[Federal Register Volume 89, Number 206 (Thursday, October 24, 2024)]
[Rules and Regulations]
[Pages 84822-84827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24399]



[[Page 84822]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

RIN 0937-AA09


Department of Health and Human Services Policy for the Protection 
of Human Research Subjects: Update to the Additional Protections for 
Specific Populations

AGENCY: Department of Health and Human Services.

ACTION: Final rule.

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SUMMARY: In this final rule, the Department of Health and Human 
Services (HHS) is amending its regulations that govern the protection 
of human subjects for conformity with 2018 revisions made to the 
Federal policy for protection of human research subjects (the ``Common 
Rule''), as well as to maintain consistency with the prior version of 
the Common Rule for research that remains subject to those 
requirements. Amendments include updating citations that were 
renumbered, adding updated descriptions of the applicability of 
exemptions, and correcting a technical error. No substantive amendments 
are included in this final rule.

DATES: This final rule is effective October 24, 2024.

FOR FURTHER INFORMATION CONTACT: Julie Kaneshiro, Office for Human 
Research Protections (OHRP), Department of Health and Human Services, 
1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-
453-8293 or 1-866-447-4777; facsimile: 240-453-8430; email 
<a href="/cdn-cgi/l/email-protection#cf85baa3a6aae1a4aea1aabca7a6bda08fa7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="6d271801040843060c03081e05041f022d05051e430a021b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Revision of the Common Rule

    The Common Rule, codified by HHS at subpart A of 45 CFR part 46, 
was revised by a final rule published in the Federal Register on 
January 19, 2017 (82 FR 7149), and subsequently amended by an interim 
final rule published in the Federal Register on January 22, 2018 (83 FR 
2885), and a final rule published on June 19, 2018 (83 FR 28497). The 
revised Common Rule is defined in the regulatory text as the ``2018 
Requirements.'' The prior version of the Common Rule, initially 
promulgated on June 18, 1991 (56 FR 28002), and amended on June 23, 
2005 (70 FR 36325), published in the 2016 Code of Federal Regulations 
and effective October 1, 2017, is defined by the revised Common Rule as 
the ``pre-2018 Requirements.'' For brevity, in the regulatory text of 
subparts B, C, and D, HHS is shortening the full explanation of the 
``pre-2018 Requirements'' to ``[t]he pre-2018 Requirements means 45 CFR 
part 46, subpart A, as revised October 1, 2016'' and the ``2018 
Requirements'' to ``[t]he 2018 Requirements means 45 CFR part 46, 
subpart A, as revised October 1, 2018.'' The applicability of the pre-
2018 or 2018 Requirements is defined by Sec.  46.101(l) of the 2018 
Requirements. Importantly, research that was approved under the pre-
2018 Requirements may continue to follow that rule for the duration of 
the study; however, research initiated on or after January 21, 2019, 
must comply with the 2018 Requirements.
    The preamble of the January 19, 2017 final rule indicated that, to 
the extent appropriate, HHS intended to amend the other subparts of the 
HHS human subjects protection regulations to align with the revisions 
to the Common Rule codified at subpart A. Through this final rule, HHS 
is updating subparts B, C, and D to reference both the pre-2018 
Requirements and the 2018 Requirements, as appropriate. HHS intends to 
separately amend subpart E to conform with both the pre-2018 and 2018 
Requirements.

B. Subparts B, C, and D Background

    Subpart B of 45 CFR part 46, ``Additional Protections for Pregnant 
Women, Human Fetuses and Neonates Involved in Research,'' was first 
promulgated on August 8, 1975. The most recent revision to subpart B 
was published in the Federal Register on November 13, 2001 (66 FR 
56775).
    On November 16, 1978, the then Department of Health, Education, and 
Welfare published a final rule promulgating subpart C, ``Additional 
Protections Pertaining to Biomedical and Behavioral Research Involving 
Prisoners as Subjects'' (43 FR 53652). On January 26, 1981, the Common 
Rule was first published, which substantially updated subpart A of 45 
CFR part 46 (46 FR 8366). As part of this update, HHS also published an 
amendment to subpart C in which citations were corrected or updated and 
other technical amendments were made.
    On March 8, 1983, HHS published the final rule promulgating subpart 
D, ``Additional Protections for Children Involved as Subjects in 
Research'' (43 FR 9814).

II. Amendments to Subparts B, C, and D of 45 CFR Part 46

    As described above, HHS is amending subparts B, C, and D for 
conformity with both the pre-2018 and 2018 Requirements. Through this 
rule, HHS is:
    <bullet> Adding language to subparts B, C, and D to specify when 
references to subpart A provisions refer to the pre-2018 Requirements 
or the 2018 Requirements.
    <bullet> Adding language to clarify the meaning of ``pre-2018 
Requirements'' and ``2018 Requirements.''
    <bullet> Updating language in subparts B, C, and D that explains 
the applicability of the exemptions to research regulated under each 
subpart to reflect the additional exemptions allowed by Sec.  46.104(b) 
of the 2018 Requirements.
    <bullet> Correcting a technical error contained in subpart D.

A. Amendments to Subpart B

    In this final rule, HHS makes eight amendments to subpart B, 
``Additional Protections for Pregnant Women, Human Fetuses and Neonates 
Involved in Research.'' First, 45 CFR 46.201(b) is amended to state 
that for purposes of this subpart, the pre-2018 Requirements means 
subpart A as published in the 2016 edition of the Code of Federal 
Regulations. The version of subpart A referenced in the definition of 
the term ``2018 Requirements'' refers to 45 CFR part 46, subpart A, as 
revised October 1, 2018. Section 46.201(b)(1) is added to provide that 
research subject to the pre-2018 Requirements may apply the exemptions 
at Sec.  46.101(b)(1) through (6) of the pre-2018 Requirements, while 
Sec.  46.201(b)(2) is added to provide that research subject to the 
2018 Requirements may apply the exemptions at Sec.  46.104(d)(1) 
through (8) of the 2018 Requirements.
    Second, Sec.  46.202 is amended to clarify that the definitions 
found in Sec.  46.102 of the pre-2018 Requirements or the 2018 
Requirements, as applicable, shall be applicable to this subpart.
    Third, Sec.  46.202(h) is amended to clarify that if a neonate is 
viable then it may be included in research only to the extent permitted 
and in accordance with the requirements of subpart A of the pre-2018 
Requirements or the 2018 Requirements, as applicable, and subpart D of 
part 46.
    Fourth, Sec.  46.204(d) is amended to clarify that the pregnant 
woman's consent must be obtained in accordance with the informed 
consent provisions of subpart A of the pre-2018 Requirements or the 
2018 Requirements, as applicable.
    Fifth, Sec.  46.204(e) is amended to state that the consent of the 
pregnant woman and the father must be obtained in accordance with the 
informed consent provisions of subpart A of the pre-2018 Requirements 
or the 2018 Requirements, as applicable, except that the father's

[[Page 84823]]

consent need not be obtained if he is unable to consent for the reasons 
stated therein.
    Sixth, Sec.  46.205(b)(2) is amended to state that the consent of 
either parent of the neonate or, if neither parent is able to consent 
because of unavailability, incompetence, or temporary incapacity, the 
legally effective informed consent of either parent's legally 
authorized representative is obtained in accord with the pre-2018 
Requirements or the 2018 Requirements, as applicable, except that the 
consent of the father or his legally authorized representative need not 
be obtained if the pregnancy resulted from rape or incest.
    Seventh, references in subpart B at Sec.  46.205(c)(5) to subpart 
A's waiver and alteration of consent provisions are updated to reflect 
conformity with the pre-2018 Requirements as well as the 2018 
Requirements. In order for the citation to be consistent with the 
section numbering of both the pre-2018 and 2018 Requirements, the prior 
pinpoint citation to Sec.  46.116(c) and (d) has been modified to 
instead refer to Sec.  46.116 of both the pre-2018 and 2018 
Requirements.
    Finally, the language of subpart B at Sec.  46.205(d) has been 
revised to replace the reference to subpart A with reference to the 
pre-2018 Requirements or the 2018 Requirements, as applicable.

B. Amendments to Subpart C

    In this final rule, HHS makes six amendments to subpart C, 
``Additional Protections Pertaining to Biomedical and Behavioral 
Research Involving Prisoners as Subjects.''
    First, 45 CFR 46.301(c) is revised to provide that the requirements 
of this subpart are in addition to those imposed under the other 
subparts, including the 2018 Requirements and the pre-2018 
Requirements, as applicable. This section is further revised to provide 
that the term ``pre-2018 Requirements'' means subpart A as published in 
the 2016 edition of the Code of Federal Regulations. The term ``2018 
Requirements'' refers to 45 CFR part 46, subpart A, as revised October 
1, 2018.
    Second, Sec.  46.304 is modified to clarify that in addition to 
satisfying the requirements in Sec.  46.107 of the pre-2018 
Requirements or the 2018 Requirements, as applicable, an institutional 
review board (IRB), carrying out responsibilities with respect to this 
subpart, shall also meet the specific requirements further detailed in 
this section.
    Third, Sec.  46.306(a) is modified to add the word ``nonexempt'' in 
order to clarify that, except for research involving prisoners that 
qualifies for exemption, research subject to subpart C must involve 
only a category of research reflected in 45 CFR 46.306(a)(2)(i) through 
(iv).
    Fourth, Sec.  46.306(b) is revised to provide that research 
conducted or supported by DHHS (the Department of Health and Human 
Services) shall not involve prisoners except as provided in Sec.  
46.306(b)(1) and (2).
    Fifth, Sec.  46.306(b)(1) is added to state that for research 
subject to the pre-2018 Requirements and this subpart, except as 
provided in Sec.  46.306(a), biomedical or behavioral research 
conducted or supported by DHHS shall not involve prisoners as subjects.
    Sixth, Sec.  46.306(b)(2) is added to state that for research 
subject to the 2018 Requirements and this subpart, except as provided 
in Sec.  46.306(a) or for research that is exempt pursuant to Sec.  
46.104(b)(2) and (d)(1) through (8), biomedical or behavioral research 
conducted or supported by DHHS shall not involve prisoners as subjects.

C. Amendments to Subpart D

    In this final rule, HHS makes 12 amendments to subpart D, 
``Additional Protections for Children Involved as Subjects in 
Research.''
    First, HHS revises 45 CFR 46.401(a) to provide that the term ``pre-
2018 Requirements'' means subpart A as published in the 2016 edition of 
the Code of Federal Regulations; and that the term ``2018 
Requirements'' means 45 CFR part 46, subpart A, as revised October 1, 
2018.
    Second, given that there is a new Sec.  46.401(a), the language of 
the previous Sec.  46.401(a)(1) and (2) is renumbered as Sec.  
46.401(b)(1) and (2).
    Third, HHS is correcting a technical error in the renumbered Sec.  
46.401(b)(2) in the citation to the provision of subpart A that allows 
the Secretary to waive some or all regulatory requirements. Subpart D 
cites the provision as Sec.  46.101(e). However, the Secretarial waiver 
provision in subpart A appears at Sec.  46.101(i), not Sec.  46.101(e), 
in both the pre-2018 and the 2018 Requirements. This rule corrects this 
technical error, and revises the reference to ``subpart A'' to instead 
reference the pre-2018 and 2018 Requirements.
    Fourth, 45 CFR 46.401(c) is amended to include an explanation of 
how the exemptions provided in the pre-2018 Requirements and the 2018 
Requirements apply to research regulated by subpart D.
    Fifth, Sec.  46.401(c)(1) is added to provide that, for research 
subject to the pre-2018 Requirements, the exemptions at Sec.  
46.101(b)(1) and (3) through (6) of the pre-2018 Requirements are 
applicable to research subject to subpart D. In addition, the exemption 
at Sec.  46.101(b)(2) of the pre-2018 Requirements regarding 
educational tests is also applicable to research subject to subpart D, 
with the caveat that the exemption at Sec.  46.101(b)(2) for research 
involving survey or interview procedures or observations of public 
behavior does not apply to research subject to subpart D, except for 
research involving observation of public behavior when the 
investigator(s) does (do) not participate in the activities being 
observed.
    Sixth, Sec.  46.401(c)(2) is added to provide that, for research 
subject to the 2018 Requirements, the exemptions at Sec.  46.104(d)(1), 
(4), (5), (6), (7), and (8) of the 2018 Requirements may be applied to 
research subject to subpart D; the exemptions at Sec.  46.104(d)(2)(i) 
and (ii) of the 2018 Requirements may only apply to research subject to 
this subpart involving educational tests or the observation of public 
behavior when the investigator(s) does (do) not participate in the 
activities being observed; and the exemptions at Sec. Sec.  
46.104(d)(2)(iii) and (d)(3) of the 2018 Requirements may not be 
applied to research subject to this subpart.
    Seventh, the language formerly found at 45 CFR 46.401(c) has been 
updated to reference the pre-2018 Requirements and the 2018 
Requirements, instead of ``subpart A,'' and moved to a new Sec.  
46.401(d).
    Eighth, 45 CFR 46.402 is revised to provide that the definitions in 
Sec.  46.102 of the pre-2018 Requirements and Sec.  46.102 of the 2018 
Requirements, as applicable, shall be applicable to this subpart.
    Ninth, 45 CFR 46.408(a) is modified to provide that even where the 
IRB determines that the subjects are capable of assenting, the IRB may 
still waive the assent requirement under circumstances in which consent 
may be waived in accord with Sec.  46.116 of the pre-2018 Requirements 
or the 2018 Requirements, as applicable.
    Tenth, Sec.  46.408(b) is modified to provide that in addition to 
the determinations required under other applicable sections of this 
subpart, the IRB shall determine, in accordance with and to the extent 
that consent is required by Sec.  46.116 of the pre-2018 Requirements 
or the 2018 Requirements, as applicable, that adequate provisions are 
made for soliciting the permission of each child's parents or guardian.
    Eleventh, Sec.  46.408(c) is modified to provide that in addition 
to the provisions for waiver contained in Sec.  46.116 of the pre-2018 
Requirements or the 2018 Requirements, as applicable, if the IRB 
determines that a research

[[Page 84824]]

protocol is designed for conditions or for a subject population for 
which parental or guardian permission is not a reasonable requirement 
to protect the subjects (e.g., neglected or abused children), it may 
waive the consent requirements in Sec.  46.116 of the pre-2018 
Requirements or the 2018 Requirements, as applicable, and Sec.  
46.408(b), provided an appropriate mechanism for protecting the 
children who will participate as subjects in the research is 
substituted, and provided further that the waiver is not inconsistent 
with Federal, State, or local law.
    Twelfth, Sec.  46.408(d) is modified to provide that permission by 
parents or guardians shall be documented in accordance with, and to the 
extent required by, Sec.  46.117 of the pre-2018 Requirements or the 
2018 Requirements, as applicable.

III. Legal Authority

    The legal authority is as follows: 5 U.S.C. 301; 42 U.S.C. 289(a); 
42 U.S.C. 300v-1(b).

IV. 5 U.S.C. 553(b)(B) of the Administrative Procedure Act, 5 U.S.C. 
551-559

    HHS finds that there is good cause to issue these amendments 
without advance notice and an opportunity for public comment. This 
final rule reflects changes that conform subparts B, C, and D to both 
the pre-2018 and 2018 Requirements and correct a technical error in 
subpart D that predates the publication of the 2018 Requirements. This 
final rule merely (i) adds language to each subpart specifying how the 
regulatory exemptions and provisions apply under the pre-2018 or 2018 
Requirements, as applicable; (ii) corrects an erroneous citation in 
subpart D; and (iii) changes the citation to the subpart A provisions 
that allow waiver and alteration of informed consent in Sec.  
46.205(c)(5) from Sec.  46.116(c) and (d) to Sec.  46.116, in order to 
generally reference the waiver and alteration of informed consent 
provisions in both the pre-2018 and 2018 versions of the Common Rule. 
HHS determines that advance notice and public comment are unnecessary. 
Pursuant to 5 U.S.C. 553(b)(B) of the Administrative Procedure Act, HHS 
finds good cause to dispense with advance notice and public comment as 
these procedures are unnecessary, because this rule only serves to 
update subparts B, C, and D to conform with provisions in the pre-2018 
and 2018 Requirements of 45 CFR part 46, which are already in effect, 
and to correct a citation error. HHS further finds good cause for this 
rule to be effective upon publication in accordance with 5 U.S.C. 
553(d)(3) because the provisions of the pre-2018 and 2018 Requirements 
to which these revisions conform are already in effect, and regulated 
entities already are required to comply with these provisions.

V. Regulatory Impact Analyses

    We have examined the effects of this final rule under Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), Executive Order 14094 on Modernizing Regulatory 
Review (April 6, 2023), the Paperwork Reduction Act of 1995 (Pub. L. 
104-13), the Regulatory Flexibility Act, (Pub. L. 96-354, September 19, 
1980), the Congressional Review Act (5 U.S.C. 801, Pub. L. 104-121), 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive 
Order 13132 on Federalism (August 4, 1999), and section 1102(b) of the 
Social Security Act.

A. Executive Orders 12866, 13563, and 14094

    Executive Orders 12866, 13563, and 14094 direct agencies to assess 
all benefits, costs, and transfers of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Rules are ``significant'' under Executive Order 12866 
section 3(f)(1) (as amended by Executive Order 14094) if they have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.
    This rule makes technical corrections to subparts B, C, and D that 
reflect existing requirements contained in the 2018 Requirements. The 
impacts of the 2018 Requirements are accounted for in three prior 
regulatory impact analyses (82 FR 7231, 83 FR 2880, 83 FR 28505). 
Compared to a baseline scenario of the 2018 Requirements, HHS finds 
that this rule will not have an impact on human subjects research or 
human subjects research review. This rule has not been designated as a 
``significant regulatory action'' under section 3(f) of Executive Order 
12866 (as amended by Executive Order 14094).

B. Paperwork Reduction Act

    This final rule does not impose any additional information 
collection burden under the Paperwork Reduction Act and does not 
contain any information collection activities beyond the information 
collection already approved by Office of Management and Budget under 
control numbers 0990-0260, 0990-0473 and 0990-0481.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the 
Small Business Regulatory Enforcement Fairness Act of 1996, which 
amended the RFA, require agencies that issue a regulation to analyze 
options for regulatory relief for small businesses. If a rule has a 
significant impact on a substantial number of small entities, agencies 
must specifically consider the economic effect of the rule on small 
entities and analyze regulatory options that could lessen the impact of 
the rule. The RFA generally defines a ``small entity'' as (1) a 
proprietary firm meeting the size standards of the Small Business 
Administration; (2) a nonprofit organization that is not dominant in 
its field; or (3) a small government jurisdiction with a population of 
less than 50,000 (states and individuals are not included in the 
definition of ``small entity''). HHS considers a rule to have a 
significant economic impact on a substantial number of small entities 
if at least 5 percent of small entities experience an impact of more 
than 3 percent of revenue. In making this determination, the impact of 
concern is any significant adverse economic impact on small entities. 
An agency may certify that a rule will not have a significant economic 
impact on a substantial number of small entities if the rule relieves 
regulatory burden, has no net burden, or otherwise has a positive 
economic effect on the small entities subject to the rule.
    This action does not have a significant economic impact on a 
substantial number of small entities under the RFA. Therefore, the 
regulatory flexibility analysis provided for under the RFA is not 
required.

D. Unfunded Mandates Reform Act

    Section 202(a) of the Unfunded Mandates Reform Act (UMRA) of 1995 
requires that agencies prepare a written statement, which includes an 
assessment of anticipated costs and benefits, before proposing ``any 
rule that includes any Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000

[[Page 84825]]

or more (adjusted annually for inflation) in any one year.'' The 
current threshold after adjustment for inflation is $183 million, using 
the 2023 implicit price deflator for the gross domestic product. We do 
not expect this final rule to result in expenditures that will exceed 
this amount. This action does not contain any unfunded mandate as 
described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or 
uniquely affect small governments.

E. Executive Order 13132: Federalism

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirement costs on State and local governments or has 
federalism implications. HHS has determined that this rule does not 
contain policies that have substantial direct effects on the States, on 
the relationship between the Federal Government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government. Accordingly, we have concluded that this final rule does 
not contain policies that have federalism implications as defined in 
the order and, consequently, a federalism summary impact statement is 
not required.

List of Subjects in 45 CFR Part 46

    Human research subjects, Reporting and recordkeeping requirements, 
Research.

    For the reasons set forth in the preamble, the Department of Health 
and Human Services amends 45 CFR part 46 as follows:

PART 46--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for part 46 continues to read as follows:

    Authority:  5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).

Subpart B--Additional Protections for Pregnant Women, Human Fetuses 
and Neonates Involved in Research

0
2. Amend Sec.  46.201 by revising paragraph (b) to read as follows:


Sec.  46.201  To what do these regulations apply?

* * * * *
    (b) The pre-2018 Requirements means 45 CFR part 46, subpart A, as 
revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, 
subpart A, as revised October 1, 2018.
    (1) For research subject to the pre-2018 Requirements and this 
subpart, the exemptions at Sec.  46.101(b)(1) through (6) of the pre-
2018 Requirements are applicable to this subpart.
    (2) For research subject to the 2018 Requirements and this subpart, 
the exemptions at Sec.  46.104(d)(1) through (8) of the 2018 
Requirements may be applied.
* * * * *

0
3. Amend Sec.  46.202 by revising the introductory text and paragraph 
(h) to read as follows:


Sec.  46.202  Definitions.

    The definitions in Sec.  46.102 of the pre-2018 Requirements and 
the 2018 Requirements, as applicable, shall be applicable to this 
subpart as well. In addition, as used in this subpart:
* * * * *
    (h) Viable, as it pertains to the neonate, means being able, after 
delivery, to survive (given the benefit of available medical therapy) 
to the point of independently maintaining heartbeat and respiration. 
The Secretary may from time to time, taking into account medical 
advances, publish in the Federal Register guidelines to assist in 
determining whether a neonate is viable for purposes of this subpart. 
If a neonate is viable then it may be included in research only to the 
extent permitted and in accordance with the requirements of the pre-
2018 Requirements or the 2018 Requirements, as applicable, and subpart 
D of this part.

0
4. Amend Sec.  46.204 by revising paragraphs (d) and (e) to read as 
follows:


Sec.  46.204  Research involving pregnant women or fetuses.

* * * * *
    (d) If the research holds out the prospect of direct benefit to the 
pregnant woman, the prospect of a direct benefit both to the pregnant 
woman and the fetus, or no prospect of benefit for the woman nor the 
fetus when risk to the fetus is not greater than minimal and the 
purpose of the research is the development of important biomedical 
knowledge that cannot be obtained by any other means, her consent is 
obtained in accord with the informed consent provisions of the pre-2018 
Requirements or the 2018 Requirements, as applicable;
    (e) If the research holds out the prospect of direct benefit solely 
to the fetus then the consent of the pregnant woman and the father is 
obtained in accord with the informed consent provisions of the pre-2018 
Requirements or the 2018 Requirements, as applicable, except that the 
father's consent need not be obtained if he is unable to consent 
because of unavailability, incompetence, or temporary incapacity or the 
pregnancy resulted from rape or incest;
* * * * *

0
5. Amend Sec.  46.205 by revising paragraphs (b)(2), (c)(5), and (d) to 
read as follows:


Sec.  46.205  Research involving neonates.

* * * * *
    (b) * * *
    (2) The legally effective informed consent of either parent of the 
neonate or, if neither parent is able to consent because of 
unavailability, incompetence, or temporary incapacity, the legally 
effective informed consent of either parent's legally authorized 
representative is obtained in accord with the pre-2018 Requirements or 
the 2018 Requirements, as applicable, except that the consent of the 
father or his legally authorized representative need not be obtained if 
the pregnancy resulted from rape or incest.
    (c) * * *
    (5) The legally effective informed consent of both parents of the 
neonate is obtained in accord with the pre-2018 Requirements or the 
2018 Requirements, as applicable, except that the waiver and alteration 
provisions of Sec.  46.116 of the pre-2018 Requirements or the 2018 
Requirements do not apply. However, if either parent is unable to 
consent because of unavailability, incompetence, or temporary 
incapacity, the informed consent of one parent of a nonviable neonate 
will suffice to meet the requirements of this paragraph (c)(5), except 
that the consent of the father need not be obtained if the pregnancy 
resulted from rape or incest. The consent of a legally authorized 
representative of either or both of the parents of a nonviable neonate 
will not suffice to meet the requirements of this paragraph (c)(5).
    (d) Viable neonates. A neonate, after delivery, that has been 
determined to be viable may be included in the research only to the 
extent permitted by and in accord with the requirements of the pre-2018 
Requirements or the 2018 Requirements, as applicable, and subpart D of 
this part.

Subpart C--Additional Protections Pertaining to Biomedical and 
Behavioral Research Involving Prisoners as Subjects

0
6. Amend Sec.  46.301 by revising paragraph (c) to read as follows:


Sec.  46.301  Applicability.

* * * * *
    (c) The requirements of this subpart are in addition to those 
imposed under the other subparts in this part and

[[Page 84826]]

includes the pre-2018 Requirements and the 2018 Requirements, as 
applicable. The pre-2018 Requirements means 45 CFR part 46, subpart A, 
as revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, 
subpart A, as revised October 1, 2018.

0
7. Amend Sec.  46.304 by revising the introductory text to read as 
follows:


Sec.  46.304  Composition of Institutional Review Boards where 
prisoners are involved.

    In addition to satisfying the requirements in Sec.  46.107 of the 
pre-2018 Requirements or the 2018 Requirements, as applicable, an 
Institutional Review Board, carrying out responsibilities with respect 
to this subpart, shall also meet the following specific requirements:
* * * * *

0
8. Amend Sec.  46.306 by revising paragraphs (a) introductory text and 
(b) to read as follows:


Sec.  46.306  Permitted research involving prisoners.

    (a) Nonexempt biomedical or behavioral research conducted or 
supported by DHHS may involve prisoners as subjects only if:
* * * * *
    (b) Biomedical or behavioral research conducted or supported by 
DHHS shall not involve prisoners except as follows:
    (1) For research subject to the pre-2018 Requirements and this 
subpart, except as provided in paragraph (a) of this section, 
biomedical or behavioral research conducted or supported by DHHS shall 
not involve prisoners as subjects.
    (2) For research subject to the 2018 Requirements and this subpart, 
except as provided in paragraph (a) of this section or for research 
that is exempt pursuant to Sec.  46.104(b)(2) and (d)(1) through (8) of 
the 2018 Requirements, biomedical or behavioral research conducted or 
supported by DHHS shall not involve prisoners as subjects.

Subpart D--Additional Protections for Children Involved as Subjects 
in Research

0
9. Revise Sec.  46.401 to read as follows:


Sec.  46.401  To what does this subpart apply?

    (a) The pre-2018 Requirements means 45 CFR part 46, subpart A, as 
revised October 1, 2016. The 2018 Requirements means 45 CFR part 46, 
subpart A, as revised October 1, 2018.
    (b) This subpart applies to all research involving children as 
subjects, conducted or supported by the Department of Health and Human 
Services.
    (1) This includes research conducted by Department employees, 
except that each head of an Operating Division of the Department may 
adopt such nonsubstantive, procedural modifications as may be 
appropriate from an administrative standpoint.
    (2) It also includes research conducted or supported by the 
Department of Health and Human Services outside the United States, but 
in appropriate circumstances, the Secretary may, under Sec.  46.101(i) 
of the pre-2018 Requirements or the 2018 Requirements, waive the 
applicability of some or all of the requirements of this subpart for 
research of this type.
    (c) The application of the exemptions to this subpart is as 
follows:
    (1) For research subject to the pre-2018 Requirements and this 
subpart, the exemptions at Sec.  46.101(b)(1) and (b)(3) through (6) of 
the pre-2018 Requirements are applicable to this subpart. The exemption 
at Sec.  46.101(b)(2) of the pre-2018 Requirements regarding 
educational tests also is applicable to this subpart. However, the 
exemption at Sec.  46.101(b)(2) for research involving survey or 
interview procedures or observations of public behavior does not apply 
to research covered by this subpart, except for research involving 
observation of public behavior when the investigator(s) do not 
participate in the activities being observed.
    (2) For research subject to the 2018 Requirements and this subpart, 
the exemptions at Sec.  46.104(d)(1), (4), (5), (6), (7), and (8) of 
the 2018 Requirements are applicable to this subpart. The exemptions at 
Sec.  46.104(d)(2)(i) and (ii) of the 2018 Requirements may only apply 
to research subject to this subpart that involves educational tests or 
the observation of public behavior when the investigator(s) do not 
participate in the activities being observed. The exemptions at Sec.  
46.104(d)(2)(iii) and (d)(3) of the 2018 Requirements may not be 
applied to research subject to this subpart.
    (d) The exceptions, additions, and provisions for waiver as they 
appear in Sec.  46.101(c) through (i) of the pre-2018 Requirements or 
the 2018 Requirements are applicable to this subpart.

0
10. Amend Sec.  46.402 by revising the introductory text to read as 
follows:


Sec.  46.402  Definitions.

    The definitions in Sec.  46.102 of the pre-2018 Requirements and 
the 2018 Requirements, as applicable, shall be applicable to this 
subpart as well. In addition, as used in this subpart:
* * * * *

0
11. Amend Sec.  46.408 by revising paragraphs (a) through (d) to read 
as follows:


Sec.  46.408  Requirements for permission by parents or guardians and 
for assent by children.

    (a) In addition to the determinations required under other 
applicable sections of this subpart, the IRB shall determine that 
adequate provisions are made for soliciting the assent of the children, 
when in the judgment of the IRB the children are capable of providing 
assent. In determining whether children are capable of assenting, the 
IRB shall take into account the ages, maturity, and psychological state 
of the children involved. This judgment may be made for all children to 
be involved in research under a particular protocol, or for each child, 
as the IRB deems appropriate. If the IRB determines that the capability 
of some or all of the children is so limited that they cannot 
reasonably be consulted or that the intervention or procedure involved 
in the research holds out a prospect of direct benefit that is 
important to the health or well-being of the children and is available 
only in the context of the research, the assent of the children is not 
a necessary condition for proceeding with the research. Even where the 
IRB determines that the subjects are capable of assenting, the IRB may 
still waive the assent requirement under circumstances in which consent 
may be waived in accord with Sec.  46.116 of the pre-2018 Requirements 
or of the 2018 Requirements, as applicable.
    (b) In addition to the determinations required under other 
applicable sections of this subpart, the IRB shall determine, in 
accordance with and to the extent that consent is required by Sec.  
46.116 of the pre-2018 Requirements or the 2018 Requirements, as 
applicable, that adequate provisions are made for soliciting the 
permission of each child's parents or guardian. Where parental 
permission is to be obtained, the IRB may find that the permission of 
one parent is sufficient for research to be conducted under Sec.  
46.404 or Sec.  46.405. Where research is covered by Sec. Sec.  46.406 
and 46.407 and permission is to be obtained from parents, both parents 
must give their permission unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only one parent has 
legal responsibility for the care and custody of the child.
    (c) In addition to the provisions for waiver contained in Sec.  
46.116 of the pre-2018 Requirements or the 2018 Requirements, as 
applicable, if the IRB determines that a research protocol is

[[Page 84827]]

designed for conditions or for a subject population for which parental 
or guardian permission is not a reasonable requirement to protect the 
subjects (for example, neglected or abused children), it may waive the 
consent requirements in Sec.  46.116 of the pre-2018 Requirements or 
2018 Requirements, as applicable, and paragraph (b) of this section, 
provided an appropriate mechanism for protecting the children who will 
participate as subjects in the research is substituted, and provided 
further that the waiver is not inconsistent with Federal, State, or 
local law. The choice of an appropriate mechanism would depend upon the 
nature and purpose of the activities described in the protocol, the 
risk and anticipated benefit to the research subjects, and their age, 
maturity, status, and condition.
    (d) Permission by parents or guardians shall be documented in 
accordance with and to the extent required by Sec.  46.117 of the pre-
2018 Requirements or the 2018 Requirements, as applicable.
* * * * *

Xavier Beccera,
Secretary, U.S. Department of Health and Human Services.
[FR Doc. 2024-24399 Filed 10-23-24; 8:45 am]
BILLING CODE 4150-36-P


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