Proposed Rule2022-20223
Protection of Human Subjects
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 20, 2022
Issuing agencies
Corporation for National and Community Service
Abstract
The Corporation for National and Community Service (operating as AmeriCorps) is proposing to adopt the Federal Policy for Protection of Human Subjects (referred to as the Common Rule). The Common Rule outlines the basic ethical principles and procedures that an agency will abide by when conducting or sponsoring research involving human subjects. Among the procedures required by the Common Rule are use of institutional review boards (IRBs), obtaining informed consent of research subjects, and requiring submission of assurances of compliance with the rule. AmeriCorps is proposing to make the Common Rule applicable to itself, meaning that all research involving human subjects conducted, supported, or otherwise subject to regulation by AmeriCorps will be subject to the Common Rule's ethical principles and procedures.
Full Text
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<title>Federal Register, Volume 87 Issue 181 (Tuesday, September 20, 2022)</title>
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[Federal Register Volume 87, Number 181 (Tuesday, September 20, 2022)]
[Proposed Rules]
[Pages 57435-57447]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20223]
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CORPORATION FOR NATIONAL AND COMMUNITY SERVICE
45 CFR Part 2558
RIN 3045-AA60
Protection of Human Subjects
AGENCY: Corporation for National and Community Service.
ACTION: Proposed rule.
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SUMMARY: The Corporation for National and Community Service (operating
as AmeriCorps) is proposing to adopt the Federal Policy for Protection
of Human Subjects (referred to as the Common Rule). The Common Rule
outlines the basic ethical principles and procedures that an agency
will abide by when conducting or sponsoring research involving human
subjects. Among the procedures required by the Common Rule are use of
institutional review boards (IRBs), obtaining informed consent of
research subjects, and requiring submission of assurances of compliance
with the rule. AmeriCorps is proposing to make the Common Rule
applicable to itself, meaning that all research involving human
subjects conducted, supported, or otherwise subject to regulation by
AmeriCorps will be subject to the Common Rule's ethical principles and
procedures.
DATES: Written comments must be submitted by November 21, 2022.
ADDRESSES: You may send your comments electronically through the
Federal government's one-stop rulemaking website at
<a href="http://www.regulations.gov">www.regulations.gov</a>. You may also send your comments to Elizabeth
Appel, Associate General Counsel, at <a href="/cdn-cgi/l/email-protection#6207031212070e22010c114c050d14"><span class="__cf_email__" data-cfemail="7217130202171e32111c015c151d04">[email protected]</span></a> or by mail to
AmeriCorps, 250 E Street SW, Washington DC 20525.
FOR FURTHER INFORMATION CONTACT: Mary Hyde, Ph.D., Director, AmeriCorps
Office of Research and Evaluation, at (202) 606-6834 or <a href="/cdn-cgi/l/email-protection#462b2e3f22230625283568212930"><span class="__cf_email__" data-cfemail="5d30352439381d3e332e733a322b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On June 18, 1991, the U.S. Department of
Health and Human Services (HHS) issued a rule setting forth the Common
Rule requirements for the protection of human subjects. (56 FR 28003).
The HHS regulations are codified at 45 CFR part 46. At that time, 15
other agencies joined HHS in adopting a uniform set of rules for the
protection of human subjects, identical to Subpart A of 45 CFR part 46.
The basic provisions of the Common Rule include, among other things,
requirements related to the review of human subjects research by an
IRB, obtaining and documenting informed consent of human subjects, and
submitting written assurance of institutional compliance with the
Common Rule. On January 19, 2017, HHS issued a final rule revising the
Common Rule, which, among other things, established new requirements
regarding the information that must be given to prospective research
subjects as part of the informed consent process. 82 FR 7149.
AmeriCorps is proposing to codify the text of the revised Common
Rule in its regulations at 45 CFR part 4558. This proposed rule is
substantively identical to the HHS regulations in 45 CFR part 46,
subpart A, ensuring consistency across Federal agencies. With this
proposed codification, AmeriCorps would be subject to the same ethical
principles and procedures that other agencies who have adopted the
Common Rule are subject to when conducting or supporting research
involving human subjects. The rule applies broadly: most relevant to
AmeriCorps, it covers instances when an investigator conducting
research obtains information through interaction with the individual
and uses, studies, or analyzes the information. The rule also sets out
certain research that is exempt from the rule. For any non-exempt
research, under this rule AmeriCorps would:
<bullet> Conduct or support non-exempt research only if the
institution engaged in the research has provided an assurance that it
will comply with the Common Rule, and
<bullet> Conduct or support non-exempt research only if (when
required by the rule) the institution has certified to AmeriCorps that
the research has been reviewed and approved by an IRB.
The rule also sets out requirements applicable to the IRBs,
including requirements for the IRB membership, IRB functions and
operations, IRB review of research and criteria for IRB approval of
research, IRB authority to suspend or terminate approval of research
that is not being conducted in accordance with the IRB's requirements
or has been associated with unexpected serious harm to subjects, and
IRB records. The rule also sets out the requirements for investigators
to obtain the legally effective informed consent of the subject before
involving the subject in any non-exempt research. For example, the
investigator must seek informed consent only under circumstances that
provide sufficient opportunity to discuss and consider whether to
participate in the research (to minimize the possibility of coercion or
undue influence), and the investigator must provide the prospective
subject with information a reasonable person would want to have in
order to make an informed decision as to whether to participate in the
research and provide the information in language understandable to the
prospective subject. The rule also sets out the basic elements of what
information must be provided to each prospective subject and how
informed consent must be documented.
AmeriCorps at times undertakes research that would be considered
non-exempt research under the Common Rule. The Office of Research and
Evaluation (ORE), within AmeriCorps, furthers AmeriCorps' mission by
providing accurate and timely research on national service, social
innovation,
[[Page 57436]]
volunteering, and civic engagement. ORE conducts original and sponsored
research and evaluations, among other activities, to infuse data into
AmeriCorps' programs and contribute to the public's understanding of
national service. For example, AmeriCorps surveys members/volunteers to
inform recruitment and improve member/volunteer experience. ORE uses
the survey responses to identify national service trends, such as
trends in program participation, motivations, and outcomes. As another
example, AmeriCorps sponsors evaluations of national service
interventions (e.g., Recovery Coach Programs, Tutoring Programs) that
collect information from program participants about their experiences
and outcomes.
ORE staff consists of professional social scientists and research
analysts who abide by their professions' codes of ethics, including but
not limited to those relating to integrity, respect for people's
rights, dignity, and diversity, non-exploitation, and informed consent.
AmeriCorps' research is therefore already guided by these codes of
ethics, and typically engages in practices such as ensuring that
informed consent of human subjects is properly obtained and, when
supporting research conducted by universities and other research
partners, ensuring that the research is reviewed and approved by an
IRB.
Adoption of the Common Rule will not result in major changes in
research conducted and supported by AmeriCorps, but it will provide a
more concrete framework for AmeriCorps staff to follow to ensure
protection of human research subjects. While AmeriCorps may currently
avail itself of the broad range of HHS guidance documents on the Common
Rule, adopting the Common Rule itself will ensure that it is
interpreting those guidance documents in a manner consistent with the
regulatory requirements of the Common Rule. HHS guidance includes
decisions charts to guide everything from the analysis of whether an
activity is covered by the Common Rule to whether documentation of
informed consent can be waived, frequently asked question (FAQ)
documents, and various other guidance documents--all of which will
assist AmeriCorps in ensuring that its research protects human
subjects. AmeriCorps' proposed adoption of the Common Rule would also
provide assurance to individuals who are prospective and participating
human research subjects for AmeriCorps-conducted or supported research
that AmeriCorps abides by the same ethical and procedural provisions
that HHS and 19 other agencies do. Finally, AmeriCorps' adoption of the
Common Rule will ensure consistency across agencies in their approach
to protecting human subjects in research.
At the time the Common Rule was first adopted in 1991, AmeriCorps
had just been established as the Corporation for National and Community
Service under the National and Community Service Act of 1990.
AmeriCorps was not a participating agency in either that 1991 Common
Rule rulemaking or in the more recent 2018 updates to the Common Rule;
however, as noted above, AmeriCorps believes it is important to adopt
this standard framework for AmeriCorps research professionals,
prospective and participating human subjects, and consistency among
Federal agencies, as described above. If AmeriCorps does not move
forward with this rulemaking, AmeriCorps professionals will still be
guided by their professions' ethical principles in conducting or
supporting research involving human research subjects, but would lack
the incentives of a mandatory procedural framework afforded by the
Common Rule and human research subjects will be deprived of the
assurances of their protection offered by the Common Rule.
AmeriCorps welcomes any public comment on the advisability or
inadvisability of adopting the Common Rule in whole or in part and
welcomes comment on any aspect of the rule, including but not limited
to the following. Should AmeriCorps adopt the HHS Common Rule
wholesale, as proposed, or should AmeriCorps make any adjustments to
the Common Rule (in which case it would not be considered a Common Rule
agency)? For example, is anything missing or overly burdensome in the
procedures for obtain informed consent of prospective human research
subjects? Are there any additional requirements or procedures that IRBs
should be subject to, or any that should be removed? Is there anything
the Common Rule does not address that AmeriCorps should consider in a
future rulemaking? AmeriCorps welcomes comments from all interested
parties, including but not limited to, any individuals who have
participated as a human subject in research by HHS or other an agency
that complies with the Common Rule or by AmeriCorps.
AmeriCorps anticipates there may be costs associated with its
implementation of this rule to the extent it may have to contract for
professionals to serve on an IRB to review and approve research that
AmeriCorps is directly conducting. In most cases, AmeriCorps partners
with universities or other research institutions that already have an
IRB, so AmeriCorps anticipates that the instances in which it will be
directly responsible for paying for an IRB will be negligible. The
benefits of adopting the rule, beyond the clarity afforded to
AmeriCorps research professionals and consistency in approach across
Federal agencies, are the protections that compliance with the Common
Rule will provide to prospective and participating human research
subjects. AmeriCorps anticipates that individuals may be more willing
to participate in AmeriCorps research as human subjects knowing that
AmeriCorps will be following the same Common Rule standards as multiple
other Federal agencies; however, AmeriCorps is unable to quantify any
anticipated increase in participation by human subjects in its research
because doing so would be too speculative.
Regulatory Analyses
A. Executive Orders 12866 and 13563
Executive Orders (E.O.) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
The Office of Information and Regulatory Affairs in the Office of
Management and Budget does not anticipate that this will be a
significant regulatory action.
B. Congressional Review Act (Small Business Regulatory Enforcement
Fairness Act of 1996, Title II, Subtitle E)
As required by the Congressional Review Act (5 U.S.C. 801-808)
before an interim or final rule takes effect, AmeriCorps will submit
for an interim or final rule a report to each House of the Congress and
to the Comptroller General of the United States. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. The Office of Information and Regulatory Affairs in the
Office of Management and Budget anticipates that this will not be a
major rule under 5 U.S.C. 804 because this rule will not result in (1)
an annual effect on the economy of $100 million or more; (2) a major
increase in costs or prices for consumers, individual industries,
[[Page 57437]]
Federal, state, or local government agencies, or geographic regions; or
(3) significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic and
export markets.
C. Regulatory Flexibility Act
As required by the Regulatory Flexibility Act of 1980 (5 U.S.C. 601
et seq.), AmeriCorps certifies that this rule, if adopted, will not
have a significant economic impact on a substantial number of small
entities. Therefore, AmeriCorps has not performed the initial
regulatory flexibility analysis that is required under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) for rules that are expected to
have such results.
D. Unfunded Mandates Reform Act of 1995
For purposes of Title II of the Unfunded Mandates Reform Act of
1995, 2 U.S.C. 1531-1538, as well as Executive Order 12875, this
regulatory action does not contain any Federal mandate that may result
in increased expenditures in either Federal, State, local, or Tribal
governments in the aggregate, or impose an annual burden exceeding $100
million on the private sector.
E. Paperwork Reduction Act
Under the PRA, an agency may not conduct or sponsor a collection of
information unless the collections of information display valid control
numbers. The information collections in this proposed rule at proposed
sections 2558.103, 2558.104, 2558.108, 2558.109, 2558.113, and
2558.115-2558.17 are approved by the Office of Management and Budget
under Control Number 0990-0260.
F. Executive Order 13132, Federalism
Executive Order 13132, Federalism, prohibits an agency from
publishing any rule that has Federalism implications if the rule
imposes substantial direct compliance costs on State and local
governments and is not required by statute, or the rule preempts State
law, unless the agency meets the consultation and funding requirements
of section 6 of the Executive Order. This rule does not have any
Federalism implications, as described above.
G. Takings (E.O. 12630)
This proposed rule does not affect a taking of private property or
otherwise have taking implications under Executive Order 12630 because
this proposed rule does not affect individual property rights protected
by the Fifth Amendment or involve a compensable ``taking.'' A takings
implication assessment is not required.
H. Civil Justice Reform (E.O. 12988)
This proposed rule complies with the requirements of Executive
Order 12988. Specifically, this rule: (a) meets the criteria of section
3(a) requiring that all regulations be reviewed to eliminate errors and
ambiguity and be written to minimize litigation; and (b) meets the
criteria of section 3(b)(2) requiring that all regulations be written
in clear language and contain clear legal standards.
I. Consultation With Indian Tribes (E.O. 13175)
AmeriCorps recognizes the inherent sovereignty of Indian Tribes and
their right to self-governance. We have evaluated this rule under our
consultation policy and the criteria in E.O. 13175 and determined that
this proposed rule does not impose substantial direct effects on
federally recognized Tribes.
J. Clarity of This Regulation
We are required by Executive Orders 12866 (section 1(b)(12)), and
12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the
Presidential Memorandum of June 1, 1998, to write all rules in plain
language. This means that each proposed rule we publish must: (a) be
logically organized; (b) use the active voice to address readers
directly; (c) use clear language rather than jargon; (d) be divided
into short sections and sentences; and (e) use lists and tables
wherever possible. If you feel that we have not met these requirements,
please send us comments by one of the methods listed in the ADDRESSES
section. To help us revise the rule, your comments should be as
specific as possible.
List of Subjects in 45 CFR Part 2558
Human research subjects, Reporting and recordkeeping requirements,
Research.
For the reasons stated in the preamble, the Corporation for
National and Community Service proposes to amend title 45 of the Code
of Federal Regulations to add part 2558 to read as follows:
PART 2558--PROTECTION OF HUMAN SUBJECTS
Sec.
2558.101 To what does this policy apply?
2558.102 Definitions for purposes of this policy.
2558.103 Assuring compliance with this policy--research conducted or
supported by any Federal department or agency.
2558.104 Exempt research.
2558.105 [Reserved]
2558.106 [Reserved]
2558.107 IRB membership.
2558.108 IRB functions and operations.
2558.109 IRB review of research.
2558.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
2558.111 Criteria for IRB approval of research.
2558.112 Review by institution.
2558.113 Suspension or termination of IRB approval of research.
2558.114 Cooperative research.
2558.115 IRB records.
2558.116 General requirements for informed consent.
2558.117 Documentation of informed consent.
2558.118 Applications and proposals lacking definite plans for
involvement of human subjects.
2558.119 Research undertaken without the intention of involving
human subjects.
2558.120 Evaluation and disposition of applications and proposals
for research to be conducted or supported by a Federal department or
agency.
2558.121 [Reserved]
2558.122 Use of Federal funds.
2558.123 Early termination of research support: Evaluation of
applications and proposals.
2558.124 Conditions.
Authority: 42 U.S.C. 12651c(c)
Sec. 2558.101 To what does this policy apply?
(a) Except as detailed in Sec. 2558.104, this policy applies to
all research involving human subjects conducted, supported, or
otherwise subject to regulation by any Federal department or agency
that takes appropriate administrative action to make the policy
applicable to such research. This includes research conducted by
Federal civilian employees or military personnel, except that each
department or agency head may adopt such procedural modifications as
may be appropriate from an administrative standpoint. It also includes
research conducted, supported, or otherwise subject to regulation by
the Federal Government outside the United States. Institutions that are
engaged in research described in this paragraph and institutional
review boards (IRBs) reviewing research that is subject to this policy
must comply with this policy.
(b) [Reserved]
(c) Department or agency heads retain final judgment as to whether
a particular activity is covered by this policy and this judgment shall
be
[[Page 57438]]
exercised consistent with the ethical principles of the Belmont
Report.\1\
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\1\ The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research, The Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of
Research (Apr. 18, 1979).
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(d) Department or agency heads may require that specific research
activities or classes of research activities conducted, supported, or
otherwise subject to regulation by the Federal department or agency but
not otherwise covered by this policy comply with some or all of the
requirements of this policy.
(e) Compliance with this policy requires compliance with pertinent
federal laws or regulations that provide additional protections for
human subjects.
(f) This policy does not affect any state or local laws or
regulations (including tribal law passed by the official governing body
of an American Indian or Alaska Native tribe) that may otherwise be
applicable and that provide additional protections for human subjects.
(g) This policy does not affect any foreign laws or regulations
that may otherwise be applicable and that provide additional
protections to human subjects of research.
(h) When research covered by this policy takes place in foreign
countries, procedures normally followed in the foreign countries to
protect human subjects may differ from those set forth in this policy.
In these circumstances, if a department or agency head determines that
the procedures prescribed by the institution afford protections that
are at least equivalent to those provided in this policy, the
department or agency head may approve the substitution of the foreign
procedures in lieu of the procedural requirements provided in this
policy. Except when otherwise required by statute, Executive Order, or
the department or agency head, notices of these actions as they occur
will be published in the Federal Register or will be otherwise
published as provided in department or agency procedures.
(i) Unless otherwise required by law, the department or agency head
may waive the applicability of some or all of the provisions of this
policy to specific research activities or classes of research
activities otherwise covered by this policy, provided the alternative
procedures to be followed are consistent with the principles of the
Belmont Report.\2\ Except when otherwise required by statute or
Executive Order, the department or agency head shall forward advance
notices of these actions to the Office for Human Research Protections,
Department of Health and Human Services (HHS), or any successor office,
or to the equivalent office within the appropriate Federal department
or agency, and shall also publish them in the Federal Register or in
such other manner as provided in department or agency procedures. The
waiver notice must include a statement that identifies the conditions
under which the waiver will be applied and a justification as to why
the waiver is appropriate for the research, including how the decision
is consistent with the principles of the Belmont Report.
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\2\ Id.
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(j) Federal guidance on the requirements of this policy shall be
issued only after consultation, for the purpose of harmonization (to
the extent appropriate), with other Federal departments and agencies
that have adopted this policy, unless such consultation is not
feasible.
(k) [Reserved]
(l) Compliance dates and transition provisions
(1) Pre-2018 Requirements. For purposes of this section, the pre-
2018 Requirements means this subpart as published in the 2016 edition
of the Code of Federal Regulations.
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this subpart. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 46.114(b) (cooperative research) of the 2018 Requirements is
January 20, 2020.
(3) Research subject to pre-2018 requirements. The pre-2018
Requirements shall apply to the following research, unless the research
is transitioning to comply with the 2018 Requirements in accordance
with paragraph (l)(4) of this section:
(i) Research initially approved by an IRB under the pre-2018
Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to Sec.
46.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research
was exempt under Sec. 46.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 46.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 46.102(d) of the pre-2018 Requirements);
(2) Section 46.103(d) of the 2018 Requirements (revised
certification requirement that eliminates IRB review of application or
proposal) (instead of Sec. 46.103(f) of the pre-2018 Requirements);
and
(3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements
(exceptions to mandated continuing review) (instead of Sec. 46.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 46.109, of the pre-2018 Requirements); and
(B) Beginning on January 21, 2019, comply with the 2018
Requirements.
(ii) If the determination to transition is documented on or after
January 21, 2019, the research shall, beginning on the date of such
documentation, comply with the 2018 Requirements.
(5) Research subject to 2018 Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an IRB on or after January 21,
2019;
(ii) Research for which IRB review is waived pursuant to paragraph
(i) of this section on or after January 21, 2019; and
(iii) Research for which a determination is made that the research
is exempt on or after January 21, 2019.
(m) Severability: Any provision of this part held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this part and shall not affect the
remainder thereof or the application of the provision to other persons
not similarly situated or to other dissimilar circumstances.
Sec. 2558.102 Definitions for purposes of this policy.
(a) Certification means the official notification by the
institution to the supporting Federal department or agency component,
in accordance with the requirements of this policy, that a research
project or activity involving human subjects has been reviewed and
[[Page 57439]]
approved by an IRB in accordance with an approved assurance.
(b) Clinical trial means research study in which one or more human
subjects are prospectively assigned to one or more interventions (which
may include placebo or other control) to evaluate the effects of the
interventions on biomedical or behavioral health-related outcomes.
(c) Department or agency head means the head of any Federal
department or agency, for example, the Secretary of HHS, and any other
officer or employee of any Federal department or agency to whom the
authority provided by these regulations to the department or agency
head has been delegated.
(d) Federal department or agency refers to a Federal department or
agency (the department or agency itself rather than its bureaus,
offices or divisions) that takes appropriate administrative action to
make this policy applicable to the research involving human subjects it
conducts, supports, or otherwise regulates (e.g., the U.S. Department
of Health and Human Services, the U.S. Department of Defense, or the
Central Intelligence Agency).
(e)(1) Human subject means a living individual about whom an
investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or
interaction with the individual, and uses, studies, or analyzes the
information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable
private information or identifiable biospecimens.
(2) Intervention includes both physical procedures by which
information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are
performed for research purposes.
(3) Interaction includes communication or interpersonal contact
between investigator and subject.
(4) Private information includes information about behavior that
occurs in a context in which an individual can reasonably expect that
no observation or recording is taking place, and information that has
been provided for specific purposes by an individual and that the
individual can reasonably expect will not be made public (e.g., a
medical record).
(5) Identifiable private information is private information for
which the identity of the subject is or may readily be ascertained by
the investigator or associated with the information.
(6) An identifiable biospecimen is a biospecimen for which the
identity of the subject is or may readily be ascertained by the
investigator or associated with the biospecimen.
(7) Federal departments or agencies implementing this policy shall:
(i) Upon consultation with appropriate experts (including experts
in data matching and re-identification), reexamine the meaning of
``identifiable private information,'' as defined in paragraph (e)(5) of
this section, and ``identifiable biospecimen,'' as defined in paragraph
(e)(6) of this section. This reexamination shall take place within 1
year and regularly thereafter (at least every 4 years). This process
will be conducted by collaboration among the Federal departments and
agencies implementing this policy. If appropriate and permitted by law,
such Federal departments and agencies may alter the interpretation of
these terms, including through the use of guidance.
(ii) Upon consultation with appropriate experts, assess whether
there are analytic technologies or techniques that should be considered
by investigators to generate ``identifiable private information,'' as
defined in paragraph (e)(5) of this section, or an ``identifiable
biospecimen,'' as defined in paragraph (e)(6) of this section. This
assessment shall take place within 1 year and regularly thereafter (at
least every 4 years). This process will be conducted by collaboration
among the Federal departments and agencies implementing this policy.
Any such technologies or techniques will be included on a list of
technologies or techniques that produce identifiable private
information or identifiable biospecimens. This list will be published
in the Federal Register after notice and an opportunity for public
comment. The Secretary, HHS, shall maintain the list on a publicly
accessible website.
(f) Institution means any public or private entity, or department
or agency (including federal, state, and other agencies).
(g) IRB means an institutional review board established in accord
with and for the purposes expressed in this policy.
(h) IRB approval means the determination of the IRB that the
research has been reviewed and may be conducted at an institution
within the constraints set forth by the IRB and by other institutional
and federal requirements.
(i) Legally authorized representative means an individual or
judicial or other body authorized under applicable law to consent on
behalf of a prospective subject to the subject's participation in the
procedure(s) involved in the research. If there is no applicable law
addressing this issue, legally authorized representative means an
individual recognized by institutional policy as acceptable for
providing consent in the nonresearch context on behalf of the
prospective subject to the subject's participation in the procedure(s)
involved in the research.
(j) Minimal risk means that the probability and magnitude of harm
or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations or
tests.
(k) Public health authority means an agency or authority of the
United States, a state, a territory, a political subdivision of a state
or territory, an Indian tribe, or a foreign government, or a person or
entity acting under a grant of authority from or contract with such
public agency, including the employees or agents of such public agency
or its contractors or persons or entities to whom it has granted
authority, that is responsible for public health matters as part of its
official mandate.
(l) Research means a systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute
to generalizable knowledge. Activities that meet this definition
constitute research for purposes of this policy, whether or not they
are conducted or supported under a program that is considered research
for other purposes. For example, some demonstration and service
programs may include research activities. For purposes of this part,
the following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history,
journalism, biography, literary criticism, legal research, and
historical scholarship), including the collection and use of
information, that focus directly on the specific individuals about whom
the information is collected.
(2) Public health surveillance activities, including the collection
and testing of information or biospecimens, conducted, supported,
requested, ordered, required, or authorized by a public health
authority. Such activities are limited to those necessary to allow a
public health authority to identify, monitor, assess, or investigate
potential public health signals, onsets of disease outbreaks, or
conditions of public health importance (including trends, signals, risk
factors, patterns in diseases, or increases in injuries from using
consumer products). Such activities
[[Page 57440]]
include those associated with providing timely situational awareness
and priority setting during the course of an event or crisis that
threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or
records by or for a criminal justice agency for activities authorized
by law or court order solely for criminal justice or criminal
investigative purposes.
(4) Authorized operational activities (as determined by each
agency) in support of intelligence, homeland security, defense, or
other national security missions.
(m) Written, or in writing, for purposes of this part, refers to
writing on a tangible medium (e.g., paper) or in an electronic format.
Sec. 2258.103 Assuring compliance with this policy--research
conducted or supported by any Federal department or agency.
(a) Each institution engaged in research that is covered by this
policy, with the exception of research eligible for exemption under
Sec. 2558.104, and that is conducted or supported by a Federal
department or agency, shall provide written assurance satisfactory to
the department or agency head that it will comply with the requirements
of this policy. In lieu of requiring submission of an assurance, the
department or agency head shall accept the existence of a current
assurance, appropriate for the research in question, on file with the
Office for Human Research Protections, HHS, or any successor office,
and approved for Federal-wide use by that office. When the existence of
an HHS-approved assurance is accepted in lieu of requiring submission
of an assurance, reports (except certification) required by this policy
to be made to department and agency heads shall also be made to the
Office for Human Research Protections, HHS, or any successor office.
Federal departments and agencies will conduct or support research
covered by this policy only if the institution has provided an
assurance that it will comply with the requirements of this policy, as
provided in this section, and only if the institution has certified to
the department or agency head that the research has been reviewed and
approved by an IRB (if such certification is required by Sec.
2558.103(d)).
(b) The assurance shall be executed by an individual authorized to
act for the institution and to assume on behalf of the institution the
obligations imposed by this policy and shall be filed in such form and
manner as the department or agency head prescribes.
(c) The department or agency head may limit the period during which
any assurance shall remain effective or otherwise condition or restrict
the assurance.
(d) Certification is required when the research is supported by a
Federal department or agency and not otherwise waived under Sec.
2558.101(i) or exempted under Sec. 2558.104. For such research,
institutions shall certify that each proposed research study covered by
the assurance and this section has been reviewed and approved by the
IRB. Such certification must be submitted as prescribed by the Federal
department or agency component supporting the research. Under no
condition shall research covered by this section be initiated prior to
receipt of the certification that the research has been reviewed and
approved by the IRB.
(e) For nonexempt research involving human subjects covered by this
policy (or exempt research for which limited IRB review takes place
pursuant to Sec. 2558.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), or (d)(8))
that takes place at an institution in which IRB oversight is conducted
by an IRB that is not operated by the institution, the institution and
the organization operating the IRB shall document the institution's
reliance on the IRB for oversight of the research and the
responsibilities that each entity will undertake to ensure compliance
with the requirements of this policy (e.g., in a written agreement
between the institution and the IRB, by implementation of an
institution-wide policy directive providing the allocation of
responsibilities between the institution and an IRB that is not
affiliated with the institution, or as set forth in a research
protocol).
Sec. 2558.104 Exempt research.
(a) Unless otherwise required by law or by the department or agency
head, research activities in which the only involvement of human
subjects will be in one or more of the categories in paragraph (d) of
this section are exempt from the requirements of this policy, except
that such activities must comply with the requirements of this section
and as specified in each category.
(b) Use of the exemption categories for research subject to the
requirements of subparts B, C, and D. Application of the exemption
categories to research subject to the requirements of 45 CFR part 46,
subparts B, C, and D, is as follows:
(1) Subpart B. Each of the exemptions at this section may be
applied to research subject to Subpart B if the conditions of the
exemption are met.
(2) Subpart C. The exemptions at this section do not apply to
research subject to Subpart C, except for research aimed at involving a
broader subject population that only incidentally includes prisoners.
(3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6),
(7), and (8) of this section may be applied to research subject to
Subpart D if the conditions of the exemption are met. Paragraphs
(d)(2)(i) and (ii) of this section only may apply to research subject
to Subpart D involving educational tests or the observation of public
behavior when the investigator(s) do not participate in the activities
being observed. Paragraph (d)(2)(iii) of this section may not be
applied to research subject to Subpart D.
(c) [Reserved.]
(d) Except as described in paragraph (a) of this section, the
following categories of human subjects research are exempt from this
policy:
(1) Research, conducted in established or commonly accepted
educational settings, that specifically involves normal educational
practices that are not likely to adversely impact students' opportunity
to learn required educational content or the assessment of educators
who provide instruction. This includes most research on regular and
special education instructional strategies, and research on the
effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
(2) Research that only includes interactions involving educational
tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior
(including visual or auditory recording) if at least one of the
following criteria is met:
(i) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects cannot readily be
ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects' responses outside the
research would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial standing,
employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects can readily be
ascertained, directly or through identifiers linked to the subjects,
and an IRB conducts a
[[Page 57441]]
limited IRB review to make the determination required by Sec.
2558.111(a)(7).
(3) (i) Research involving benign behavioral interventions in
conjunction with the collection of information from an adult subject
through verbal or written responses (including data entry) or
audiovisual recording if the subject prospectively agrees to the
intervention and information collection and at least one of the
following criteria is met:
(A) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects cannot readily be
ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects' responses outside the
research would not reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial standing,
employability, educational advancement, or reputation; or
(C) The information obtained is recorded by the investigator in
such a manner that the identity of the human subjects can readily be
ascertained, directly or through identifiers linked to the subjects,
and an IRB conducts a limited IRB review to make the determination
required by Sec. 2558.111(a)(7).
(ii) For the purpose of this provision, benign behavioral
interventions are brief in duration, harmless, painless, not physically
invasive, not likely to have a significant adverse lasting impact on
the subjects, and the investigator has no reason to think the subjects
will find the interventions offensive or embarrassing. Provided all
such criteria are met, examples of such benign behavioral interventions
would include having the subjects play an online game, having them
solve puzzles under various noise conditions, or having them decide how
to allocate a nominal amount of received cash between themselves and
someone else.
(iii) If the research involves deceiving the subjects regarding the
nature or purposes of the research, this exemption is not applicable
unless the subject authorizes the deception through a prospective
agreement to participate in research in circumstances in which the
subject is informed that he or she will be unaware of or misled
regarding the nature or purposes of the research.
(4) Secondary research for which consent is not required: Secondary
research uses of identifiable private information or identifiable
biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable
biospecimens are publicly available;
(ii) Information, which may include information about biospecimens,
is recorded by the investigator in such a manner that the identity of
the human subjects cannot readily be ascertained directly or through
identifiers linked to the subjects, the investigator does not contact
the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and
analysis involving the investigator's use of identifiable health
information when that use is regulated under 45 CFR parts 160 and 164,
subparts A and E, for the purposes of ``health care operations'' or
``research'' as those terms are defined at 45 CFR 164.501 or for
``public health activities and purposes'' as described under 45 CFR
164.512(b); or
(iv) The research is conducted by, or on behalf of, a Federal
department or agency using government-generated or government-collected
information obtained for nonresearch activities, if the research
generates identifiable private information that is or will be
maintained on information technology that is subject to and in
compliance with section 208(b) of the E-Government Act of 2002, 44
U.S.C. 3501 note, if all of the identifiable private information
collected, used, or generated as part of the activity will be
maintained in systems of records subject to the Privacy Act of 1974, 5
U.S.C. 552a, and, if applicable, the information used in the research
was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C.
3501 et seq.
(5) Research and demonstration projects that are conducted or
supported by a Federal department or agency, or otherwise subject to
the approval of the department or agency head (or the approval of the
heads of bureaus or other subordinate agencies that have been delegated
authority to conduct the research and demonstration projects), and that
are designed to study, evaluate, improve, or otherwise examine public
benefit or service programs, including 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. Such projects include, but are not limited to, internal
studies by Federal employees, and studies under contracts or consulting
arrangements, cooperative agreements, or grants. Exempt projects also
include waivers of otherwise mandatory requirements using authorities
such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the
research and demonstration projects must establish, on a publicly
accessible Federal website or in such other manner as the department or
agency head may determine, a list of the research and demonstration
projects that the Federal department or agency conducts or supports
under this provision. The research or demonstration project must be
published on this list prior to commencing the research involving human
subjects.
(ii) [Reserved]
(6) Taste and food quality evaluation and consumer acceptance
studies:
(i) If wholesome foods without additives are consumed, or
(ii) If a food is consumed that contains a food ingredient at or
below the level and for a use found to be safe, or agricultural
chemical or environmental contaminant at or below the level found to be
safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection
Service of the U.S. Department of Agriculture.
(7) Storage or maintenance for secondary research for which broad
consent is required: Storage or maintenance of identifiable private
information or identifiable biospecimens for potential secondary
research use if an IRB conducts a limited IRB review and makes the
determinations required by Sec. 46.111(a)(8).
(8) Secondary research for which broad consent is required:
Research involving the use of identifiable private information or
identifiable biospecimens for secondary research use, if the following
criteria are met:
(i) Broad consent for the storage, maintenance, and secondary
research use of the identifiable private information or identifiable
biospecimens was obtained in accordance with Sec. 46.116(a)(1) through
(4), (a)(6), and (d);
(ii) Documentation of informed consent or waiver of documentation
of consent was obtained in accordance with Sec. 46.117;
(iii) An IRB conducts a limited IRB review and makes the
determination required by Sec. 46.111(a)(7) and makes the
determination that the research to be conducted is within the scope of
the broad consent referenced in paragraph (d)(8)(i) of this section;
and
(iv) The investigator does not include returning individual
research results to subjects as part of the study plan. This provision
does not prevent an
[[Page 57442]]
investigator from abiding by any legal requirements to return
individual research results.
Sec. 2558.105 [Reserved]
Sec. 2558.106 [Reserved]
Sec. 2558.107 IRB membership.
(a) Each IRB shall have at least five members, with varying
backgrounds to promote complete and adequate review of research
activities commonly conducted by the institution. The IRB shall be
sufficiently qualified through the experience and expertise of its
members (professional competence), and the diversity of its members,
including race, gender, and cultural backgrounds and sensitivity to
such issues as community attitudes, to promote respect for its advice
and counsel in safeguarding the rights and welfare of human subjects.
The IRB shall be able to ascertain the acceptability of proposed
research in terms of institutional commitments (including policies and
resources) and regulations, applicable law, and standards of
professional conduct and practice. The IRB shall therefore include
persons knowledgeable in these areas. If an IRB regularly reviews
research that involves a category of subjects that is vulnerable to
coercion or undue influence, such as children, prisoners, individuals
with impaired decision-making capacity, or economically or
educationally disadvantaged persons, consideration shall be given to
the inclusion of one or more individuals who are knowledgeable about
and experienced in working with these categories of subjects.
(b) Each IRB shall include at least one member whose primary
concerns are in scientific areas and at least one member whose primary
concerns are in nonscientific areas.
(c) Each IRB shall include at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate
family of a person who is affiliated with the institution.
(d) No IRB may have a member participate in the IRB's initial or
continuing review of any project in which the member has a conflicting
interest, except to provide information requested by the IRB.
(e) An IRB may, in its discretion, invite individuals with
competence in special areas to assist in the review of issues that
require expertise beyond or in addition to that available on the IRB.
These individuals may not vote with the IRB.
Sec. 2558.108 IRB functions and operations.
(a) In order to fulfill the requirements of this policy each IRB
shall:
(1) Have access to meeting space and sufficient staff to support
the IRB's review and recordkeeping duties;
(2) Prepare and maintain a current list of the IRB members
identified by name; earned degrees; representative capacity;
indications of experience such as board certifications or licenses
sufficient to describe each member's chief anticipated contributions to
IRB deliberations; and any employment or other relationship between
each member and the institution, for example, full-time employee, part-
time employee, member of governing panel or board, stockholder, paid or
unpaid consultant;
(3) Establish and follow written procedures for:
(i) Conducting its initial and continuing review of research and
for reporting its findings and actions to the investigator and the
institution;
(ii) Determining which projects require review more often than
annually and which projects need verification from sources other than
the investigators that no material changes have occurred since previous
IRB review; and
(iii) Ensuring prompt reporting to the IRB of proposed changes in a
research activity, and for ensuring that investigators will conduct the
research activity in accordance with the terms of the IRB approval
until any proposed changes have been reviewed and approved by the IRB,
except when necessary to eliminate apparent immediate hazards to the
subject.
(4) Established and follow written procedures for ensuring prompt
reporting to the IRB; appropriate institutional officials; the
department or agency head; and the Office for Human Research
Protections, HHS, or any successor office, or the equivalent office
within the appropriate Federal department or agency of
(i) Any unanticipated problems involving risks to subjects or
others or any serious or continuing noncompliance with this policy or
the requirements or determinations of the IRB; and
(ii) Any suspension or termination of IRB approval
(b) Except when an expedited review procedure is used (as described
in Sec. 2558.110), an IRB must review proposed research at convened
meetings at which a majority of the members of the IRB are present,
including at least one member whose primary concerns are in
nonscientific areas. In order for the research to be approved, it shall
receive the approval of a majority of those members present at the
meeting.
Sec. 2558.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all research
activities covered by this policy, including exempt research activities
under Sec. 2258.104 for which limited IRB review is a condition of
exemption (under Sec. 2558.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), and
(d)(8)).
(b) An IRB shall require that information given to subjects (or
legally authorized representatives, when appropriate) as part of
informed consent is in accordance with Sec. 2558.116. The IRB may
require that information, in addition to that specifically mentioned in
Sec. 2558.116, be given to the subjects when in the IRB's judgment the
information would meaningfully add to the protection of the rights and
welfare of subjects.
(c) An IRB shall require documentation of informed consent or may
waive documentation in accordance with Sec. 2558.117.
(d) An IRB shall notify investigators and the institution in
writing of its decision to approve or disapprove the proposed research
activity, or of modifications required to secure IRB approval of the
research activity. If the IRB decides to disapprove a research
activity, it shall include in its written notification a statement of
the reasons for its decision and give the investigator an opportunity
to respond in person or in writing.
(e) An IRB shall conduct continuing review of research requiring
review by the convened IRB at intervals appropriate to the degree of
risk, not less than once per year, except as described in Sec.
2558.109(f).
(f)(1) Unless an IRB determines otherwise, continuing review of
research is not required in the following circumstances:
(i) Research eligible for expedited review in accordance with Sec.
2558.110;
(ii) Research reviewed by the IRB in accordance with the limited
IRB review described in Sec. 2558.104(d)(2)(iii), (d)(3)(i)(C),
(d)(7), or (d)(8);
(iii) Research that has progressed to the point that it involves
only one or both of the following, which are part of the IRB-approved
study:
(A) Data analysis, including analysis of identifiable private
information or identifiable biospecimens, or
(B) Accessing follow-up clinical data from procedures that subjects
would undergo as part of clinical care.
(2) [Reserved.]
[[Page 57443]]
(g) An IRB shall have authority to observe or have a third party
observe the consent process and the research.
Sec. 2558.110 Expedited review procedures for certain kinds of
research involving no more than minimal risk, and for minor changes in
approved research.
(a) The Secretary of HHS has established, and published as a Notice
in the Federal Register, a list of categories of research that may be
reviewed by the IRB through an expedited review procedure. The
Secretary will evaluate the list at least every 8 years and amend it,
as appropriate, after consultation with other federal departments and
agencies and after publication in the Federal Register for public
comment. A copy of the list is available from the Office for Human
Research Protections, HHS, or any successor office.
(b)(1) An IRB may use the expedited review procedure to review the
following:
(i) Some or all of the research appearing on the list described in
paragraph (a) of this section, unless the reviewer determines that the
study involves more than minimal risk;
(ii) Minor changes in previously approved research during the
period for which approval is authorized; or
(iii) Research for which limited IRB review is a condition of
exemption under Sec. 2558.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and
(d)(8)
(2) Under an expedited review procedure, the review may be carried
out by the IRB chairperson or by one or more experienced reviewers
designated by the chairperson from among members of the IRB. In
reviewing the research, the reviewers may exercise all of the
authorities of the IRB except that the reviewers may not disapprove the
research. A research activity may be disapproved only after review in
accordance with the non-expedited procedure set forth in. Sec.
2558.108(b)
(c) Each IRB that uses an expedited review procedure shall adopt a
method for keeping all members advised of research proposals that have
been approved under the procedure.
(d) The department or agency head may restrict, suspend, terminate,
or choose not to authorize an institution's or IRB's use of the
expedited review procedure.
Sec. 2258.111 Criteria for IRB approval of research.
(a) In order to approve research covered by this policy the IRB
shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized:
(i) By using procedures that are consistent with sound research
design and that do not unnecessarily expose subjects to risk, and
(ii) Whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects, and the importance of the knowledge that
may reasonably be expected to result. In evaluating risks and benefits,
the IRB should consider only those risks and benefits that may result
from the research (as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the
research). The IRB should not consider possible long-range effects of
applying knowledge gained in the research (e.g., the possible effects
of the research on public policy) as among those research risks that
fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment
the IRB should take into account the purposes of the research and the
setting in which the research will be conducted. The IRB should be
particularly cognizant of the special problems of research that
involves a category of subjects who are vulnerable to coercion or undue
influence, such as children, prisoners, individuals with impaired
decision-making capacity, or economically or educationally
disadvantaged persons.
(4) Informed consent will be sought from each prospective subject
or the subject's legally authorized representative, in accordance with,
and to the extent required by, Sec. 2558.116.
(5) Informed consent will be appropriately documented or
appropriately waived in accordance with Sec. 2558.117.
(6) When appropriate, the research plan makes adequate provision
for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
(i) The Secretary of HHS will, after consultation with the Office
of Management and Budget's privacy office and other Federal departments
and agencies that have adopted this policy, issue guidance to assist
IRBs in assessing what provisions are adequate to protect the privacy
of subjects and to maintain the confidentiality of data.
(ii) [Reserved.]
(8) For purposes of conducting the limited IRB review required by
Sec. 2558.104(d)(7)), the IRB need not make the determinations at
paragraphs (a)(1) through (7) of this section, and shall make the
following determinations:
(i) Broad consent for storage, maintenance, and secondary research
use of identifiable private information or identifiable biospecimens is
obtained in accordance with the requirements of Sec. 2558.116(a)(1)-
(4), (a)(6), and (d);
(ii) Broad consent is appropriately documented or waiver of
documentation is appropriate, in accordance with Sec. 2558.117; and
(iii) If there is a change made for research purposes in the way
the identifiable private information or identifiable biospecimens are
stored or maintained, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects are likely to be vulnerable to
coercion or undue influence, such as children, prisoners, individuals
with impaired decision-making capacity, or economically or
educationally disadvantaged persons, additional safeguards have been
included in the study to protect the rights and welfare of these
subjects.
Sec. 2558.112 Review by Institution.
Research covered by this policy that has been approved by an IRB
may be subject to further appropriate review and approval or
disapproval by officials of the institution. However, those officials
may not approve the research if it has not been approved by an IRB.
Sec. 2258.113 Suspension or Termination of IRB Approval of Research.
An IRB shall have authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's
requirements or that has been associated with unexpected serious harm
to subjects. Any suspension or termination of approval shall include a
statement of the reasons for the IRB's action and shall be reported
promptly to the investigator, appropriate institutional officials, and
the department or agency head.
Sec. 2558.114 Cooperative Research.
(a) Cooperative research projects are those projects covered by
this policy that involve more than one institution. In the conduct of
cooperative research projects, each institution is responsible for
safeguarding the rights and welfare of human subjects and for complying
with this policy.
(b)(1) Any institution located in the United States that is engaged
in cooperative research must rely upon approval by a single IRB for
that portion
[[Page 57444]]
of the research that is conducted in the United States. The reviewing
IRB will be identified by the Federal department or agency supporting
or conducting the research or proposed by the lead institution subject
to the acceptance of the Federal department or agency supporting the
research.
(2) The following research is not subject to this provision:
(i) Cooperative research for which more than single IRB review is
required by law (including tribal law passed by the official governing
body of an American Indian or Alaska Native tribe); or
(ii) Research for which any Federal department or agency supporting
or conducting the research determines and documents that the use of a
single IRB is not appropriate for the particular context.
(c) For research not subject to paragraph (b) of this section, an
institution participating in a cooperative project may enter into a
joint review arrangement, rely on the review of another IRB, or make
similar arrangements for avoiding duplication of effort.
Sec. 2558.115 IRB Records.
(a) An institution, or when appropriate an IRB, shall prepare and
maintain adequate documentation of IRB activities, including the
following:
(1) Copies of all research proposals reviewed, scientific
evaluations, if any, that accompany the proposals, approved sample
consent forms, progress reports submitted by investigators, and reports
of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to
show attendance at the meetings; actions taken by the IRB; the vote on
these actions including the number of members voting for, against, and
abstaining; the basis for requiring changes in or disapproving
research; and a written summary of the discussion of controverted
issues and their resolution.
(3) Records of continuing review activities, including the
rationale for conducting continuing review of research that otherwise
would not require continuing review as described in Sec.
2558.109(f)(1).
(4) Copies of all correspondence between the IRB and the
investigators.
(5) A list of IRB members in the same detail as described in Sec.
2558.108(a)(2).
(6) Written procedures for the IRB in the same detail as described
in Sec. 2558.108(a)(3) and (4).
(7) Statements of significant new findings provided to subjects, as
required by Sec. 2558.116(c)(5).
(8) The rationale for an expedited reviewer's determination under
Sec. 2558.110(b)(1)(i) that research appearing on the expedited review
list described in Sec. 2558.110(a) is more than minimal risk.
(9) Documentation specifying the responsibilities that an
institution and an organization operating an IRB each will undertake to
ensure compliance with the requirements of this policy, as described in
Sec. 2558.103(e).
(b) The records required by this policy shall be retained for at
least 3 years, and records relating to research that is conducted shall
be retained for at least 3 years after completion of the research. The
institution or IRB may maintain the records in printed form, or
electronically. All records shall be accessible for inspection and
copying by authorized representatives of the Federal department or
agency at reasonable times and in a reasonable manner.
Sec. 2558.116 General Requirements for Informed Consent.
(a) General. General requirements for informed consent, whether
written or oral, are set forth in this paragraph and apply to consent
obtained in accordance with the requirements set forth in paragraphs
(b) through (d) of this section. Broad consent may be obtained in lieu
of informed consent obtained in accordance with paragraphs (b) and (c)
of this section only with respect to the storage, maintenance, and
secondary research uses of identifiable private information and
identifiable biospecimens. Waiver or alteration of consent in research
involving public benefit and service programs conducted by or subject
to the approval of state or local officials is described in paragraph
(e) of this section. General waiver or alteration of informed consent
is described in paragraph (f) of this section. Except as provided
elsewhere in this policy:
(1) Before involving a human subject in research covered by this
policy, an investigator shall obtain the legally effective informed
consent of the subject or the subject's legally authorized
representative.
(2) An investigator shall seek informed consent only under
circumstances that provide the prospective subject or the legally
authorized representative sufficient opportunity to discuss and
consider whether or not to participate and that minimize the
possibility of coercion or undue influence.
(3) The information that is given to the subject or the legally
authorized representative shall be in language understandable to the
subject or the legally authorized representative.
(4) The prospective subject or the legally authorized
representative must be provided with the information that a reasonable
person would want to have in order to make an informed decision about
whether to participate, and an opportunity to discuss that information.
(5) Except for broad consent obtained in accordance with paragraph
(d) of this section:
(i) Informed consent must begin with a concise and focused
presentation of the key information that is most likely to assist a
prospective subject or legally authorized representative in
understanding the reasons why one might or might not want to
participate in the research. This part of the informed consent must be
organized and presented in a way that facilitates comprehension.
(ii) Informed consent as a whole must present information in
sufficient detail relating to the research, and must be organized and
presented in a way that does not merely provide lists of isolated
facts, but rather facilitates the prospective subject's or legally
authorized representative's understanding of the reasons why one might
or might not want to participate.
(6) No informed consent may include any exculpatory language
through which the subject or the legally authorized representative is
made to waive or appear to waive any of the subject's legal rights, or
releases or appears to release the investigator, the sponsor, the
institution, or its agents from liability for negligence.
(b) Basic elements of informed consent. Except as provided in
paragraph (d), (e), or (f) of this section, in seeking informed consent
the following information shall be provided to each subject or the
legally authorized representative:
(1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and
identification of any procedures that are experimental;
(2) A description of any reasonably foreseeable risks or
discomforts to the subject;
(3) A description of any benefits to the subject or to others that
may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which
confidentiality of
[[Page 57445]]
records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation
as to whether any compensation and an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they
consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom to
contact in the event of a research-related injury to the subject;
(8) A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled; and
(9) One of the following statements about any research that
involves the collection of identifiable private information or
identifiable biospecimens:
(i) A statement that 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 this might be a
possibility; or
(ii) A statement that the subject's information or biospecimens
collected as part of the research, even if identifiers are removed,
will not be used or distributed for future research studies.
(c) Additional elements of informed consent. Except as provided in
paragraph (d), (e), or (f) of this section, one or more of the
following elements of information, when appropriate, shall also be
provided to each subject or the legally authorized representative:
(1) A statement that the particular treatment or procedure may
involve risks to the subject (or to the embryo or fetus, if the subject
is or may become pregnant) that are currently unforeseeable;
(2) Anticipated circumstances under which the subject's
participation may be terminated by the investigator without regard to
the subject's or the legally authorized representative's consent;
(3) Any additional costs to the subject that may result from
participation in the research;
(4) The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by the
subject;
(5) A statement that significant new findings developed during the
course of the research that may relate to the subject's willingness to
continue participation will be provided to the subject;
(6) The approximate number of subjects involved in the study;
(7) A statement that the subject's biospecimens (even if
identifiers are removed) may be used for commercial profit and whether
the subject will or will not share in this commercial profit;
(8) A statement regarding whether clinically relevant research
results, including individual research results, will be disclosed to
subjects, and if so, under what conditions; and
(9) For research involving biospecimens, whether the research will
(if known) or might include whole genome sequencing (i.e., sequencing
of a human germline or somatic specimen with the intent to generate the
genome or exome sequence of that specimen).
(d) Elements of broad consent for the storage, maintenance, and
secondary research use of identifiable private information or
identifiable biospecimens. Broad consent for the storage, maintenance,
and secondary research use of identifiable private information or
identifiable biospecimens (collected for either research studies other
than the proposed research or nonresearch purposes) is permitted as an
alternative to the informed consent requirements in paragraphs (b) and
(c) of this section. If the subject or the legally authorized
representative is asked to provide broad consent, the following shall
be provided to each subject or the subject's legally authorized
representative:
(1) The information required in paragraphs (b)(2), (b)(3), (b)(5),
and (b)(8) and, when appropriate, (c)(7) and (9) of this section;
(2) A general description of the types of research that may be
conducted with the identifiable private information or identifiable
biospecimens. This description must include sufficient information such
that a reasonable person would expect that the broad consent would
permit the types of research conducted;
(3) A description of the identifiable private information or
identifiable biospecimens that might be used in research, whether
sharing of identifiable private information or identifiable
biospecimens might occur, and the types of institutions or researchers
that might conduct research with the identifiable private information
or identifiable biospecimens;
(4) A description of the period of time that the identifiable
private information or identifiable biospecimens may be stored and
maintained (which period of time could be indefinite), and a
description of the period of time that the identifiable private
information or identifiable biospecimens may be used for research
purposes (which period of time could be indefinite);
(5) Unless the subject or legally authorized representative will be
provided details about specific research studies, a statement that they
will not be informed of the details of any specific research studies
that might be conducted using the subject's identifiable private
information or identifiable biospecimens, including the purposes of the
research, and that they might have chosen not to consent to some of
those specific research studies;
(6) Unless it is known that clinically relevant research results,
including individual research results, will be disclosed to the subject
in all circumstances, a statement that such results may not be
disclosed to the subject; and
(7) An explanation of whom to contact for answers to questions
about the subject's rights and about storage and use of the subject's
identifiable private information or identifiable biospecimens, and whom
to contact in the event of a research-related harm.
(e) Waiver or alteration of consent in research involving public
benefit and service programs conducted by or subject to the approval of
state or local officials.
(1) Waiver. An IRB may waive the requirement to obtain informed
consent for research under paragraphs (a) through (c) of this section,
provided the IRB satisfies the requirements of paragraph (e)(3) of this
section. If an individual was asked to provide broad consent for the
storage, maintenance, and secondary research use of identifiable
private information or identifiable biospecimens in accordance with the
requirements at paragraph (d) of this section, and refused to consent,
an IRB cannot waive consent for the storage, maintenance, or secondary
research use of the identifiable private information or identifiable
biospecimens.
(2) Alteration. An IRB may approve a consent procedure that omits
some, or alters some or all, of the elements of informed consent set
forth in paragraphs (b) and (c) of this section provided the IRB
satisfies the requirements of paragraph (e)(3) of this section. An IRB
may not omit or alter any of the requirements described in paragraph
(a) of this section. If a broad consent
[[Page 57446]]
procedure is used, an IRB may not omit or alter any of the elements
required under paragraph (d) of this section.
(3) Requirements for waiver and alteration. In order for an IRB to
waive or alter consent as described in this subsection, the IRB must
find and document that:
(i) The research or demonstration project is to be conducted by or
subject to the approval of state or local government officials and is
designed to study, evaluate, or otherwise examine:
(A) Public benefit or service programs;
(B) Procedures for obtaining benefits or services under those
programs;
(C) Possible changes in or alternatives to those programs or
procedures; or
(D) Possible changes in methods or levels of payment for benefits
or services under those programs; and
(ii) The research could not practicably be carried out without the
waiver or alteration.
(f) General waiver or alteration of consent.
(1) Waiver. An IRB may waive the requirement to obtain informed
consent for research under paragraphs (a) through (c) of this section,
provided the IRB satisfies the requirements of paragraph (f)(3) of this
section. If an individual was asked to provide broad consent for the
storage, maintenance, and secondary research use of identifiable
private information or identifiable biospecimens in accordance with the
requirements at paragraph (d) of this section, and refused to consent,
an IRB cannot waive consent for the storage, maintenance, or secondary
research use of the identifiable private information or identifiable
biospecimens.
(2) Alteration. An IRB may approve a consent procedure that omits
some, or alters some or all, of the elements of informed consent set
forth in paragraphs (b) and (c) of this section provided the IRB
satisfies the requirements of paragraph (f)(3) of this section. An IRB
may not omit or alter any of the requirements described in paragraph
(a) of this section. If a broad consent procedure is used, an IRB may
not omit or alter any of the elements required under paragraph (d) of
this section.
(3) Requirements for waiver and alteration. In order for an IRB to
waive or alter consent as described in this subsection, the IRB must
find and document that:
(i) The research involves no more than minimal risk to the
subjects;
(ii) The research could not practicably be carried out without the
requested waiver or alteration;
(iii) If the research involves using identifiable private
information or identifiable biospecimens, the research could not
practicably be carried out without using such information or
biospecimens in an identifiable format;
(iv) The waiver or alteration will not adversely affect the rights
and welfare of the subjects; and
(v) Whenever appropriate, the subjects or legally authorized
representatives will be provided with additional pertinent information
after participation.
(g) Screening, recruiting, or determining eligibility. An IRB may
approve a research proposal in which an investigator will obtain
information or biospecimens for the purpose of screening, recruiting,
or determining the eligibility of prospective subjects without the
informed consent of the prospective subject or the subject's legally
authorized representative, if either of the following conditions are
met:
(1) The investigator will obtain information through oral or
written communication with the prospective subject or legally
authorized representative, or
(2) The investigator will obtain identifiable private information
or identifiable biospecimens by accessing records or stored
identifiable biospecimens.
(h) Posting of clinical trial consent form
(1) For each clinical trial conducted or supported by a Federal
department or agency, one IRB-approved informed consent form used to
enroll subjects must be posted by the awardee or the Federal department
or agency component conducting the trial on a publicly available
Federal website that will be established as a repository for such
informed consent forms.
(2) If the Federal department or agency supporting or conducting
the clinical trial determines that certain information should not be
made publicly available on a Federal website (e.g., confidential
commercial information), such Federal department or agency may permit
or require redactions to the information posted.
(3) The informed 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.
(i) Preemption. The informed consent requirements in this policy
are not intended to 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.
(j) Emergency medical care. 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).
Sec. 2558.117 Documentation of informed consent.
(a) Except as provided in paragraph (c) of this section, informed
consent shall be documented by the use of a written informed consent
form approved by the IRB and signed (including in an electronic format)
by the subject or the subject's legally authorized representative. A
written copy shall be given to the person signing the informed consent
form.
(b) Except as provided in paragraph (c) of this section, the
informed consent form may be either of the following:
(1) A written informed consent form that meets the requirements of
Sec. 2558.116. The investigator shall give either the subject or the
subject's legally authorized representative adequate opportunity to
read the informed consent form before it is signed; alternatively, this
form may be read to the subject or the subject's legally authorized
representative.
(2) A short form written informed consent form stating that the
elements of informed consent required by Sec. 2558.116 have been
presented orally to the subject or the subject's legally authorized
representative, and that the key information required by Sec.
2558.116(a)(5)(i) was presented first to the subject, before other
information, if any, was provided. The IRB shall approve a written
summary of what is to be said to the subject or the legally authorized
representative. When this method is used, there shall be a witness to
the oral presentation. Only the short form itself is to be signed by
the subject or the subject's legally authorized representative.
However, the witness shall sign both the short form and a copy of the
summary, and the person actually obtaining consent shall sign a copy of
the summary. A copy of the summary shall be given to the subject or the
subject's legally authorized representative, in addition to a copy of
the short form.
(c)(1) An IRB may waive the requirement for the investigator to
obtain a signed informed consent form for some or all subjects if it
finds any of the following:
[[Page 57447]]
(i) That the only record linking the subject and the research would
be the informed consent form and the principal risk would be potential
harm resulting from a breach of confidentiality. Each subject (or
legally authorized representative) will be asked whether the subject
wants documentation linking the subject with the research, and the
subject's wishes will govern;
(ii) That the research presents no more than minimal risk of harm
to subjects and involves no procedures for which written consent is
normally required outside of the research context; or
(iii) If the subjects or legally authorized representatives are
members of a distinct cultural group or community in which signing
forms is not the norm, that the research presents no more than minimal
risk of harm to subjects and provided there is an appropriate
alternative mechanism for documenting that informed consent was
obtained.
(2) In cases in which the documentation requirement is waived, the
IRB may require the investigator to provide subjects or legally
authorized representatives with a written statement regarding the
research.
Sec. 2558.118 Applications and proposals lacking definite plans for
involvement of human subjects.
Certain types of applications for grants, cooperative agreements,
or contracts are submitted to Federal departments or agencies with the
knowledge that subjects may be involved within the period of support,
but definite plans would not normally be set forth in the application
or proposal. These include activities such as institutional type grants
when selection of specific projects is the institution's
responsibility; research training grants in which the activities
involving subjects remain to be selected; and projects in which human
subjects' involvement will depend upon completion of instruments, prior
animal studies, or purification of compounds. Except for research
waived under Sec. 2558.101(i) or exempted under Sec. 2558.104, no
human subjects may be involved in any project supported by these awards
until the project has been reviewed and approved by the IRB, as
provided in this policy, and certification submitted, by the
institution, to the Federal department or agency component supporting
the research.
Sec. 2558.119 Research undertaken without the intention of involving
human subjects.
Except for research waived under Sec. 2558.101(i) or exempted
under Sec. 2558.104, in the event research is undertaken without the
intention of involving human subjects, but it is later proposed to
involve human subjects in the research, the research shall first be
reviewed and approved by an IRB, as provided in this policy, a
certification submitted by the institution to the Federal department or
agency component supporting the research, and final approval given to
the proposed change by the Federal department or agency component.
Sec. 2558.120 Evaluation and disposition of applications and
proposals for research to be conducted or supported by a Federal
department or agency.
(a) The department or agency head will evaluate all applications
and proposals involving human subjects submitted to the Federal
department or agency through such officers and employees of the Federal
department or agency and such experts and consultants as the department
or agency head determines to be appropriate. This evaluation will take
into consideration the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research
to the subjects and others, and the importance of the knowledge gained
or to be gained.
(b) On the basis of this evaluation, the department or agency head
may approve or disapprove the application or proposal, or enter into
negotiations to develop an approvable one.
Sec. 2558.121 [Reserved]
Sec. 2558.122 Use of Federal funds.
Federal funds administered by a Federal department or agency may
not be expended for research involving human subjects unless the
requirements of this policy have been satisfied.
Sec. 2558.123 Early termination of research support: Evaluation of
applications and proposals.
(a) The department or agency head may require that Federal
department or agency support for any project be terminated or suspended
in the manner prescribed in applicable program requirements, when the
department or agency head finds an institution has materially failed to
comply with the terms of this policy.
(b) In making decisions about supporting or approving applications
or proposals covered by this policy the department or agency head may
take into account, in addition to all other eligibility requirements
and program criteria, factors such as whether the applicant has been
subject to a termination or suspension under paragraph (a) of this
section and whether the applicant or the person or persons who would
direct or has/have directed the scientific and technical aspects of an
activity has/have, in the judgment of the department or agency head,
materially failed to discharge responsibility for the protection of the
rights and welfare of human subjects (whether or not the research was
subject to federal regulation).
Sec. 2558.124 Conditions.
With respect to any research project or any class of research
projects the department or agency head of either the conducting or
supporting Federal department or agency may impose additional
conditions prior to or at the time of approval when in the judgment of
the department or agency head additional conditions are necessary for
the protection of human subjects.
Fernando Laguarda,
General Counsel.
[FR Doc. 2022-20223 Filed 9-19-22; 8:45 am]
BILLING CODE 6050-28-P
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</html>Indexed from Federal Register on September 20, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.