HIC#: insert number
COMPOUND AUTHORIZATION AND CONSENT FOR PARTICIPATION IN A RESEARCH
PROJECT
200 FR. 4 ( 2014-1)
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 – 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.
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 and mailing address.]
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 take part in a research study designed to 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 consent form gives you detailed information
about the 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
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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.
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.
 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 consent form.
Suggested Text:
If you agree to take part 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:
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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 participation in
this study that may affect your willingness to continue to participate.

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.
>If appropriate, include:
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.)
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
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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;

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 at [XX phone] 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). You must follow up this
request with a written request, mailed to [X address].
I agree to allow my samples and information to be stored and used for future research as described above:
(initial your choice)
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_____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.
 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:
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 various 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
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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 a metallic object flying through the air toward the magnet and hitting you. 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. Nothing 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 clinical examination of the brain.
The scans performed in this study are not designed to find abnormalities. The primary 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 diagnostic 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 primary 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 solely 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
clinical MR exam and for that reason, they will not be made available for diagnostic purposes.
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 necessary 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 resolve 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 inform 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.
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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.
 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
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(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
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 information will be released to any other party for any reason, identify the person/agency to which 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 below.
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 permitted 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 identity unless your specific consent for this activity is obtained.
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We understand that information about you obtained in connection with your health is personal, and we are
committed to protecting the privacy of that information. If you decide to be in this study, the researcher will get
information that identifies you and your personal health information. This may include information that might
directly identify you, such as your 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 identifying information with a code that does not directly identify you. The principal investigator will keep
a link that identifies you to your 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 you 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 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 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
[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 you received
 Records about the study device
Information about you and your health which might identify you 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 individuals at Yale who are responsible for the financial oversight of research including
billings and payments
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
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
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 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 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 you 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 health information during the study or at the end of the
study. When Yale researchers send information about you to the sponsor, they will not send information that
directly identifies you such as your 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 you for other purposes
related to this research or to similar research studies.]
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You have the right to review and copy your health information in your medical record in accordance with
institutional medical records policies. [If study involves blinding include the following] However, by deciding
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 study related information until after the research is completed.
This authorization to use and disclose your health information collected during your participation in this study
will never expire.
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.
 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:
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
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insurance carrier will be expected to pay the costs of this treatment.
compensation for injury or lost wages is available.
No additional financial
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 followup 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 remoyed 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 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 non-compliance).]
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.”]
Withdrawing Your Authorization to Use and Disclose Your Health Information
You may withdraw or take away your permission to use and disclose your health information at any time. You
may withdraw your permission by telling the study staff or by writing to [Enter name and address of the data
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repository’s principal investigator] at the Yale University _______________________________New Haven,
CT 06520.
If you withdraw your permission, you will not be able to stay in this study.
When you withdraw your permission, 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.
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Authorization and Permission
NOTE: The authorization and the validation box must both be on the same page of the compound 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.
By signing this form, I give permission to the researchers to use [and give out] information about me for the
purposes described in this form. By refusing to give permission, I understand that I will not be able to be in
this research.
Name of Subject:_____________________________
Signature:___________________________________
Date:______________________________________
___________________________________________
Signature of Principal Investigator
or
___________________________________________
Signature of Person Obtaining Consent
___________________
Date
___________________
Date
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 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 [Add country code, if applicable].
THIS FORM IS NOT VALID UNLESS THE FOLLOWING BOX
HAS BEEN COMPLETED IN THE HIC OFFICE
THIS FORM IS VALID ONLY THROUGH:
___________________________________
INITIALED:
_______________________________________
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