Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 85867 

TABLE 4 TO PARAGRAPH (d)(1) 

Commodity Parts per 

million 

Barley, hay ............................ 0.40 

Barley, straw ......................... 0.40 

Buckwheat, fodder ................ 0.40 

Buckwheat, forage ................ 0.40 

Oat, forage ............................ 0.40 

Oat, hay ................................ 0.40 

Oat, straw ............................. 0.40 

Rye, forage ........................... 0.40 

Rye, straw ............................. 0.40 

Teosinte ................................ 0.40 

Triticale ................................. 0.40 

Wheat, forage ....................... 0.40 

Wheat, hay ........................... 0.40 

Wheat, straw ......................... 0.40 

(2) Tolerances are established for 

indirect or inadvertent residues of 

glufosinate-P, including its metabolites 

and degradates, in or on the 

commodities in table 5 to paragraph 

(d)(2), as a result of the application of 

glufosinate-P or glufosinate-Pammonium to crops listed in paragraph 

(a)(2) of this section. Compliance with 

the tolerance levels specified in table 5 

to paragraph (d)(2) is to be determined 

by measuring the sum of glufosinate (2- 

amino-4-(hydroxymethylphosphinyl) 

butanoic acid) and its metabolite, 3- 

(hydroxymethylphosphinyl) propanoic 

acid, expressed as 2-amino-4-(hydroxy

methylphosphinyl)butanoic acid 

equivalents.’’ 

TABLE 5 TO PARAGRAPH (d)(2) 

Commodity Parts per 

million 

Barley, hay ............................ 0.4 

Barley, straw ......................... 0.4 

Buckwheat, fodder ................ 0.4 

Buckwheat, forage ................ 0.4 

Oat, forage ............................ 0.4 

Oat, hay ................................ 0.4 

Oat, straw ............................. 0.4 

Rye, forage ........................... 0.4 

Rye, straw ............................. 0.4 

Teosinte ................................ 0.4 

Triticale ................................. 0.4 

Wheat, forage ....................... 0.4 

Wheat, hay ........................... 0.4 

Wheat, straw ......................... 0.4 

[FR Doc. 2024–24831 Filed 10–28–24; 8:45 am] 

BILLING CODE 6560–50–P 

CORPORATION FOR NATIONAL AND 

COMMUNITY SERVICE 

45 CFR Part 2584 

RIN 3045–AA60 

Protection of Human Subjects 

AGENCY: Corporation for National and 

Community Service. 

ACTION: Final rule. 

SUMMARY: The Corporation for National 

and Community Service (operating as 

AmeriCorps) is finalizing its adoption of 

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 making 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: This rule is effective on 

November 29, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Mary Hyde, Ph.D., Director, AmeriCorps 

Office of Research and Evaluation, at 

(202) 606–6834 or mhyde@

americorps.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. This Final Rule 

III. Comments on and Finalization of the 

Proposed Rule 

IV. Regulatory Analyses 

A. Executive Orders 12866 and 13563 

B. Regulatory Flexibility Act 

C. Unfunded Mandates Reform Act of 1995 

D. Paperwork Reduction Act 

E. Federalism (E.O. 13132) 

F. Takings (E.O. 12630) 

G. Civil Justice Reform (E.O. 12988) 

H. Consultation With Indian Tribes (E.O. 

13175) 

I. Background 

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 (82 

FR 7149), 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. 

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 subsequent amendments to the 

Common Rule; however, 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. This final rule 

provides the incentives of a mandatory 

procedural framework and provides 

human research subjects the assurance 

of protection offered by the Common 

Rule. 

II. Final Rule 

AmeriCorps is codifying the text of 

the revised Common Rule in its 

regulations at 45 CFR part 2584 (the 

proposed rule projected its placement at 

45 CFR part 2558, but AmeriCorps has 

since determined that part 2584 is more 

appropriate given a planned 

improvement of chapter 25’s 

organization). This rule is substantively 

identical to the HHS regulations in 45 

CFR part 46, subpart A, ensuring 

consistency across Federal agencies. 

With this 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. 


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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, 

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 the agency typically engages in 

practices such as ensuring that informed 

consent of human subjects is properly 

obtained and, when supporting research 

is conducted by universities and other 

research partners, ensuring that the 

research is reviewed and approved by 

an IRB. 

Issuance of this 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’ adoption of the Common 

Rule also provides assurance to 

individuals who are prospective and 

participating human research subjects 

for AmeriCorps-conducted or supported 

research that AmeriCorps abides by the 

same ethical and procedural provisions 

that HHS and 19 other agencies do. 

Finally, AmeriCorps’ adoption of the 

Common Rule will ensure consistency 

across agencies in their approach to 

protecting human subjects in research. 

III. Comments on and Finalization of 

the Proposed Rule 

AmeriCorps proposed adoption of the 

Common Rule on September 20, 2022, 

at 87 FR 57435 and invited public 

comment on the advisability or 

inadvisability of adopting the Common 

Rule in whole or in part. In response, 

AmeriCorps received seven public 

comments on the proposed rule, all of 

which expressed support for the rule. 

Several noted that the rule would 

provide a more standardized way of 

conducting ethical research to protect 

subjects from harm, following the same 

processes as the other Federal agencies 

that have adopted the common rule. 

Several also specifically expressed 

support for the requirement for 

informed consent. Several also 

specifically expressed support for IRB 

review. AmeriCorps has reviewed these 

comments and determined that it is 

appropriate to finalize the proposed rule 

without change, with one exception. 

The Agency is removing the provisions 

that transition research projects from the 

pre-2018 requirements to current 

requirements because the Agency has no 

pre-2018 requirements to transition 

away from. AmeriCorps is publishing 

this final rule after a delay of over a year 

because the Agency first finalized 

internal guidance to ensure compliance 

with the Common Rule before finalizing 

it. 

IV. 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 has 

determined that this is not a significant 

regulatory action and, therefore, was not 

subject to review under section 6(b) of 

E.O. 12866. 

B. Regulatory Flexibility Act 

As required by the Regulatory 

Flexibility Act of 1980 (5 U.S.C. 601 et 

seq.), AmeriCorps certifies that this rule 

does 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. 

C. 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. 

D. Paperwork Reduction Act 

Under the PRA, an agency may not 

conduct or sponsor a collection of 


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Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 85869 

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. 

information unless the collections of 

information display valid control 

numbers. The information collections in 

this rule at sections 2584.103, 2584.104, 

2584.108, 2584.109, 2584.113, and 

2584.115–2584.17 are approved by the 

Office of Management and Budget under 

Control Number 0990–0260. 

E. Federalism (E.O. 13132) 

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. 

F. Takings (E.O. 12630) 

This rule does not affect a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630 because this rule does not 

affect individual property rights 

protected by the Fifth Amendment or 

involve a compensable ‘‘taking.’’ A 

takings implication assessment is not 

required. 

G. Civil Justice Reform (E.O. 12988) 

This 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. 

H. 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 

rule does not impose substantial direct 

effects on federally recognized Tribes. 

List of Subjects in 45 CFR Part 2584 

Human research subjects, Reporting 

and recordkeeping requirements, 

Research. 

■ For the reasons stated in the preamble, 

the Corporation for National and 

Community Service amends title 45 of 

the Code of Federal Regulations by 

adding part 2584 to read as follows: 

PART 2584—PROTECTION OF HUMAN 

SUBJECTS 

Sec. 

2584.101 To what does this part apply? 

2584.102 Definitions for purposes of this 

part. 

2584.103 Assuring compliance with this 

part—research conducted or supported 

by any Federal department or agency. 

2584.104 Exempt research. 

2584.105–2584.106 [Reserved] 

2584.107 IRB membership. 

2584.108 IRB functions and operations. 

2584.109 IRB review of research. 

2584.110 Expedited review procedures for 

certain kinds of research involving no 

more than minimal risk, and for minor 

changes in approved research. 

2584.111 Criteria for IRB approval of 

research. 

2584.112 Review by institution. 

2584.113 Suspension or termination of IRB 

approval of research. 

2584.114 Cooperative research. 

2584.115 IRB records. 

2584.116 General requirements for 

informed consent. 

2584.117 Documentation of informed 

consent. 

2584.118 Applications and proposals 

lacking definite plans for involvement of 

human subjects. 

2584.119 Research undertaken without the 

intention of involving human subjects. 

2584.120 Evaluation and disposition of 

applications and proposals for research 

to be conducted or supported by a 

Federal department or agency. 

2584.121 [Reserved] 

2584.122 Use of Federal funds. 

2584.123 Early termination of research 

support: Evaluation of applications and 

proposals. 

2584.124 Conditions. 

Authority: 42 U.S.C. 12651c(c). 

§ 2584.101 To what does this part apply? 

(a) Except as detailed in § 2584.104, 

this part 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 part. 

(b) [Reserved] 

(c) Department or agency heads retain 

final judgment as to whether a 

particular activity is covered by this part 

and this judgment shall be 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 part comply with some 

or all of the requirements of this part. 

(e) Compliance with this part requires 

compliance with pertinent Federal laws 

or regulations that provide additional 

protections for human subjects. 

(f) This part 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 part 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 

part takes place in foreign countries, 

procedures normally followed in the 

foreign countries to protect human 

subjects may differ from those set forth 

in this part. 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 part, the department or agency head 

may approve the substitution of the 

foreign procedures in lieu of the 

procedural requirements provided in 

this part. 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 part to specific 

research activities or classes of research 

activities otherwise covered by this part, 

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 


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85870 Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 

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 part 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)–(l) [Reserved] 

(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. 

§ 2584.102 Definitions for purposes of this 

part. 

Certification means the official 

notification by the institution to the 

supporting Federal department or 

agency component, in accordance with 

the requirements of this part, that a 

research project or activity involving 

human subjects has been reviewed and 

approved by an IRB in accordance with 

an approved assurance. 

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. 

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. 

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 part 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). 

Human subject means: 

(1) 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 (5) of this definition, and 

‘‘identifiable biospecimen,’’ as defined 

in paragraph (6) of this definition. 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 (5) of this definition, or an 

‘‘identifiable biospecimen,’’ as defined 

in paragraph (6) of this definition. 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 part. 

(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. 


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Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 85871 

(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 part, 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 

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. 

§ 2558.103 Assuring compliance with this 

part—research conducted or supported by 

any Federal department or agency. 

(a) Each institution engaged in 

research that is covered by this part, 

with the exception of research eligible 

for exemption under § 2584.104, 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 part. 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 HHSapproved assurance is accepted in lieu 

of requiring submission of an assurance, 

reports (except certification) required by 

this part 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 

part, 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 paragraph (d) of this 

section). 

(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 part 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 § 2584.101(i) or exempted 

under § 2584.104. 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 part (or 

exempt research for which limited IRB 

review takes place pursuant to 

§ 2584.104(d)(2)(iii), (d)(3)(i)(C), or 

(d)(7) or (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 part (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). 

§ 2584.104 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 part, 

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 

45 CFR part 46, subparts B, C, and D. 

Application of the exemption categories 

to research subject to the requirements 

of 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 45 CFR part 46, 

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 45 CFR part 46, 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 45 CFR part 46, 

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 


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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 part: 

(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 

limited IRB review to make the 

determination required by 

§ 2584.111(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 

§ 2584.111(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 part 

160 and part 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: 


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(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 

§ 2584.111(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 § 2584.116(a)(1) 

through (4) and (6) and (d); 

(ii) Documentation of informed 

consent or waiver of documentation of 

consent was obtained in accordance 

with § 2584.117; 

(iii) An IRB conducts a limited IRB 

review and makes the determination 

required by § 2584.111(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 

investigator from abiding by any legal 

requirements to return individual 

research results. 

§§ 2584.105–2584.106 [Reserved] 

§ 2584.107 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. 

§ 2584.108 IRB functions and operations. 

(a) In order to fulfill the requirements 

of this part 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 part 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 

§ 2584.110), 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. 

§ 2584.109 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 part, including exempt 

research activities under § 2584.104 for 

which limited IRB review is a condition 

of exemption (under 

§ 2584.104(d)(2)(iii), (d)(3)(i)(C), and 

(d)(7) and (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 § 2584.116. The 

IRB may require that information, in 

addition to that specifically mentioned 

in § 2584.116, be given to the subjects 


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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 § 2584.117. 

(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 paragraph (f) of this 

section. 

(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 § 2584.110; 

(ii) Research reviewed by the IRB in 

accordance with the limited IRB review 

described in § 2584.104(d)(2)(iii), 

(d)(3)(i)(C), or (d)(7) or (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] 

(g) An IRB shall have authority to 

observe or have a third party observe the 

consent process and the research. 

§ 2584.110 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 § 2584.104(d)(2)(iii), (d)(3)(i)(C), 

and (d)(7) and (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 § 2584.108(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 part 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, § 2584.116. 

(5) Informed consent will be 

appropriately documented or 

appropriately waived in accordance 

with § 2584.117. 

(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 

§ 2584.104(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 

§ 2584.116(a)(1) through (4) and (6) and 

(d); 

(ii) Broad consent is appropriately 

documented or waiver of 

documentation is appropriate, in 

accordance with § 2584.117; 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 


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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. 

§ 2584.112 Review by institution. 

Research covered by this part 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. 

§ 2584.114 Cooperative research. 

(a) Cooperative research projects are 

those projects covered by this part that 

involve more than one institution. In the 

conduct of cooperative research 

projects, each institution is responsible 

for safeguarding the rights and welfare 

of human subjects and for complying 

with this policy. 

(b)(1) Any institution located in the 

United States that is engaged in 

cooperative research must rely upon 

approval by a single IRB for that portion 

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. 

§ 2584.115 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 § 2584.109(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 § 2584.108(a)(2). 

(6) Written procedures for the IRB in 

the same detail as described in 

§ 2584.108(a)(3) and (4). 

(7) Statements of significant new 

findings provided to subjects, as 

required by § 2584.116(c)(5). 

(8) The rationale for an expedited 

reviewer’s determination under 

§ 2584.110(b)(1)(i) that research 

appearing on the expedited review list 

described in § 2584.110(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 part, as 

described in § 2584.103(e). 

(b) The records required by this part 

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. 

§ 2584.116 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 part: 

(1) Before involving a human subject 

in research covered by this part, 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 


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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 

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), (3), (5), and (8) of this 

section and, when appropriate, 

paragraphs (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 


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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 

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 IRBapproved 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 part 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 part 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). 

§ 2584.117 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 


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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 

§ 2584.116. 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 

§ 2584.116 have been presented orally to 

the subject or the subject’s legally 

authorized representative, and that the 

key information required by 

§ 2584.116(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: 

(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. 

§ 2584.118 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 

§ 2584.101(i) or exempted under 

§ 2584.104, 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 part, and certification 

submitted, by the institution, to the 

Federal department or agency 

component supporting the research. 

§ 2584.119 Research undertaken without 

the intention of involving human subjects. 

Except for research waived under 

§ 2584.101(i) or exempted under 

§ 2584.104, 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 part, 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. 

§ 2584.120 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. 

§ 2584.121 [Reserved] 

§ 2584.122 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 part have been satisfied. 

§ 2584.123 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 part. 

(b) In making decisions about 

supporting or approving applications or 

proposals covered by this part 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). 

§ 2584.124 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 


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Federal Register / Vol. 89, No. 209 / Tuesday, October 29, 2024 / Rules and Regulations 85879 

additional conditions are necessary for 

the protection of human subjects. 

Andrea Grill, 

Acting General Counsel. 

[FR Doc. 2024–24517 Filed 10–28–24; 8:45 am] 

BILLING CODE 6050–28–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 635 

[Docket No. 241010–0271] 

RIN 0648–BK89 

Atlantic Highly Migratory Species; 

Updates Regarding Sea Turtle Careful 

Release Equipment and Techniques 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: In this final rule, NMFS 

updates the Atlantic highly migratory 

species (HMS) regulations regarding the 

sea turtle safe handling and release 

requirements and equipment in the 

HMS pelagic and bottom longline 

fisheries. This action is based in part on 

two technical memoranda published by 

NMFS’ Southeast Fisheries Science 

Center (SEFSC). The regulatory updates 

replace some of the more technical 

terms with those that are more 

commonly used, add more detail to 

make the regulations more 

understandable, and add additional 

tools or options for fishermen to use to 

safely handle and release sea turtles. In 

addition, this final rule simplifies the 

regulations by removing redundancies, 

making minor changes in formatting, 

and revising wording to clarify 

responsibility of implementation. 

DATES: This final rule is effective 

November 29, 2024. 

ADDRESSES: Additional information 

related to this final rule, including 

electronic copies of the supporting 

documents are available from the HMS 

Management Division website at: 

https://www.fisheries.noaa.gov/topic/ 

atlantic-highly-migratory-species, at: 

https://www.regulations.gov (enter 

‘‘NOAA–NMFS–2024–0046’’ in the 

Search box), or by contacting Becky 

Curtis at becky.curtis@noaa.gov. The 

referenced technical memoranda are 

available from the HMS Management 

Division website at: https://

www.fisheries.noaa.gov/resource/ 

outreach-materials/atlantic-highlymigratory-species-safe-handling-releaseand. These documents are also available 

upon request from the HMS 

Management Division by phone at 301– 

427–8503. 

FOR FURTHER INFORMATION CONTACT: 

Becky Curtis, becky.curtis@noaa.gov, 

Steve Durkee, steve.durkee@noaa.gov or 

Karyl Brewster-Geisz, karyl.brewstergeisz@noaa.gov; 301–427–8503. 

SUPPLEMENTARY INFORMATION: 

Background 

Atlantic HMS fisheries are managed 

under the 2006 Consolidated HMS 

Fishery Management Plan (FMP) and its 

amendments, pursuant to the 

Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act) (16 U.S.C. 1801 

et seq.) and consistent with the Atlantic 

Tunas Convention Act (ATCA) (16 

U.S.C. 971 et seq.). HMS implementing 

regulations are at 50 CFR part 635. The 

sea turtle handling and release 

requirements and equipment are located 

at § 635.21(b) through (d). 

This final rule is issued pursuant to, 

and subject to requirements of, the 

Magnuson-Stevens Act. Specifically in 

regard to the sea turtle safe handling 

and release measures implemented in 

this rule, 16 U.S.C. 1851(a)(9) requires 

NMFS to implement fishery 

management measures that minimize 

bycatch, and to the extent bycatch 

cannot be avoided, minimize the 

mortality of bycatch. The MagnusonStevens Act defines bycatch as fish 

which are harvested but which are not 

sold or kept for personal use at 16 

U.S.C. 1802(2) (see also 16 U.S.C. 

1802(12) (defining ‘‘fish’’)). Sea turtles 

are listed and protected under the 

Endangered Species Act and cannot be 

sold or kept for personal use (see 16 

U.S.C. 1538(a)(1) and 16 U.S.C. 

1533(d)). 

Background information about the 

need for regulatory updates to modify 

the sea turtle handling and release 

requirements and equipment and 

specific examples of updates made 

under this action were provided in the 

preamble to the proposed rule (89 FR 

24416, April 8, 2024) and are not 

repeated here. In summary, two 

technical memoranda were published 

by the SEFSC in 2019: NMFS–SEFSC 

TM735: ‘‘Careful Release Protocols for 

Sea Turtle Release with Minimal 

Injury,’’ and NMFS–SEFSC TM738: 

‘‘Design Standards and Equipment for 

Careful Release of Sea Turtles Caught in 

Hook-and-Line Fisheries.’’ NMFS 

decided that it would be helpful to 

revise the existing regulations in light of 

the 2019 technical memoranda. Based in 

part on those memoranda, this final rule 

modifies the regulations by: (1) adding 

additional options for tools and 

procedures for fishermen to use to safely 

handle and release sea turtles; (2) 

replacing some of the more technical 

terms with those that are more 

commonly used; (3) adding more detail 

to make the regulations more 

understandable; and (4) simplifying the 

regulations by removing redundancies. 

NMFS received five written comments 

during the public comment period for 

the proposed rule, which closed on May 

8, 2024. The comments received, and 

responses to those comments, are 

summarized in the Response to 

Comments section. No changes to the 

final rule are planned in response to the 

comments received. However, one 

minor change from the proposed rule is 

outlined in the Changes from Proposed 

Rule section. 

Under this final rule, fishermen are 

able to continue using existing, 

approved sea turtle bycatch mitigation 

equipment. The final rule also provides 

additional tool and procedural options 

that fishermen may use to meet the sea 

turtle safe handling and release 

requirements. 

Response to Comments 

Written comments can be found at: 

https://www.regulations.gov; type 

‘‘NOAA–NMFS–2024–0046’’ in the 

Search box. Below, NMFS summarizes 

and responds to the comments made on 

the proposed rule during the comment 

period. Comments covering the same 

topics were consolidated. 

Comment 1: NMFS received multiple 

comments expressing support for the 

proposed update of sea turtle careful 

handling and release regulations. 

Commenters noted that the updates 

would improve outcomes for 

incidentally-caught sea turtles released 

by fishermen and improve clarity of the 

sea turtle safe handling and release 

regulations, improve awareness of and 

confidence in sea turtle release 

techniques, and, due to the additional 

approved tools, reduce instances where 

the required tools are forgotten or not on 

hand. 

Response: NMFS agrees that the 

proposed changes would provide clarity 

regarding sea turtle safe handling and 

release requirements. Additionally, the 

proposed changes will increase 

flexibility for complying with these 

requirements. 

Comment 2: NMFS received one 

comment expressing concerns about the 

cost of the new, optional tools that 

would be authorized for sea turtle safe 

handling techniques, and whether that 


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