Protection of Human Subjects, 57435-57447 [2022-20223]

Agencies

• Corporation for National and Community Service

[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 [www.gpo.gov]
[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 
www.regulations.gov. You may also send your comments to Elizabeth 
Appel, Associate General Counsel, at [email protected] 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 [email protected].

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:
     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
     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

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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