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CONSENT FOR PARTICIPATION IN A RESEARCH PROJECT
200 FR. 1 (2016-2)
Specify both the Yale University academic research entity, and, if applicable, the non-academic
partner, e.g.:
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL:
SAINT RAPHAEL CAMPUS
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL:
SMILOW CANCER CENTER
YALE UNIVERSITY SCHOOL OF MEDICINE—CONNECTICUT MENTAL HEALTH
CENTER
YALE UNIVERSITY SCHOOL OF PUBLIC HEALTH
YALE UNIVERSITY SCHOOL OF NURSING—YALE NEW HAVEN HOSPITAL
YALE UNIVERSITY SCHOOL OF MEDICINE—THE APT FOUNDATION
YALE UNIVERSITY SCHOOL OF NURSING
Be sure to delete any entities that do not apply.
Study Title: [Insert title of the study.]
Principal Investigator: [Insert name.]
Funding Source: [Insert name of company, agency or department.]
[If the study involves different populations or study arms, identify the population or group/arm
as a subtitle of the study here. Example Healthy Controls Form vs. the Form for Non-treatment
Seeking Substance Abusers]
Invitation to Participate and Description of Project
Suggested Text:
You are invited to participate in a research study designed to look at [state what the study
is designed to discover or establish.] You have been asked to participate because [explain briefly
why the prospective subject is eligible to participate]. [If appropriate, state the approximate
number of subjects or research sites involved in the study.]
In order to decide whether or not you wish to be a part of this research study you should
know enough about its risks and benefits to make an informed decision. This consent form gives
you detailed information about the research study, which a member of the research team will
discuss with you. This discussion should go over all aspects of this research: its purpose, the
procedures that will be performed, any risks of the procedures, possible benefits and possible
alternative treatments. [Note: If the protocol is not a treatment protocol, delete “and possible
alternative treatments”.] Once you understand the study, you will be asked if you wish to
participate; if so, you will be asked to sign this form.
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Description of Procedures
Guidelines:
 Describe the procedures using lay language, short sentences and short paragraphs. The
use of subheadings may help to organize this section and improve readability.
 Define and explain medical and scientific terms in ordinary language (for example, the
amount of blood to be drawn should be given in terms of teaspoons, tablespoons, or
ounces). A medical or scientific term, drug name, etc. may be used throughout the
consent form once it has been explained in lay language.
 Distinguish clearly between any procedures that are experimental and those that are part
of the subjects’ standard clinical care.
Specify the subject’s assignment to study groups, length of time for participation in each
procedure, the total length of time for participation, frequency of procedures, location of the
procedures to be done, etc.
 For research involving randomization of subjects into different groups, specify (and
explain) the randomization procedures.
 For research involving the use of placebo, clearly define the term placebo.
 For research involving interviews, surveys, questionnaires, etc., clearly describe the
content of the instruments. It may also be helpful to provide a representative sample of
the types of questions subjects will be asked.
 For research involving review of subject’s medical record, the consent form should
explain what types of information will be collected, and why.
 When relevant, any plans to return information to subjects, to medical records, to
primary care physicians, or others must be made explicit in the consent form
Suggested Text:
If you agree to participate in this study, you will be asked to [describe the study procedures
clearly, in roughly chronological order.]
If this is a Phase II or III controlled clinical trial with FDA oversight, or a controlled trial with
health outcomes of an FDA regulated device, the following language is required by the FDA.
This language can also be used for NIH-supported clinical trials registered at clinicaltrials.gov:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law. This Web site will not include information that can identify you. At most, the Web
site will include a summary of the results. You can search this Web site at any time.
(For more information on registering clinical trials, contact YCCI.)
>If appropriate, add:
You will be told of any significant new findings that are developed during the course of your
participation in this study that may affect your willingness to continue to participate.
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
For research involving optional genetic or related testing, the consent form should
describe the scope of the research that will be performed with subjects’ DNA or tissue (e.g.,
cancer, aging, mental health, etc.) If the genetic testing is not optional, revise the wording as
appropriate.

>If appropriate, include:
Risks and Inconveniences
Guidelines:
 Identify all reasonably foreseeable risks, discomforts or inconveniences associated with
the study, and describe how they will be managed.
 For studies where the primary risk is breach of confidentiality, use this: There are no
physical risks associated with this study. However [some questions may make you
uncomfortable and] there is the possible risk of loss of confidentiality. Every effort will
be made to keep your information confidential; however, this cannot be guaranteed.
 Risks should be listed in hierarchical order, from most likely to least likely to occur.
 When relevant, risks to pregnant women or to a fetus should be explicitly stated.
 For studies taking place at the YNHH-Saint Raphael campus the reproductive risks section
of the consent document should instruct study participants to practice "family planning methods"
acceptable to the study investigator.” The terms “contraception” and “birth control” may not be
used.
 In addition to physiological risks/discomforts, describe any psychological, social, legal
or financial risks that might result from participating in the research.
 Where such information is available, the consent form should state the likelihood of risks
occurring. For example, “most subjects in a similar study had headaches and felt
nauseous,” or “10 out of 100 people who took drug X felt dizzy.”
 If appropriate (e.g., if the research involves an experimental intervention or therapy),
please include the following statement: “Participation in this study may involve risks that
are currently not known.”
 Include only those risks that are associated with the research. Risks associated with
standard clinical procedures that would be done whether or not the patient is in the study
should not be listed.
 For studies involving investigational drugs or devices, the consent form should describe
a means whereby information about the drug or device may be obtained in emergency
situations.
 For research involving genetic or related testing, subjects must be informed of any risks
associated with the genetic information that may result [see sample language in
preceding ‘future storage’ section]. Such risks could include reduced access to or
retention of benefits or entitlements (e.g., insurance, educational opportunities,
employment, etc.); stigmatization; psychological distress in response to information; or
detection of biological relationships within a family.
 Include the following:
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There is a federal law called the Genetic Information Nondiscrimination Act (GINA)
that, in general, makes it illegal for health insurance companies, group health plans, and
most employers, except those with fewer than 15 employees, to discriminate against you
based on your genetic information. However, it does not protect you against
discrimination by companies that sell life insurance, disability insurance, or long-term
care insurance.
 For studies using the Magnetic Resonance Research Center (MRRC) at The Anlyan
Center (TAC), the following language should be included:
Risks and Inconveniences
Magnetic resonance (MR) is a technique that uses magnetism and radio waves, not xrays, to take pictures and measure chemicals of different parts of the body. The United States
Food and Drug Administration (FDA) has set guidelines for magnet strength and exposure to
radio waves, and we carefully observe those guidelines.
You will be watched closely throughout the MR study. Some people may feel
uncomfortable or anxious. If this happens to you, you may ask to stop the study at any time and
we will take you out of the MR scanner. On rare occasions, some people might feel dizzy, get an
upset stomach, have a metallic taste or feel tingling sensations or muscle twitches. These
sensations usually go away quickly but please tell the research staff if you have them.
There are some risks with an MR study for certain people. If you have a pacemaker or
some metal objects inside your body, you may not be in this study because the strong magnets in
the MR scanner might harm you. Another risk is the possibility of metal objects being pulled
into the magnet and hitting you. To lower this risk all people involved with the study must
remove all metal from their clothing and all metal objects from their pockets. We also ask all
people involved with the study to walk through a detector designed to detect metal objects. It is
important to know that no metal can be brought into the magnet room at any time. Also, once
you are in the magnet, the door to the room will be closed so that no one from outside
accidentally goes near the magnet.
We want you to read and answer very carefully the questions on the MR Safety
Questionnaire related to your personal safety. Take a moment now to be sure that you have read
the MR Safety Questionnaire and be sure to tell us any information you think might be
important.
This MR study is for research purposes only and is not in any way a healthcare
examination of the brain. The scans performed in this study are not designed to find
abnormalities. The principal investigator, the lab, the MR technologist, and the Magnetic
Resonance Research Center are not qualified to interpret the MR scans and are not responsible
for providing a healthcare evaluation of the images. If a worrisome finding is seen on your scan,
a radiologist or another physician will be asked to review the relevant images. Based on his or
her recommendation (if any), the principal investigator or consulting physician will contact you,
inform you of the finding, and recommend that you seek medical advice as a precautionary
measure. The decision for additional examination or treatment would lie only with you and your
physician. The investigators, the consulting physician, the Magnetic Resonance Research
Center, and Yale University are not responsible for any examination or treatment that you
receive based on these findings. The images collected in this study are not a healthcare MR
exam and for that reason, they will not be made available for healthcare purposes.
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If contrast is used, also include the following:
Contrast Risks and Procedures Statements.
Having an intravenous (IV) line placed is a very safe procedure. There is a slight chance
that multiple needle-sticks will be needed to make sure the IV is placed correctly. You might
feel a small amount of pain when the IV is placed but it does not last very long. A bruise or a
minor infection might develop where the IV is placed. A bruise will go away by itself and it
might help if you wrap a warm towel around your arm. Infections can also be treated if
necessary.
The FDA approves the contrast agent Gadolinium for use with human participants. You
need to know that there are certain risks associated with the use of that contrast. Some healthy
subjects (fewer than 3%) may experience mild nausea, headache or dizziness after the injection.
These side effects usually go away themselves without need for treatment. There is also a risk of
allergic reaction (less than 1%). An allergic reaction can cause hives and itching or difficulty
breathing. In individuals with kidney dysfunction, the gadolinium can cause a serious condition
called nephrogenic systemic fibrosis. This is why prior to your MR study you will have to
undergo blood work to make sure that your kidney function is normal. Detailed information on
the contrast agent Gadolinium can be provided to you at your request.
You should tell your principal investigator: (1) if you are pregnant or breast feeding, (2)
if you have a history of allergic reactions to MR or CT contrast agents, (3) if you have a history
of kidney disease, seizure, asthma, or allergic respiratory disorders, and (4) if you have anemia
or disease that affects red blood cells.
 For studies using radiation, include the following language:
Risks Associated with Radiation
This research study involves exposure to radiation from [Describe: e.g., research required extra
head CT scan]. Please note that this radiation exposure is not necessary for your medical care
and is for research purposes only. Although each organ will receive a different dose, the amount
of radiation exposure will receive from this study is equal to a uniform whole-body exposure of
[XX] rem. This calculated value is known as the “effective dose” and is used to relate the dose
received by each organ to a single value.
This amount of radiation is well below the dose guidelines established by the federal government
and adhered to by the Yale-New Haven Hospital Radiation Safety Committee for research
subjects. To give you an idea about how much radiation you will get, we will make a comparison
with an every-day situation. Everyone receives a small amount of unavoidable radiation each
year. Some of this radiation comes from space and some from naturally-occurring radioactive
forms of water and minerals. This research gives your body the equivalent of about YY extra
years' worth of this natural radiation.
(Note: average natural exposure is 300mrem or 0.3rem, so compare XX to 0.3rem)
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Benefits
Guidelines:
 Describe any benefits that can be reasonably expected to result from the research.
Please note that benefits include those that accrue directly to the subject (e.g., improved
health outcomes), to the population the subject represents (e.g., a better understanding of
the subject’s condition that may lead to new treatments), or to society at large (e.g.,
general advancement of scientific knowledge).
 If there is no likelihood that subjects will benefit directly from their participation, this
should be stated.
 Financial rewards for participating in research are not considered a benefit, and should
not be included in this section.
 Please note that, by definition, the benefits of research are unproven. Therefore, subjects
should be told that participation “may,” rather than “will” yield benefit.
Economic Considerations
Guidelines:
 Describe any compensation that will be made to subjects (including direct monetary
payment, payment in the form of a gift, or reimbursement for costs such as travel,
parking, childcare, etc.), and the conditions for receiving this compensation.
 For studies that compensate subjects, include the following statement: ‘According to the
rules of the Internal Revenue Service (IRS), payments that are made to you as a result of
your participation in a study may be considered taxable income.’
 If payment will be prorated for subjects who do not complete the study, this should be
clearly explained. If payment is conditional on completing the study, this should be
clearly explained.
 Clearly describe the subject’s costs associated with participation in the research. If it is
possible that research procedures or tests will not be covered by the subject’s insurance,
health plan benefits, or other third party payers, this should be indicated. If the subject
will be receiving standard of care treatment as well as the research intervention, add the
following: You will still be responsible for any co-pays required by your insurance
company for standard treatment.
 Clearly describe the parts of the research (drugs, tests, procedures, etc.) that will be
provided at no cost to the subjects.
 Subjects may be offered an estimate of the charges they will be expected to cover.
Treatment Alternatives/Alternatives
(Note: This paragraph is a required element of informed consent for all research involving
treatment or therapeutic intervention. Certain non-treatment protocols may also require
an “Alternatives” section detailing appropriate treatment or procedures that are available
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outside of the research. Investigators may also choose to state that the only alternative is to
decline participation in the study. If the “Alternative Treatments” section does not apply
to your study, you may omit this entry and delete the heading.)
Guidelines:
 Describe any appropriate alternative therapeutic, diagnostic or preventive procedures
that should be considered before the subject decides whether or not to participate in the
study.
 Please note that alternatives are not limited to curative procedures. For chronic or
terminally ill subjects, alternatives may include procedures for symptom management,
improving the ability to function, or palliative care.
Confidentiality
Guidelines:
 Please state how long subjects’ data will be kept before it is destroyed or de-identified.
 If study information will be entered into the subject’s Electronic Medical Record (EMR),
insert the following language: Information about your study participation will be entered
into your Electronic Medical Record (EMR). Once placed in your EMR, these results are
accessible to all of your providers who participate in the EMR system. Information within
your EMR may also be shared with others who are appropriate to have access to your
EMR (e.g. health insurance company, disability provider.)
 If information will be released to any other party for any reason, identify the
person/agency to whom the information will be furnished, the nature of the information,
and the purpose of the disclosure. Examples include legal reporting requirements for
child or elder abuse, or identification of reportable infectious diseases.
 Any FDA-regulated clinical research study may be subject to an inspection. Funding
agencies and industrial sponsors may also conduct inspections, therefore the following
must be included: “Authorized representatives of the Food and Drug Administration
(FDA) [or a funding agency, such as the National Institutes of Health] and the
manufacturer of the [drug/device] being tested [insert name of company] may need to
review records of individual subjects. As a result, they may see your name; but they are
bound by rules of confidentiality not to reveal your identity to others.”
 If the research involves audio or videotaping, describe the subject’s right to review or
edit the tapes, and indicate when they will be erased.
 If the research requires a Certificate of Confidentiality, refer to 400 PR.2 Certificate of
Confidentiality for alternative language for the first paragraph above.
Suggested Text:
Any identifiable information that is obtained in connection with this study will remain
confidential and will be disclosed only with your permission or as required by U.S. or State law.
Examples of information that we are legally required to disclose include abuse of a child or
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elderly person, or certain reportable diseases. [Describe the methods used to safeguard the
confidentiality of subjects’ data (e.g., coding data or samples with numbers, storing research
materials in locked cabinets, password-protecting data stored on a computer, etc.] When the
results of the research are published or discussed in conferences, no information will be included
that would reveal your identity unless your specific consent for this activity is obtained.
Representatives from the Yale Human Research Protection Program, the Yale Human
Investigation Committee (the committee that reviews, approves, and monitors research on human
subjects) may inspect study records during internal auditing procedures. However, these
individuals are required to keep all information confidential.
In Case of Injury
(Note: This paragraph is a required element of informed consent for all research presenting
greater than minimal risk. It should also be used for minimal risk research that presents the
potential for physical harm (e.g., research involving blood draws). If the “In Case of Injury”
section does not apply to your study, please omit this entry and delete the heading.
However, the sentence, “You do not give up any of your legal rights by signing this form.”
must then be included in the Voluntary Participation section.]
Guidelines:
 For studies sponsored by for-profit entities, the sponsor is encouraged to provide funds for the
treatment of injuries sustained as a direct result of participation in the research. Per HIC
policy, sponsors are expected to cover expenses without first seeking payment from the subject’s
insurance.
 The following text should be used.
If you are injured while on study, seek treatment and contact the study doctor as soon as you are
able.
If you become ill or are physically injured due to the study [drug/device] [provide name of agent]
or any investigational procedure specifically required by the plan for this study, you will not be
responsible for the costs required to diagnose or treat such injury. The costs of diagnosis and
medical care for any complication, injury, or illness caused by the study [drug/device] or
properly performed non-standard of care investigational procedure required by the study will be
covered by the Sponsor as long as you have followed the directions of the study doctor.
If you receive a bill for any costs related to the diagnosis or treatment of your injury, please
contact the study doctor.
You will not receive any other kind of payment. There are no plans to pay you for such things as
lost wages, disability, or discomfort as part of this study. You do not give up any of your legal
rights by signing this consent form.
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 For studies sponsored by a non-profit entity (e.g., investigator’s own funds, federal
funding, or a private non-profit organization), the following paragraph should be used:
If you are injured while on study, seek treatment and contact the study doctor as soon as you are
able.
Yale School of Medicine and [Specify health care facility, e.g., Yale-New Haven Hospital, the
Connecticut Mental Health Center] do not provide funds for the treatment of research-related
injury. If you are injured as a result of your participation in this study, treatment will be
provided. You or your insurance carrier will be expected to pay the costs of this treatment. No
additional financial compensation for injury or lost wages is available.
You do not give up any of your legal rights by signing this form.
Voluntary Participation and Withdrawal
Guidelines:
 Subjects should be informed whether they will have the ability to withdraw their data
from the research once it is collected. Unlike tissue samples, which often can be
withdrawn and destroyed, data derived as part of the research usually will not be
covered by an option for withdrawal. If data or samples will be unable to be withdrawn
(for example, if they have been de-identified), subjects should be apprised of this fact in
the consent form.
 If there are medical needs required by the subject upon withdrawal, these should be
stated. Any follow-up procedures or assessments accompanying the withdrawal should
be clearly explained.
Suggested Text:
Participating in this study is voluntary. You are free to choose not to take part in this study.
Refusing to participate will involve no penalty or loss of benefits to which you are otherwise
entitled (such as your health care outside the study, the payment for your health care, and your
health care benefits). However, you will not be able to enroll in this research study and will not
receive study procedures as a study participant if you do not allow use of your information as
part of this study.
Withdrawing From the Study
If you do become a subject, you are free to stop and withdraw from this study at any time during
its course. (Tailor the statement about the ability to withdraw from participation to the specifics
of the study. For example, in a study on an experimental device or surgery, the subject who has
received the intervention can withdraw from the follow-up portion of the study, but the device
will not be removed and the surgery cannot be undone.)
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To withdraw from the study, you can call a member of the research team at any time and tell
them that you no longer want to take part. This will cancel any future appointments (if
applicable).
The researchers may withdraw you from participating in the research if necessary. [Describe the
conditions under which a subject might be withdrawn from the research (e.g., progression of
disease/poor response to treatment, development of serious side effects, or subject noncompliance).]
Withdrawing from the study will involve no penalty or loss of benefits to which you are
otherwise entitled. It will not harm your relationship with your own doctors or with [Specify
health care facility, e.g., Yale-New Haven Hospital, the Connecticut Mental Health Center]. [If
applicable: “We would still treat you with standard therapy or, at your request, refer you to a
clinic or doctor who can offer this treatment.”]
When you withdraw from the study, no new health information identifying you will be gathered
after that date. Information that has already been gathered may still be used and given to others
until the end of the research study, as necessary to insure the integrity of the study and/or study
oversight.
Questions
We have used some technical terms in this form. Please feel free to ask about anything
you don't understand and to consider this research and the consent form carefully – as long as
you feel is necessary – before you make a decision.
Optional Specimens for Future Storage/Genetic Testing
You are invited to allow some of your samples (called specimens) and related information to be
stored (banked) for future research [for X purpose]. This may help researchers in the future learn
more about how to prevent, find and treat [X disease(s)/condition(s)].
Your specimens will be stored for an unlimited time [If specific dates of storage are known,
describe], and may be used to make a cell line that will live indefinitely. Future research may
look at your genes, which are the units of inheritance that are passed down from generation to
generation. Genes are responsible for many things about you such as eye color, hair color, blood
type and hundreds of other traits. Future genetic analysis may possibly include finding out the
details of how your DNA is put together, such as whole exome or genome sequencing, or
genome wide association studies (that is, looking at genes other than those associated with a
specific disease). The materials at some point may be injected into animals in some of the
research. We expect that there will be widespread sharing of these specimens and associated
information. (Exclude what is inapplicable to your type of research: e.g., in pharmacogenetic
research, genome sequencing and animal studies are unlikely.)
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When your specimens and information are stored, we are careful to try to protect your identity
from discovery by others. Your samples and information will receive a unique code. Other
researchers will only receive coded samples and information, and will not be able to link the
code to you. Strict security safeguards are in place to reduce the chance of misuse or unplanned
release of information.
Using your specimens for research will probably not help you. We do hope the research results
will help people in the future.
There is a risk that your information could be misused [Give examples]. The chance of this
happening is very small. We have protections in place to lower this risk [Describe]. There can
also be a risk in uncovering genetic information. New health information about inherited traits
that might affect you or your blood relatives could be found during a research study. Very
rarely, health or genetic information could be misused by employers, health insurance
companies, and others. There is a federal law called the Genetic Information Nondiscrimination
Act (GINA) that, in general, makes it illegal for health insurance companies, group health plans,
and most employers(except those with fewer than 15 employees) to discriminate against you
based on your genetic information. However, it does not protect you against discrimination by
companies that sell life insurance, disability insurance, or long-term care insurance.
Your specimens and information will only be used for research and will not be sold. There is a
possibility that this research may lead to development of products that will be commercialized.
If this happens, there is no plan to share any financial gain with you.
Research results will not be returned to you or your doctor. If research results are published,
your name and other personal information will not be given.
If you know that your study will involve a GWAS analysis and depositing to the NIH GWAS
repository, include the following:
Your specimen will also be given to the National Institutes of Health Genome-Wide Association
Studies (GWAS) repository. GWAS studies look at the genetic differences that exist along the
human genome, which is the complete set of human genes. These studies look for common
traits, such as blood pressure or weight, or for the presence or absence of a disease or condition.
The NIH GWAS repository stores genetic information from many studies and shares that
information with researchers. We will send the genetic information about you and other
participants in this study to the NIH GWAS repository. It will be coded and de-identified. NIH
will not identify or make any attempt to identify information as coming from you or any other
individual. NIH will share the collected information with researchers who submit applications to
NIH. Special data sharing committees will review those applications and decide whether or not
to share the genetic information. The researchers who receive data must promise to keep the
data confidential and to use it only for the purpose approved by NIH.
The goal of GWAS studies is to look for genetic connections which may explain how to identify,
prevent, and treat health problems. For example, GWAS data may be used to find out:
•
who is more likely to develop a certain illness, such as asthma, cancer, or diabetes, or a
condition like high blood pressure or obesity;
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•
what genes affect the progress of a certain disease or condition; and
•
what genes may affect treatments which now may or may not work in certain people.
GWAS research will not directly benefit you, but could lead to a greater understanding of the
interaction between genes and health. This knowledge could help others in the future.
The choice to take part is up to you. You may choose not to let us store and use your samples,
and your care will not be affected by this decision. If you decide that your samples can be kept,
you may change your mind at any time. Contact the study staff by phone or mail at [XX
phone—add country code if applicable and XX address] to let them know you do not want your
samples used any longer. Your samples will either [Researcher should choose one or allow
subject to indicate choice] be destroyed, or made anonymous (the code linking them to you will
be destroyed).
I agree to allow my samples and information to be stored and used for future research as
described above: (initial your choice)
_____YES
______No
Authorization
I have read (or someone has read to me) this form and have decided to participate in the project
described above. Its general purposes, the particulars of my involvement and possible hazards
and inconveniences have been explained to my satisfaction. My signature also indicates that I
have received a copy of this consent form.
Name of Subject:_____________________________
Signature:___________________________________
Relationship:________________________________
Date:______________________________________
___________________________________________
Signature of Principal Investigator
___________________
Date
or
___________________________________________
Signature of Person Obtaining Consent
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___________________
Date
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If you have further questions about this project or if you have a research-related problem, you
may contact the Principal Investigator [cite name and full telephone number].
If, after you have signed this form you have any questions about your privacy rights, please
contact the Yale Privacy Officer at 203-432-5919. If you would like to talk with someone other
than the researchers to discuss problems, concerns, and questions you may have concerning this
research, or to discuss your rights as a research subject, you may contact the Yale Human
Investigation Committee at (203) 785-4688.
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