Att 9_Example Consent Forms

IRB File #
Page 1 of 4

Assent to Participate in a Research Study Minor Subjects (7-14 yrs)
SEARCH 4 Registry Study – In-Person Visit
________________________________________________________________________
INSTITUTION IRB Study #
Consent Form Version Date:
Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), Registry Study Visit
(Population-based Diabetes Youth Registry)
SEARCH Site Principal Investigators:
Funding Source and/or Sponsor: National Center for Chronic Disease Prevention and Health
Promotion (GRANT #1U18DP006031-01)
Study Contact telephone number: [Center-specific]
Study Contact email: [Center-specific]
Names, degrees, and affiliations of the researchers conducting the study:
[Center-specific]
_________________________________________________________________
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 832 people at five sites across the US will take part in the Registry Study visit,
including about XXX people from the (Site Specific) SEARCH site.
WFU School of Medicine
Institutional Review Board
IRB Number: IRB00015926
Meeting Date Approved 11/19/2015
Version Valid Until: 11/4/2016

IRB File #
Page 2 of 4

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.



This study visit will last about 60 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.
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
What if your parents don’t want you to be in this study?
WFU School of Medicine
Institutional Review Board
IRB Number: IRB00015926
Meeting Date Approved 11/19/2015
Version Valid Until: 11/4/2016

IRB File #
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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 be paid $80 for completing the study visit.
You may also be paid $5 for providing updated contact information in the future.
Will it cost you anything for your child to be in this study?
There will be no costs 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. You can
contact [Center-specific] anytime.

WFU School of Medicine
Institutional Review Board
IRB Number: IRB00015926
Meeting Date Approved 11/19/2015
Version Valid Until: 11/4/2016

IRB File #
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-------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), Registry Study Visit (IPV)
(Population-based Diabetes Youth Registry)
Principal Investigators: [Center-specific]

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

Date

Printed Name of Research Team Member Obtaining Assent

WFU School of Medicine
Institutional Review Board
IRB Number: IRB00015926
Meeting Date Approved 11/19/2015
Version Valid Until: 11/4/2016

KAISER FOUNDATION HOSPITALS
SOUTHERN CALIFORNIA PERMANENTE
MEDICAL GROUP

PATIENT’S NAME_________________________
M.R. #__________________

INFORMED CONSENT TO PARTICIPATE IN RESEARCH STUDY OF DIABETES
INCIDENCE, COMPLICATIONS, AND QUALITY OF CARE
SEARCH FOR DIABETES IN YOUTH (SEARCH), REGISTRY STUDY
Consent for Registry Visit
For Persons with Diabetes 18 years of age or older
SPONSOR:

Centers for Disease Control and Prevention

INVESTIGATOR:

Jean M. Lawrence, ScD, MPH, MSSA
Kaiser Permanente Southern California
Research & Evaluation
100 S. Los Robles Ave., 4th Floor
Pasadena CA 91101

TELEPHONE:

Department

of

(626) 564-3106

You are being invited to be in a research study. Taking part in this study is
voluntary.
This informed consent form tells you about the purpose, risks, and benefits of this
research study. You may ask questions and take time to think about the study
before you decide to join it. You should decide if you want to participate in the study
only when you have received all the information you need.
Your doctor or health care provider may be working on this research study. He or
she is interested in your healthcare as well as the conduct of this study. If that
makes you feel the doctor can’t be objective about the best care for you, yo u may
ask for another doctor or staff member who is not involved in this research.
Kaiser Permanente is being reimbursed by the study sponsor, Centers for
Disease Control and Prevention, to conduct this study.
PURPOSE AND BACKGROUND
The purpose of this research study being conducted by Kaiser Permanente, and in four
other locations in the United States, is to improve our understanding of the incidence,
natural history, complications, and quality of care for children, adolescents, and young
adults with diabetes. You were asked to take part in the SEARCH study because
you have diabetes. Dr. Jean Lawrence is the lead investigator for this study for Kaiser
Permanente. This study is sponsored by the Centers for Disease Control.

KPSC IRB Approved: 06/21/2016

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

SEARCH for Diabet es in Youth, Phase 3

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Diabetes is the third most common life-long disease in people under 20 years of age.
The total number of persons with 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 persons 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 collect
information to answer these questions.
This study will include over 7,000 children and youth with diabetes who were
members of Kaiser Permanente Southern California when they were diagnosed with
diabetes. A member of the SEARCH research team has discussed the requirements
for participating in this study with you. Before agreeing to participate in this research
study, it is important that you understand this form or have a member of the study staff
read it to you.
Before agreeing to participate in this research study, it is important that you read and
understand this form or have a member of the study staff read it to you.
If you have personal, religious, cultural, or ethical beliefs that you think might limit the
types of tests you would agree to receive, please discuss them fully with your
physicians or appropriate members of the research team before entering this study.
This consent form may contain some words that are not familiar to you. Please discuss
any questions you have about this study with the research staff members before
you sign this form.
STUDY PROCEDURES
The SEARCH Registry visit includes a brief physical examination, collecting a blood and
urine sample, and completing one or more questionnaires. You can agree to participate
in all or only some parts of the study.
A research team member has set up an appointment for you. The appointment will be
in the morning or early afternoon. You will come to the appointment after not having
anything to eat or drink other than water for 10 hours. You will not take your usual
diabetes medications until after your blood has been drawn. The study visits will take
approximately 1-2hours.
Before your scheduled appointment, you will be mailed a container with detailed
instructions to collect the first morning urine the day of your study visit. You will be
asked to bring this urine container with you to your visit. We may ask you to repeat the
urine collection for research purposes; we will not know if this additional urine sample
will be needed until the sample is reviewed by the laboratory.
PHYSICAL EXAMINATION
The physical examination includes measurements of height, weight, waist, blood
pressure, and examination of the skin on the neck. The time to complete this part of the
visit is approximately 30 minutes.

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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COLLECTION OF BLOOD AND URINE SAMPLES
Blood will be taken to measure blood sugar, hemoglobin Alc (a measure of long-term
blood sugar control), C-peptide (a measure of internal insulin production), different
types of cholesterol (fat), and diabetes autoantibodies (markers in the blood for type 1
diabetes). Two genetic markers for diabetes (HLA and ZNT8) will also be tested. The
total amount of blood drawn for these tests are based on your weight but will not
exceed 3 tablespoons.
A fi r s t m o r n i ng urine sample will b e requested and tested to see if diabetes is
affecting your kidneys. After these tests are done, you will be given a snack. You
may also bring your own snack to the Registry visit. After your snack, you will take your
usual diabetes medicine and have your medicines recorded by trained staff.
SAVING / STORAGE OF BLOOD AND URINE
If you agree, your blood and urine will be saved for the duration of the study at the
University of Washington, Northwest Lipid Research Laboratories and used in the future
as new tests are developed to learn more about the types of diabetes and when
someone has or is at risk to get the complications of diabetes. If the results of the tests
affect your health, you will be informed of the test results.
I agree to have my blood a n d u r i n e saved and used in the future for new
tests as they are developed to learn more about the types of diabetes and the
risk of developing complications of diabetes.
Initials
I do not agree to have my blood and urine saved and used in the future for new tests
as they are developed to learn more about the types of diabetes and the risk of
developing complications of diabetes.
Initials
SAVING / STORAGE OF DNA
DNA is found in all cells. DNA makes up genes. Genes determine height, hair color,
and all other body traits. The DNA in each person’s body is different from every other
person’s DNA (except identical twins or triplets who have the same DNA). The
differences may be why some people are more likely to get certain diseases like
diabetes.
If you agree, DNA will be saved at the University of Washington, Northwest Lipid
Research Laboratories and used in the future as new tests are developed to tell your type
of diabetes and the risk of developing the complications of diabetes, insulin resistance
(insulin is not working as well as it should), and being overweight. The total amount of
blood required is approximately 1¾ teaspoons (8.5 cc).
I agree to have my DNA stored for the duration of the study at the University of

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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Washington, Northwest Lipid Research Laboratories and used in the future as new
tests are developed to define the type of diabetes and the risk of developing the
complications of diabetes, insulin resistance (insulin is not working as well as it
should), and obesity.
Initials
I do not agree to have my DNA stored for the duration of the study at
University of Washington, Northwest Lipid Research Laboratories and used in
future as new tests are developed to define the type of diabetes and
risk of developing the complications of diabetes, insulin resistance (insulin is
working as well as it should), and obesity.
Initials

the
the
the
not

CENTRAL STORAGE FACILITY AT THE NATIONAL INSTITUTES OF HEALTH
We are asking if you would agree that you blood, urine and DNA samples and data that
are collected for the study may be sent to the central storage facility at the National
Institute of Diabetes, Digestive and Kidney Diseases or NIDDK. This is a research
resource supported by the National Institutes of Health or NIH. The facility collects,
stores, and distributes biological samples and associated data from people with many
kinds of disorders and from healthy people.
The purpose of this collection is to make samples and data available for use in research
of the study of diabetes, obesity, and heart disease and their complications after the
current study is completed. Sending data and samples may give scientists valuable
research material that can be used to develop new diagnostic tests, new treatments,
and new ways to prevent diseases. Scientists who want to use the samples and study
data have to go through a formal proposal process and all proposals are reviewed by
an external panel of experts.
Your samples and data will be stored de-identified, which means that no identifying
information will be stored with it. Researchers will not know the name, date of birth,
medical record number, social security number, etc., of the person who donated the
sample. Your donation is voluntary, and if you choose not to participate there will be
no penalty or loss of benefits to which you are entitled. If you agree donate your
samples, you can change your mind up until the end of the SEARCH study. When
study researchers receive written instructions from you, they will destroy your sample
and all information that identifies you.
Storage of blood, urine and study data
I agree for my blood and urine samples and SEARCH study data to be donated to
the NIDDK storage facility. _____ Initials
I do not agree for my blood and urine samples and SEARCH study data to be
donated to the NIDDK storage facility. _____ Initials

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

SEARCH for Diabet es in Youth, Phase 3

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Storage of DNA
I agree for my DNA to be donated to the NIDDK storage facility. _____ Initials
I do not agree for my DNA to be donated to the NIDDK storage facility.
_____ Initials
FULL GENE ANALYSIS (LOOKING AT ALL OF YOUR GENES) AND THE NATIONAL
STORAGE CENTER (NIH/dbGaP)
As a part of the SEARCH study, your DNA may be analyzed to identify a complete picture
of your genetic makeup. This is called Genome Wide Association (GWAS). This
information would be sent to a national data bank to help researchers better understand
how genes affect the risk of developing diseases. The data may be included in larger
studies or diabetes or other conditions. No personal information would be included, such
as name, date of birth, or address. Thus, researchers would not be able to link this
information back to you.
I agree to allow my information about my DNA to be included in the NIH data bank.
_____ Initials
I do not agree to allow my information about my DNA to be included in the NIH
data bank. _____ Initials
MEDICAL RECORDS REVIEW
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 laboratory and other test results .
CONTACT BY THE SEARCH STUDY IN THE FUTURE
The researchers conducting the SEARCH study may wish to call you as new studies
are developed to let you know about these new studies and ask you if you would like to
participate 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.
I agree to be called in the future.
I do not agree to be called in the future.

Initials
Initials

RELEASE OF TEST RESULTS
The results of tests that may be important to your health will be mailed to you once the
samples are tested at the laboratory. Some participants like their physician to have
copies of these test results as well. Please check one of the two boxes below to

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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give the study permission to release your test results to your physician if you would like
us to do this.
I agree to have the test results sent to my physician.
I do not agree to have the test results sent to my physician.

Initials
Initials

RISKS, DISCOMFORTS, AND PRECAUTIONS
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 medical staff.
The blood tests require that you not eat any food overnight (you may drink water). In
order to prevent low or high blood sugars, your blood sugar will be checked by fingerstick and diabetes medicine will be given as needed to control your blood sugar.
Some of the tests will look for the presence of 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 local mental health professionals for evaluation and treatment.
This research study includes genetic testing of blood samples that we ask you
to provide. You are free to refuse to take part in this genetic testing. It is your choice.
A federal law called the Genetic Information Nondiscrimination Act (GINA) limits the use
of genetic information by employers with 15 or more employees and by health
insurers and group or individual health plans. GINA generally makes it illegal to
discriminate against you based on your genetic information. If you agree to take part in
genetic testing, the genetic information we collect or obtain through this research will
not affect your eligibility for future medical care, membership in Kaiser Foundation
Health Plan, or cost of your premiums or benefits.
The researchers have taken steps to minimize the risks of this study, and it is not
expected that you will experience any adverse effects. However, you may still
encounter problems or side effects. If this happens, please tell the researchers
about any injuries, side effects, or other problems that you have during this study. You
should also tell your regular doctors.
WHAT ARE THE POSSIBLE BENEFITS IF I JOIN THIS STUDY?

There are no direct benefits to you from participating in this study. However, your
results from this study may more clearly define your type of diabetes and the presence
or absence of some of the complications of diabetes. You will also learn if your
laboratory tests are outside the normal range. If you give permission, some of this
information will be shared with your health care professionals, which could impact the
management of your diabetes.

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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ALTERNATIVES
There are no treatments involved in this study, and participation is entirely
voluntary. You may choose not to participate in this study. Your decision to
participate or not to participate will not affect your future medical care. You may
withdraw from this study at any time.
COST
There is no cost to you to participate in this study.
COMPENSATION
To reimburse you for your time to complete the Registry visit, you will receive up to
$80.00 in gift cards or a check.
You will receive:
$30.00 for completing the survey(s),
$30.00 for completing the physical examination,
$20.00 for having your blood drawn
We may ask you to provide another sample of your urine in the future. You will be paid
$20.00 for providing this additional urine sample.
CONFIDENTIALITY
Only SEARCH project staff will be able to view the information that you give to us.
Information that would identify you will not be released without your consent. All
answers that you give will be kept private. This is so because this study has been
given a Certificate of Confidentiality. This means that 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.
Under the law, we must report if you tell us you are planning to cause serious harm to
yourself or others.
A special number will be assigned to you upon entering the study. 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 will be kept
in a password-protected database in the Department of Research & Evaluation at
Kaiser Permanente Southern California. Thus, no one other than the research staff will
be able to link any of the information collected in the study to you.
It is possible that members of the research team might use e-mail to contact you for
study purposes, for example to remind you of a scheduled visit. We will not do this if you
do not give us permission, and we will never put your private health information in an email. However if you give us permission to contact you using e-mail, Kaiser Permanente
cannot guarantee that the message will get to you or that the message will not go to
someone else by mistake.

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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The information from the research study may be presented or published; however, you
will not be identified in such publications. When the study is over, your information
will be kept in a computer database for a period of time required by the funding agency
and then will be destroyed.
RIGHT TO WITHDRAWAL
You may leave this study at any time. Leaving the study will have no effect on
your ability to get medical care or health insurance nor will it have any effect on the kind
of care your health care professionals are giving to you. In order to withdraw from
this study, please contact the Principal Investigator whose contact information is on the
signature page. If you withdraw from this study, no further tests will be done on
the stored samples that you provided. However, survey data and other tests conducted
on samples collected at the visit will still be included in the dataset to be used for future
studies. You will no longer be contacted to participate in this study.
The Centers for Medicare and Medicaid Services requires compliance with Section 111
of the Medicare, Medicaid and SCHIP Extension Act of 2007 (the MMSEA) which
amended the Medicare Secondary Payer statute. Section II J requires sponsors of
clinical trials to report payments made to Medicare beneficiaries for treatment,
complications, and injuries that arise from clinical trials. When required, information
about Medicare beneficiaries’ participation in a research study, medical services
received, Medicare claims, and other information, will be released to the Centers for
Medicare and Medicaid Services and its agents and/or contractors.
Information
disclosed may be re-disclosed by the recipient and may no longer be protected by law.
WHAT DOES MY SIGNATURE ON THIS FORM MEAN?
My signature on this form would mean that I acknowledge:
1. Personal information about me that is collected in this study will be protected
to the full extent of the law. No information from this study that could be linked to
me will be released without my consent.
2. The results of this study may be reported in articles, books or at meetings. My
identity will not be revealed at any time. Research records will be kept
confidential to the extent provided by law. All study records will be kept in a
locked room and accessed only by staff working on this research study.
3. Being in this study is my choice. I may decide to leave this study at any time.
If I choose not to be in the study or leave the study, it will not affect my
insurance benefits or my future medical care at Kaiser Permanente.
4. I may be asked to leave the study at any time for medical reasons, if the
researcher feels that it is in my best interest, or if the study is stopped.
5. My questions regarding this study have been answered. If I have any questions
about this study or if I experience a study-related injury, I may contact

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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Jean M. Lawrence, ScD, MPH, SEARCH Study Principal Investigator
(626) 564-3106 or [email protected]
If I have any questions about my rights as a research subject, I may contact
Armida Ayala, PhD, Director, Human Research Subjects Protection Office at
626-405-3665 or [email protected]
6. If I am injured by being in this study, the physicians and/or employees of
Southern California Permanente Medical Group and/or Kaiser Foundation
Hospitals will provide medical care and treatment according to the terms of my
plan benefits. These benefits are described in my Evidence of Coverage or
Summary Plan Description. I may have to pay co-payments, coinsurance and/or
deductibles. No additional financial payment is available
I have read the entire consent, including the Supplemental HIPAA Authorization and
Experimental Subject’s Bill of Rights and voluntarily consent to participate in this
research study conducted by the physicians or employees of Southern California
Permanente Medical Group and/or Kaiser Foundation Hospitals.
Your signature shows that the research study has been explained to you and all of your
questions have been answered.
If you still have questions or do not
understand what this study is about, do not sign this form. Give this form back to
the study staff and get more information.
A copy of this signed and dated Informed Consent Form will be given to me for my
records

Printed First and Last Name of Participant/ Legally
Authorized Representative

Signature of Participant/Legally Authorized
Representative

Relationship to Participant

Date

Printed Name of Person Obtaining Consent

Signature of Person Obtaining Consent

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

Date

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AUTHORIZATION TO USE YOUR PRIVATE HEALTH INFORMATION
What is private health information?
Private health information is any information that can be traced back to you.
We need your authorization (permission) to use your private health
information in this research study. The private health information that we
will use and share for this study includes:
 Your past, present and future health information is used by the
SEARCH study but is not disclosed with identifiers;
 Your date of birth is used by the SEARCH study and disclosed to
collaborating researchers at Wake Forest University, School of
Medicine;
 Your address is used by the SEARCH study local research staff
to send out letters and cards for the study but is not disclosed;
 Your social security number may be used by the SEARCH staff and
disclosed to the National Center for Health Statistics;
 Your phone number is used by the SEARCH study local research
staff but it is not disclosed;
 Your medical record number is used by the SEARCH staff, but it is
not disclosed;
 The results of your medical tests and lab work done for this
research study are disclosed to the data coordinating center at Wake
Forest University, School of Medicine but without identifiers.
Laboratory tests performed by collaborating researchers at the
University of Washington, Northwest Lipid Research Laboratory are
completed without identifiers.
Who else will see my information?
This information may be shared with the following:
 The study sponsor, the Centers for Disease Control and
Prevention;
 The study’s data coordinating center Wake Forest University, School
of Medicine;
 The Kaiser Permanente Southern California Institutional Review
Board (IRB);
 Kaiser Permanente Principal Investigator, co-Investigators, research
project manager and other research staff (research assistants,
associates, programmers and biostatisticians);
IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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Once we have shared your information we cannot be sure that it will stay
private. If you share your information with people outside the research
team, it will no longer be private. Your child’s name will not be used in
any report that is written. Your name will not be used in any report or
publication that is written.
How long will Kaiser Permanente researchers and the affiliated
researchers noted above use and share my information?
Your info rm ation will be used until the research is completed. This
authorization will expire at the end of the study.
What if I change my mind about sharing my research information?
If you decide not to share your information anymore:
 The research team can continue to use any of the private information
that they already have.
 You will no longer be contacted as part of this research study.
 Decisions about sharing your research information will not affect
your medical care or health care coverage.
 You must write to the study Principal Investigator and tell her that you
no longer want to share your information. Write to the study
principal investigator at:
Jean M. Lawrence, ScD, MPH, MSSA
Department of Research & Evaluation
Southern California Permanente Medical Group
100 South Los Robles Ave., 4th Floor
Pasadena, California 91101
Do I have the right to see and copy my research information?
The results of your laboratory tests will be sent to you (except for genetic
test results other than monogenic forms of diabetes) and, if you have
provided written authorization, copies of the test results sent to you will
also be sent to your health care provider, including specific genetic test
results for monogenic diabetes. In addition, you and your physician must
be notified if your laboratory test results are above alert values described
in the study protocol.

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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If you agree to share your information, you should sign this form below. You
will be given a copy of this form.
I agree to share my information as described in this form

Printed First and Last Name of
Participant/ Legally Authorized Representative

Relationship to
Participant

Signature of Participant/Legally Authorized
Representative

Date

If you have questions or concerns about your privacy and the use of your
protected health information, contact the investigator at the telephone number
listed in the consent form.

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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EXPERIMENTAL SUBJECT’S BILL OF RIGHTS
Any person who is requested to consent to participate as a subject in a research study
involving a medical experiment, or who is requested to consent on behalf of
another, has the right to:
1.

Be informed of the nature and purpose of the experiment.

2.

Be given an explanation of the procedures to be followed in the medical
experiment, and any drug or device to be used.

3.

Be given a description of any attendant discomforts and risks reasonably to be
expected from the experiment.

4.

Be given an explanation of any benefits to the subject reasonably to be
expected from the experiment, if applicable.

5.

Be given a disclosure of any appropriate alternative procedures, drugs, or
devices that might be advantageous to the subject, and their relative risks and
benefits.

6.

Be informed of the avenues of medical treatment, if any, available to the
subject after the experiment if complications should arise.

7.

Be given an opportunity to ask any questions concerning the experiment or the
procedures involved.

8.

Be instructed that consent to participate in the medical experiment may be
withdrawn at any time, and the subject may discontinue participation in the
medical experiment without prejudice.

9.

Be given a copy of a signed and dated written consent form when one is
required.

10.

Be given the opportunity to decide to consent or not to consent to a medical
experiment without the intervention of any element of force, fraud, deceit,
duress, coercion, or undue influence on the subject’s decision.

Original – Chart or Study

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

Copy - Patient

KAISER FOUNDATION HOSPITALS
SOUTHERN CALIFORNIA PERMANENTE
MEDICAL GROUP

PATIENT’S NAME_________________________
M.R. #__________________

INFORMED CONSENT TO PARTICIPATE IN RESEARCH STUDY
OF DIABETES INCIDENCE, COMPLICATIONS, AND QUALITY OF CARE
SEARCH FOR DIABETES IN YOUTH (SEARCH), REGISTRY STUDY
Parent/Guardian Consent for Registry Visit
For Persons with Diabetes less than 18 years of age
SPONSOR:

Centers for Disease Control and Prevention

INVESTIGATOR:

Jean M. Lawrence, ScD, MPH, MSSA Kaiser Permanente
Southern California Department of Research & Evaluation
100 S. Los Robles Ave., 4th Floor
Pasadena CA 91101

TELEPHONE:

(626) 564-3106

Your child is being invited to be in a research study. Taking part in this study is
voluntary.
This informed consent form tells you about the purpose, risks, and benefits of this
research study. You may ask questions and take time to think about the study before
you decide to join it. You should decide if you want to participate in the study only
when you have received all the information you need.
Your doctor or health care provider may be working on this research study. He or
she is interested in your\your child’s healthcare as well as the conduct of this study.
If that makes you feel the doctor can’t be objective about the best care for your child,
you may ask for another doctor or staff member who is not involved in this research.
Kaiser Permanente is being reimbursed by the study sponsor, Centers for
Disease Control and Prevention, to conduct this study.
PURPOSE AND BACKGROUND
The purpose of this research study being conducted by Kaiser Permanente, and in four
other locations in the United States, is to improve our understanding of the incidence,
natural history, complications, and quality of care for children, adolescents, and young
adults with diabetes. You and your child were asked to take part in the SEARCH study
because your child has diabetes. Dr. Jean Lawrence is the lead investigator for
this study for Kaiser Permanente. This study is sponsored by the Centers for Disease
KPSC IRB Approved: 06/21/2016

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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Control.
Diabetes is the third most common life-long disease in people under 20 years of age.
The total number of persons with 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 persons 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 collect
information to answer these questions.
This study will include over 7,000 children and youth with diabetes who were
members of Kaiser Permanente Southern California when they were diagnosed with
diabetes. A member of the SEARCH research team has discussed the requirements
for participating in this study with you and your child. Before agreeing to participate in
this research study, it is important that you/your child read and understand this form or
have a member of the study staff read it to you/your child.
If you/your child have personal, religious, cultural, or ethical beliefs that you think might
limit the types of tests you would agree to have your child receive, please discuss them
fully with your/your child’s physicians or appropriate members of the research team
before entering this study.
This consent form may contain some words that are not familiar to you or to your child.
Please discuss any questions you or your child may have about this study with the
research staff members before you sign this form.
STUDY PROCEDURES
The SEARCH Registry visit includes a brief physical examination, collecting a blood and
urine sample, and completing one or more questionnaires. You and your child can
agree to participate in all or only some parts of the study.
A research team member has set up an appointment for your child. The appointment
will be in the morning or early afternoon. Your child will come to the appointment after
not having anything to eat or drink other than water for 10 hours. Your child will not take
their usual diabetes medications until after their blood has been drawn. The study
visits will take approximately 1 -2hours.
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. We may ask your child to repeat the
urine collection for research purposes; we will not know if this additional urine sample will be
needed until the sample is reviewed by the laboratory

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IRB EXPIRATION DATE: 05/25/2017

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PHYSICAL EXAMINATION
The physical examination includes measurements of height, weight, waist, blood
pressure, and examination of the skin on the neck. The time to complete this part of
the visit is approximately 30 minutes.
COLLECTION OF BLOOD AND URINE SAMPLES
Blood will be taken to measure blood sugar, hemoglobin Alc (a measure of long-term
blood sugar control), C-peptide (a measure of internal insulin production), different
types of cholesterol (fat), and diabetes autoantibodies (markers in the blood for type 1
diabetes). Two genetic markers for diabetes (HLA and ZNT8) will also be tested. The
total amount of blood drawn for these tests is based on your child’s weight but will not
exceed 3 tablespoons.
A first morning urine sample will be requested and tested to see if diabetes is affecting
your child’s kidneys. After these tests are done, your child will be given a snack. You
may also bring your own snack to the Registry visit. After your snack, your child will
take his or her usual diabetes medicine and have his or her medicines recorded by
trained staff.
SAVING / STORAGE OF BLOOD AND URINE
If you agree, your child’s blood a nd ur i ne will be saved for the duration of the study
at the University of Washington, Northwest Lipid Research Laboratories and used in
the future, as new tests are developed to learn more about the types of diabetes and
when someone has or is at risk to get the complications of diabetes. If the results of
the tests affect your child’s health, you will be informed of the test results.
I agree to have my child’s blood and urine saved and used in the future for new tests
as they are developed to learn more about the types of diabetes and the risk of
developing complications of diabetes.
Initials
I do not agree to have my child’s blood and uri ne saved and used in the future for
new tests as they are developed to learn more about the types of diabetes and the risk
of developing complications of diabetes.
Initials
SAVING / STORAGE OF DNA
DNA is found in all cells. DNA makes up genes. Genes determine height, hair
color, and all other body traits. The DNA in each person’s body is different from
every other person’s DNA (except identical twins or triplets who have the same DNA).
The differences may be why some people are more likely to get certain diseases like
diabetes.

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IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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If you agree, your child’s DNA will be saved at the University of Washington, Northwest
Lipid Research Laboratories and used in the future as new tests are developed to tell
your child’s type of diabetes and the risk of developing the complications of diabetes,
insulin resistance (insulin is not working as well as it should), and being overweight. The
total amount of blood required is approximately 1¾ teaspoons (8.5 cc).
I agree to have my child’s DNA stored for the duration of the study at the
University of Washington, Northwest Lipid Research Laboratories and used in the
future as new tests are developed to define the type of diabetes and the risk
of developing the complications of diabetes, insulin resistance (insulin is not working
as well as it should), and obesity.
Initials
I do not agree to have my child’s DNA stored for the duration of the study at the
University of Washington, Northwest Lipid Research Laboratories and used in the
future as new tests are developed to define the type of diabetes and the risk of
developing the complications of diabetes, insulin resistance (insulin is not working
as well as it should), and obesity.
Initials
CENTRAL STORAGE FACILITY AT THE NATIONAL INSTITUTES OF HEALTH
We are asking if you would agree that your child’s blood, urine and DNA samples and
data that are collected for the study may be sent to the central storage facility at the
National Institute of Diabetes, Digestive and Kidney Diseases or NIDDK. This is a
research resource supported by the National Institutes of Health or NIH. The facility
collects, stores, and distributes biological samples and associated data from people with
many kinds of disorders and from healthy people.
The purpose of this collection is to make samples and data available for use in research
of the study of diabetes, obesity, and heart disease and their complications after the
current study is completed. Sending data and samples may give scientists valuable
research material that can be used to develop new diagnostic tests, new treatments, and
new ways to prevent diseases. Scientists who want to use the samples and study data
have to go through a formal proposal process and all proposals are reviewed by an
external panel of experts.
Your child’s samples and data will be stored de-identified, which means that no
identifying information will be stored with it. Researchers will not know the name, date of
birth, medical record number, social security number, etc., of the person who donated the
sample. Your child’s donation is voluntary, and if you choose not to participate there will
be no penalty or loss of benefits to which your child is entitled. If you agree donate your
child’s samples, you can change your mind up until the end of the SEARCH study.
When study researchers receive written instructions from you, they will destroy your
child’s sample and all information that identifies your child.

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IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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Storage of blood, urine and study data
I agree for my child’s blood and urine samples and SEARCH study data to be donated
to the NIDDK storage facility. _____ Initials
I do not agree for my child’s blood and urine samples and SEARCH study data to be
donated to the NIDDK storage facility. _____ Initials
Storage of DNA
I agree for my child’s DNA to be donated to the NIDDK storage facility. _____ Initials
I do not agree for my child’s DNA to be donated to the NIDDK storage facility.
_____ Initials
FULL GENE ANALYSIS (LOOKING AT ALL OF YOUR GENES) AND THE NATIONAL
STORAGE CENTER (NIH/dbGaP)
As a part of the SEARCH study, your child’s DNA may be analyzed to identify a complete
picture of his or her genetic makeup. This is called Genome Wide Association (GWAS).
This information would be sent to a national data bank to help researchers better
understand how genes affect the risk of developing diseases. The data may be included in
larger studies or diabetes or other conditions. No personal information would be included,
such as name, date of birth, or address. Thus, researchers would not be able to link this
information back to your child.
I agree to allow my child’s information about his/her DNA to be included in the NIH
data bank. _____ Initials
I do not agree to allow my child’s information about his/her DNA to be included in the
NIH data bank. _____ Initials

MEDICAL RECORDS REVIEW
It may be necessary to review your child’s 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 laboratory and other test results
CONTACT BY THE SEARCH STUDY IN THE FUTURE
The researchers conducting the SEARCH study may wish to call you as new studies
are developed to let you know about these new studies and ask you if your child
would like to participate 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
IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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are agreeing to take part in any future study. If this study is developed after your child
turns 18 years, we may contact your child directly.
 I agree to be called in the future.

Initials

 I do not agree to be called in the future.

Initials

RELEASE OF TEST RESULTS
The results of tests that may be important to your child’s health will be mailed to you
once the samples are tested at the laboratory. If your child turns 18 years before
the test results become available, the results will only be mailed to your child. Some
participants like their child’s physician to have copies of these test results as
well. Please check one of the two boxes below to give the study permission to release
test results to your child’s physician if you would like us to do this.
I agree to have the test results sent to my child’s physician.
I do not agree to have the test results sent to my child’s physician.

Initials
Initials

RISKS, DISCOMFORTS, AND PRECAUTIONS
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 medical staff.
The blood tests require that your child not eat any food overnight (the child may drink
water). In order to prevent low or high blood sugars, your child’s blood sugar will
be checked by finger-stick and diabetes medicine will be given as needed to control
your child’s blood sugar.
Some of the tests will look for the presence of 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.
This research study includes genetic testing of blood samples that we ask you
to provide. You are free to refuse to take part in this genetic testing. It is your choice.
A federal law called the Genetic Information Nondiscrimination Act (GINA) limits the use
of genetic information by employers with 15 or more employees and by health
insurers and group or individual health plans. GINA generally makes it illegal to
discriminate against you based on your genetic information. If you agree to have your
child take part in genetic testing, the genetic information we collect or obtain through
this research will not affect your child’s eligibility for future medical care,
membership in Kaiser Foundation Health Plan, or the cost of your premiums or
benefits.
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The researchers have taken steps to minimize the risks of this study, and it is not
expected that your child will experience any adverse effects. However, your child may
still encounter problems or side effects.
If this happens, please tell the
researchers about any injuries, side effects, or other problems that your child has
during this study. You should also tell your child’s regular doctors.

WHAT ARE THE POSSIBLE BENEFITS IF I JOIN THIS STUDY?

There are no direct benefits to you or your child from participating in this study.
However, your child’s results from this study may more clearly define your child’s type
of diabetes and the presence or absence of some of the complications of diabetes. You
will also lear n if yo ur child’s laborator y tests are outside the normal ra nge. If
you give permission, some of this information will be shared with your child’s health
care professionals, which could impact the management of your child’s diabetes.
ALTERNATIVES
There are no treatments involved in this study, and participation is entirely
voluntary. You may choose not to participate or not to have your child participate in
this study. Your decision to participate or not to participate will not affect your future
medical care or your child’s future medical care. You may withdraw your child from this
study at any time.
COST
There is no cost to you/your child to participate in this study.
COMPENSATION
To reimburse you for your time to complete the Registry visit, you and your child
will receive up to $80.00 in gift cards or a check.
You will receive:
$30.00 for completing the surveys;
$30.00 for completing the physical examination;
$20.00 for having your child’s blood drawn;
We may ask your child to provide another sample of your child’s urine in the future. You
will be paid $20.00 for providing this additional urine sample.
CONFIDENTIALITY
Only SEARCH project staff will be able to view the information that you give to us.
Information that would identify you/your child will not be released without your consent.
All answers that you/your child give will be kept private. This is so because this
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study has been given a Certificate of Confidentiality. This means that anything you or
you and your child tell us will not have to be given out to anyone, even if a court orders
us to do so, unless you or you and your child say it’s okay. Under the law, we must
report if you or your child tells us you or your child is planning to cause serious harm to
yourself or others.
A special number will be assigned to your child upon entering the study. 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 will be kept in a password-protected database in the Department
of Research & Evaluation at Kaiser Permanente Southern California. Thus, no one
other than the research staff will be able to link any of the information collected in the
study to you or your child.
It is possible that members of the research team might use e-mail to contact you for
study purposes, for example to remind you of a scheduled visit. We will not do this if you
do not give us permission, and we will never put your private health information in an email. However if you give us permission to contact you using e-mail, Kaiser Permanente
cannot guarantee that the message will get to you or that the message will not go to
someone else by mistake.
The information from the research study may be presented or published; however, your
child will not be identified in such publications. When the study is over, your child’s
information will be kept in a computer database for a period required by the funding
agency and then will be destroyed.
RIGHT TO WITHDRAWAL
You and your child may leave this study at any time. Leaving the study will have
no effect on your ability or your child’s ability to get medical care or health insurance
nor will it have any effect on the kind of care your health care professionals are giving to
you and your child. In order to withdraw from this study, please contact the Principal
Investigator whose contact information is on the signature page. If you withdraw
from this study, no further tests will be done on the stored samples that you provided.
However, survey data and other tests conducted on samples collected at the visit
will still be included in the dataset to be used for future studies. You will no longer be
contacted to participate in this study.
WHAT DOES MY SIGNATURE ON THIS FORM MEAN?
My signature on this form would mean that I acknowledge:
1. Personal information about my child that is collected in this study will be protected
to the full extent of the law. No information from this study that could be linked to me
or my child will be released without my consent.

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2. The results of this study may be reported in articles, books or at meetings. My
child’s identity will not be revealed at any time. Research records will be kept
confidential to the extent provided by law. All study records will be kept in a
locked room and accessed only by staff working on this research study.
3. Being in this study is my/m y child’s choice. I/my child may decide to leave this
study at any time. If I/my child choose(s) not to be in the study or leave the
study, it will not affect my/my child’s insurance benefits or my/my child’s future
medical care at Kaiser Permanente.
4.

My child may be asked to leave the study at any time for medical reasons, if
the researcher feels that it is in my child’s best interest, or if the study is stopped.

5.

My questions regarding this study have been answered. If my child or I have any
questions about this study or if my child experiences a study-related injury, I may
contact
Jean M. Lawrence, ScD, MPH, SEARCH Study Principal Investigator
(626) 564-3106 or [email protected]
If I have any questions about my rights as a research subject, I may contact
Armida Ayala, PhD, Director, Human Research Subjects Protection Office at
626-405-3665 or [email protected]

6.

If I am injured by being in this study, the physicians and/or employees of Southern
California Permanente Medical Group and/or Kaiser Foundation Hospitals will
provide medical care and treatment according to the terms of my plan benefits.
These benefits are described in my Evidence of Coverage or Summary Plan
Description. I may have to pay co-payments, coinsurance and/or deductibles. No
additional financial payment is available

I have read the entire consent, including the Supplemental HIPAA Authorization and
Experimental Subject’s Bill of Rights and voluntarily consent to participate in this
research study conducted by the physicians or employees of Southern California
Permanente Medical Group and/or Kaiser Foundation Hospitals.
Your signature shows that the research study has been explained to you and all of your
questions have been answered.
If you still have questions or do not
understand what this study is about, do not sign this form. Give this form back to
the study staff and get more information.
A copy of this signed and dated Informed Consent Form will be given to me for
my records

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IRB EXPIRATION DATE: 05/25/2017

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Printed First and Last Name of Parent of Legal Guardian
Signature of Parent or Legal Guardian

Date

Printed Child’s First and Last Name

Assent of Child

Date

Printed Name of Person Obtaining Consent

Signature of Person Obtaining Consent

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

Date

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AUTHORIZATION TO USE YOUR CHILD’S PRIVATE HEALTH
INFORMATION
What is private health information?
Private health information is any information that can be traced back to you
or your child. We need your authorization (permission) to use your child’s
private health information in this research study. The private health
information that we will use and share for this study includes:
 Your child’s past, present and future health information is used by
the SEARCH study but is not disclosed with identifiers;
 Your child’s date of birth is used by the SEARCH study and
disclosed to collaborating researchers at Wake Forest University,
School of Medicine;
 Your address is used by the SEARCH study local research staff
to send out letters and cards for the study, but is not disclosed;
 Your child’s social security number may be used by the SEARCH
staff and disclosed to the National Center for Health Statistics;
 Your phone number is used by the SEARCH study local research
staff but it is not disclosed;
 Your child’s medical record number is used by the SEARCH staff,
but it is not disclosed;
 The results of your child’s medical tests and lab work done for
this research study are disclosed to the data coordinating center at
Wake Forest University, School of Medicine but without identifiers.
Laboratory tests performed by collaborating researchers at the
University of Washington, Northwest Lipid Research Laboratory are
completed without identifiers.
Who else will see my child’s information?
This information may be shared with the following:
 The study sponsor, the Centers for Disease Control and
Prevention;
 The Kaiser Permanente Southern California Institutional Review
Board (IRB);
 The study’s data coordinating center Wake Forest University, School
of Medicine;
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 Kaiser Permanente Principal Investigator, co-Investigators, research
project manager and other research staff (research assistants,
associates, programmers and biostatisticians);
Once we have shared your child’s information we cannot be sure that it will
stay private. If you share your child’s information with people outside the
research team, it will no longer be private. Your child’s name will not be
used in any report that is written. Your child’s name will not be used in any
report or publication that is written.
How long will Kaiser Permanente researchers and the affiliated
researchers noted above use and share my child’s information?
Your child’s information will be used until the research is completed. This
authorization will expire at the end of the study.
What if I change my mind about sharing my child’s research
information?
If you decide not to share your child’s information anymore:
 The research team can continue to use any of the private information
that they already have.
 You will no longer be contacted as part of this research study.
 Decisions about sharing your child’s research information will not
affect your child’s medical care or health care coverage.
 You must write to the study Principal Investigator and tell her that you
no longer want to share your child’s information. Write to the study
principal investigator at:
Jean M. Lawrence, ScD, MPH, MSSA
Department of Research & Evaluation
Southern California Permanente Medical Group
100 South Los Robles Ave., 4th Floor
Pasadena, California 91101
Do I have the right to see and copy my child’s research information?
The results of your child’s laboratory tests will be sent to you (except for
genetic test results other than monogenic forms of diabetes) and, if you
have provided written authorization, copies of the test results sent to you
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will also be sent to your child’s health care provider, including specific
genetic test results for monogenic diabetes. In addition, you and your
physician must be notified if your child’s laboratory test results are above
alert values described in the study protocol.
If you agree to share your child’s information, you should sign this form
below. You will be given a copy of this form.
I agree to share my child’s information as described in this form.

Printed First and Last Name of
Participant/ Legally Authorized Representative

Relationship to
Participant

Signature of Participant/Legally Authorized
Representative

Date

If you have questions or concerns about your privacy and the use of your
protected health information, contact the investigator at the telephone number
listed in the consent form.

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

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EXPERIMENTAL SUBJECT’S BILL OF RIGHTS
Any person who is requested to consent to participate as a subject in a research study
involving a medical experiment, or who is requested to consent on behalf of
another, has the right to:
1.

Be informed of the nature and purpose of the experiment.

2.

Be given an explanation of the procedures to be followed in the medical
experiment, and any drug or device to be used.

3.

Be given a description of any attendant discomforts and risks reasonably to be
expected from the experiment.

4.

Be given an explanation of any benefits to the subject reasonably to be
expected from the experiment, if applicable.

5.

Be given a disclosure of any appropriate alternative procedures, drugs, or
devices that might be advantageous to the subject, and their relative risks and
benefits.

6.

Be informed of the avenues of medical treatment, if any, available to the
subject after the experiment if complications should arise.

7.

Be given an opportunity to ask any questions concerning the experiment or the
procedures involved.

8.

Be instructed that consent to participate in the medical experiment may be
withdrawn at any time, and the subject may discontinue participation in the
medical experiment without prejudice.

9.

Be given a copy of a signed and dated written consent form when one is
required.

10.

Be given the opportunity to decide to consent or not to consent to a medical
experiment without the intervention of any element of force, fraud, deceit,
duress, coercion, or undue influence on the subject’s decision.

Original – Chart or Study

IRB NUMBER: 5836
IRB APPROVAL DATE: 06/21/2016
IRB EXPIRATION DATE: 05/25/2017

Copy - Patient

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 1 of 7

Consent to Participate in a Research Study
Adult Subjects, SEARCH 4 Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: February 2016
Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), 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: Christine Turley, MD (803-576-5926)
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. 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.
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.

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 2 of 7

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?
About 832 people at five sites across the US will take part in the Registry Study visit, including
approximately 207 people from the Carolina SEARCH site.
How long will your part in this study last?
The Registry Study visit will take about an hour. We may contact you every year to be sure we
have your correct contact information. If your address/phone number has changed, we may
attempt to update your contact information through a public database, such as LexisNexis. 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?
These are the things that will happen during the study:
 Fast for 8-10 hours before the visit (no food or drinks, except water). You will not take
your usual diabetes medicines until after you have eaten at your visit.
 Bring in a urine sample to be tested for albumin and creatinine to see how well your
kidneys are working. (You will be mailed a container with detailed instructions before
your appointment).
 Measure height, weight, waist, and blood pressure. Each will be done 2-3 times.
 Look at the skin on the back of neck.
 Blood will be taken from your arm to measure blood sugar, hemoglobin A1c (measures
average blood sugar over past 3 months), different types of cholesterol (fat), c-peptide
(measures your own insulin production), cystatin-C and creatinine (measures kidney
function), and diabetes antibodies (markers in the blood for type 1 diabetes). 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 (HbA1c, cholesterol, c-peptide,
diabetes 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




A sample of your blood, urine, and DNA may be saved after the visit, if you agree by
signing the Stored Specimens Consent Form. Some of these saved samples may be used
in the future for tests related to diabetes.
After the blood and urine samples are obtained, you can take your pills or insulin and you
will be given a snack.
You will be asked questions about your diabetes, medical care, current medications,
family history of diabetes, education, family income level and health insurance.
Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 3 of 7

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 or drink anything other than water 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.
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.

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 4 of 7

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. 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 secure, 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. Turley at the University of South Carolina (USC)) and the SEARCH
Carolina research team will be able to access this database and link 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 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.

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 5 of 7

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 $60 in gift cards for completing the study visit, plus an extra $20 for
bringing in your first morning urine collection. In the rare circumstance that a blood redraw or
repeat urine collection 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.
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.

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 6 of 7

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].

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 7 of 7

------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD, PhD (GHS data collection site)
Deborah Bowlby, MD (MUSC data collection site)
Christine Turley, MD (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

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

__________________
Date

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 1 of 6

Assent to Participate in a Research Study
Adolescent Subjects age 15-17, Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Assent Form Version Date: February 2016
Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), 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: Christine Turley, MD (803-576-5926)
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. We are
asking you and others with diabetes to be in the research because we want to count the number of

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 2 of 6

children and teens with diabetes. We also want to learn more about the types of diabetes that
affect children and teens.
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?
About 832 people at five sites across the US will take part in the Registry Study visit, including
about 207 people from the Carolina SEARCH site.
How long will your part in this study last?
The Registry Study visit will take about an hour. 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?
These are the things that will happen during the study:
 Fast for 8-10 hours before the visit (no food or drinks, except water). You will not take
your usual diabetes medicines until after you have eaten at your visit.
 Bring in a urine sample to be tested for albumin and creatinine to see how well your
kidneys are working. (You will be mailed a container with detailed instructions before
your appointment).
 Measure height, weight, waist, and blood pressure. Each will be done 2-3 times.
 Look at the skin on back of neck
 Blood will be taken from your arm to test blood sugar, hemoglobin A1c (measures
average blood sugar over past 3 months), different types of fat, c-peptide (measures your
own insulin production), cystatin-C and creatinine (measures kidney function), and
diabetes antibodies (markers in the blood for type 1 diabetes). 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, cpeptide, diabetes 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

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 3 of 6





A sample of your blood, urine, and DNA may be saved after the visit, if you agree by
signing the Stored Specimens Consent Form. Some of these saved samples may be used
in the future for tests related to diabetes.
After the blood and urine samples are obtained, you can take your pills or insulin and you
will be given a snack.
You will be asked questions about your diabetes, medical care, current medications,
family history of diabetes, education, family income level, and health insurance.

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 or drink anything other than water 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.
Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 4 of 6

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 secure, 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. Turley at the University of South Carolina (USC)) and the SEARCH
Carolina research team will be able to access this database and link 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.

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 5 of 6

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 gift cards for taking part in this study along with an extra $20 gift card for
bringing in your first morning urine collection. Your parents will also get $20 in gift cards at the
end of the visit. In the rare circumstance that a blood redraw or repeat urine 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
at Greenville Health System (864-522-2097;email [email protected]) or at UNC-Chapel Hill (919966-3113; email: [email protected]).

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB 10-2341
GHS IRB File # Pro00010812
Page 6 of 6

-------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD, PhD (GHS data collection site)
Deborah Bowlby, MD (MUSC data collection site)
Christine Turley, MD (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

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

_________________
Date

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 1 of 7

Parental Permission for a Minor Child to Participate in a Research Study
SEARCH 4 Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: February 2016
Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), 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: Christine Turley, MD (803-576-5926)
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. We are
Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 2 of 7

asking your child and other youth 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.
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?
About 832 people at five sites across the US will take part in the Registry Study visit, including
approximately 207 people from the Carolina SEARCH site.
How long will your child’s part in this study last?
The Registry Study visit will take about an hour. We may contact you every year to be sure we
have your correct contact information. If your address/phone number has changed, we may
attempt to update your contact information through a public database, such as LexisNexis. 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?
These are the things that will happen during the study:
 Your child will fast for 8-10 hours before the visit (no food or drinks, except water).
Your child will not take your usual diabetes medicines until after he/she has eaten at the
study visit.
 Bring in a sample of your child’s urine to be tested for albumin and creatinine to see how
well his/her kidneys are working. (You will be mailed a container with detailed
instructions before your appointment).
 Measure your child’s height, weight, waist and blood pressure. Each will be done 2-3
times.
 Look at the skin on the back of your child’s neck.
 Blood will be taken from your child’s arm to measure blood sugar, hemoglobin A1c
(measures average blood sugar over past 3 months), different types of cholesterol (fat), cpeptide (measures your child’s own insulin production), cystatin-C and creatinine
(measures of kidney function), and diabetes antibodies (markers in the blood for type 1
diabetes). 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, cpeptide, diabetes antibodies, and urine albumin/creatinine) will be shared with your
child’s doctor.
Mark the line that best matches your choice:
Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 3 of 7





_____ 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
A sample of your child’s blood, urine, and DNA may be saved after the visit, if you agree
by signing the Stored Specimens Consent Form. Some of these saved samples may be
used in the future for tests related to diabetes.
After the blood and urine samples are obtained, your child can take his/her pills or insulin
and will be given a snack.
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.

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
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 or drink anything other than water
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 fast-acting 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

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 4 of 7

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. 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 secure, 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. Turley at the University of South Carolina (USC))
and the SEARCH Carolina research team will be able to access this database and link 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,
Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 5 of 7

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 receive a $20 gift card for completing the study visit. Your child will get $40 in gift
cards for completing the study visit and an extra $20 gift card for bringing in the first morning
urine collection. In the rare circumstance that a blood redraw or repeat urine 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?
Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 6 of 7

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]).

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 7 of 7

-------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD, PhD (GHS data collection site)
Deborah Bowlby, MD (MUSC data collection site)
Christine Turley, MD (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

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

_________________
Date

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 1 of 3

Assent to Participate in a Research Study
Minor Subjects (7-14 yrs), SEARCH 4 Registry Study Visit
________________________________________________________________________
UNC IRB Study #10-2341
Consent Form Version Date: February 2016
Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), 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: Christine Turley, MD (803-576-5926)
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?
About 832 people at five sites in the U.S. will take part in this study, including about 207 people
from South Carolina.

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 2 of 3

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. If you agree, 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.


This study visit will last about 60 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 password-protected
database. 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

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

UNC IRB# 10-2341
GHS IRB File # Pro00010812
Page 3 of 3

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 plus an extra $20 for bringing in
your first morning urine collection. If we are not able to get your blood and you return for a 2nd
blood draw or you need to do a 2nd urine collection, you will get another $20 gift card.
Your parents will get $20 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]).
-----------------------------------------------------------------------------------------------------------------Title of Study: SEARCH for Diabetes in Youth 4 (SEARCH 4), Registry Study Visit
Principal Investigators:
Elizabeth Mayer-Davis, PhD (UNC-Chapel Hill Coordinating Site);
Bryce Nelson, MD, PhD (GHS data collection site)
Deborah Bowlby, MD (MUSC data collection site)
Christine Turley, MD (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

Greenville Health System
IRB Number: Pro00010812
Approved: 3/23/2016
Expiration: 3/22/2017

________________
Date

Assent Form

COMIRB
APPROVED
For Use
10-May-2016
09-May-2017

Principal Investigator: Dana Dabelea, MD, PhD
COMIRB No: Protocol 01-934
Version Date: 01/29/2016
Version No: 4.0

Study Title: SEARCH for Diabetes in Youth Registry Study
_________________________________________________________________________________
Assent Format for participants 8 - 13 years of age
What is this study about?
I am being asked to decide if I want to be in this research study. The goal of this study is to know more
about diabetes in children and how it affects my life.
Why are you asking me?
I am being asked to be in the study because I have diabetes.
What do I have to do?
I know that to be in the study I will come to the clinic for one visit, for approximately 1 hour, which includes
questionnaires, blood draw, urine collection and body measurements.
Will this hurt?
The blood draw might hurt but we can use a numbing cream so that you do not feel the pain.
Can I ask questions?
I asked any questions I have now about the study. All my questions were answered. I know that I can ask
any questions about this study at any time. If I want to, I can call Dr. Dana Dabelea at (303) 724-4414.
Do I have to do this?
I know that I do not have to be in this study. No one will be mad at me if I say no.
I want to be in the study at this time.



YES



NO

I will get a copy of this form to keep.
Child’s Printed Name: ____________________________________________
Child’s Signature: ______________________________________________ Date: __________
Witness or Mediator: __________________________________________

Date: __________

I have explained the research at a level that is understandable by the child and believe that the child
understands what is expected during this study.
Signature of person obtaining assent: _______________________________ Date: ____________

Version 4.0

Page 1

Consent and Authorization Form

COMIRB
APPROVED
For Use
10-May-2016
09-May-2017

Principal Investigator: Dana Dabelea, MD, PhD
COMIRB No: Protocol 01-934
Version Date: 04/15/2016
Version No: 4.0
Study Title:

SEARCH for Diabetes in Youth Registry Study

You (in this form ‘you’ refers to you and/or your child) are being asked to participate in a research
study. This form provides you with information about the study. A member of the research team will
describe this study to you and answer all of your questions. Please read the information below and ask
questions about anything you don’t understand before deciding whether or not to take part.
Why is this study being done?
You are being asked to take part in a research study called the SEARCH for Diabetes in Youth Registry
Study because you have diabetes and were diagnosed under the age of 20. The study’s aims are to count
how many children have diabetes and determine whether diabetes is increasing in children and
adolescents, to more accurately determine what type of diabetes you have, and to identify how diabetes
affects the lives of youth with diabetes.
Diabetes is the third most common chronic disease in individuals under 20 years of age. The total number
of cases of diabetes in this age group is increasing. Also, types of diabetes not seen previously in young
people are now being seen. We do not know how many cases and types of diabetes in children and
adolescents there are in the United States and whether diabetes is increasing. We also do not know the
type of care young people with diabetes receive, or the effect of diabetes on their lives. Specifically, this
project is interested in studying the following questions.
a.
b.
c.
d.
e.

How many cases of diabetes are there in the United States in people under 20 years old?
How many new cases of diabetes develop every year?
What can we learn about each type of diabetes?
What medical care is given to youth with diabetes?
How does diabetes affect the lives of youth with diabetes?

What is the purpose of this study?
In this research study we want to learn more about diabetes in people less than 20 years of age. You are
being asked to be in the study because you have diabetes and were under the age of 20 and living in
Colorado when the diabetes started.
Are there any reasons you should not be in this study?
You should not complete a study visit if currently pregnant. You may take part in the study visit when it has
been at least four months after the end of the pregnancy.
How long will your part in this study last?
The Registry Study visit will take about 60 minutes.
Other people in this study
Up to 10,500 youth less than 20 years old will be enrolled locally, and up to 30,000 youth less than 20
years old will be invited to participate nationally in this study. A total of approximately 832 people at five
sites across the US will take part in the Registry Study visit, including approximately 220 people from the
Colorado SEARCH site from 2016-2020.

Version 4.0

Page 1

Initials_____

Consent and Authorization Form
SEARCH for Diabetes in Youth Registry Study - COMIRB #01-934

What will happen if I take join 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.
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 visit. We may ask you to repeat the urine collection for research purposes; we will not know
this until the sample is reviewed by the laboratory.
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), islet cell antibodies (markers in the
blood for type 1 diabetes), c-peptide, and cystatin-C and serum creatinine (measures of kidney function).
The total amount of blood drawn will be based on weight tables and will not exceed 3 tablespoons. The
total amount of blood drawn 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.
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.
After the blood and urine samples are obtained, you can take your diabetes pills or insulin and will be given
a snack.
Physical Exam and Questionnaires
After eating, we will ask you some questions about the medicines you uses. 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 fill out a brief form to update your contact
information. We will also ask you about the type of providers you see for your diabetes care.
Medical Record Release
In the future, the SEARCH Study staff may ask you for permission to see your medical record. We are
particularly interested in key medical events such as hospitalizations. If you give permission, you will be
asked to sign a medical release form, which will specify which doctor’s or health care professionals will be
contacted.
What will happen to the specimens?
The blood, and urine will be sent to the study’s central laboratory at the University of Washington,
Northwest Lipid Research Laboratories, for storage and testing. 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 Colorado site in a password-protected file.
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.
Central Storage Facility at the National Institutes of Health
Version 4.0
Page 2

Initials_____

Consent and Authorization Form
SEARCH for Diabetes in Youth Registry Study - COMIRB #01-934

We are asking if you would agree that some of the remainingblood, urine and DNA samples and data
that are collected for that study may be sent to the central storage facility at the National Institute of
Diabetes, Digestive and Kidney Diseases or NIDDK once the study is complete. This is a research
resource supported by the National Institutes of Health or NIH. The facility collects, stores, and
distributes biological samples and associated data from people with many kinds of disorders and from
healthy people.
The purpose of this collection is to make samples and data available for use in research of the study of
diabetes, obesity, and heart disease and their complications after the current study is completed.
Sending data and samples may give scientists valuable research material that can be used to develop
new diagnostic tests, new treatments, and new ways to prevent diseases. Scientists who want to use
the samples and study data have to go through a formal proposal process and all proposals are
reviewed by an external panel of experts.
Your samples and data will be stored de-identified, which means that no identifying information will be
stored with it. Researchers will not know the name, date of birth, medical record number, social security
number, etc., of the person who donated the sample. Your child’s donation is voluntary, and if you/your
child choose not to participate there will be no penalty or loss of benefits to which you are entitled. If
you/your child agree donate samples, you can change your mind up until the end of the SEARCH
study. When study researchers receive written instructions from you/your child, they will destroy your
sample and all information that identifies your child. However, after we send the samples to the
NIDDK repository at the end of the study, we will be unable to destroy your samples or data because it
will be unlinked and impossible for us to identify which samples or data belong to you.

Full Gene Analysis (looking at all of your genes) and the National Storage Center (NIH/dbGaP)
As a part of the SEARCH study, your DNA may be analyzed to identify a complete picture of your genetic
makeup. This is called Genome Wide Association (GWAS). This information would be sent to a national
data bank to help researchers better understand how genes affect the risk of developing diseases. The
data may be included in larger studies or diabetes or other conditions. No personal information would be
included, such as name, date of birth, or address. Thus, researchers would not be able to link this
information back to you.
_____ I agree to allow information about my DNA to be included in the NIH data bank.
_____ I do not agree to allow information about my DNA to be included in the NIH data bank.
Participation in this study is voluntary and you may choose to withdraw from the study at any time. You
may request that your stored samples be permanently removed from the Central Laboratory if you choose
to withdraw consent. To request that your sample be permanently removed from the central laboratory,
contact:
Dr. Dana Dabelea
UCD Colorado School of Public Health
Dept. of Epidemiology
Bldg 500, Box B-119
Aurora, CO 80045
Ph. (303) 724-4414
FAX (303) 724-4491
We will send a request to the central laboratory and they will then destroy the samples and send us a letter
certifying that the sample has been destroyed. We will send you a copy of this letter. However, please note
that if you request for your samples or data to be destroyed after the conclusion of the study, we will be
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unable to destroy samples and data that were sent to the NIDDK Repository and/or the dbGaP data bank.
All samples held at the central laboratory at the University of Washington can be destroyed at any time.
Please read each sentence below and think about your choice. After reading each sentence, check “Yes”
or “No” and write your initials. If you have questions, please talk to the SEARCH study staff, Dr. Dabelea or
your healthcare provider. Remember, no matter what you decide to do about the storage and future use of
your data, blood, DNA, and urine samples, you may still take part in the study.
1. I wish to have the results of my blood and urine tests given to my doctor or diabetes care provider.
Yes

No

_________Initials

2. I give my permission for my blood and urine samples to be stored in a central laboratory at the University
of Washington, Seattle for future use by study investigators in studies of diabetes and diabetes risk factors
and complications.
Yes

No

_________Initials

3. I give my permission for my DNA (genes) blood sample to be tested for inherited factors in the
development of diabetes, diabetes risk factors and complications.
Yes

No

_________Initials

4. I give my permission for my DNA (genes) blood sample to be stored by the SEARCH study laboratory at
the University of Washington, Seattle for future use in diabetes and diabetes-related studies.
Yes

No

_________Initials

5. I give my permission for the results of my DNA analysis and associated data to be sent to a national
storage center for future study on how genes may affect the risk of diseases such as asthma, cancer,
diabetes and heart disease.
Yes

No

_________Initials

6. I give my permission for my study doctor (or someone he or she chooses) to contact me in the future to
ask me to take part in more research.
Yes

No

_________Initials

What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. Youwill 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
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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.
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.
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. 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 the University of Colorado Denver.
In addition, there may be uncommon or previously unknown risks that might occur. You should report any
problems to the researchers.
Are there alternative treatments?
There are no treatments proposed in this study, and the decision to participate in this study will not affect
your treatment. Blood and urine test results will be available approximately 3 months after the samples are
collected. Someone from the study will explain the results to you if you wish. Your diabetes provider will
also receive the results, if you have given your permission.
Who is paying for this study?
This research is being paid for by the Centers for Disease Control and Prevention (CDC) (PA number DP10-001).
Will I be paid for being in the study?
You will be given a gift card worth $10 for completing the Initial Participant Survey. You will be given a gift
card worth $40 for having a blood draw and an additional $40 in gift cards for completing the
questionnaires and physical measurements. It is important for you to know that payment for participation in
the study is taxable income. If needed, we can offer assistance with transportation to the visit. We may be
asked to repeat your urine sample. You will be paid an extra $20 for providing these urine samples. You
may be paid $5 for providing updated contact information annually (for years you do not come for a
SEARCH Study visit).
Will I have to pay for anything? It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study. If you
choose to take part, you have the right to stop at any time. If you refuse or decide to withdraw later, you
will not lose any benefits or rights to which you are entitled.
If you leave this study, you will still receive your normal medical care. The only medical care that you will
lose is the medical care you are getting as part of this study. You might be able to get that same kind of
medical care outside of the study. Ask your study doctor.
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If you drop out of the research study, you can request that all blood or DNA samples that have been
collected be destroyed before the end of the study. Withdrawal from this research study will have no effect
on access to medical care nor will it have any effect on the standard of care your health care professionals
are providing. If there are any new findings during the study that may affect whether you want to continue
to take part, you will be told about them. Significant new findings that relate to your participation in this
study will be discussed with you and/or your health care provider with your permission.
Can I be removed from this study?
You may be taken out of this study if the study doctor thinks it is not safe for you to be in the study. You
can be taken out of the study even if you do not want to leave the study. The study doctor may decide to
stop your participation without your permission if the study doctor thinks that being in the study may cause
you harm, or for any other reason. Also, the sponsor may stop the study at any time.
What happens if I am injured or hurt during the study?
If you are hurt by this research, you should call Dr. Dana Dabelea immediately at (303) 724-4414. We will
arrange to get you medical care if you have an injury that is caused by this research. However, you or your
insurance company will have to pay for the care that is needed. You should inform your health care
providers if you decide to participate in this research study. If you have questions about injury related to the
research, you may call Dr. Dabelea and/or your private physician.
Who do I call if I have questions?
If you have questions right now, you can ask the person who is talking to you about this consent form. The
researcher carrying out this study is Dr. Dana Dabelea. If you have questions, concerns or complaints
later, you may call Dr. Dana Dabelea at (303) 724-4414. You will be given a copy of this form to keep. If
you have questions about your rights as a subject in this study, you can call the Colorado Multiple
Institutional Review Board (COMIRB) office at (303) 724-1055.
Who will see my research information?
The University of Colorado Denver (UCD) and its affiliated hospital(s) have rules to protect information
about you. Federal and state laws including the Health Insurance Portability and Accountability Act
(HIPAA) also protect your privacy. This part of the consent form tells you what information about you may
be collected in this study and who might see or use it.
The institution involved in this study is the University of Colorado Denver. We cannot do this study without
your permission to see, use and give out your information. You do not have to give us this permission. If
you do not, then you may not join this study.
We will see, use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be
covered by this obligation.
We will do everything we can to maintain the confidentiality of your personal information but confidentiality
cannot be guaranteed.
The use and disclosure of your information has no time limit. You can cancel your permission to use and
disclose your information at any time by writing to the study’s Primary Investigator, at the name and
address listed below. If you do cancel your permission to use and disclose your information, your part in
this study will end and no further information about you will be collected. Your cancellation would not affect
information already collected in this study.
Dr. Dana Dabelea
UCD Colorado School of Public Health
Dept. of Epidemiology
Bldg 500, Box B-119
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Aurora, CO 80045
Ph. (303) 724-4414

FAX (303) 724-4491

Both the research records that identify you and the consent form signed by you may be looked at by
the following people:
 Federal offices such as the Food and Drug Administration (FDA) and the Office of Human
Research Protections (OHRP) that protect research subjects like you.
 People at the Colorado Multiple Institutional Review Board (COMIRB)
 The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health
(NIH), who are the sponsors paying for this study
 Officials at the institution where the research is being conducted and officials at other
institutions involved in this study who are in charge of making sure that we follow all of the rules
for research.
We might talk about this research study at meetings. We might also print the results of this research study
in relevant journals. But we will always keep the names of the research subjects, like you, private.
You have the right to request access to your personal health information from the Investigator. To ensure
proper evaluation of test results, your access to these study results may not be allowed until after the study
has been completed.
The investigator (or staff acting on behalf of the investigator) will use your information for the
research purpose outlined in this consent form. They will also make all or some of the following
health information about you collected in this study available to:
 Wake Forest University Biostatistics Center Northwest Lipid Metabolism and Diabetes Research
Laboratory
 NIH Genome-Wide Association Studies (GWAS) Repository dbGaP
 The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK)
 IMS
Information about you that will be seen, collected, used and disclosed in this study:
 Age, sex, race/ethnicity
 Date of birth
 Date of diabetes diagnosis
 Portions of your previous and current Medical Records that are relevant to this study, including but
not limited to Diagnoses, History and Physical, or laboratory studies, procedure results
 Research visit and research test records including questionnaires and physical examinations
 Blood, DNA and urine samples
 Results of genetic analyses and the associated data
What happens to Data, Blood and Specimens that are collected in this study?
Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the
causes and cures of disease. The data, blood and specimens collected from you during this study are
important to this study and to future research. If you join this study:
 The data, blood, or other specimens given by you to the investigators for this research no longer belong
to you.
 Both the investigators and any sponsor of this research may study your data, blood, or other specimens
collected from you.
 If data, blood, or other specimens are in a form that identifies you, UCD or the hospitals involved in this
study may use them for future research only with your consent or Institutional Review Board (IRB)
approval.
 Any product or idea created by the researchers working on this study will not belong to you.
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 There is no plan for you to receive any financial benefit from the creation, use or sale of such a product
or idea.
All information gathered during this study will be held in strict confidence. Once you decide to join the
research study, a unique number, called a research study number, will be assigned to you. The unique
identifying number will be used instead of your name. The list linking the number assigned to you to your
name will be kept in a locked file at the clinic site in Denver, Colorado. Thus, no one other than Dr. Dana
Dabelea and her research team will be able to connect any of the research study information to you.
All answers that you give will be kept private. This is so because this study has been given a certificate of
confidentiality. This means that anything you tell us will not have to be given to anyone even if a court
orders us to do so unless you give permission. However, 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 damage to yourself or
others.
HIPAA Authorization for Optional Additional Study Procedures –
In this form, you were given the option to agree to additional, optional research procedures. You must also
give us your permission, under HIPAA rules, to use and disclose the information collected from these
optional procedures, as described above.
Some of these optional procedures may involve genetic testing or the use of your genetic information.
Your genetic information will be released to the NIH Genome-Wide Association Studies Repository.
If you decline to give us permission to use and disclose your information, you cannot take part in these
optional procedures, but you can still participate in the main study. Please initial next to your choice:
_____ I give permission for my information, from the optional procedures I have agreed to above, to be
used and disclosed as described in this section.
_____ I do not give permission for my information for any optional procedures to be used and disclosed; I
understand that I will not participate in any optional procedures.
Contact in the Future
We may contact you every year to be sure we have your correct contact information.
The researchers will also 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.
_____ I agree for you to contact me/my child in the future to tell me about other studies
_____ I do not agree for you to contact me/my child in the future to tell me about other studies
Agreement to be in this study
I have read this paper about the study or it was read to me. I understand the possible risks and benefits of
this study. I understand and authorize the access, use and disclosure of my information as stated in this
form. I choose to be in this study. I will get a signed and dated copy of this consent form. (Please initial all
previous pages of the consent form).
Signature: ___________________________ Print Name: _________________________ Date: _______
Parent or guardian if subject ≤ 17 years
Signature: ___________________________ Print Name __________________________Date: _______
Subject >18 years
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Consent form explained by: ________________________________________________Date:_______
Signature
Print Name
Witnessed by: ________________________________________________Date:_______
Signature
Print Name
Investigator’s Signature: ________________________________________

Date: ___________

Investigator must sign with 30 days

For children ages 14-17 who can read this form:
___________________________________________
Child’s Name

Date_________

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STUDY TITLE: SEARCH FOR DIABETES IN YOUTH
(STUDY VISIT: 2016 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. There
will be about 1,000 people invited to participate in this study.
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
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
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 and
cystatin C (measure 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 3 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

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 If you agree, extra blood will be collected for DNA. This blood sample may
be tested to identify your genetic makeup. DNA testing may help
researchers better understand how genes affect the risk of developing
diseases such as asthma, cancer, diabetes, and heart disease. You will be
notified of any significant results. Incidental results will not be reported 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.

Central Storage Facility at the National Institutes of Health
 If you agree, your blood, urine, DNA samples and data may be sent to the
central storage facility at the National Institute of Diabetes, Digestive and
Kidney Diseases (NIDDK). This is a research resource supported by the
National Institutes of Health. This facility collects, stores, and distributes
biological samples and associated data from healthy people and people
with many kinds of disorders.
The purpose of this collection is to make samples and data available for use in
research of the study of diabetes, obesity, and heart disease and their
complications after the current study is completed. Sending data and samples
may give scientists valuable research material that can be used to develop
new diagnostic tests, new treatments, and new ways to prevent diseases.
Scientists who want to use the samples and study data have to go through a
formal proposal process and all proposals are reviewed by an external panel of
experts.
Your samples and data will be stored de-identified, which means that no
identifying information will be stored with it. Researchers will not know your
name, date of birth, medical record number, social security number, etc. Your
donation is voluntary, and if you choose not to participate there will be no
penalty or loss of benefits to which you are entitled. If you agree to donate
samples, you can change your mind up until the end of the SEARCH study.
When study researchers receive written instructions from you, they will destroy

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your sample and all information that identifies you.
I agree for my blood and urine samples and SEARCH
study data to be donated to the NIDDK storage facility.
__________initials
I do not agree for my blood and urine samples and SEARCH
study data to be donated to the NIDDK storage facility.
__________initials

I agree for my DNA to be donated to the NIDDK storage facility.
__________initials
I do not agree for my DNA to be donated to the NIDDK storage facility.
__________initials

Full Gene Analysis and the National Data Storage Center
 If you agree, your DNA may be analyzed to identify a complete picture of
your genetic makeup. This information would be sent to the National
Institutes of Health (NIH) data storage center to help researchers better
understand how genes affect the risk of developing diseases. The data
may be included in larger studies of diabetes or other conditions. Your
personal information, such as name, date of birth, etc. would not be
included. Thus, researchers would not be able to link this information back
to you.
I agree to allow information about my DNA to
be included in the NIH data storage center.
I do not agree to allow information about my DNA
to be included in the NIH data storage center.

__________initials

_________initials

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

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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,
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

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number assigned to you is kept in a password-protected database at CCHMC.
Thus, no one other than Dr. Dolan and his research team 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.
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 your urine sample. You will be paid an extra $20 for
providing this urine sample.
You will receive your payment in the form of a debit card (MasterCard); and
you will be given a handout that will explain how to use the card.
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.

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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
 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).
Because this research study involves payment for participation we are required
by federal Internal Revenue Service (IRS) rules to collect and use your social
security or tax ID number (SSN) in order to track the amount of money that we
pay you. We will use your SSN to keep track of how much money we pay you
and your SSN will not be used as part of this research.
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

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laws that apply to them.
To help us protect your privacy, we have obtained a Certificate of
Confidentiality from the National Institutes of Health. The researchers can use
this Certificate to legally refuse to disclose information that may identify you in
any federal, state, or local civil, criminal, administrative, legislative, or other
proceedings, for example, if there is a court subpoena. The researchers will
use the Certificate to resist any demands for information that would identify
you.
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
to this study, payment for services, enrollment in a health plan or eligibility of
benefits will not be affected.

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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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STUDY TITLE: SEARCH FOR DIABETES IN YOUTH
(STUDY VISIT: 2016 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. There will be about 1,000 people invited to participate in this study.
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. 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
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 and cystatin C (measure 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 2½ 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.
I agree to have my child’s blood and urine stored.
I do not agree to have my child’s blood and urine

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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. DNA testing may help
researchers better understand how genes affect the risk of developing
diseases such as asthma, cancer, diabetes, and heart disease. You will be
notified of any significant results. Incidental results will not be reported to
you. 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.

Central Storage Facility at the National Institutes of Health
 If you agree, your child’s blood, urine, DNA samples and data may be sent
to the central storage facility at the National Institute of Diabetes, Digestive
and Kidney Diseases (NIDDK). This is a research resource supported by
the National Institutes of Health. This facility collects, stores, and
distributes biological samples and associated data from healthy people and
people with many kinds of disorders.
The purpose of this collection is to make samples and data available for
use in research of the study of diabetes, obesity, and heart disease and
their complications after the current study is completed. Sending data and
samples may give scientists valuable research material that can be used to
develop new diagnostic tests, new treatments, and new ways to prevent
diseases. Scientists who want to use the samples and study data have to
go through a formal proposal process and all proposals are reviewed by an
external panel of experts.
Your child’s samples and data will be stored de-identified, which means that
no identifying information will be stored with it. Researchers will not know
your child’s name, date of birth, medical record number, social security
number, etc. Your child’s donation is voluntary, and if you choose not to
participate there will be no penalty or loss of benefits to which you are
entitled. If you agree to donate samples, you can change your mind up until
the end of the SEARCH study. When study researchers receive written
instructions from you, they will destroy your sample and all information that

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identifies your child.
I agree for my child’s blood and urine samples and SEARCH study data
to be donated to the NIDDK storage facility.
__________initials
I do not agree for my child’s blood and urine samples and SEARCH study
data to be donated to the NIDDK storage facility.
__________initials

I agree for my child’s DNA to be donated to the
NIDDK storage facility.

__________initials

I do not agree for my child’s DNA to be donated to
the NIDDK storage facility.

__________initials

Full Gene Analysis and the National Data Storage Center
 If you agree, your child’s DNA may be analyzed to identify a complete
picture of his or her genetic makeup. This information would be sent to the
National Institutes of Health (NIH) data storage center to help researchers
better understand how genes affect the risk of developing diseases. The
data may be included in larger studies of diabetes or other conditions. Your
child’s personal information, such as name, date of birth, etc. would not be
included. Thus, researchers would not be able to link this information back
to you or your child.
I agree to allow information about my child’s DNA to
be included in the NIH data storage center.
__________initials
I do not agree to allow information about my child’s
DNA to be included in the NIH data storage center.

_________initials

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,

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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
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 will be able to link any of the information collected in the

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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 $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 the urine sample. Your child will be paid an
extra $20 for providing this urine sample.
You will receive your payment in the form of a debit card (MasterCard); and
you will be given a handout that will explain how to use the card.
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

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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:
 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).
Because this research study involves payment for participation we are required
by federal Internal Revenue Service (IRS) rules to collect and use your social
security or tax ID number (SSN) in order to track the amount of money that we
pay you. We will use your SSN to keep track of how much money we pay you
and your SSN will not be used as part of this research.
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

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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.
To help us protect your privacy, we have obtained a Certificate of
Confidentiality from the National Institutes of Health. The researchers can use
this Certificate to legally refuse to disclose information that may identify you in
any federal, state, or local civil, criminal, administrative, legislative, or other
proceedings, for example, if there is a court subpoena. The researchers will
use the Certificate to resist any demands for information that would identify
you.
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.
Will your child’s other medical care be impacted?
By signing this document you agree for your 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.

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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

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