Federal Register / Vol. 87, No. 181 / Tuesday, September 20, 2022 / Proposed Rules 57435 

■ 3. Amend § 770.99 by revising the 

introductory text and paragraphs (d)(5) 

and (6) to read as follows: 

§ 770.99 Incorporation by reference. 

Certain material is incorporated by 

reference into this part with the 

approval of the Director of the Federal 

Register in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. To enforce 

any edition other than that specified in 

this section, the Environmental 

Protection Agency (EPA) must publish a 

document in the Federal Register and 

the material must be available to the 

public. All approved incorporation by 

reference (IBR) material is available for 

inspection at the EPA and at the 

National Archives and Records 

Administration (NARA). Contact EPA 

at: OPPT Docket in the Environmental 

Protection Agency Docket Center (EPA/ 

DC), West William Jefferson Clinton 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW, Washington, DC. The EPA/DC 

Public Reading Room hours of operation 

are 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number of the 

EPA/DC Public Reading room is (202) 

566–1744, and the telephone number for 

the OPPT Docket is (202) 566–0280. For 

information on the availability of this 

material at NARA, email: fr.inspection@

nara.gov; website: www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

The material may be obtained from the 

following source(s): 

* * * * * 

(d) * * * 

(5) ANSI A208.1–2022, Particleboard, 

Approved June 22, 2022, IBR approved 

for § 770.3. 

(6) ANSI A208.2–2022, Medium 

Density Fiberboard (MDF) for Interior 

Applications, Approved April 14, 2022, 

IBR approved for § 770.3. 

[FR Doc. 2022–20043 Filed 9–19–22; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 eappel@

cns.gov 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 mhyde@cns.gov. 

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 nonexempt 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, 


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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 AmeriCorpsconducted 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, 


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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 foreignbased 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) 

§ 2558.101 To what does this policy apply? 

(a) Except as detailed in § 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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57438 Federal Register / Vol. 87, No. 181 / Tuesday, September 20, 2022 / Proposed Rules 

1The 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). 

2 Id. 

exercised consistent with the ethical 

principles of the Belmont Report.1

(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. 

(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 § 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 § 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 § 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 § 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 

§ 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 

§ 46.103(b), as related to the 

requirement for continuing review, and 

in addition to § 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. 

§ 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 


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Federal Register / Vol. 87, No. 181 / Tuesday, September 20, 2022 / Proposed Rules 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 


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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. 

§ 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 § 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 § 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 § 2558.101(i) or exempted 

under § 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 

§ 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). 

§ 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 


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limited IRB review to make the 

determination required by 

§ 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 

§ 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 

§ 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 § 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 § 46.117; 

(iii) An IRB conducts a limited IRB 

review and makes the determination 

required by § 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 


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investigator from abiding by any legal 

requirements to return individual 

research results. 

§ 2558.105 [Reserved] 

§ 2558.106 [Reserved] 

§ 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 decisionmaking 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. 

§ 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 

§ 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. 

§ 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 

§ 2258.104 for which limited IRB review 

is a condition of exemption (under 

§ 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 § 2558.116. The 

IRB may require that information, in 

addition to that specifically mentioned 

in § 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 § 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 § 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 § 2558.110; 

(ii) Research reviewed by the IRB in 

accordance with the limited IRB review 

described in § 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.] 


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(g) An IRB shall have authority to 

observe or have a third party observe the 

consent process and the research. 

§ 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 § 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. § 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. 

§ 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 longrange 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 decisionmaking 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, § 2558.116. 

(5) Informed consent will be 

appropriately documented or 

appropriately waived in accordance 

with § 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 

§ 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 

§ 2558.116(a)(1)–(4), (a)(6), and (d); 

(ii) Broad consent is appropriately 

documented or waiver of 

documentation is appropriate, in 

accordance with § 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. 

§ 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. 

§ 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. 

§ 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 

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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. 

§ 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 § 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 § 2558.108(a)(2). 

(6) Written procedures for the IRB in 

the same detail as described in 

§ 2558.108(a)(3) and (4). 

(7) Statements of significant new 

findings provided to subjects, as 

required by § 2558.116(c)(5). 

(8) The rationale for an expedited 

reviewer’s determination under 

§ 2558.110(b)(1)(i) that research 

appearing on the expedited review list 

described in § 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 § 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. 

§ 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 


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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 


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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). 

§ 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 

§ 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 

§ 2558.116 have been presented orally to 

the subject or the subject’s legally 

authorized representative, and that the 

key information required by 

§ 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: 


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(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. 

§ 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 

§ 2558.101(i) or exempted under 

§ 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. 

§ 2558.119 Research undertaken without 

the intention of involving human subjects. 

Except for research waived under 

§ 2558.101(i) or exempted under 

§ 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. 

§ 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. 

§ 2558.121 [Reserved] 

§ 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. 

§ 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). 

§ 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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 1 

[WT Docket No. 19–38; FCC 22–53; FR ID 

99880] 

Partition, Disaggregation, and Leasing 

of Spectrum 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule; request for 

comments. 

SUMMARY: In this document, a Second 

Further Notice of Proposed Rulemaking 

(Second FNPRM) seeks comment on 

whether potential future expansion of 

the Enhanced Competition Incentive 

Program (ECIP) for wireless services 

could further the Congressional goals set 

out in the Making Opportunities for 

Broadband Investment and Limiting 

Excessive and Needless Obstacles to 

Wireless Act (MOBILE NOW Act). It 

also proposes a framework for creating 

alternatives to population-based 

performance requirements for a variety 

of wireless radio service stakeholders 

with communications plans and 

business models not specifically 

targeted towards providing commercial 

wireless service to subscribers. It seeks 

specific comment on these proposals 

and a variety of alternatives to develop 


lotter on DSK11XQN23PROD with PROPOSALS1