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ADOLESCENT ASSENT FOR PARTICIPATION IN A RESEARCH PROJECT
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.
310 FR 3 (2016-1)
INSTRUCTIONS: This template is designed to provide guidance in the development of an adolescent
assent form for subjects ages 13 - 17. It is recommended that the information presented in the assent
form closely matches the information in the parental permission/adult consent form. Should the subject
present with a lower mental age, for whom this assent form might be too difficult to comprehend, a child
assent form can be used instead.
Italicized sections include suggested text and further instruction and guidance. Note that sections shown
in square brackets must be edited for each specific protocol. Not all sections will apply to every protocol.
Therefore, delete those which do not apply, as well as this and other instruction paragraphs, prior to
submitting the form(s) to the HIC.
Study Title: [Insert title of the study.]
Principal Investigator: [Insert name and mailing address.](the person who is responsible for this research)
Funding Source: [Insert name of company or agency or University 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 Diabetic Adolescents]
Invitation to Participate and Description of Project
Suggested Text:
You are invited to take part in a research study that will look at [state what the study is designed to
discover or establish.] You have been asked to take part because [explain briefly why the prospective subject is
eligible to participate]. [If appropriate, state the approximate number of subjects and/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 assent form gives you detailed information
about the study, which a member of the research team will discuss with you and your parents. 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
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wish to be in the study; if you do, you will be asked to sign this form. Your parents will also be asked to allow
you to be in the study.
Description of Procedures
Guidelines:
 Describe the procedures using simple, 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 introduced and explained in
lay language.
 Distinguish clearly between any procedures that are experimental and those that are part of the
subject’s 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 purpose and
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 assent.
Suggested Text:
If you agree to be 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 research study 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.
>If appropriate, add:
You and your parents will be told of any important new findings that are found while you are in this study that
may change your decision about participating.
For research involving pregnancy testing, the assent form should inform the female adolescent that only she
will learn the results of that test.
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>If appropriate, include:
We will ask you to have a pregnancy test before you start this study. Only you will be told the results. If you are
pregnant, we will also advise you to get care for your pregnancy and also to get the support of an adult. You
will be asked not to be in the study or you will be removed from the study if your pregnancy test is positive. If
you are younger than age 13 and have a positive pregnancy test, we will report your pregnancy to the
Department of Children and Families.
You need to know that your parents may ask you why you cannot be in the study or why you were asked to
leave the study. So if there is any chance that you are pregnant or you might become pregnant during the time of
this study, we would recommend that you think really carefully about whether you should be in the study. It is
okay if you decide that you do not want to be in the study or to stay in this study. You do not need to give a
reason for not being in the study.

For research involving optional genetic or related testing, the consent form should describe the scope of
the research that will be performed with subject’s DNA or tissue (e.g., cancer, aging, mental health, etc.). If
the genetic testing is not optional, revise the wording as appropriate. Should there be plans to contact
adolescent subjects to provide consent for ongoing research use of their specimens once they reach the
age of majority, it should be part of this section.
>If appropriate, include:
Optional Specimens for Future Storage/Genetic Testing
You are invited to allow some of your blood/tissue 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 samples will be stored for an unlimited time, and may be used to make a cell line that will live indefinitely
(forever). Future research may look at your genes, which are part of your samples and 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 (characteristics). Future studies on genes may
possibly include finding out the details of how your DNA (DNA is a part of your gene) is put together, or how
genes are connected with a specific disease. Parts of your specimens, including genes, 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 connected information, which means that we will share your information (but not your identity)
with other researchers working on studies like this.
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 instead of your name. 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 lower 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.
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There is a risk that your information could be misused (handled incorrectly). The chance of this happening is
very small. We have protections in place to lower this risk. There can also be a risk in uncovering genetic
information, such as new health information about inherited traits that might affect you or your blood relatives
that 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.
Research results will not be returned to you, your parents 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 your child 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;

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 specimens and you still
will be able to be in this research study. If you decide that your specimens can be kept, you may change your
mind at any time. Contact the study staff by phone or mail at [XX phone, XX address] to let them know you do
not want your specimens used any longer. Then your specimens 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).
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I agree to allow my specimens and information to be stored and used for future research as described above:
(initial your choice)
_____YES
______No
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.
 If not previously stated, include the following:
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
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Magnetic resonance (MR) is a technique that uses magnetism and radio waves, not x-rays, to take
pictures and measure chemicals of different parts of the body. The United States Food and Drug Administration
(FDA) have 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 health care 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 health care 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
and your parents 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 parents 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 health care MR exam and for that reason, they will not be made available for health care
purposes.
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 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.
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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.
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, 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 parts of the research (drugs, tests, procedures, etc.) that will be provided at no cost
to the subjects.
Treatment Alternatives/Alternatives to This Research
(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 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.
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 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 and Privacy
Guidelines:
 Please state whether identifiers will be maintained and if so please describe why it is necessary to
maintain the identifiers, the length of time they will be kept and how access to identified data will be
secured. For example, will the participant’s data be coded with the linking code stored separately from
the data?
 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 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 we obtain about you during this study will stay confidential and will be shared
only if you agree to it. There are also situations where we would have to release your identifiable information
(your name for example) according to the U.S. or State law. Examples of information that we have to report to
authorities include abuse of a child, certain reportable diseases (such as being HIV positive or having Hepatitis
B), or when we believe you may harm yourself or someone else. When the results of the research are published
or discussed in conferences, no information will be included that would reveal your identity unless you allow us
to do so.
We understand that information about your health is personal, and we are committed to protecting the privacy
of that information. If you decide to be in this study, the researchers will get information that identifies you and
your personal health information. For example, we will collect [list other direct identifiers as appropriate and
if required]. This information will be de-identified as soon as possible, which means that we will replace your
identifying information with a code. The principal investigator (the person who is responsible for this research)
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will keep a link that matches you to your coded information, and this link will be kept safe and available only to
a few people on this research team. The link to your personal information will be kept for [state time in months
or years], and then it will be destroyed and the data will become anonymous. The data will be kept in this
anonymous form [indefinitely / for X months/years until it is destroyed]. [Describe additional methods used to
safeguard the confidentiality of subjects’ data (e.g., storing research materials in locked cabinets, passwordprotecting data stored on a computer, etc.] The research team will only give coded information to others to
carry out this research study.
The information about your health that will be collected in this study includes: (Specify as appropriate, delete what
is not appropriate)
 Research study records
 Medical and laboratory records of only those services provided in connection with this Study.
 The entire research record and any medical records held by [Institution] created from: _________ to:
________
 The following information: [Complete with specific information that is being collected]
Suggested Text (add and delete as appropriate):
 Records about phone calls made as part of this research
 Records about your study visits
 Records about any study drug you received
 Records about the study device
Information about you and your health may be used by or given to:
 The U.S. Department of Health and Human Services (DHHS) agencies
 Representatives from Yale Human Research Protection Program and the Yale Human Investigation
Committee (the committee that reviews, approves, and monitors research on human subjects), who
are responsible for ensuring research compliance. These individuals are required to keep all
information confidential.
 Those providers who are participants in the Electronic Medical Record (EMR) system.
 Those individuals at Yale who are responsible for the financial oversight of research including
billings and payments
 The Principal Investigator (Insert Name)
Select as appropriate the following additional groups with whom the data may be shared and delete those that
do not apply.







The U.S. Food and Drug Administration (FDA) This is done so that the FDA can review information
about the new drug product [or device] involved in this research. The information may also be used to
meet the reporting requirements of drug regulatory agencies.
The study sponsor or manufacturer of study drug/device
Drug regulatory agencies in other countries
Governmental agencies to whom certain diseases (reportable diseases) must be reported
Health care providers who provide services to you in connection with this study.
Laboratories and other individuals and organizations that analyze your health information in
connection with this study, according to the study plan.
Co-Investigators and other investigators
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


Study Coordinator and Members of the Research Team
Data and Safety Monitoring Boards and others authorized to monitor the conduct of the Study: List any
separate or local committees not in the protocol, if applicable
Others as noted:
By signing this form, you let us use the information in the way we described above for this research study.
This authorization to use and disclose your health information collected during your participation in this study
will never expire.
The research staff at the Yale School of Medicine and [Specify health care facility, e.g., Yale-New Haven
Hospital, the Connecticut Mental Health Center].have to obey the privacy laws and make sure that your
information stays confidential. Some of the people or agencies listed above may not have to obey those laws,
which means that they do not have to protect the data in the same way we do. They could use or share your
information in ways not mentioned in this form. However, to better protect your health information,
agreements are in place with these individuals and/or companies that require that they keep your 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 required 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:
Suggested Text
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 is 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 your parents receive a bill for any costs related to the diagnosis or treatment of your injury, they
should 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 text should be used:
Suggested Text
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. Your parents
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:
 The investigators are encouraged to respect the rights of adolescent subjects and honor and comply with
their decision to withdraw their authorization to use their data. Should the Principal Investigator
believe that there is sound justification for not allowing adolescent subjects to withdraw their
authorization, this should be stated in the protocol application.
 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 assent form.
 If there are plans to contact the subject at the age of majority to provide consent for ongoing research
use of their study information and/or specimens, this should be clearly stated.
 If there are medical needs required by the subject upon withdrawal, these should be stated. Any followup procedures or assessments accompanying the withdrawal should be clearly explained.
Suggested Text:
You do not have 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). Your health care outside the study will not change if you do not agree to
participate. 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 decide to take part in this study, and then change your mind, you can always 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
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received the intervention can withdraw from the follow-up portion of the study, but the device will not be
remoyed and the surgery cannot be undone.) 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.”]
To stop your participation in 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). Even if you stop
participating in the study, the researchers will still be able to use the information that has already been collected
about you. That information could also be given to others until the end of the research study, to make sure that
the study produces valid results.
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 non-compliance).]
Withdrawing your Authorization to Use and Share Your Health Information
If you do not want researchers to use and disclose your health information as described in the Confidentiality
section, you and your parent(s) may withdraw your permission by telling the study staff or by writing to [Enter
name and address of the data repository’s principal investigator] at the Yale University
_______________________________New Haven, CT 06520.
When you do that, no new health information identifying you will be collected after that date. Again, the
investigators will be able to use the information that they already collected about you to finish the study.
If you withdraw your authorization, you will not be able to stay in this study.
Questions
We have used some complicated terms in this form. Please feel free to ask about anything you don't
understand and to think about this research and the assent form carefully – as long as you need to – before you
make a decision. We encourage that you talk to your family about your decision as well. If you come up with
questions after reading this form, you can call me at [phone number].
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Authorization and Permission
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 things I will do in the study and possible risks and inconveniences have been
explained to my satisfaction. My signature also shows that I have been given a copy of this assent form.
By signing this form, I give permission to the researchers to use [and give out] information about me for the
reasons described in this form. If I decide not to give permission, I understand that I will not be able to be in
this research.
Name of Subject: _____________________________
Signature: ___________________________________
Date: ______________________________________
___________________________________________
Signature of Person Obtaining Assent
___________________
Date
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 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. 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.
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