University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
Page 1 of 12
Paper copies of the Policy may not be the current version. The current version of this Policy is maintained and
available on the OHSP shared network.
POLICY
1. Purpose
This policy describes the requirements for Investigators to appropriately obtain informed
consent and document the consent process, including requests for waivers or alterations of the
consent process. In addition, this policy describes the requirements for the RSRB to evaluate
the consent process when approving research as the Reviewing IRB.
2. Scope
This policy applies to all human subject research conducted or supported by employees or
agents of the University of Rochester (UR), the RSRB, and the RSRB office.
The informed consent requirements in this policy do not preempt any applicable Federal,
state, or local laws (including tribal laws passed by the official governing body of an
American Indian or Alaska Native tribe) that require additional information to be disclosed
in order for informed consent to be legally effective.
Nothing in this policy is intended to limit the authority of a physician to provide emergency
medical care, to the extent the physician is permitted to do so under applicable Federal,
state, or local law (including tribal law passed by the official governing body of an
American Indian or Alaska Native tribe).
3. Definitions
3.1. Informed Consent – An ongoing process of information exchange that takes place
between the potential subject and the Investigator, which begins at the time the potential
subject initially learns about the research and continues throughout the course of the
study.
3.2. Written or In Writing – Writing on a tangible medium (e.g., paper) or in an electronic
format.
4. References
4.1. HHS 45 CFR 46.116; HHS 45 CFR 46.117; FDA 21 CFR 50.20; FDA 21 CFR 50.24;
FDA 21 CFR 50.25; FDA 21 CFR50.3(k) and 56.102(j); New York State Law Article
24-A Section 2442
4.2. Policy 404 Criteria for Approval of Research;
Policy 504 IRB Reliance and Collaborative Research;
Policy 601 Research Involving Children;
Policy 604 Research Involving Adults with Decisional Impairment;
Policy 703 Recruitment and Subject Payment;
Policy 704 Exception from Informed Consent Requirements for Emergency Research
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
Page 2 of 12
Paper copies of the Policy may not be the current version. The current version of this Policy is maintained and
available on the OHSP shared network.
4.3. Guideline for Informed Consent;
FDA Guidance, July 2017 – IRB Waiver or Alteration of Informed Consent for Clinical;
Investigations Involving No More Than Minimal Risk to Human Subjects;
FDA Guidance, April 2013 – Exception from Informed Consent Requirements for
Emergency Research
NIH Policy for Issuing Certificates of Confidentiality
4.4. RSRB Protocol Templates;
RSRB Consent Form Templates
5. Responsibilities
5.1. Investigators have a legal and ethical obligation to ensure the following in regard to
informed consent in accordance with federal regulations HHS 45 CFR 46.116, FDA 21
CFR 50.20, NYS Law Article 24-A Section 2442, institutional policies, and the Guideline
for Informed Consent:
5.1.1. That a prospective subject, or subject’s legally authorized representative, is
provided information that a reasonable person would want to have, that is presented
with sufficient detail to most likely facilitate understanding of the reasons why one
might or might not want to participate, with sufficient opportunity to discuss and
consider whether or not to participate, and that minimizes the possibility of coercion
or undue influence, in order to make an informed decision [HHS 45 CFR
46.116(a)(1-6)].
5.1.2. The information must be provided in a language understandable to the subject, or
the subject’s legally authorized representative.
5.1.3. When enrolling non-English speaking subjects, all consent documents and relevant
subject completed forms are translated into the language understandable to that
study population.
5.1.4. In addition to 5.1.1 and 5.1.2 above, for research involving adults with decisional
impairment, to allow participation in research if a legally authorized representative
is delegated according to Policy 604 Research Involving Adults with Decisional
Impairment.
5.1.5. In addition to 5.1.1 and 5.1.2 above, for research involving children, to allow
permission for a child to participate in research according to Policy 601 Research
Involving Children.
5.2. When the RSRB is the Reviewing IRB, the RSRB is responsible for determining whether
the research satisfies the criteria for approval relevant to the process for obtaining
informed consent, as well as the criteria for approval relevant to appropriate
documentation of consent, according to federal regulations, Policy 404 Criteria for
Approval of Research, and the Guideline for Informed Consent when reviewing protocol
materials at the time of initial and continuing review, and when reviewing modifications
to research.
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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5.3. When the RSRB is the Relying IRB, the RSRB is responsible for reviewing the consent
form(s) to ensure compliance with institutional review requirements described in Policy
504 IRB Reliance and Collaborative Research.
6. General Requirements for Informed Consent
6.1. The Investigator must obtain legally effective informed consent of the subject, or the
subject’s legally authorized representative, before involving a human subject in
research.
6.1.1. The Investigator must begin the consent form with a concise and focused
presentation of key information that will most likely assist the subject, or subject’s
legally authorized representative, in understanding the reasons why one might or
might not want to participate. This must be organized and presented in a way that
facilitates comprehension.
6.2. The Investigator must provide a description of the process for obtaining and documenting
informed consent and provide all consenting documents to the Reviewing IRB for review
and approval.
6.2.1. All required elements and applicable additional elements of consent, as well as
additional institutional and regulatory considerations, listed in Sections 6.3 – 6.7
below must be included, unless a waiver or alteration of informed consent (Section
8) or waiver of documentation of consent (Section 9) is requested by the
Investigator.
6.2.2. Recruitment methods and materials are considered part of the informed consent
process and must be submitted to the RSRB (see Policy 703 Recruitment and
Subject Payment).
6.2.3. RSRB Protocol Templates and RSRB Consent Form Templates are available to
researchers to help ensure required elements and standard institutional language is
incorporated into the documents.
6.3. The Investigator will include the following basic elements of informed consent required
by federal regulations HHS 45 CFR 46.116(b) and, for FDA regulated studies 21 CFR
50.25(a).
6.3.1. An introduction that indicates the study involves research; explanation of the
purpose of the research; and, description of study procedures, which includes
identification of research procedures, as well as those that are investigational or
standard of care procedures.
6.3.2. A description of any reasonably foreseeable risks or discomforts to the subject;
6.3.3. A description of any benefits to the subject or to others which might reasonably be
expected from the research;
6.3.4. Appropriate alternatives (procedures or course of treatment), if any, that might be
advantageous to the subject (not applicable if the only alternative is not to
participate);
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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6.3.5. Description of the extent to which confidentiality of records identifying the
subject will be maintained;
6.3.6. For research involving more than minimal risk, indication whether any
compensation or medical treatment will be provided if injury occurs;
6.3.7. Contact persons for questions about the research, whom to contact in the event of
a research-related injury, and whom to contact for questions about subject’s rights;
6.3.8. A statement that participation is voluntary, refusal to participate involves no
penalty or loss of benefits to which subject is otherwise entitled, and the subject
may discontinue participation at any time without penalty or loss of benefits;
and,
6.3.9. If there is collection of identifiable private information or identifiable
biospecimens, one of the following statements regarding future use of
information and/or biospecimens:
Identifiers might be removed from the identifiable private information or
identifiable biospecimens and that, after such removal, the information or
biospecimens could be used for future research studies or distributed to
another investigator for future research studies without additional informed
consent from the subject or the legally authorized representative, if
applicable;
The subject’s information or biospecimens collected as part of the research
will not be used or distributed for future research studies, even if the
identifiers are removed.
6.4. The Investigator will include the following additional elements of informed consent, as
applicable to the study [HHS 45 CFR 46.116(c)], and for FDA regulated studies 21 CFR
50.25(b):
6.4.1. A statement that the treatment or procedure may involve unforeseeable risks to
the subject (or to the embryo or fetus, if the subject is or may become pregnant);
6.4.2. Circumstances under which the subject’s participation may be terminated by the
Investigator without regard to the subject’s, or the subject’s legally authorized
representative’s, consent;
6.4.3. Additional costs to the subject to participate;
6.4.4. Consequences of subject withdrawal from the study, including procedures for
withdrawal that may be necessary to protect the subject’s safety;
6.4.5. A statement that significant new findings which may relate to the subject’s
willingness to continue participation will be provided to the subject.
6.4.6. Approximate number of subjects in the study;
6.4.7. Statement that subject’s biospecimens (even if identifiers are removed) may be used
for commercial profit, including whether subject will or will not share in this
commercial profit;
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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6.4.8. Statement whether clinically relevant research results (including individual
results) will be disclosed to the subject, and if so, under what conditions; and,
6.4.9. If research involves biospecimens, whether the research will (if known) or might
include whole genome sequencing.
6.5. For FDA regulated research, the Investigator will apply the following additional elements
of informed consent, when applicable:
6.5.1. A statement that the test article is “investigational” or “not FDA-approved”;
6.5.2. No claims may be made which state or imply, directly or indirectly, that the test
article is safe or effective for the purpose(s) under investigation or that the product
is in any way superior to another product;
6.5.3. Description of any plans for randomization;
6.5.4. Description of any plans for use of placebo and the probability of the subject
receiving the test article or the placebo;
6.5.5. For applicable FDA regulated research, a statement regarding study registration at
ClinicalTrials.gov;
6.5.6. Conditions for breaking the code, if the study is blinded;
6.5.7. For phase I studies, disclosure that the purpose of the research includes examining
the safety and toxicity of the test article;
6.5.8. For phase II and phase III studies, the consent document must disclose that the
purpose of the research includes examining the test article for safety and efficacy.
6.6. The Investigator will include the following additional elements of informed consent
required by the University of Rochester:
6.6.1. HIPAA Authorization, if applicable (see Policy 702 HIPAA Privacy Rule);
6.6.2. A statement that subjects will be given a copy of the consent form, if the consent is
written (when the consent includes HIPAA Authorization, it must be a signed
copy);
6.6.3. Identification of the entity sponsoring the study, for sponsor-initiated studies;
6.6.4. Whether subjects are paid, and if so, the amount of payment and how/when
payments are made;
6.6.5. A disclosure statement regarding any financial conflicts of interest, for both the
Investigator and the University, as applicable;
6.6.6. Additional information as indicated in the RSRB Consent Form Template(s) (i.e.,
Biomedical Consent Form Template, Non-biomedical Consent Form Template, or
Permission Form Template).
6.7. For additional consent issues and considerations pertaining to vulnerable research
populations and special types of study procedures, Investigators should also refer to the
following policies and guidelines, as applicable:
6.7.1. Policy 601 Research Involving Children
6.7.2. Policy 602 Research Involving Pregnant Women, Fetuses and Neonates
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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6.7.3. Policy 604 Research Involving Adults with Decisional Impairment
6.7.4. Policy 608 Research Involving Genetic Testing and Gene Transfer and the Consent
for Genetic Testing Template Language
6.7.5. Policy 704 Exception from Informed Consent Requirements for Emergency
Research
6.7.6. Guideline for Research Involving HIV Testing
6.7.7. Guideline for Research Involving Repositories (for research involving specimen or
data banking)
6.8. When the RSRB is the Reviewing IRB, the RSRB will review the protocol materials to
evaluate the consent process and ensure that it is adequate and meets the criteria for
approval according to Policy 404 Criteria for Approval of Research, and other policies
as applicable, including but not limited to the following determinations, when applicable
[HHS 45 CFR 46.116, FDA 21 CFR 56.111]:
6.8.1. The Investigator will obtain legally effective consent from the subject, or subject’s
legally authorized representative;
6.8.2. The consent process provides sufficient opportunity for the subject, or subject’s
legally authorized representative, to discuss and consider whether to participate,
and minimizes the possibility of coercion or undue influence;
6.8.3. The information communicated to the subject, or subject’s legally authorized
representative, is provided in a language understandable to the subject or
representative;
6.8.4. The subject, or subject’s legally authorized representative, is provided with
information that a reasonable person would want to have in order to make an
informed decision whether or not to participate, and provided an opportunity to
discuss that information;
6.8.5. The consent form begins with a presentation of key information that will most likely
assist the subject, or subject’s legally authorized representative, in understanding
the reasons why one might or might not want to participate;
6.8.6. The consent form as a whole is presented with sufficient detail relating to the
research which facilitates the subject’s or subject’s legally authorized
representative’s understanding of the reasons why one might or might not want to
participate;
6.8.7. The information communicated to the subject, or subject’s legally authorized
representative, doesn’t include exculpatory language through which the subject or
representative is made to waive, or appear to waive, any legal rights, or appears to
release, the Investigator, Sponsor, University, or its agents from liability for
negligence.
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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7. Documentation of Informed Consent when the RSRB is the Reviewing IRB
7.1. Documentation of informed consent must be obtained using one of the following
methods:
7.1.1. A written consent form approved by the Reviewing IRB and signed by the subject,
or subject’s legally authorized representative (including in an electronic format
when research is not FDA regulated) [45 CFR 46.117(b)(1) and 21 CFR
50.27(b)(1)] before any research procedures may begin, unless a waiver of
documentation of consent has been granted, when allowed (see Section 9).
The RSRB will consider when the signature of the person obtaining consent
is required or when other documentation can be used to document the
signature of the person obtaining consent.
7.1.2. A short form written consent form [45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2)
which states that all elements of consent (see Sections 6.3 and 6.4) were presented
orally to the subject, or subject’s authorized representative, and key information
was presented first to the subject before other information, if any, was provided.
The Reviewing IRB will approve a written summary of what is to be said
to the subject. The consent form often represents this written summary.
Only the short form requires signature by the subject, or subject’s
authorized representative.
A witness is required when this process of informed consent is used. The
witness must sign both the short form and the summary document.
The person obtaining consent is required to sign the summary document.
7.2. When obtaining consent, the Investigator is responsible for giving the subject, or
subject’s authorized representative, adequate opportunity to read the consent form before
it is signed. The form may, alternatively, be read to the person providing consent.
7.3. After written documentation of consent is obtained, the person signing consent (i.e.,
subject or subject’s legally authorized representative) must receive a copy of the entire
consent document, unless a waiver or alteration of informed consent has been granted
(see Section 8). This also applies to use of short form written consent, in which case a
copy of both the short form and the summary document must be provided.
7.3.1. If the consent document includes HIPAA Authorization, a signed copy must be
provided.
8. Waiver or Alteration of Informed Consent Requirements when the RSRB is the
Reviewing IRB
8.1. The RSRB may waive or alter some or all requirements for obtaining informed consent,
provided the RSRB finds and documents that the research meets the criteria of 8.1.1 or
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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8.1.2 below [45 CFR 46.116(f)(3)], or 8.1.3 below for FDA regulated research [FDA
Guidance, July 2017 – IRB Waiver or Alteration of Informed Consent for Clinical
Investigations Involving No More Than Minimal Risk to Human Subjects]:
8.1.1. The research meets all of the following criteria:
The research involves no more than minimal risk to the subjects;
The research could not practicably be carried out without the waiver or
alteration;
If the research involves use of identifiable private information or
identifiable specimens, the research could not practicably be carried out
without using such information or specimens in an identifiable format;
The waiver will not adversely affect the rights and welfare of the subjects,
and
When appropriate, the subjects will provided with additional pertinent
information after participation.
8.1.2. The research is to be conducted by or under the approval of state or local
government officials, the research could not practicably be carried out without the
waiver or alteration, and the research is designed to study, evaluate, or otherwise
examine:
Public benefit or service programs;
Procedures for obtaining benefits or services under those programs;
Possible changes in or alternatives to those programs or procedures; or
Possible changes in methods or levels of payment for benefits or services
under those programs.
8.1.3. The research is FDA regulated and meets all of the following criteria:
The clinical investigation involves no more than minimal risk [as defined in
21CFR50.3(k) or 56.102(j)] to the subjects;
The waiver or alteration will not adversely affect the rights and welfare of
the subjects;
The clinical investigation could not practicably be carried out without the
waiver or alteration; and
When appropriate, the subjects will provided with additional pertinent
information after participation.
9. Waiver of Documentation of Informed Consent when the RSRB is the Reviewing IRB
Note: For FDA regulated research, the RSRB may only waive documentation of
informed consent under Section 9.1.2 below.
9.1. The RSRB may waive the requirement to obtain a signed consent form provided the
RSRB finds and documents that the research meets one of the criteria below, as
applicable:
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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9.1.1. The only record linking the subject and the research is the consent document and
the principal risk is potential harm from breach of confidentiality [45 CFR
46.117(c)],
9.1.2. The research presents no more than minimal risk of harm to subjects and involves
no procedures for which written consent is normally required outside the research
context [45 CFR 46.117(c) and 21 CFR 56.109(c)], or
9.1.3. If the subjects are members of a distinct cultural group or community in which
signing forms is not the norm, the research presents no more than minimal risk of
harm to the subjects, and there is an appropriate alternative mechanism for
documenting that informed consent was obtained.
9.2. If the RSRB waives the requirement for documentation of informed consent, the RSRB
may require the Investigator to provide subjects with a written description of the study
(see Consent Form Templates for sample Information Sheets).
10. Requirements for FDA-Regulated Research Requiring Special Consideration when the
RSRB is the Reviewing IRB
10.1. For FDA-regulated research, the requirements for obtaining informed consent for
expanded access of investigational drugs or devices in the clinical treatment of patients
are outlined in Policy 605 Research Involving FDA Regulated Drug, Biologics, and
Supplements and Policy 606 Research Involving FDA Regulated Devices. Refer also to
the RSRB Treatment Use Consent Template.
10.2. For FDA-regulated research, the exceptions to informed consent requirements for
emergency use of a test article are outlined in Policy 607 Emergency Use of
Investigational Drugs, Biologics, and Medical Devices. Refer also to the RSRB
Emergency Use Consent Template.
10.3. For FDA-regulated emergency research requiring waiver of informed consent [FDA 21
CFR 50.24], refer to Policy 704 Exception from Informed Consent Requirements for
Emergency Research and the Guideline for Informed Consent.
10.4. For FDA-regulated in vitro diagnostics (IVD) device investigations, it is possible in
certain circumstances to conduct research without informed consent using leftover
specimens, as long as the subject cannot be identified and where results of the
investigational test are not communicated to or otherwise associated with the identified
subject (Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human
Specimens that are Not Individually Identifiable).
University of
Rochester
Office for Human Subject Protection
Research Subjects Review Board
Effective Date: 01/21/2019
Informed Consent
Policy 701
Version: 2.1
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11. Informed Consent for Deception Research when the RSRB is the Reviewing IRB
11.1. The Investigator must provide an adequate description and rationale for the procedures
to be conducted, in addition to fulfilling the requirements for an alteration of informed
consent (see Section 8) or waiver of documentation of consent (see Section 9).
11.2. The Investigator must provide the consent documents that will be utilized before the
study procedures begin (see RSRB Consent Form to Procedures Template), as well as
those used at the conclusion of participation (see RSRB Consent Form to Data Use
Template). See the Guideline for Informed Consent.
12. Use of Non-English Consent Forms when the RSRB is the Reviewing IRB
12.1. Enrollment of non-English speaking subjects (one or more) requires that the consent,
document and any relevant subject completed materials, must be translated into a
language understandable to the subject, and RSRB approved prior to use.
12.1.1. The Investigator must determine that the lack of English proficiency will not affect
a subject’s ability to make an informed and voluntary decision to participate in the
study, or the ability to report problems or adverse events, when considering whether
enrollment of the non-English speaking subjects is appropriate.
12.1.2. The RSRB may permit the use of a short form (See Section 7.1.2), in conjunction
with the English consent form, for conducting an oral presentation of informed
consent when an Investigator needs to unexpectedly enroll a subject who does not
read and/or speak English (e.g., when clinical care or treatment is part of the
research). See the Guideline for Informed Consent when proposing the use of a
short form.
12.1.3. The short form may only be used for the initial presentation of informed consent
and to obtain the subject’s consent to participate. Once the subject is enrolled, the
informed consent, and any relevant subject completed materials, must be translated
into the language understandable to the subject, and RSRB approved prior to use.
13. Certificates of Confidentiality
13.1. Certificates of Confidentiality (CoC) are automatically issued by the National Institutes
of Health (NIH) for NIH-funded research, according to the NIH Policy for Issuing
Certificates of Confidentiality, to protect identifiable research information from forced
disclosure. NIH will also consider requests for Certificates for non-federally funded
research.
13.1.1. Certificates do not protect against voluntary disclosures by the subject or
researcher; however, those disclosures must be specified in the consent document
(e.g., evidence of child abuse or a subject’s threatened violence to self or others).
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13.2. The Biomedical Consent Form template and the Non-Biomedical Consent Form template
provides standard language to include in the informed consent document for NIH funded
research or when a CoC is issued.
14. Posting of Clinical Trial Consent Forms
14.1. The awardee or funding agency of a clinical trial that receives federal funding must post
one IRB-approved consent form used to enroll subjects on a publicly available federal
website [45 CFR 46.116(h)] (see Guideline for Informed Consent).
14.1.1. If the funding agency determines that certain information should not be made
publicly available on the federal website (e.g., confidential commercial
information), such funding agency may permit or require redactions to the
information posted.
14.2. The consent form must be posted on the federal website after the clinical trial is closed
to recruitment and no later than 60 days after the last study visit by any subject, as
required by the protocol.
