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COMPOUND AUTHORIZATION AND PARENTAL PERMISSION FOR PARTICIPATION IN A
RESEARCH PROJECT
310 FR. 3a (2016-1)
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—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.
INSTRUCTIONS: This template is designed to provide guidance in the development of a consent form
that also incorporates and satisfies the elements required of a HIPAA Research Authorization Form
(RAF). (The combination of these 2 forms is known as a Compound Authorization Form). 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.]
Funding Source: [Insert name of company or agency.]
[If the study involves different consent forms for different populations, identify the population group as the
subtitle of the study. Example Healthy Controls Form vs. the Form for Diabetic Adolescents.]
Invitation to Participate and Description of Project
Suggested Text:
We are inviting your child to participate in a research study designed to look at [state what the study is
designed to discover or establish.] Your child has been asked to participate because he/she [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 your child to be a part of this research study you should
know enough about its risks and benefits to make an informed decision. This permission 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 “any possible alternative treatments”.] Once you understand the study, you will be
asked if you wish your child to participate; if so, you will be asked to sign this form.
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Description of Procedures
Suggested Text:
If you agree to your child participating in this study, your child will be asked to [describe the study
procedures clearly, in roughly chronological order.]
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, ounces or milliliters). A medical or
scientific term, drug name, etc. may be used throughout the permission form once it has been explained
in lay language.
 Distinguish clearly between any procedures that are experimental and those that are part of 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 subjects’ medical record, the permission form should explain what
types of information will be collected, and why.
 Under HIPAA the consent form and HIPAA Research Authorization form (RAF) can be combined for
the same study, e.g., a single research purpose. (Example: the collection of blood in a clinical trial to
evaluate response to ALS treatment.) HIPAA also allows combining the consent and authorization for a
study with authorization for the creation or maintenance of a research database or repository.
Combining study authorization with database or repository authorization requires that these distinct
uses must be clear and must allow for the research subject to provide separate authorization for the
database or repository. Example: the subject is given the option to provide permission for sharing
information for purposes related to the ALS trial AND in a separate statement, the subject provides a
‘second” permission to bank the biologic material for use in future research studies. If selecting this
option, investigators are reminded to retain the signed combined form for the full duration that the
banked data or biologic sample will be retained for future research purposes.
 When relevant, any plans to return information to subjects, to medical records, to primary care
physicians, or others must be made explicit in the permission form.
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:
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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 child’s
participation in this study that may affect your willingness to continue to participate.
 For research involving optional genetic or related testing, the permission 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:
Optional Specimens for Future Storage/Genetic Testing
You are invited to allow some of your child’s 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 child’s 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 child’s 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 child’s 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.)
When your child’s specimens and information are stored, we are careful to try to protect your child’s identity
from discovery by others. Your child’s 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 your child. Strict
security safeguards are in place to reduce the chance of misuse or unplanned release of information.
Using your child’s specimens for research will probably not help him/her. We do hope the research results will
help people in the future.
There is a risk that your child’s 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 your child 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 or your
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child 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 child’s 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 or your child.
Research results will not be returned to you or your child’s doctor. If research results are published, your
child’s 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 child’s 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 your child 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 your child, 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 child’s samples, and your
child’s care will not be affected by this decision. If you decide that your child’s 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, XX address] to let them know you do not want your child’s samples used any longer. Your child’s
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 child’s samples and information to be stored and used for future research as described
above: (initial your choice)
_____YES
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______No
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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 child’s 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 permission 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 permission 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:
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 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.
Your child will be watched closely throughout the MR study. Some people may feel uncomfortable or
anxious. If this happens to your child, he/she may ask to stop the study at any time and we will take him/her out
of the MR scanner. On rare occasions, some people might feel dizzy, get an upset stomach, have a metallic
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taste or feel tingling sensations or muscle twitches. These sensations usually go away quickly but your child
should tell the research staff if he/she has them.
There are some risks with an MR study for certain people. If your child has a pacemaker or some metal
objects inside his/her body, he/she may not be in this study because the strong magnets in the MR scanner might
harm him/her. Another risk is the possibility of metal objects being pulled into the magnet and hitting him/her.
To reduce this risk we require that all people involved with the study 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 your child is 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 child’s 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. 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 regarding your child, 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 your child receives 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.
If contrast is used, also include the following:
Contrast Risks and Procedures Statements.
Having an intravenous (IV) line placed is a very common procedure. There is a slight chance that
multiple needle-sticks will be needed to make sure the IV is placed correctly. Your child 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 child’s arm. Infections can also be treated if necessary.
The FDA approves the contrast agent Gadolinium for use with human participants and does not
recognize any major risks associated with its use. Some subjects (less than 3%) may experience mild nausea,
headache or dizziness after the injection. These side effects usually resolve themselves without need for
treatment. There is a very low risk of allergic reaction (less than 1%). An allergic reaction can cause hives and
itching or difficulty breathing. Prior to your child’s MR study, we request that your principal investigator
arranges for your child to have blood work to make sure that your child’s kidney function is normal. Detailed
information on the contrast agent Gadolinium can be provided to you at your request.
You or your child should inform your principal investigator: (1) if she is pregnant or breast feeding, (2)
if he/she has a history of allergic reactions to MR or CT contrast agents, (3) if he/she has a history of kidney
disease, seizure, asthma, or allergic respiratory disorders, and (4) if he/she has anemia or disease that affects red
blood cells.
 For studies using radiation, include the following language:
Risks Associated with Radiation
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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)
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 or your child as a result of your/your
child’s 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.
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 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 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 and Privacy
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 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 child’s identity unless your specific permission for this activity is obtained.
We understand that information about your child obtained in connection with their health is personal,
and we are committed to protecting the privacy of that information. If you decide to allow your child to be in
this study, the researcher will get information that identifies your child and his or her personal health
information. This may include information that might directly identify your child, such as his or her name and
[list other direct identifiers as appropriate and if required]. This information will be de-identified at the
earliest reasonable time after we receive it, meaning we will replace your child’s identifying information with a
code that does not directly identify him or her. The principal investigator will keep a link that identifies your
child to his or her coded information, and this link will be kept secure and available only to the PI or selected
members of the research team. Any information that can identify your child will remain confidential. [Describe
additional methods used to safeguard the confidentiality of subjects’ data (e.g., storing research materials in
locked cabinets, password-protecting data stored on a computer, etc.] The research team will only give this
coded information to others to carry out this research study. The link to your child’s personal information will
be kept for [state time in months or years], after which time the link 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].
The information about your child’s health that will be collected in this study includes: (Specify as appropriate,
delete what is not appropriate)
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 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 child’s study visits
[Select additional information sources from below as appropriate]
Information obtained during this research regarding
HIV / AIDS
Hepatitis infection
Sexually transmitted diseases
Other reportable infectious diseases
Physical exams
Laboratory, x-ray, and other test results
Diaries and questionnaires
The diagnosis and treatment of a mental health condition
Use of illegal drugs or the study of illegal behavior
 Records about any study drug your child received
 Records about the study device
Information about your child and your child’s health which might identify your child may be used by or given
to:
 The U.S. Department of Health and Human Services (DHHS) agencies
 Representatives from Yale University, the 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 your child in connection with this study.
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




Laboratories and other individuals and organizations that analyze your child’s health information in
connection with this study, according to the study plan.
Co-Investigators and other investigators
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 authorize the use and/or disclosure of the information described above for this
research study. The purpose for the uses and disclosures you are authorizing is to ensure that the information
relating to this research is available to all parties who may need it for research purposes.
All health care providers subject to HIPAA (Health Insurance Portability and Accountability Act) are
required to protect the privacy of your information. 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].are
required to comply with HIPAA and to ensure the confidentiality of your child’s information. Some of the
individuals or agencies listed above may not be subject to HIPAA and therefore may not be required to
provide the same type of confidentiality protection. They could use or disclose your information in ways not
mentioned in this form. However to better protect your child’s health information, agreements are in place
with these individuals and/or companies that require that they keep your information confidential.
[If appropriate to your study:]
The sponsor will see the research information we collect about your child when they come to Yale to monitor the
conduct of this research study. The “Sponsor” includes any persons that work for or are hired by the sponsor to
conduct research activities related to this study. For this study the sponsor includes [insert the company name or
CRO here]. Yale researchers will also send the sponsor your child’s health information during the study or at the
end of the study. When Yale researchers send information about your child to the sponsor, they will not send
information that directly identifies your child such as your child’s name or [include other direct identifiers such as
street address and social security number, if appropriate.] [Add the following sentence ONLY when a research
contract, agreed to by Yale, specifies the use of subject information for future research conducted by the
sponsor and the contract provides confidentiality and privacy safeguards regarding the protection of the
information for the secondary use. Example of appropriate language: The sponsor may also use the
information about your child for other purposes related to this research or to similar research studies.]
You have the right to review and copy your child’s health information in your child’s medical record in
accordance with institutional medical records policies. [If study involves blinding include the following]
However, by deciding to allow your child to take part in a single or double blinded treatment study and sign this
permission form, you will not be allowed to look at or copy your child’s study related information until after the
research is completed.
This authorization to use and disclose your child’s health information collected during your child’s participation
in this study will never expire.
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
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





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 child’s study participation will be entered into your child’s
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 child’s 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.
If pregnancy testing of the child is required, add the following:
Your daughter will be asked to have a pregnancy test before starting this study. Only your daughter will
be told the results. If she is pregnant, we will also advise her to get care for her pregnancy and to get the
support of an adult. If your daughter is under age 13 and has a positive pregnancy test, we will report
the pregnancy to the Department of Children and Families.
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:
Suggested Text
If your child is injured while on study, seek treatment and contact the study doctor as soon as you are
able.
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If your child becomes 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 you receive a bill for any costs related to the diagnosis or treatment of your child’s 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.
 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 your child is 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
your child is injured as a result of his or her 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
Suggested Text:
You are free to choose not to have your child participate in this study. Refusing to participate will involve no
penalty or loss of benefits to which your child is otherwise entitled (such as your child’s health care outside the
study, the payment for your child’s health care, and your child’s health care benefits). However, your child
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 child’s information as part of this study.
Withdrawing From the Study
If your child does become a subject, he or she is 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
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withdraw from the follow-up portion of the study, but the device will not be removed and the surgery cannot be
undone.)
To withdraw from the study, you can call a member of the research team at any time and tell them that your
child no longer wants to take part. This will cancel any future appointments (if applicable).
The researchers may withdraw your child 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 from the study will involve no penalty or loss of benefits to which your child is otherwise entitled.
If your child chooses not to participate or if your child withdraws it will not harm your child’s 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.”]
Withdrawing Your Authorization to Use and Disclose Your Child’s Health Information
You or your child may withdraw or take away his or her permission to use and disclose his or her health
information at any time. You do this by telling the study staff or by writing to the study doctor [insert name
and address from page 1 of this form]. If you withdraw your permission, your child will not be able to stay in
this study.
When you withdraw your child’s permission, no new health information identifying your child 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.
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 anonymized), subjects should be apprised of this
fact in the permission form.
 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.
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 permission form carefully – as long as you feel is necessary –
before you make a decision.
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Authorization and Permission
I have read (or someone has read to me) this form and have decided to allow my child to participate in the
project described above. Its general purposes, the particulars of my child’s involvement and possible hazards
and inconveniences have been explained to my satisfaction. My signature also indicates that I have received a
copy of this permission form.
By signing this form, I give permission to the researchers to use [and give out] information about my child for
the purposes described in this form. By refusing to give permission, I understand that my child will not be able
to be in this research.
Name of Child: _____________________________
Parent 1 Signature: ____________________
Parent 2 Signature (if applicable):____________________
Date: ________________________
Date: ________________________
___________________________________________
Signature of Person Obtaining Permission
___________________
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 after you have signed this form you have any questions about your privacy rights, please contact the Yale
Privacy Officer at (203) 432-5919 [Add country code, if applicable]
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 [Add country code, if applicable].
*Note that the signature of two parents is required for certain types of research as required by the HIC (45
CFR § 46.406)*
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