child. No other
identifying information would be used. The research study number would be used to identify
only the tests and interview information that was collected during the research study. The
research number assigned to you/your child, and not your child’s name, would be sent to the
study Coordinating Center at Wake Forest University in order to study the information. The list
containing the research study number assigned to you/your child would be kept in a locked file
in the research office of Dr. Pihoker, the research study's Principal Investigator. No one other
than Dr. Pihoker and her research team would be able to connect any of research study
information to you/your child.
Any stored samples would be kept in a central laboratory and stored for upcoming studies of
diabetes. The central laboratory is at the University of Washington. The samples would be
banked with a code, with no information at the laboratory that could link the samples to you/your
child. Dr. Pihoker and the study coordinators on this project would be the only people with
access to the code. The banked samples would be stored indefinitely, although would likely be
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 8 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
used within 7 years. When there is another researcher who wants to do a diabetes study and
use the stored samples, he/she would need to talk to Dr. Pihoker. If the study seems to be
important and reasonable, an Institutional Review Board (IRB) would review the study, and
samples could be used only after the study is approved. The IRB is a committee responsible for
protecting the rights of persons taking part in research.
All answers that you/your child give and other information gathered about you/your child during
this study would be kept private. This is so because this study has been given a Certificate of
Confidentiality. This means that anything you/your child tells us or information we learn about
you/your child would not have to be given out to anyone, even if a court orders us to do so,
unless you say it’s OK. But under the law, we must report to the state suspected cases of child
abuse or if you/your child tell us he/she is planning to cause serious harm to self or others.
If you take part, we would make every effort to keep your information confidential.
If you join this study, we may put information about this study in your medical record. We do
this because the research study involves patient care.
Information collected about you during the study would be kept until all information has been
studied and results have been published. Future funding may allow the study to continue for a
longer period of time, however, the information about you would be destroyed as soon as it is no
longer necessary for the conduct of the research study.
12. Would it cost me money to be in the study?
If you take part in this study, there would be no cost to you and no cost to your
insurance company.
13. What if I were injured because I joined the study?
If you were injured as the direct result of this research study, Seattle Children's Hospital
would provide treatment. We would refer you for treatment if needed.
You would NOT need to pay for this treatment and neither would your insurance
company. This is the only compensation offered for study-related injuries. It is
important that you tell the Principal Researcher Catherine Pihoker, if you think that you
have been injured as a result of taking part in this study. You can call her at 206-9875037.
14. Would I be paid if I join this study?
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 9 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
If needed, we may be able to offer some assistance with travel costs, dependent on availability
of study funds. Important: You would need to give us receipts that clearly show your costs.
To thank you for taking part in the study we would give you/your child a $10 gift card for
completion of the Initial Participant Survey, and an $80 gift card for completion of the visit. In
the rare circumstance that a blood redraw is necessary, you would receive an additional $20 gift
card. If you are fasting for the visit, we will provide a $6 breakfast voucher, or breakfast, after
you complete the blood draw.
The IRS has certain rules about paying people who take part in research studies. If you
took part in this study, we would ask you to provide your name, mailing address, and
social security number so we could pay you.
You can be in this study even if you do not give us this information. If you decide not to
give us this information, you could receive a gift card or no payment.
The payments you would receive for being in this study might be taxable. Seattle
Children’s is required to report to the IRS study payments of $600 or more made to
anyone in any year.
Your samples could be used to make new products, tests or findings. These may have value
and may be developed and owned by the research team and/or others. If this happens, there
are no plans to provide any money to you.
15. Who do I call if I have problems or questions?
If I have questions or
would like to know about …
• Emergencies
• General study
questions
• Research-related
injuries
• Any research concerns
or complaints
• Emergencies
• General study
questions
• Research-related
injuries
• Any research concerns
or complaints
• Your rights as a
You can call …
At …
Catherine Pihoker, MD or
Endocrinologist on call
Phone: 206-987-2000
Diabetes Research Team
Phone: 206-987-2540
Multicare Health System
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 10 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
If I have questions or
would like to know about …
research participant
•
•
Assistance with figuring
out what questions to
ask the research team
Help understanding the
research process
You can call …
Institutional Review Board
This is a group of scientists
and community members
who make sure research
meet legal and ethical
standards.
Research and Family
Liaison
A person who works with
families to ensure they
receive the information they
need to make an informed
decision about taking part in
a research study.
At …
Phone: (253) 403-3844
Phone: (206) 884-7858
Pager: (206) 469-3983
16. If I join the study, can I stop?
Yes. Taking part in research is always a choice. If you decide to be in the study, you can
change your mind at any time. We ask that you tell the study team at 206-987-2540.
If you choose to leave the study, it will not affect your care at Seattle Children’s. You will
not lose any benefits or be penalized if you choose to leave the study.
17. What would my signature on this form mean?
Your signature on this form would mean:
• The research study was explained to you.
• You had a chance to ask all the questions you have at this time. All your questions have
been answered in a way that is clear.
• You understand that the persons listed on this form will answer any other questions you
may have about the study or your rights as a research study participant.
• You have rights as a research participant. We will tell you about new information or
changes to the study that may affect your health or your willingness to stay in the
study.
• By signing this consent form, you do not give up any of your legal rights. The
researcher(s) or sponsor(s) are not relieved of any liability they may have.
o You agree to take part in the research study.
o If the person reading this form is a parent/guardian, you agree to have your child take
part in this research study.
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 11 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
Please Note: If the person taking part in this research study is a foster child or a ward of the
state, then please tell the researcher or their staff.
___________________________________
Printed Name of Research Participant
______________________________________
Signature of Research Participant (required if 14 years or older)
Date/Time
______________________________________
Printed Name of Parent or Legal Guardian
______________________________________
Signature of Parent or Legal Guardian
Date/Time
Permissions:
Storage of Blood and Urine Samples
Do you give permission to have your/your child’s blood and urine samples saved and used in
current and future research?
Yes, I give my permission
No, I do not give permission
Storage of DNA Samples (looking at specific genes)
Do you give permission to have your/your child’s DNA saved and used in current and future
research?
Yes, I give my permission
No, I do not give permission
Genetic Test Results (looking at specific genes)
If researchers determine that genetic results could impact clinical care, would you like the
results sent to you and your/your child’s diabetes provider?
Yes, I give my permission
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 12 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
No, I do not give permission
Full Gene Analysis (looking at all of your genes) and the National Storage Center
(NIH/dbGaP)
Do you give permission to have your/your child’s DNA analyzed to identify a complete picture of
your genetic makeup? This information would be sent to a national storage center to help
researchers better understand how genes affect the risk of developing diseases. When your
DNA and clinical information is sent to the storage center, no personal information would be
included, such as your name, date of birth, or address. Thus, researchers would not be able to
link this information back to you.
Yes, I give my permission
No, I do not give permission
Future contact
Do you give permission for researchers to contact you/your child in the future, to ask if you/your
child are interested in participating in new research studies that are developed? As with this
research study, taking part in any future studies is voluntary. Participation in this present study
does not mean that you/your child are automatically volunteering to take part in any future
studies. You/your child would be asked to sign a consent form for any future research studies in
which you/your child agree to participate.
Yes, I give my permission
No, I do not give permission
18. Researcher’s Signature
I have fully explained the research study described by this form. I have answered the
participant and/or parent/guardians questions and will answer any future questions to the best of
my ability. I will tell the family and/or the person taking part in this research of any changes in
the procedures or in the possible harms/possible benefits of the study that may affect their
health or their willingness to stay in the study.
_________________________________
Printed Name of Researcher Obtaining Parental Permission or Consent
_______________________________
Signature of Researcher Obtaining Parental Permission or Consent
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Date/Time
Template Version: 6/10/2014
Page 13 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
19. Interpreter Information
_____________________________________
Printed Name of Interpreter during initial presentation of study
Date/Time
______________________________________
Printed Name of Interpreter when translated form is presented (if applicable)
Date/Time
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 14 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
PARENT PARTICIPANT ADDENDUM
Parent Participants
Why do parents have the option of taking part?
As a part of this research study, we would like to ask you to complete a brief survey on the
amount of food that is available in your household and any assistance you may receive to
provide enough food for your family. If it looks like it is hard for you to access food, we may
refer you to a social worker to help you find available resources. This study will look at how
difficult it is for families of youth with diabetes to access food and how that may affect youth with
diabetes. Completing this questionnaire should take about 5 minutes.
Do parents have to take part?
Taking part in research is optional. If you decide not to join you will not be penalized or lose any
benefits that you are otherwise entitled to.
What are the possible risks?
The main risk of participating as a parent participating in this study would be breach of
confidentiality. Some of the questions may be sensitive in nature and may make you feel
embarrassed or upset. You are free not to answer any questions you don't want to answer, and
you may stop taking the survey at any time. If you decide not to answer any of the questions,
your child can still take part in the rest of the research study.
What are the possible benefits?
We do not expect you to benefit directly from participating in this research study. We hope that
the information learned in this research study will benefit young people with diabetes in the
future.
How will you protect my information?
The same procedures that are in place to protect your child’s medical information are also in
place to protect your confidentiality. You can find these in the form under the section “How
would you keep my or my child’s information confidential?”
Can I change my mind?
You can decide to take part and change your mind at anytime. Taking part in research is
voluntary.
If you have questions about the study, your rights, or feel you have been harmed by the study,
please contact the study team members listed on the front of this form.
What would my signature mean?
• You agree to take part in the research study.
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
Page 15 of 16
Approved 6/2/2014 Approval Expires 6/1/2015
IRB #: Multicare 20-271
Study Title: SEARCH for Diabetes in Youth
Principal Researcher: Catherine Pihoker, MD
Revision Date: June 2014
Protocol Version: December 2010
•
You keep all your legal rights. The researcher(s) or sponsor(s) are not relieved of any
liability they may have.
___________________________________
Printed Name of Parent or Legal Guardian
______________________________________
Signature of Parent or Legal Guardian
___________
Date
_____________
Time
Original form to:
Research Team File
Copies to:
Participant
Parents/Guardians (if applicable)
Medical Records (if applicable)
Consent, Assent and Parental Permission Form
Participant Initials_____
Institutional Review Board
Template Version: 6/10/2014
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Navajo
Consents
| File Type | application/pdf |
| Author | Gena Hargis |
| File Modified | 2014-07-30 |
| File Created | 2014-07-30 |