Offspring and Omni Group Cohorts- Consent Forms

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Background
You are participating in the continuation of the Framingham Heart Study (FHS), Offspring Cohort. This
ninth examination of the FHS Offspring will be similar to previous visits in many ways. There are also
some new study activities. Exam components, both old and new, are described below.
Purpose
The purpose of this research is 1) to better understand the development of heart and blood vessel
diseases, lung and blood diseases, stroke, memory loss, cancer, and other major diseases and health
conditions; and 2) to examine DNA and its relationship to the risks of developing these diseases and
other health conditions.
THIS EXAMINATION IS FOR RESEARCH AND DOES NOT TAKE THE PLACE OF A ROUTINE
MEDICAL CHECK UP BY YOUR PHYSICIAN
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you
choose to take part, you have the right to stop at any time.
What Happens In This Research Study
You will be one of approximately 5124 subjects to be asked to participate in this study.
All or part of the research in this study will take place at the following location(s): Boston University
Medical Center.
Your research examination will take place at the FHS at 73 Mt. Wayte Avenue in Framingham, MA, or
may take place in your home or other residence.

New Study Activities:
1) With your permission, white cells (from the blood collected as a regular part of the FHS exam) will be
processed so that they function like cells from other organs such as liver cells, fat cells heart cells or
nerve cells. The resulting cells are called Induced Pluripotent Stem cells. These cells may be studied in
laboratories to learn more about causes of health and disease in such organs. FHS investigators will
not alter white cells to behave as reproductive cells.
2) We will ask if we may obtain a sample of cells from the inside of your cheek by gently scraping the
inside surface with a single-use plastic utensil. The cells will be used to examine how changes in DNA
called DNA methylation are related to lung function and lung diseases and other diseases,
3) You will be asked to wear a physical activity monitor on a belt for a week and to return it to FHS. It
measures how active you are throughout the day.
4) You will be asked after your visit to use a kit to collect urine samples for 24 hours and send it by mail
to a laboratory. The kit will be mailed to you for a day convenient to you shortly after this exam visit.

Offspring Exam 9
Res. v15.
Page | 1
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Ongoing Exam components for which you have previously given informed consent: In addition
to the new procedures described above, the following procedures will be done at this visit:
1) Medical History Interview.
2) Physical Examination including ECG
3) Collection of blood (up to 117.5 cc or four ounces) and urine specimens to test for many risk factors
for the diseases and health conditions under investigation.
4) Genetic Studies: You will be asked if a sample of the blood you donate may be used for additional
genetic studies.
5) Vascular Function Testing: Arterial Tonometry is a measure of arterial stiffness. Along with a very
limited view of the aorta (the large artery carrying blood flow from the base of the heart), a waveform is
obtained by gently placing a flat sensor over arteries on the arm (brachial and radial), the groin
(femoral) and the neck (carotid).
6) Pulmonary function testing is performed by breathing into a tube connected to a machine that
measures exhaled air volume and flow. Some individuals may be asked to repeat the testing after using
an inhaler to improve airflow.
7) Questionnaires about memory, mood and physical function; diet and exercise
8) Blood pressures in your arms and ankles
(In the event that you may have a stroke, you would be examined during your hospitalization (if
applicable) and at 3, 6, 12 and 24 months. The examination would include a neurological-evaluation
and an assessment of your ability to perform daily activities.)
9) Medical Records: You will be asked to sign a form to allow FHS to obtain copies of hospital and
Medicare (CMS) and medical records. The release form is valid to obtain these records unless
canceled by you. You will be asked for your social security number for the purpose of locating you in
the future. You may choose to decline this request. You will also be asked if investigators and their
research collaborators at other institutions, in this case Duke University, may link your Social Security
Number to CMS data to obtain Medicare information. Social Security Numbers to will not be released to
outside institutions.
10) Results of some FHS research measurements will be sent to you and/or to your physician within six
weeks of your FHS visit. However, some other measurements could be made months or years later as
part of special research projects. You may receive results of some measurements long after your FHS
visit.

Offspring Exam 9
Res. v15.
Page | 2
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
11) Follow Up: You may be contacted later by mail or by phone to obtain additional health information
or to be invited to participate in further FHS health-related studies. You may be invited to return for
another examination in the future.
Risks and Discomforts
Risk or injury, as a result of participation, is not expected. In the unlikely event that during the
examination you require medical care, first aid will be available.
The Blood Draw: Minimal bruising, pain, bleeding, or in rare circumstances, an infection may occur.
The Cheek Swab: There may be minor irritation of brief duration and/or some may experience a minor
sensation of gagging.
The Lung Function test involves a low level of risk. You may feel lightheaded or you may faint and risk
injury from falling. Participants asked to inhale the medication called albuterol, used during lung
function testing, may notice an increase in heart rate (pulse) or symptoms of jitteriness or shakiness
(tremors). Pregnant women, as determined by self-report or by a positive pregnancy test, will be
excluded from the second part of the pulmonary function test, which includes the albuterol challenge.
Other discomforts include headaches, feeling hungry due to fasting, fatigue and chill during the visit.
The exam is time consuming and repetitive. The 24 hour urine collection is inconvenient.
Safeguards are in place to protect the security of your study information. FHS ID numbers are used on
most data files instead of names. Firewalls and password protection are in place on the computer
systems. Staff is trained in safe computer practices. However there is still a minimal risk of a breach in
confidentiality.
There is potential risk in genetic testing for uncovering and conveying unwanted information regarding
parentage or specific risk of disease. Also, sometimes, knowledge of DNA test results can provoke
anxiety and influence decisions regarding marriage and family planning:
Both Massachusetts state laws and a new Federal law, called the Genetic Information
Nondiscrimination Act (GINA), generally make it illegal for health insurance companies, group health
plans, and most employers to discriminate against you based on your genetic information. These laws
generally will protect you in the following ways:
1.

Health insurance companies and group health plans may not request your genetic
information that we get from this research.

Offspring Exam 9
Res. v15.
Page | 3
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
2.

Health insurance companies and group health plans may not use your genetic information
when making decisions regarding your eligibility or premiums.

3.

Employers with 6 or more employees may not use your genetic information that we get
from this research when making a decision to hire, promote, or fire you or when setting the
terms of your employment.

All health insurance companies and group health plans must follow the GINA law by May 21, 2010. All
employers with 15 or more employees must follow the GINA law as of November 21, 2009.
Massachusetts law currently applies to all employers of 6 or more employees.
Be aware that neither Massachusetts law nor the new Federal law protects you against genetic
discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Thus, life insurance, disability insurance and long-term care insurance companies may legally ask
whether you have had genetic testing and deny coverage for refusal to answer this question.
There may be unknown risks/discomforts involved. Study staff will update you in a timely way on any
new information that may affect your health, welfare, or decision to stay in this study
Potential Benefits
You will receive no direct benefit from your participation in this study. However, your participation may
help the investigators better understand the causes and prevention of cardiovascular disease and other
medical conditions, including the potential of genetic factors.
Alternatives
Your alternative is to not participate in the study.
Subject Costs and Payments
You will not be charged or paid for any part of the examination. If the examination finds medical
problems that require tests or treatments, information will be provided to you and to the physician or
clinic that you have named to receive your test results. If your physician decides that follow up tests or
treatments are necessary, then you (or a third party such as health insurance or Medicare) will be
responsible for the cost. No special arrangement will be made by the Framingham Heart Study for
compensation or payment solely because of your participation in this study. This does not waive any of
your legal rights. Costs that you may incur on the day of your participation include, but are not limited
to, loss of work, and transportation (gas, tolls, etc.). You will not receive payment for your participation.

Offspring Exam 9
Res. v15.
Page | 4
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Patenting Discoveries
Research from this study may, one day, result in new tests to diagnose or predict diseases. It may also
lead to the development of new medicines to prevent or cure diseases. As is true of all federally-funded
research, researchers and their employers are permitted by Federal law to patent discoveries from
which they may gain financially. It was the judgment of the U.S. Congress that permitting such patents
would greatly increase the likelihood that a public health benefit would be realized from federally funded
research.
CONFIDENTIALITY
Information obtained about you will be treated as confidential. A code number will be assigned to your
data and specimens. The codes will only be provided to qualified investigators but your name and other
personally identifying information will not be provided. Your samples will be kept until they are not of
scientific value. You will not be routinely informed of results of research performed upon your genetic
samples, although with your permission you may be informed of some findings about genetics,
cardiovascular disease or other health conditions generated from DNA analyses, directly to you or
through publication in newsletters.
When study results are published, your name and other identifying information will not be revealed.
Information from this study and from your medical record may be reviewed and photocopied by state
and federal regulatory agencies, such as the Office of Human Research Protection, as applicable, and
the Institutional Review Board of Boston University Medical Center.
To help us further protect your privacy, the investigators have obtained a Certificate of Confidentiality
from the Department of Health and Human Services (DHHS). With this Certificate, the investigators
cannot be forced (for example by court subpoena) to disclose research information that may identify
you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings.
Disclosure will be necessary, however, upon request of DHHS for audit or program evaluation
purposes. A Certificate of Confidentiality does not prevent you or a member of your family from
voluntarily releasing information about yourself or your involvement in this research. If an insurer or
employer learns of your participation, and obtains your consent to receive research information, then
FHS is not allowed to use the Certificate of Confidentiality to withhold this information. This means that
you and your family must also actively protect your own privacy. Finally, you should understand that the
Certificate of Confidentiality does not prevent the investigators from taking steps, including reporting to
authorities, to prevent serious harm to yourself or others.

Offspring Exam 9
Res. v15.
Page | 5
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Please check the appropriate box above each of the following statements:
1) |___| YES |___| NO (Office Code 0)
I agree to participate in the FHS clinic examination, the collections of blood, cheek cells and urine, and
studies of the factors contributing to heart and blood vessel diseases, lung and blood diseases, stroke,
memory loss, cancer, and other major diseases and health conditions.
2|___| YES |___|NO (Office Code 3)
I agree to allow my data, cheek cells, blood and urine samples to be used in future genetic studies of
factors contributing to heart and blood vessel diseases, lung and blood diseases, stroke, memory loss,
cancer, and other diseases and health conditions.
3) |___| YES |___| NO (Office Code 12)
I agree to allow my data, cheek cells, blood and urine and DNA samples to be used in future genetic
studies of reproductive conditions, and mental health conditions such as alcohol use and depress ive
symptoms.
4 |___| YES |___|NO (Office Code 13)
I agree to provide a blood sample from which Induced Pluripotent Stem Cells can be made and from
which a range of cell products such as RNA, proteins and metabolites can be obtained. This means
that white cells from my blood may be processed to become stem cells and then altered so that they
function like cells from other organs such as liver cells, fat cells, heart cells or nerve cells.
5 |___| YES |___| NO (Office Code 4)
I agree to allow researchers from commercial companies to have access to my blood and urine
samples, DNA, other genetic material, and data in the future which may be used to develop new lab
tests or treatments that could benefit many people. (You or your heirs will not benefit financially from
this, nor will your DNA be sold to anyone.)
6) |___| YES |___| NO (Office Code 30)
I agree to allow the FHS to release the findings of non-genetic tests and examinations to my physician,
clinic, or hospital.
7) |___| YES |___| NO (Office Code 31)
If a genetic condition is identified that may have important health and treatment implications for me, I
agree to allow the FHS to notify me, and then with my permission to notify my physician.

Offspring Exam 9
Res. v15.
Page | 6
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Subject's Rights
By consenting to participate in this study you do not waive any of your legal rights. Giving consent
means that you have heard or read the information about this study and that you agree to participate.
You will be given a copy of this form to keep.
If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to which
you are entitled.
You may obtain further information about your rights as a research subject by calling the Office of the
Institutional Review Board of Boston University Medical Center at 617-638-7207.
The investigator or a member of the research team will try to answer all of your questions. If you have
questions or concerns at any time, or if you need to report an injury while participating in this research,
contact PHILIP WOLF, MD or DANIEL LEVY, MD at (508) 872-6562.
Compensation for Research Related Injury
If you think that you have been injured by being in this study, please let the investigator know right
away. If your part in this study takes place at Boston Medical Center, you can get treatment for the
injury at Boston Medical Center. If your part of the study is not at Boston Medical Center, ask the
investigator where treatment for injury would be available locally. Boston University Medical Center and
the sponsor do not offer a program to provide compensation for the cost of care for research related
injury or other expenses such as lost wages, disability, pain, or discomfort. You will be sent a bill for the
medical care you receive for research injury if your medical insurance does not pay for your medical
care. You are not giving up any of your legal rights by signing this form.
Right to Refuse or Withdraw
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you decide
to be in the study and then change your mind, you can withdraw from the research. Your participation is
completely up to you. Your decision will not affect you being able to get health care at this institution or
payment for your health care. It will not affect your enrollment in any health plan or benefits you can
get.
If you choose to take part, you have the right to stop at any time. 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 as soon
as possible.
The investigator may decide to discontinue your participation without your permission because he/she
may decide that staying in the study will be bad for you, or the sponsor may stop the study.

Offspring Exam 9
Res. v15.
Page | 7
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Protection of Subject Health Information
You have certain rights related to your health information. These include the right to know who will get
your health information and why they will get it. If you choose to be in this research study, we will get
information about you as explained below.
HEALTH INFORMATION ABOUT YOU THAT MIGHT BE USED OR GIVEN OUT DURING THIS
RESEARCH:
Information from your hospital or office health records at BUMC/BMC or elsewhere. This information is
reasonably related to the conduct and oversight of the research study. If health information is needed
from your doctors or hospitals outside of BUMC/BMC, you will be asked to give permission for these
records to be sent to the researcher.
New health information from tests, procedures, visits, interviews, or forms filled out as part of this
research study.
WHY HEALTH INFORMATION ABOUT YOU MIGHT BE USED OR GIVEN OUT TO OTHERS
The reasons we might use or share your health information are:
- To do the research described here
- To make sure we do the research according to certain standard set by ethics, law, and quality groups
PEOPLE AND GROUPS THAT MAY USE OR GIVE OUT YOUR HEALTH INFORMATION
1. PEOPLE OR GROUPS WITHIN BUMC/BMC
- Researchers involved in this research study
- The BUMC Institutional Review Board that oversees this research
2. PEOPLE OR GROUPS OUTSIDE BUMC/BMC
- People or groups that we hire to do certain work for us, such as data storage companies, or
laboratories.
- Federal and state agencies if they are required by law or involved in research oversight. Such
agencies may include the U.S. Department of Health and Human Services, the Food and Drug
Administration, the National Institutes of Health, the Massachusetts Department of Public Health.
- Organizations that make sure hospital standards are met
- The sponsor(s) of the research study, and people or groups it hires to help them do the research
- Other researchers that are part of this research study
- A group that oversees the research information and safety of this study
Offspring Exam 9
Res. v15.
Page | 8
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G

Other:
Some people or groups who get your health information might not have to follow the same privacy rules
that we follow. We share your health information only when we must. We ask anyone who gets it from
us to protect your privacy. However, once the information leaves BUMC, we cannot promise that it will
be kept private.
In most cases any health data that is being given out to others is identified by a unique study number
and not with your name. So, although in some cases it is possible to link your name to the study data,
this is not usually done.
TIME PERIOD FOR USING OR GIVING OUT YOUR HEALTH INFORMATION
Because research is an ongoing process, we cannot give you an exact date when we will either destroy
or stop using or sharing your health information.
YOUR PRIVACY RIGHTS
You have the right not to sign this form that allows us to use and give out your health information for
research. If you don't sign this form, you can't be in the research. This is because we need to use the
health information to do the research.
You have the right to withdraw your permission to use or share your health information in this research
study. If you want to withdraw your permission, you must write a letter to the researchers in charge of
this research study.
If you withdraw your permission, you will not be able to take back information that has already been
used or shared with others. This includes information used or shared to do the research study or to be
sure the research is safe and of high quality.
If you withdraw your permission, you cannot continue to be in the study.
You have the right to see and get a copy of your health information that is used or shared for research.
However, you may only get this after the research is finished. To ask for this information, please contact
the person in charge of this research study.
IF RESEARCH RESULTS ARE PUBLISHED OR USED TO TEACH OTHERS
The results of this research study may be published in a medical book or journal, or used to teach
others. However, your name or other identifying information will not be used for these purposes without
your specific permission.

Offspring Exam 9
Res. v15.
Page | 9
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Offspring Examination 9
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Signing this consent form indicates that you have read this consent form (or have had it
read to you), that your questions have been answered to your satisfaction, and that you
voluntarily agree to participate in this research study. You will receive a copy of this signed
consent form.

________________________________l________________________________l__________
Participant’s Signature
Printed Name
Date

________________________________l _______________________________l__________
Legally Authorized Representative
Printed Name
Date
(LAR)’s Signature

________________________________l_______________________________l__________
Person Obtaining Consent Signature
Printed Name
Date

Offspring Exam 9
Res. v15.
Page | 10
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Background
You are participating in the continuation of the Framingham Heart Study (FHS), Omni 1 Cohort. This
ninth examination of the FHS Omni 1 will be similar to previous visits in many ways. There are also
some new study activities. Exam components, both old and new, are described below.
Purpose
The purpose of this research is 1) to better understand the development of heart and blood vessel
diseases, lung and blood diseases, stroke, memory loss, cancer, and other major diseases and health
conditions; and 2) to examine DNA and its relationship to the risks of developing these diseases and
other health conditions.
THIS EXAMINATION IS FOR RESEARCH AND DOES NOT TAKE THE PLACE OF A ROUTINE
MEDICAL CHECK UP BY YOUR PHYSICIAN
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you
choose to take part, you have the right to stop at any time.
What Happens In This Research Study
You will be one of approximately 520 subjects to be asked to participate in this study.
All or part of the research in this study will take place at the following location(s): Boston University
Medical Center.
Your research examination will take place at the FHS at 73 Mt. Wayte Avenue in Framingham, MA, or
may take place in your home or other residence.

New Study Activities:
1) With your permission, white cells (from the blood collected as a regular part of the FHS exam) will be
processed so that they function like cells from other organs such as liver cells, fat cells heart cells or
nerve cells. The resulting cells are called Induced Pluripotent Stem cells. These cells may be studied in
laboratories to learn more about causes of health and disease in such organs. FHS investigators will
not alter white cells to behave as reproductive cells.
2) We will ask if we may obtain a sample of cells from the inside of your cheek by gently scraping the
inside surface with a single-use plastic utensil. The cells will be used to examine how changes in DNA
called DNA methylation are related to lung function and lung diseases and other diseases,
3) You will be asked to wear a physical activity monitor on a belt for a week and to return it to FHS. It
measures how active you are throughout the day.
4) You will be asked after your visit to use a kit to collect urine samples for 24 hours and send it by mail
to a laboratory. The kit will be mailed to you for a day convenient to you shortly after this exam visit.

Omni 1 Exam 4
Res.v15.
Page | 1
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Ongoing Exam components for which you have previously given informed consent: In addition
to the new procedures described above, the following procedures will be done at this visit:
1) Medical History Interview.
2) Physical Examination including ECG
3) Collection of blood (up to 117.5 cc or four ounces) and urine specimens to test for many risk factors
for the diseases and health conditions under investigation.
4) Genetic Studies: You will be asked if a sample of the blood you donate may be used for additional
genetic studies.
5) Vascular Function Testing: Arterial Tonometry is a measure of arterial stiffness. Along with a very
limited view of the aorta (the large artery carrying blood flow from the base of the heart), a waveform is
obtained by gently placing a flat sensor over arteries on the arm (brachial and radial), the groin
(femoral) and the neck (carotid).
6) Pulmonary function testing is performed by breathing into a tube connected to a machine that
measures exhaled air volume and flow. Some individuals may be asked to repeat the testing after using
an inhaler to improve airflow.
7) Questionnaires about memory, mood and physical function; diet and exercise
8) Blood pressures in your arms and ankles
(In the event that you may have a stroke, you would be examined during your hospitalization (if
applicable) and at 3, 6, 12 and 24 months. The examination would include a neurological-evaluation
and an assessment of your ability to perform daily activities.)
9) Medical Records: You will be asked to sign a form to allow FHS to obtain copies of hospital and
Medicare (CMS) and medical records. The release form is valid to obtain these records unless
canceled by you. You will be asked for your social security number for the purpose of locating you in
the future. You may choose to decline this request. You will also be asked if investigators and their
research collaborators at other institutions, in this case Duke University, may link your Social Security
Number to CMS data to obtain Medicare information. Social Security Numbers to will not be released to
outside institutions.
10) Results of some FHS research measurements will be sent to you and/or to your physician within six
weeks of your FHS visit. However, some other measurements could be made months or years later as
part of special research projects. You may receive results of some measurements long after your FHS
visit.
11) Follow Up: You may be contacted later by mail or by phone to obtain additional health information

Omni 1 Exam 4
Res.v15.
Page | 2
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
or to be invited to participate in further FHS health-related studies. You may be invited to return for
another examination in the future.
Risks and Discomforts
Risk or injury, as a result of participation, is not expected. In the unlikely event that during the
examination you require medical care, first aid will be available.
The Blood Draw: Minimal bruising, pain, bleeding, or in rare circumstances, an infection may occur.
The Cheek Swab: There may be minor irritation of brief duration and/or some may experience a minor
sensation of gagging.
The Lung Function test involves a low level of risk. You may feel lightheaded or you may faint and risk
injury from falling. Participants asked to inhale the medication called albuterol, used during lung
function testing, may notice an increase in heart rate (pulse) or symptoms of jitteriness or shakiness
(tremors). Pregnant women, as determined by self-report or by a positive pregnancy test, will be
excluded from the second part of the pulmonary function test, which includes the albuterol challenge.
Other discomforts include headaches, feeling hungry due to fasting, fatigue and chill during the visit.
The exam is time consuming and repetitive. The 24 hour urine collection is inconvenient.
Safeguards are in place to protect the security of your study information. FHS ID numbers are used on
most data files instead of names. Firewalls and password protection are in place on the computer
systems. Staff is trained in safe computer practices. However there is still a minimal risk of a breach in
confidentiality.
There is potential risk in genetic testing for uncovering and conveying unwanted information regarding
parentage or specific risk of disease. Also, sometimes, knowledge of DNA test results can provoke
anxiety and influence decisions regarding marriage and family planning:
Both Massachusetts state laws and a new Federal law, called the Genetic Information
Nondiscrimination Act (GINA), generally make it illegal for health insurance companies, group health
plans, and most employers to discriminate against you based on your genetic information. These laws
generally will protect you in the following ways:
1.

Health insurance companies and group health plans may not request your genetic
information that we get from this research.

Omni 1 Exam 4
Res.v15.
Page | 3
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
2.

Health insurance companies and group health plans may not use your genetic information
when making decisions regarding your eligibility or premiums.

3.

Employers with 6 or more employees may not use your genetic information that we get
from this research when making a decision to hire, promote, or fire you or when setting the
terms of your employment.

All health insurance companies and group health plans must follow the GINA law by May 21, 2010. All
employers with 15 or more employees must follow the GINA law as of November 21, 2009.
Massachusetts law currently applies to all employers of 6 or more employees.
Be aware that neither Massachusetts law nor the new Federal law protects you against genetic
discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
Thus, life insurance, disability insurance and long-term care insurance companies may legally ask
whether you have had genetic testing and deny coverage for refusal to answer this question.
There may be unknown risks/discomforts involved. Study staff will update you in a timely way on any
new information that may affect your health, welfare, or decision to stay in this study
Potential Benefits
You will receive no direct benefit from your participation in this study. However, your participation may
help the investigators better understand the causes and prevention of cardiovascular disease and other
medical conditions, including the potential of genetic factors.
Alternatives
Your alternative is to not participate in the study.
Subject Costs and Payments
You will not be charged or paid for any part of the examination. If the examination finds medical
problems that require tests or treatments, information will be provided to you and to the physician or
clinic that you have named to receive your test results. If your physician decides that follow up tests or
treatments are necessary, then you (or a third party such as health insurance or Medicare) will be
responsible for the cost. No special arrangement will be made by the Framingham Heart Study for
compensation or payment solely because of your participation in this study. This does not waive any of
your legal rights. Costs that you may incur on the day of your participation include, but are not limited
to, loss of work, and transportation (gas, tolls, etc.). You will not receive payment for your participation.

Omni 1 Exam 4
Res.v15.
Page | 4
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Patenting Discoveries
Research from this study may, one day, result in new tests to diagnose or predict diseases. It may also
lead to the development of new medicines to prevent or cure diseases. As is true of all federally-funded
research, researchers and their employers are permitted by Federal law to patent discoveries from
which they may gain financially. It was the judgment of the U.S. Congress that permitting such patents
would greatly increase the likelihood that a public health benefit would be realized from federally funded
research.
CONFIDENTIALITY
Information obtained about you will be treated as confidential. A code number will be assigned to your
data and specimens. The codes will only be provided to qualified investigators but your name and other
personally identifying information will not be provided. Your samples will be kept until they are not of
scientific value. You will not be routinely informed of results of research performed upon your genetic
samples, although with your permission you may be informed of some findings about genetics,
cardiovascular disease or other health conditions generated from DNA analyses, directly to you or
through publication in newsletters.
When study results are published, your name and other identifying information will not be revealed.
Information from this study and from your medical record may be reviewed and photocopied by state
and federal regulatory agencies, such as the Office of Human Research Protection, as applicable, and
the Institutional Review Board of Boston University Medical Center.
To help us further protect your privacy, the investigators have obtained a Certificate of Confidentiality
from the Department of Health and Human Services (DHHS). With this Certificate, the investigators
cannot be forced (for example by court subpoena) to disclose research information that may identify
you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings.
Disclosure will be necessary, however, upon request of DHHS for audit or program evaluation
purposes. A Certificate of Confidentiality does not prevent you or a member of your family from
voluntarily releasing information about yourself or your involvement in this research. If an insurer or
employer learns of your participation, and obtains your consent to receive research information, then
FHS is not allowed to use the Certificate of Confidentiality to withhold this information. This means that
you and your family must also actively protect your own privacy. Finally, you should understand that the
Certificate of Confidentiality does not prevent the investigators from taking steps, including reporting to
authorities, to prevent serious harm to yourself or others.
Please check the appropriate box above each of the following statements:
1) |___| YES |___| NO (Office Code 0)

Omni 1 Exam 4
Res.v15.
Page | 5
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
I agree to participate in the FHS clinic examination, the collections of blood, cheek cells and urine, and
studies of the factors contributing to heart and blood vessel diseases, lung and blood diseases, stroke,
memory loss, cancer, and other major diseases and health conditions.
2|___| YES |___|NO (Office Code 3)
I agree to allow my data, cheek cells, blood and urine samples to be used in future genetic studies of
factors contributing to heart and blood vessel diseases, lung and blood diseases, stroke, memory loss,
cancer, and other diseases and health conditions.
3) |___| YES |___| NO (Office Code 12)
I agree to allow my data, cheek cells, blood and urine and DNA samples to be used in future genetic
studies of reproductive conditions, and mental health conditions such as alcohol use and depressive
symptoms.
4 |___| YES |___|NO (Office Code 13)
I agree to provide a blood sample from which Induced Pluripotent Stem Cells can be made and from
which a range of cell products such as RNA, proteins and metabolites can be obtained. This means
that white cells from my blood may be processed to become stem cells and then altered so that they
function like cells from other organs such as liver cells, fat cells, heart cells or nerve cells.
5 |___| YES |___| NO (Office Code 4)
I agree to allow researchers from commercial companies to have access to my blood and urine
samples, DNA, other genetic material, and data in the future which may be used to develop new lab
tests or treatments that could benefit many people. (You or your heirs will not benefit financially from
this, nor will your DNA be sold to anyone.)
6) |___| YES |___| NO (Office Code 30)
I agree to allow the FHS to release the findings of non-genetic tests and examinations to my physician,
clinic, or hospital.
7) |___| YES |___| NO (Office Code 31)
If a genetic condition is identified that may have important health and treatment implications for me, I
agree to allow the FHS to notify me, and then with my permission to notify my physician.
Subject's Rights
By consenting to participate in this study you do not waive any of your legal rights. Giving consent

Omni 1 Exam 4
Res.v15.
Page | 6
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
means that you have heard or read the information about this study and that you agree to participate.
You will be given a copy of this form to keep.
If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to which
you are entitled.
You may obtain further information about your rights as a research subject by calling the Office of the
Institutional Review Board of Boston University Medical Center at 617-638-7207.
The investigator or a member of the research team will try to answer all of your questions. If you have
questions or concerns at any time, or if you need to report an injury while participating in this research,
contact PHILIP WOLF, MD or DANIEL LEVY, MD at (508) 872-6562.
Compensation for Research Related Injury
If you think that you have been injured by being in this study, please let the investigator know right
away. If your part in this study takes place at Boston Medical Center, you can get treatment for the
injury at Boston Medical Center. If your part of the study is not at Boston Medical Center, ask the
investigator where treatment for injury would be available locally. Boston University Medical Center and
the sponsor do not offer a program to provide compensation for the cost of care for research related
injury or other expenses such as lost wages, disability, pain, or discomfort. You will be sent a bill for the
medical care you receive for research injury if your medical insurance does not pay for your medical
care. You are not giving up any of your legal rights by signing this form.
Right to Refuse or Withdraw
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you decide
to be in the study and then change your mind, you can withdraw from the research. Your participation is
completely up to you. Your decision will not affect you being able to get health care at this institution or
payment for your health care. It will not affect your enrollment in any health plan or benefits you can
get.
If you choose to take part, you have the right to stop at any time. 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 as soon
as possible.
The investigator may decide to discontinue your participation without your permission because he/she
may decide that staying in the study will be bad for you, or the sponsor may stop the study.

Omni 1 Exam 4
Res.v15.
Page | 7
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Protection of Subject Health Information
You have certain rights related to your health information. These include the right to know who will get
your health information and why they will get it. If you choose to be in this research study, we will get
information about you as explained below.
HEALTH INFORMATION ABOUT YOU THAT MIGHT BE USED OR GIVEN OUT DURING THIS
RESEARCH:
Information from your hospital or office health records at BUMC/BMC or elsewhere. This information is
reasonably related to the conduct and oversight of the research study. If health information is needed
from your doctors or hospitals outside of BUMC/BMC, you will be asked to give permission for these
records to be sent to the researcher.
New health information from tests, procedures, visits, interviews, or forms filled out as part of this
research study.
WHY HEALTH INFORMATION ABOUT YOU MIGHT BE USED OR GIVEN OUT TO OTHERS
The reasons we might use or share your health information are:
- To do the research described here
- To make sure we do the research according to certain standard set by ethics, law, and quality groups
PEOPLE AND GROUPS THAT MAY USE OR GIVE OUT YOUR HEALTH INFORMATION
1. PEOPLE OR GROUPS WITHIN BUMC/BMC
- Researchers involved in this research study
- The BUMC Institutional Review Board that oversees this research
2. PEOPLE OR GROUPS OUTSIDE BUMC/BMC
- People or groups that we hire to do certain work for us, such as data storage companies, or
laboratories.
- Federal and state agencies if they are required by law or involved in research oversight. Such
agencies may include the U.S. Department of Health and Human Services, the Food and Drug
Administration, the National Institutes of Health, the Massachusetts Department of Public Health.
- Organizations that make sure hospital standards are met
- The sponsor(s) of the research study, and people or groups it hires to help them do the research
- Other researchers that are part of this research study
- A group that oversees the research information and safety of this study
Omni 1 Exam 4
Res.v15.
Page | 8
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G

Other:
Some people or groups who get your health information might not have to follow the same privacy rules
that we follow. We share your health information only when we must. We ask anyone who gets it from
us to protect your privacy. However, once the information leaves BUMC, we cannot promise that it will
be kept private.
In most cases any health data that is being given out to others is identified by a unique study number
and not with your name. So, although in some cases it is possible to link your name to th e study data,
this is not usually done.
TIME PERIOD FOR USING OR GIVING OUT YOUR HEALTH INFORMATION
Because research is an ongoing process, we cannot give you an exact date when we will either destroy
or stop using or sharing your health information.
YOUR PRIVACY RIGHTS
You have the right not to sign this form that allows us to use and give out your health information for
research. If you don't sign this form, you can't be in the research. This is because we need to use the
health information to do the research.
You have the right to withdraw your permission to use or share your health information in this research
study. If you want to withdraw your permission, you must write a letter to the researchers in charge of
this research study.
If you withdraw your permission, you will not be able to take back information that has already been
used or shared with others. This includes information used or shared to do the research study or to be
sure the research is safe and of high quality.
If you withdraw your permission, you cannot continue to be in the study.
You have the right to see and get a copy of your health information that is used or shared for research.
However, you may only get this after the research is finished. To ask for this information, please contact
the person in charge of this research study.
IF RESEARCH RESULTS ARE PUBLISHED OR USED TO TEACH OTHERS
The results of this research study may be published in a medical book or journal, or used to teach
others. However, your name or other identifying information will not be used for these purposes without
your specific permission.

Omni 1 Exam 4
Res.v15.
Page | 9
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Omni 1 Exam 4
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Signing this consent form indicates that you have read this consent form (or have had it
read to you), that your questions have been answered to your satisfaction, and that you
voluntarily agree to participate in this research study. You will receive a copy of this signed
consent form.

________________________________l________________________________l__________
Participant’s Signature
Printed Name
Date

________________________________l _______________________________l__________
Legally Authorized Representative
Printed Name
Date
(LAR)’s Signature

________________________________l_______________________________l__________
Person Obtaining Consent Signature
Printed Name
Date

Omni 1 Exam 4
Res.v15.
Page | 10
BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Blood Draw Consent for Cell Line Creation
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Background
A cell line is a frozen sample of specially processed white cells from your blood that allows the
Framingham Heart Study to grow more white cells and get more DNA from them in future as needed for
research projects.
Purpose
A cell line will be created from a blood sample you provide in order to study the cause and prevention of
cardiovascular disease and other health conditions, including the possibility of how genetic factors
influence health status.
What Happens In This Research Study
You will be one of approximately 1080 subjects to be asked to participate in this study.
All or part of the research in this study will take place at the following location(s): Boston University
Medical Center.
Your research blood draw will take place at the Framingham Heart Study located at 73 Mount Wayte
Avenue in Framingham, MA, or the place where you reside. A laboratory technician will draw a sample
of your blood (16 cc or about 1 tablespoon) for the preparation of DNA (genetic material) and for the
creation of a living sample of white blood cells (cell line).
Risks and Discomforts
Minimal bruising, pain, or bleeding may occur as a result of the blood draw. A latex allergy can occur
from the gloves worn by the technician. If you have a known latex allergy, inform the technician and
he/she will use another form of protection.
There may be unknown risks/discomforts involved. Study staff will update you in a timely way on any
new information that may affect your health, welfare, or decision to stay in this study
Potential Benefits
You will receive no direct benefit from your participation in this study. However, your participation may
help the investigators better understand the cause and prevention of cardiovascular disease and other
health conditions, including the possibility of how genetic factors influence health status.
Alternatives
Your alternative is to not participate in the study.

Blood Draw Consent
Creation Res.v10

for

Cell Line

Page | 1

BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Blood Draw Consent for Cell Line Creation
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
Subject Costs and Payments
You will not be charged for the examination. If the examination finds any medical problems requiring
medical diagnosis or treatment, you will be so advised and that information will be provided to the
physician or clinic that you choose.
In the event that your physician decides that follow up clinical tests or treatments are necessary,
payment must be provided by you or your third party payer, if applicable (for example, health insurance
or Medicare). No special arrangements will be made by the Framingham Heart Study for compensation
or for payment of treatment solely because of your participation in this study. This does not waive any
of your legal rights.
Costs that you might incur the day of your participation include, but are not limited to, transportatio n
costs (gas, tolls, etc). You will not receive payment for your participation. However, if necessary, we will
provide transportation to the clinic and your return home at no cost.
Confidentiality
Information obtained during this study will be treated as strictly confidential. A code number will be
assigned to you and to your personally identifying information. Cell lines will be stored at a central site.
Files linking names to samples will be kept locked and accessible only to the Framingham Heart Study
(FHS) data managers. The coded samples will be stored securely and kept until no longer of scientific
value. The risk in providing this sample is minimal.
Data and DNA will be distributed to the FHS researchers and other qualified researchers interested in
the genetics of heart and blood vessel diseases, lung and blood diseases, stroke, memory loss, joint
disease, bone loss, deafness, cancer, and other major diseases and health conditions. The researchers
will be given the DNA without any personally identifying information. Information gained from research
on your DNA may be used for the development of diagnostic procedures or new treatments for major
diseases. Your DNA will not be sold to any person, institution, or company for financial gain or
commercial profit. However, neither you nor your heirs will gain financially from discoveries made using
the information and/or specimens that you provide.
When study results are published, your name and any other identifying information will not be revealed.
You will be informed through periodic publications from the FHS of some findings about genetics,
cardiovascular disease or other health conditions generated from the DNA analyses.

Blood Draw Consent
Creation Res.v10

for

Cell Line

Page | 2

BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Blood Draw Consent for Cell Line Creation
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
To help us further protect your privacy, the investigators have obtained a Confidentiality Certificate from
the Department of Health and Human Services (DHHS). With this Certificate, the investigators cannot
be forced (for example by court subpoena) to disclose research information that may identify you in any
Federal, State, or local civil, criminal, administrative, legislative, or other proceedings. Disclosure will be
necessary, however, upon request of DHHS for audit or program evaluation purposes. You should
understand that a Confidentiality Certificate does not prevent you or a member of your family from
voluntarily releasing information about yourself or your involvement in this research. Note however, that
if an insurer or employer learns about your participation, and obtains your consent to receive research
information, then the investigator may not use the Certificate of Confidentiality to withhold this
information. This means that you and your family must also actively protect your own privacy. Finally,
you should understand that the investigator is not prevented from taking steps, including reporting to
authorities, to prevent serious harm to yourself or others.
You may choose to withdraw your blood samples and your samples would be destroyed after the
request is received. If you choose to withdraw your samples, you should call the Framingham Heart
Study at (508) 935-3477 and ask for the lab manager.
The FHS is a medical research project sponsored by the National Institutes of Health. It is authorized
under 42USC 285b-3. The system of records which applies to the FHS is documented in the Federal
Register: September 26, 2002 (Vol. 67, No. 1879) pages 60776-60780.
Please check the appropriate box below:
1) |___| YES |___| NO (Office Code 1)
I agree to allow a cell line to be made from my blood to provide a renewable supply of DNA. (A cell line
is a frozen sample of specially processed white cells from your blood that allows us to grow more white
cells and obtain more DNA from them as needed for future research projects).

Subject's Rights
By consenting to participate in this study you do not waive any of your legal rights. Giving consent
means that you have heard or read the information about this study and that you agree to participate.
You will be given a copy of this form to keep.

Blood Draw Consent
Creation Res.v10

for

Cell Line

Page | 3

BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Blood Draw Consent for Cell Line Creation
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G
If at any time you withdraw from this study you will not suffer any penalty or lose any benefits to which
you are entitled.
You may obtain further information about your rights as a research subject by calling the Office of the
Institutional Review Board of Boston University Medical Center at 617-638-7207.
The investigator or a member of the research team will try to answer all of your questions. If you have
questions or concerns at any time, or if you need to report an injury while participating in this research,
contact PHILIP A. WOLF, MD, or DANIEL LEVY, MD, at (508) 872-6562.
Compensation for Research Related Injury
If you think that you have been injured by being in this study, please let the investigator know right
away. If your part in this study takes place at Boston Medical Center, you can get treatment for the
injury at Boston Medical Center. If your part in the study is not at Boston Medical Center, ask the
investigator where treatment for injury would be available locally. You and your insurance company will
be billed for this treatment. Some research sponsors may offer a program to cover some of the
treatment costs which are not covered by your insurance. You should ask the research team if such a
program is available.
Right to Refuse or Withdraw
Taking part in this study is voluntary. You have the right to refuse to take part in this study. If you decide
to be in the study and then change your mind, you can withdraw from the research. Your participation is
completely up to you. Your decision will not affect your being able to get health care at this institution or
payment for your health care. It will not affect your enrollment in any health plan or benefits you can
get.

If you choose to take part, you have the right to stop at any time. 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 as soon
as possible.
The investigator may decide to discontinue your participation without your permission because he/she
may decide that staying in the study will be bad for you, or the sponsor may stop the study.

Blood Draw Consent
Creation Res.v10

for

Cell Line

Page | 4

BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014

OMB #: 0925–0216
Expiration Date: xx/xxxx

RESEARCH CONSENT FORM
Blood Draw Consent for Cell Line Creation
THE FRAMINGHAM HEART STUDY N01-HC-25195 1910G

Protection of Subject Health Information
N/A

Signing this consent form indicates that you have read this consent form (or have had it
read to you), that your questions have been answered to your satisfaction, and that you
voluntarily agree to participate in this research study. You will receive a copy of this signed
consent form.

___________________________________________________________________
Subject (Signature and Printed Name) Date
___________________________________________________________________
Legally Authorized Representative (LAR) (Signature and Printed Name) Date
___________________________________________________________________
Person Obtaining Consent (Signature and Printed Name) Date

Blood Draw Consent
Creation Res.v10

for

Cell Line

Page | 5

BUMC/BMC Institutional Review Board
IRB NUMBER: H-32132
IRB APPROVAL DATE: 01/16/2013
IRB EXPIRATION DATE: 01/15/2014