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Consent Form Template
Informed Consent for Participation in Research
or
Parental Permission to Participate in Research *
* When enrolling minors Parental Permission (rather than Consent), and Assent are
required unless specifically waived by the IRB.
Title of Project
Purpose and Overview
This section should restate the primary aim of the study. Also include the source of
funding and explain why the participant is being asked to participate (e.g. “you are
between 18 and 25 years old and have been diagnosed with depression”).
Please present a brief overview of the study in one or two sentences.
Voluntary
Participation in this research study is voluntary. If you decide not to participate, or if
you later decide to stop participating, you will not lose any benefits to which you are
otherwise entitled. A decision not to participate or withdraw your participation will not
affect your current or future treatment at the New York State Psychiatric Institute or
Columbia University.
You may also add information specific to your study regarding the right to withdraw (e.g.
samples will be destroyed in the event that you withdraw). If applicable, state that
subjects will be notified of significant new findings that may relate to their willingness to
continue to participate. (This statement is no required for simple interview studies.)
Alternative Treatments/Alternatives to Participation
This section is necessary for treatment related studies or studies in which known effective
treatment is being delayed. This section also may be included for studies that don’t offer
treatment, but where it may be helpful to highlight the available treatment options.
Statements such as, “the only alternative is not to participate,” don’t convey any meaning
and should not be used. The option not to participate is stated in the voluntary section.
The alternatives mentioned should describe the standard of care for the diagnosis, if any,
and other frequently used clinical options.
* For alternatives relevant to MRI studies, please see the NYSPI IRB Guidelines for
Research Involving MRI available on the IRB website (see the Policies tab).
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Procedures
This section should be a brief description of study procedures. Detailed and repetitive
descriptions of study visits should be eliminated. Additional information may be
included in the appendix.
Risks and Inconveniences
Describe any physical, social, and psychological risks in this section. You should also
discuss side effects and their significance here. List the risks in order of frequency and
severity. Inconveniences such as the time involved, travel, and other minor
inconveniences should also be included.
For studies using PET, the following language is an example of what should be included:
Everyone is exposed to natural background radiation daily from sources such as
radon, food, water and the sun's rays. The average exposure of people in the U.S.
each year is estimated to be 360 mrem (units for measuring radiation). As a very
rough comparison, the amount of radiation you will receive in one PET scan is in
the same range as what you would be exposed to in one year from natural
background sources. There are no known risks associated with this level of
radiation; however, radiation adds up throughout a person's lifetime. It is not
possible to tell whether the small additional radiation you will be exposed to by
participating in this study will increase your long-term risk for diseases such as
cancer.
Benefits
State clearly whether there is or is not potential direct benefit to the participant. If no
benefit is expected, simply state that this study was not designed for the benefit of the
participant. Briefly state whether there is expected societal benefit.
Monetary compensation may not be listed as a benefit.
Confidentiality
Describe how identifiable data will be stored, who will have access, how long it will be
kept, and measures to be taken to ensure confidentiality of electronically
stored/transmitted data (e.g. “All records will be stored in locked files and will be kept
confidential to the extent permitted by law”)
Also include our standard language regarding confidentiality:
Records will be available to research staff, and to Federal, State and Institutional
regulatory personnel (who may review records as part of routine audits).
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Describe measures to be taken to ensure confidentiality of electronically
stored/transmitted data.
→ For applicable clinical trials initiated on or after March 7, 2012, the following
statement is required. {Note: This exact language is required.):
“ 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 individuals recruited and seen at NYSPI, include the following electronic
medical record disclosure: "Your name and other personal identifying information will
be stored in an electronically secure database at New York Psychiatric Institute."
If it is a drug company sponsored study, indicate that drug company personnel may also
review the research records.
→ For any other applicable limitations to confidentiality, or if your study involves
genetics or MRI, of if you have a Certificate of Confidentiality, please see below.

If the study is covered by a Certificate of Confidentiality, describe the protections
and limitations afforded by the certificate. Although required language may vary,
depending on which agency will be granting the Certificate, the essential point is
that it protects the researchers from having to release any research data - including
the names of participants, even under court order or subpoena.
This research is covered by a Certificate of Confidentiality issued by the [AGENCY
NAME HERE (e.g., Department of Health and Human Services (DHHS))]. With this
Certificate, the researchers cannot be forced to release any research data in which you
are identified, even under a court order or subpoena, without your written consent. The
Certificate does not prevent the researchers from reporting suspected or known neglect
or sexual or physical abuse of a child, or threatened violence to self or others. Such
information will be reported to the appropriate authorities.
You should understand that a Certificate of Confidentiality does not prevent you or a
member of your family from voluntarily releasing information about yourself or your
involvement in this research. If an insurer, employer, or other person obtains your
written consent to receive research information, then the researchers may not use the
Certificate to withhold that information.
Records will be available to research staff, and State and Institutional regulatory
personnel (who may review records as part of the routine audits).” [If the study receives
federal support, revise to read] “...and Federal, State and Institutional personnel ...
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→ For studies involving an MRI, include the following statement and highlight it in
discussion with prospective participants:
“Your MRI will be interpreted and the results will be shared with you or a
physician who you may designate. Your MRI report will be maintained as part of
the clinical database at the New York State Psychiatric Institute or the Columbia
University Medical Center along with your name and will be accessible to
clinicians at the Medical Center. Your psychiatric diagnosis will not be a part of
the report.” [delete last sentence for controls]
→ Consent forms for genetic studies must describe new protections under the Genetic
Information Nondiscrimination Act (GINA). Please review the Genetics CF template
available on the IRB website. Consent forms for existing studies may be revised at the
time that they are submitted for continuing review or modification.
In addition to the confidentiality protections described in this consent form, a federal law
called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal
for health insurance companies, group health plans, and most employers to discriminate
against you based on your genetic information. GINA does not protect you against
genetic discrimination by companies that sell life insurance, disability insurance, or
long-term care insurance or by adoption agencies. GINA also does not protect you
against discrimination based on an already diagnosed genetic condition or disease. If
you would like to know more about it you can discuss this with the principal investigator
of this study or you can go to the following website www.genome.gov/10002328

Describe any other limitations to the confidentiality participants can expect:
For example: “If your answers indicate a serious problem that may jeopardize
your safety or health, then the researchers will contact your parents and
appropriate school personnel to see how they can help you, unless there is a very
good reason not to contact them. Research staff may not be able to discuss this
with you first.”
For example "Suspected or known neglect or sexual or physical abuse of a child,
or threatened violence to self or others will be reported to the appropriate
authorities."
For example: “Because you will take part in a group interview, the other people
in the group interview will also hear your responses. We ask that everyone
respect the confidentiality of the other participants....
Study Compensation
Compensation is provided for time, effort, and reimbursement of transportation costs.
For compensation of more than $600 the following paragraph is necessary:
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We are required by law to report your earnings to the IRS. Therefore, your Social
Security Number and amount earned will be reported, and you will receive the
appropriate IRS form at the end of the year in which you were paid. Please note that
payment for this study may affect your eligibility for Medicaid and other city and state
support services. No information about which study you participated in will be provided
to the IRS.
In Case of Injury
For all minimal risk studies:
Federal regulations require that we inform participants about our institution's policy with
regard to compensation and payment for treatment of research-related injuries.
If you believe that you have sustained an injury as a result of participating in a research
study, you may contact the Principal Investigator at (___) ___-_____ so that you can
review the matter and identify the medical resources that may be available to you.
For more than minimal risk studies please use the following standard language:
In case of injury, New York State Psychiatric Institute will provide short term
emergency medical treatment, which has been determined to be necessary by New
York State Psychiatric Institute's doctors, and which is within the capability of New
York State Psychiatric Institute to provide. In addition, we will provide assistance in
arranging follow up care in such instances.
New York State Psychiatric Institute and Research Foundation for Mental Hygiene do
not provide compensation or payment for treatment of research related
injuries. However, you should be aware that you do not give up your legal right to
seek such compensation through the court by participating in this research.
For studies conducted at or funded through Columbia University Medical Center, please
include the following additional information regarding the injury compensation policy
must be included. The following language is recommended:
Please be aware that:
1. The New York State Psychiatric Institute, Columbia University and New York
Presbyterian Hospital will furnish that emergency medical care determined to be
necessary by the medical staff of this hospital
2. You will be responsible for the cost of such care, either personally or through
your medical insurance or other form of medical coverage.
3. No monetary compensation for wages lost as a result of injury will be paid to you
by * the New York State Psychiatric Institute, Columbia University or by New
York Presbyterian Hospital.
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4. By signing this consent form, you are not waiving any of your legal rights to seek
compensation through the courts.
* If funding is through Research Foundation, this should say "....Research Foundation
for Mental Hygiene, the New York State Psychiatric Institute, Columbia University and
New York Presbyterian Hospital."
Questions
State that the investigator will answer to the best of his/her ability any questions that the
participant may have now or in the future about the research procedures, or about the
subject's response to the procedures. Please include the principal investigator's name and
telephone number participation in the study, the participant may call the Principal
Investigator.
If applicable, state that subjects will be notified of significant new findings that may
relate to their willingness to continue to participate. (This statement is not required for
simple interview studies.)
Include the following text:
If you have any questions about your rights as a research participant, want to provide
feedback, or have a complaint, you may call the NYSPI Institutional Review Board (IRB).
(An IRB is a committee that protects the rights of human subjects in research studies).
You may call the IRB Executive Director at (646)774-7161 during regular office hours.
Documentation of Consent
I voluntarily agree to participate in the research study described above.
Print name: __________________
Signed: _____________________
Date: _______________________
I have discussed the proposed research with this participant including the risks, benefits,
and alternatives to participation (including the alternative of not participating in the
research). The participant has had an opportunity to ask questions and in my opinion is
capable of freely consenting to participate in this research.
Print name: ________________
Person Designated to Obtain Consent
Signed: ___________________
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Date: _____________________
* Consent may only be obtained by persons named in the PSF as being authorized
to obtain consent.
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