Rule2024-24399
Department of Health and Human Services Policy for the Protection of Human Research Subjects: Update to the Additional Protections for Specific Populations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 24, 2024
Effective
October 24, 2024
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 206 (Thursday, October 24, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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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</html>Indexed from Federal Register on October 24, 2024.
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