Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period, 17595-17613 [2018-08231]
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Proposed Rules
DEPARTMENT OF HOMELAND
SECURITY
NATIONAL SCIENCE FOUNDATION
45 CFR Part 690
6 CFR Part 46
DEPARTMENT OF TRANSPORTATION
DEPARTMENT OF AGRICULTURE
49 CFR Part 11
7 Part 1c
Federal Policy for the Protection of
Human Subjects: Proposed Six Month
Delay of the General Compliance Date
While Allowing the Use of Three
Burden-Reducing Provisions During
the Delay Period
DEPARTMENT OF ENERGY
10 CFR Part 745
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
14 CFR Part 1230
DEPARTMENT OF COMMERCE
15 CFR Part 27
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1028
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 431
AGENCY FOR INTERNATIONAL
DEVELOPMENT
22 CFR Part 225
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 60
DEPARTMENT OF LABOR
29 CFR Part 21
DEPARTMENT OF DEFENSE
32 CFR Part 219
DEPARTMENT OF EDUCATION
34 CFR Part 97
DEPARTMENT OF VETERANS
AFFAIRS
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38 CFR Part 16
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 26
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 46
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Department of Homeland
Security; Department of Agriculture;
Department of Energy; National
Aeronautics and Space Administration;
Department of Commerce; Consumer
Product Safety Commission; Social
Security Administration; Agency for
International Development; Department
of Housing and Urban Development;
Department of Labor; Department of
Defense; Department of Education;
Department of Veterans Affairs;
Environmental Protection Agency;
Department of Health and Human
Services; National Science Foundation;
and Department of Transportation.
ACTION: Notice of proposed rulemaking.
AGENCY:
In a final rule published on
January 19, 2017, federal departments
and agencies made revisions to the
Federal Policy for the Protection of
Human Subjects (hereafter the ‘‘2018
Requirements’’). The Consumer Product
Safety Commission (CPSC) adopted the
same regulatory changes in a separate
final rule published on September 18,
2017. The 2018 Requirements were
scheduled to become effective on
January 19, 2018, with a general
compliance date of January 19, 2018
(with the exception of the revisions to
the cooperative research provision). The
departments and agencies listed in this
document have also published an
interim final rule delaying the effective
date and general compliance date for the
2018 Requirements for six months, to
cover the time period of January 19,
2018 until July 19, 2018.
As per the interim final rule, the
effective date of the 2018 Requirements
is now July 19, 2018. The departments
and agencies listed in this document
propose delaying the general
compliance date for the 2018
Requirements for an additional six
months, for the time period of July 19,
2018 until January 21, 2019. This
proposed rule is intended to provide
additional time to regulated entities for
the preparations necessary to implement
the 2018 Requirements. This proposed
rule, if finalized, would require
SUMMARY:
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17595
regulated entities to continue to comply
with the requirements of the current
Federal Policy for the Protection of
Human Subjects (hereafter the ‘‘pre2018 Requirements’’) until January 21,
2019.
This proposal also takes comment on
whether to permit institutions to
implement, for certain research studies,
the following provisions in the 2018
Requirements during the period from
July 19, 2018, until January 21, 2019,
that the general compliance date is
delayed. Those three provisions,
intended to reduce burdens on regulated
entities, are the 2018 Requirements’
definition of ‘‘research,’’ which deems
certain activities not to be research, the
allowance for no annual continuing
review of certain categories of research,
and the elimination of the requirement
that institutional review boards (IRBs)
review grant applications related to the
research. The way that this option is
proposed, regulated entities would be
required to comply with all pre-2018
Requirements during the period that the
general compliance date is delayed,
except for provisions substituted by the
three burden-reducing provisions of the
2018 Requirements.
As described in section III, below, this
flexibility is proposed only for studies
for which an institution makes a choice
to transition to comply with the 2018
Requirements, beginning on July 19,
2018. In order to clearly describe this
proposed flexibility, including how it
would impact institutions choosing to
transition research to comply with the
2018 Requirements, this document
proposes a redrafted transition
provision.
To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 11:59 p.m. Eastern Standard Time
on May 21, 2018.
ADDRESSES: You may submit comments,
identified by docket ID number HHS–
OPHS–2018–0007 by one of the
following methods:
• Federal eRulemaking Portal (https://
www.regulations.gov):
Æ Enter the following link into your
web browser’s address bar: https://
www.regulations.gov/document?D=
HHS-OPHS-2018-0007.
Æ Click the blue ‘‘Comment Now!’’
button in the upper right hand corner
and follow the instructions on how to
submit a comment.
Æ Alternatively, you can enter the
docket ID number into the ‘‘search’’ box
on the main page of the Federal
eRulemaking Portal (https://
www.regulations.gov) to find the
electronic docket.
DATES:
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• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]
to: Jerry Menikoff, M.D., J.D., OHRP,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852.
• Comments received, including any
personal information, will be posted
without change to https://
www.regulations.gov.
Jerry
Menikoff, M.D., J.D., Office for Human
Research Protections (OHRP),
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852; telephone:
240–453–6900 or 1–866–447–4777;
facsimile: 301–402–2071; email
Jerry.Menikoff@hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
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I. Background
On September 8, 2015, HHS and 15
other federal departments and agencies
published a notice of proposed
rulemaking (NPRM) proposing revisions
to each agency’s codification of the
Federal Policy for the Protection of
Human Subjects, originally promulgated
as a Common Rule in 1991. 80 FR
53931. On January 19, 2017, HHS and
other federal departments and agencies
published a final rule revising the
Federal Policy for the Protection of
Human Subjects. 82 FR 7149. The CPSC
adopted the same regulatory changes,
also with a scheduled effective date of
January 19, 2018, in a separate final rule
published on September 18, 2017. 82 FR
43459. For this reason, references in this
document to the January 2017 final rule
also extend to the CPSC’s September
2017 final rule. The revised policy,
reflected in both final rules, is hereafter
referred to as the ‘‘2018 Requirements.’’
The 2018 Requirements were originally
scheduled to become effective on
January 19, 2018, with a general
compliance date of January 19, 2018
(with the exception of the revisions to
the cooperative research provision at
§ ll.114(b), for which the compliance
date is January 20, 2020).
After publication of the 2018
Requirements, some representatives of
the regulated community, including
organizations representing recipients of
federal human subjects research awards,
expressed concern regarding the
regulated community’s ability to
implement all of the 2018 Requirements
by the scheduled general compliance
date.1 One of the two letters asked for
1 Two unsolicited comments were received. See
the June 21, 2017 letter to Jerry Menikoff from the
Association of American Medical Colleges,
Association of American Universities, Association
of Public & Land-grant Universities, and Council on
Governmental Relations, available at https://
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a delay in the general compliance date
of the 2018 Requirements, with the
option to adopt burden-reducing
provisions of the 2018 Requirements
during the delay period, including
certain carve-outs from the definition of
‘‘research,’’ exemptions, elimination of
the continuing review requirement for
certain categories of research, and the
elimination of the requirement that
institutional review boards (IRBs)
review grant applications. The HHS
Secretary’s Advisory Committee on
Human Research Protections (SACHRP)
also recommended in August 2017 that
the required implementation of the 2018
Requirements should be delayed.2 On
January 17, 2018, HHS and other federal
departments and agencies placed on
display in the Federal Register an
interim final rule delaying the effective
date and general compliance date of the
2018 requirements to July 19, 2018. 83
FR 2885 (published January 22, 2018).
On January 26, 2018, HUD published an
interim final rule adopting the January
17, 2018 interim final rule. 83 FR 3589.
This NPRM proposes to delay the
general compliance date of the 2018
Requirements by an additional six
months, during the time period of July
19, 2018 to January 21, 2019.
II. Proposed Delay of the General
Compliance Date
We propose to delay the general
compliance date of the 2018
Requirements for six months after the
effective date of July 19, 2018 until
January 21, 2019. Given the degree of
complexity involved with implementing
the revised rule, we believe the delay
we are proposing in this action is both
an appropriate action to take at this
juncture, and a reasonable time period
to allow the regulated community to be
prepared for compliance with the 2018
Requirements and for HHS and the
other Common Rule agencies to develop
implementation guidance. The 2018
requirements include new exemptions,
new IRB review procedures, and new
provisions pertaining to informed
consent, among other revisions, and
guidance would be helpful to the
regulated community in understanding
www.cogr.edu/sites/default/files/AAMC_AAU_
APLU_COGR%20Common%20Rule
%20Delay%20Letter%206-21-2017.pdf. See the
June 9, 2017 letter to Secretary Thomas Price from
the American Medical Informatics Association at
https://www.amia.org/sites/default/files/AMIA%20
Letter%20Regarding%20the%20Common
%20Rule.pdf.
2 August 2, 2017 SACHRP Letter to HHS
Secretary, Attachment A-Recommendations on
Compliance Dates and Transition Provisions,
https://www.hhs.gov/ohrp/sachrp-committee/
recommendations/attachment-a-august-2-2017/
index.html.
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and complying with these requirements.
As described below, we propose to
revise § ll.101(l)(2) to specify that the
general compliance date for the 2018
Requirements is January 21, 2019. We
also propose to revise the dates in the
transition provision at
§ ll.101(l)(3),(4) and (5) to reflect this
revised general compliance date.
As proposed, regulated entities would
be required to comply with the pre-2018
Requirements prior to January 21, 2019,
and the pre-2018 Requirements would
be applied by the Common Rule
departments and agencies during this
period. To clarify, under this proposal,
regulated entities would not be allowed,
prior to January 21, 2019, to comply
with all provisions of the 2018
Requirements in lieu of all provisions of
the pre-2018 Requirements. As
described below in section III, an
exception would exist during the sixmonth period between July 19, 2018,
and January 21, 2019, with respect to
three specified burden-reducing
provisions contained in the 2018
Requirements.
Research initiated (i.e., initially
approved by an IRB, or for which IRB
review was waived pursuant to
§ ll.101(i), or determined to be
exempt) before the general compliance
date of the 2018 Requirements (which
would now become January 21, 2019)
would, as a default, continue to be
subject to the pre-2018 Requirements for
their duration. This will maintain the
ability of institutions to hold such
studies to the same set of standards
throughout the studies’ duration, and
will avoid a requirement that such
research be subject to two sets of rules.
Research initiated (i.e., initially
approved by an IRB, or for which IRB
review was waived pursuant to
§ ll.101(i), or determined to be
exempt) on or after January 21, 2019
(proposed as the new general
compliance date), would need to be
conducted entirely in compliance with
the 2018 Requirements. This document
proposes to restructure § ll.101(1)(3)
and (4) (now numbered (5)) to aid
readability. A new section
§ ll.101(l)(4) is proposed to be
inserted to explain how the
requirements would apply to research
transitioning to take advantage of the
burden-reducing provisions.
We do not propose delaying the
compliance date for the cooperative
research provision of the 2018
Requirements (§ l.114(b)), which will
remain January 20, 2020.
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III. Proposed Flexibility for Taking
Advantage of Certain Burden-Reducing
Provisions Without a Delay
This proposed rule also proposes to
permit institutions, during the period
from July 19, 2018, until January 21,
2019, that the general compliance date
is proposed to be delayed, to take
advantage of three provisions in the
2018 Requirements intended to
minimize burdens on regulated entities
(hereinafter ‘‘three burden-reducing
2018 Requirements’’).
As under the January 2017 final rule,
under this proposed rule, studies
initiated prior to the general compliance
date of the 2018 Requirements, would,
as a default, remain subject to the pre2018 Requirements for their duration
unless and until a decision to transition
to the 2018 Requirements (i.e., the
institution chooses to have a study be
subject to the 2018 Requirements) is
made and documented.
The January 2017 final rule provided
an option for institutions to transition
ongoing studies from compliance with
the pre-2018 Requirements to
compliance with the 2018 Requirements
for the studies’ duration. This proposed
rule would preserve that option, and
proposes an additional flexibility for
ongoing studies to transition to the 2018
Requirements if the decision to
transition is documented prior to
January 21, 2019, which would be the
new general compliance date of the
2018 Requirements. Between July 19,
2018 and January 21, 2019, institutions
that elect to transition studies to the
2018 Requirements would, after the
decision to transition has been
documented, be able to take advantage
of the three burden-reducing 2018
Requirements. This option is available
for ongoing studies, as well as for
studies newly initiated after July 19,
2018.
This option is described in a proposed
revision to § ll.101(l). In order to
clearly outline the operation of this
proposed flexibility, we propose to
redraft § ll.101(l) to describe how the
transition provision applies to research
subject to the pre-2018 Requirements,
research transitioned from the pre-2018
Requirements to the 2018 Requirements,
and research subject to the 2018
Requirements. The revised § ll.101(l)
describes how the pre-2018
Requirements and the 2018
Requirements apply to research initiated
(i.e., initially approved by an IRB,
waived under § ll.101(i), or
determined to be exempt), during three
time periods: Prior to July 19, 2018,
between July 19, 2018 and January 21,
2019, and on or after January 21, 2019.
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As described, studies taking
advantage of this option would be
subject to the three burden-reducing
2018 Requirements instead of, or in
addition to, the comparable provisions
of the pre-2018 Requirements. The three
burden-reducing 2018 Requirements are
(1) the 2018 Requirements’ definition of
‘‘research’’ at § ll.102(l) (instead of
§ ll.102(d) of the pre-2018
Requirements), which deems certain
activities not to be research, (2) the
elimination of the requirement that an
IRB review the grant application related
to the research at § ll.103(d) of the
2018 Requirements (instead of
§ ll.103(f) of the pre-2018
Requirements), and (3) the allowance for
no annual continuing review of certain
categories of research at
§ ll.109(f)(1)(i) and (iii) of the 2018
Requirements (instead of § ll.103(b),
as related to the requirement for
continuing review, and in addition to
§ ll.109, of the pre-2018
Requirements).
Given that studies taking advantage of
this flexibility would, if this proposal is
adopted, temporarily be subject to the
three burden-reducing 2018
Requirements, but not other provisions
in the 2018 Requirements, we are
clarifying our intended interpretations
of these provisions during a transition
period. First, the definition of
‘‘research’’ in the 2018 Requirements
references a ‘‘public health authority,’’ a
term defined in the 2018 Requirements,
but not included in the pre-2018
Requirements. The reference to a
‘‘public health authority’’ in
§ ll.102(l)(3) of the 2018
Requirements would be interpreted
consistent with the definition of ‘‘public
health authority’’ included in the 2018
Requirements (§ ll.102(k)). Second,
§ ll.103(d) of the 2018 Requirements
refers to research ‘‘exempted under
§ ll.104.’’ Because the exemptions
that will be in place during any
transition period are set forth in
§ ll.101(b) of the pre-2018
Requirements, this reference to research
‘‘exempted under § ll.104’’ would be
interpreted, during this transition
period and prior to the general
compliance date of the 2018
Requirements, as a reference to research
exempted under § ll.101(b) of the pre2018 Requirements. Third, the reference
in § ll.109(f)(1)(i) of the 2018
Requirements to research eligible for
expedited review under § ll.110
would be interpreted as a reference to
that section in the pre-2018
Requirements. Moreover, the
documentation requirements set forth in
§ ll.115(a)(3) of the 2018
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Requirements (documenting an IRB’s
rationale for conducting continuing
review that would not otherwise be
required under § ll.109(f)(1) of the
2018 Requirements) would not be
applicable during this transition period
as proposed.
As proposed above, for institutions
electing to transition a research study to
compliance with the 2018 Requirements
in order to take advantage of the three
burden-reducing provisions,
§ ll.103(d) of the 2018 Requirements
would be substituted for § ll.103(f) of
the pre-2018 Requirements. Both
sections address the requirement for
certification of research supported by a
Federal department or agency. In
addition to removing the requirement
that IRBs review grant applications or
proposals, § ll.103(d) of the 2018
Requirements reflects other minor
wording changes necessary to
accommodate the removal of the grant
application or proposal review
requirement or to provide additional
clarifications.
Except for the three burden-reducing
2018 Requirements identified in
proposed § ll.101(l)(4)(i)(A),
institutions that elect to transition a
research study to comply with the 2018
Requirements and document that
decision, at any time between July 19,
2018, and January 21, 2019, would be
required to comply with the pre-2018
Requirements until January 21, 2019.
This approach would afford institutions
additional time before they are required
to comply with all provisions of the
2018 Requirements, while enabling
them to take advantage of the three
burden-reducing 2018 Requirements
more quickly. The option of applying
the three burden-reducing 2018
Requirements would only be available
for studies that institutions decided to
transition to comply with the 2018
Requirements on or after July 19, 2018.
If an institution so chooses to apply the
three burden-reducing 2018
Requirements to certain research, those
studies would be required to comply
with all of the 2018 Requirements
beginning on January 21, 2019.
An institution’s decision about
whether to transition a study to the 2018
requirements to take advantage of the
three burden-reducing provisions might
vary depending on the nature and
progress of the study, including any
elements of the study to be conducted
on or after January 21, 2019. For
example, studies planning to recruit
some subjects on or after January 21,
2019 would have to meet the new
requirements for obtaining the informed
consent of those subjects. In contrast, for
studies whose remaining activities
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consist only of completing data
analyses, the new requirements for
informed consent generally would not
be applicable.
We considered stakeholder
suggestions to extend this approach to
other burden-reducing sections of the
2018 Requirements, such as the revised
exemption categories. We do not
propose adding the revised exemption
categories to § ll.101(l)(4)(i)(A)
because implementation of these
categories would involve significantly
greater complications. For example,
these categories use terms that are
newly defined or for which revised
definitions have been included in the
2018 Requirements, and permitting
compliance with these categories
without also selectively adopting
revised definitions could be
problematic. To minimize confusion,
this proposed rule limits those
provisions for which early adoption
would be permitted to those that would
minimize burdens without creating
significant complexities. We also
considered a delay to the effective and
general compliance dates without
proposing this additional option in the
interim period. Such an approach
would be simple to implement. We
decided against proposing this
alternative to be responsive to public
comments received and in an effort to
minimize burdens with respect to new
provisions that will not be difficult to
implement prior to the general
compliance date of the 2018
Requirements.
As proposed for § ll.101(l)(4)(ii), if
the determination to transition
previously initiated studies to the 2018
Requirements is not made until on or
after January 21, 2019, such studies
would not benefit from the additional
flexibilities created for the period
between July 19, 2018 and January 21,
2019. Such studies would be required to
comply with the 2018 Requirements
after the date of transition.
The regulatory provisions are not
prescriptive regarding how an
institution chooses to make its
transition decisions. An institution may
elect to transition research protocols to
the 2018 Requirements on a protocol-byprotocol basis, or for a class of protocols
(e.g., all minimal risk research), or for
the institution’s entire research
portfolio. While these three burden
reducing provisions are a regulatory
package, an institution that took
advantage of the flexibility proposed in
this NPRM, as a matter of institutional
policy, could adopt a more stringent
standard (such as that of the pre-2018
rule) for any or all of these three
provisions.
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We also propose a revision to
§ ll.101(l)(4) regarding
documentation of an institution’s
decision to transition research begun
under the pre-2018 Requirements to the
2018 Requirements. This proposal is
intended to offer institutions greater
flexibility regarding who documents
that decision. Under the January 19,
2017, final rule, if an institution
determines that ongoing research will
transition to comply with the 2018
Requirements, this determination must
be documented by an IRB before the
transition can take effect. We now
propose that, to allow ease in
implementing this documentation
requirement, the documentation of an
institution’s transition determination
may be performed either by an
institution (through officials who have
the authority to make such
determinations on behalf of the
institution) or an IRB. As proposed, this
documentation must include the date of
the transition determination. Records
documenting the transition decision
must be retained as per § ll.115(b).
Once the institution makes the
determination to transition the research
to the revised rule and that
determination is documented, the date
of documentation will serve as the de
facto compliance date as applied to the
research. For a study that is transitioned
in accordance with § ll.101(l)(4)(i),
between July 19, 2018, and January 20,
2019, one set of rules would apply until
the general compliance date of the final
rule and another would apply beginning
on such general compliance date. As of
the date the decision to transition is
documented until January 20, 2019, the
pre-2018 Requirements would be
applicable, except that the three burdenreducing 2018 Requirements would
apply instead of or in addition to the
pre-2018 Requirements specified in
§ ll.101(l)(4)(i)(A). Beginning on
January 21, 2019, the 2018
Requirements would apply for the
duration of the study.
As proposed, all studies that are
transitioned in accordance with
§ ll.101(l)(4)(ii) on or after January 21,
2019, and all studies that are newly
initiated on and after January 21, 2019,
would be required to follow all of the
2018 Requirements.
In summary, the proposed rule would
create three options that would be
available beginning July 19, 2018, that
institutions may choose to follow for
research studies initiated before January
21, 2019. The first option, and default,
is to continue to follow all of the pre2018 Requirements for the duration of
the study. The second option is to
choose to follow the pre-2018
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Requirements, except for the three
burden-reducing 2018 Requirements,
until January 21, 2019, when all of 2018
Requirements would become applicable.
The third option would be to follow the
pre-2018 requirements until January 21,
2019, and at some point thereafter
choose to follow all of the 2018
Requirements for the duration of the
study.
We also solicit comments about the
advisability of the alternative of
delaying the effective date and general
compliance date until January 21, 2019,
but without the option to implement
certain 2018 Requirements during that
delay period.
In addition, we solicit comments on
the desirability of the alternative of
delaying the effective date and general
compliance date beyond January 21,
2019. We do not believe the regulated
community will require this additional
time to come into compliance with the
revised rule, but we are interested in
receiving public comments on this
alternative.
While we considered the alternative
of proposing to amend the transition
provision to permit institutions to
voluntarily comply with the revised rule
beginning on July 19, 2018, and not
requiring compliance with the new rule
until January 21, 2019 or later, we
believe this approach could result in
confusion regarding implementation of
the revised Common Rule that could be
minimized with the issuance of
guidance from the Common Rule
departments and agencies. By making
the changes proposed above, we believe
the Common Rule departments and
agencies will be able to issue relevant
guidance documents that will better
enable the regulated community to
comply with the revised rule.
We also solicit comments about the
advisability of not making the changes
proposed in this NPRM (i.e., allowing
the effective date and general
compliance date to remain as July 19,
2018). Finally, we note that we will
consider public comments submitted in
response to the interim final rules
described above.
IV. Legal Authorities
The legal authorities for the
departments and agencies that are
signatories to this action are as follows:
Department of Homeland Security, 5
U.S.C. 301; Public Law 107–296, sec.
102, 306(c); Public Law 108–458, sec.
8306. Department of Agriculture, 5
U.S.C. 301; 42 U.S.C. 300v–1(b).
Department of Energy, 5 U.S.C. 301; 42
U.S.C. 7254; 42 U.S.C. 300v–1(b).
National Aeronautics and Space
Administration, 5 U.S.C. 301; 42 U.S.C.
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300v–1(b). Department of Commerce, 5
U.S.C. 301; 42 U.S.C. 300v–1(b).
Consumer Product Safety Commission,
5 U.S.C. 301; 42 U.S.C. 300v–1(b).
Social Security Administration, 5 U.S.C.
301; 42 U.S.C. 289(a). Agency for
International Development, 5 U.S.C.
301; 42 U.S.C. 300v–1(b), unless
otherwise noted. Department of Housing
and Urban Development, 5 U.S.C. 301;
42 U.S.C. 300v–1(b); 3535(d).
Department of Labor, 5 U.S.C. 301; 29
U.S.C. 551. Department of Defense, 5
U.S.C. 301. Department of Education, 5
U.S.C. 301; 20 U.S.C. 1221e–3, 3474.
Department of Veterans Affairs, 5 U.S.C.
301; 38 U.S.C. 501, 7331, 7334; 42
U.S.C. 300v–1(b). Environmental
Protection Agency, 5 U.S.C. 301; 7
U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C.
346a(e)(1)(C); sec. 201, Public Law 109–
54, 119 Stat. 531; and 42 U.S.C. 300v–
1(b). Department of Health and Human
Services, 5 U.S.C. 301; 42 U.S.C. 289(a);
42 U.S.C. 300v–1(b). National Science
Foundation, 5 U.S.C. 301; 42 U.S.C.
300v–1(b). Department of
Transportation, 5 U.S.C. 301; 42 U.S.C.
300v–1(b).
V. Regulatory Impact Analyses
We have examined the effects of this
proposed 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 13771 on
Reducing Regulation and Controlling
Regulatory Costs (January 30, 2017), the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13), the Regulatory Flexibility
Act, (Pub. L. 96–354, September 19,
1980), the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104–4), and
Executive Order 13132 on Federalism
(August 4, 1999).
A. Executive Orders 12866, 13563, and
13771
Executive Orders 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). Executive Order 13563 is
supplemental to and reaffirms the
principles, structures, and definitions
governing regulatory review as
established in Executive Order 12866,
emphasizing the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. In
accordance with the provisions of
Executive Order 12866, this proposed
rule was submitted to the Office of
Management and Budget (OMB) for
review, and has been determined to be
a ‘‘significant’’ regulatory action. The
designation, as regulatory or
deregulatory under Executive Order
13771 (Reducing Regulation and
Controlling Regulatory Costs, issued on
January 30, 2017), of any final rule
resulting from this notice of proposed
rulemaking will be informed by
comments received on the costs and
cost savings of delaying the 2018
Requirements. Details on the
preliminary estimated costs of this
proposed rule can be found in the
economic analysis below.
1. Need for This NPRM and Summary
On January 19, 2017, HHS and 15
other federal departments and agencies
published the 2018 Requirements
designed to more thoroughly address
the broader types of research conducted
or otherwise supported by all of the
Common Rule departments and
agencies. In addition, the CPSC adopted
the same regulatory changes on
September 18, 2017.
This proposed rule, if finalized,
would allow regulated entities to
continue to comply with the pre-2018
requirements until January 21, 2019. As
discussed above, this proposed rule also
proposes to permit institutions, during
17599
the period between July 19, 2018, and
January 21, 2019, to take advantage of
three provisions in the 2018
Requirements intended to minimize
burdens on regulated entities. Those
three burden-reducing 2018
Requirements are (1) the 2018
Requirements’ definition of ‘‘research,’’
which deems certain activities not to be
research, (2) the allowance for no
annual continuing review of certain
categories of research, and (3) the
elimination of the requirement that IRBs
review grant applications related to the
research. As described in section III
above, this flexibility is proposed for
studies for which an institution makes
a choice to have those studies be subject
to the 2018 Requirements.
2. Analysis of Benefits (Cost-Savings)
and Costs (Foregone Benefits) 3
The RIA for the 2018 Requirements
described the benefits and costs of 16
broad categories of changes finalized.
The RIA for this NPRM uses the
information and calculations described
in the preamble to the 2018
Requirements as a base for estimating
benefits and costs of delaying the
general implementation of the 2018
Requirements by six months. The time
period for the analysis in this RIA is the
six month period from July 2018 to
January 2019.
Table 1 summarizes the quantified
benefits and costs of delaying the
general implementation of 2018
Requirements. Over the period of July
2018 to January 2019, annualized
benefits of $6.4 million are estimated
using a 3 percent discount rate;
annualized benefits of $5.9 million are
estimated using a 7 percent discount
rate. Annualized costs of $37.2 million
are estimated using a 3 percent discount
rate; annualized costs of $34.4 million
are estimated using a 7 percent discount
rate. Note that all values are represented
in millions of 2016 dollars, and 2016 is
used as the frame of reference for
discounting.
TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE GENERAL COMPLIANCE DATE OF THE 2018 REQUIREMENTS BY
SIX MONTHS
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[From July 19, 2018 to January 21, 2019]
Annualized value
by discount rate
(millions of 2016 dollars)
3 Percent
Benefits (Cost–Savings):
Quantified Benefits ...........................................................................................................................................
Costs (Foregone Benefits):
3 Note, that the terms ‘‘benefits’’ and ‘‘costsavings’’ are used interchangeably in this RIA.
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Similarly, the terms ‘‘costs’’ and ‘‘foregone benefits’’
are also used interchangeably.
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TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE GENERAL COMPLIANCE DATE OF THE 2018 REQUIREMENTS BY
SIX MONTHS—Continued
[From July 19, 2018 to January 21, 2019]
Annualized value
by discount rate
(millions of 2016 dollars)
3 Percent
Quantified Costs ...............................................................................................................................................
The estimated benefits and costs of
delaying the general implementation
date of the 2018 Requirements by six
months are shown in Table 2 below.
Note that the categorization shown
below includes the same 16 categories
7 Percent
37.4
34.7
used in the RIA of the 2018
Requirements.
TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF
DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS BY SIX MONTHS 4
Annualized value over 1 year by discount rate
(millions of 2016 dollars)
2018 Requirement RIA Category
Benefits (cost-savings)
3%
Regulated Community Learning New Requirements and Developing Training Materials; OHRP Developing Training and Guidance Materials, and
Implementing the 2018 Requirements .........................................................
Extending Oversight to IRBs Unaffiliated with an Institution Holding an FWA
(impact to IRBs not operated by an FWA-holding institution) .....................
Excluding Activities from the Requirements of the Common Rule because
They are not Research ................................................................................
Clarifying and Harmonizing Regulatory Requirements and Agency Guidance
Modifying the Assurance Requirements ..........................................................
Requirement for Written Procedures and Agreements for Reliance on IRBs
Not Operated by the Engaged Institution (impact to FWA-holding institutions) .............................................................................................................
Eliminating the Requirement that the Grant Application Undergo IRB Review and Approval ........................................................................................
Expansion of Research Activities Exempt from Full IRB Review ...................
Elimination of Continuing Review of Research Under Specific Conditions ....
Amending the Expedited Review Procedures .................................................
Cooperative Research (single IRB mandate in multi-institutional research) 5
Changes in the Basic Elements of Consent, Including Documentation ..........
Obtaining Consent to Secondary Use of Identifiable biospecimens and Identifiable private information ............................................................................
Elimination of Pre-2018 Rule Requirement to Waive Consent in Certain
Subject Recruitment Activities .....................................................................
Requirement for Posting of Consent Forms for Clinical Trials Conducted or
supported by Common Rule Departments or Agencies ..............................
Alteration in Waiver for Documentation of Informed Consent in Certain Circumstances ..................................................................................................
Cost Savings, as indicated by public comments (unable to attribute to particular provisions) .........................................................................................
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We assume that, in almost all
categories described in the RIA for the
2018 Requirements, the foregone
4 Zeroes in Table 2 (represented by ‘‘—’’) signify
that the category has been unaffected by the six
month delay of the 2018 Requirements. The
category could be unaffected for one of two reasons:
(1) No costs or benefits were associated with the
category in the RIA for the 2018 Requirements; or
(2) the costs and benefits of the provision during the
six month delay are the same as those estimated in
the RIA for the 2018 Requirements.
5 Because compliance with this provision is not
required until 2020, benefits and costs here are not
included.
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7%
—
—
—
—
4.47
4.14
—
—
—
—
—
—
—
—
0.95
—
0.31
0.88
—
0.29
—
—
—
—
—
0.01
1.04
—
—
—
—
0.01
0.96
—
—
—
8.5
20.8
4.10
2.66
—
—
7.9
19.3
3.80
2.47
—
—
—
—
—
—
—
—
0.07
0.06
0.85
0.79
—
—
—
—
—
—
—
—
unquantified
benefits (costs) of delaying the 2018
Requirements by six months are what
would have been the benefits of
implementing the 2018 Requirements
during the period of July 2018 through
January of 2019. Similarly, we assume
that, in almost all categories described
in the RIA for the 2018 Requirements,
the benefits (cost-savings) associated
with delaying the 2018 Requirements by
six months are what would have been
the costs of implementing the 2018
Requirements during the period of July
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(Foregone benefits)
2018 through January of 2019. We
assume this because regulated entities
likely would not have difficulty
implementing these provisions in the
absence of guidance from Common Rule
departments or agencies, and thus could
have been implemented as assumed in
the economic analysis contained in the
RIA for the 2018 Requirements. We seek
comment on these assumptions.
Categories with different assumptions
are described below:
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a. Regulated Community Learning New
Requirements and Developing Training
Materials; OHRP Developing Training
and Guidance Materials, and
Implementing the 2018 Requirements
We assume that even with the
proposed six month delay, regulated
entities and OHRP would still assume
costs related to learning the new
requirements and developing training
materials. Thus, there are no effects
estimated here.
We expect that some entities would
experience cost savings as a result of
this proposed rule, and some entities
would experience costs as a result of
this proposed rule, but we lack data to
quantify these effects. We request
comments which provide data that can
be used to quantify these effects.
sradovich on DSK3GMQ082PROD with PROPOSALS2
b. Early Implementation of the Three
Burden-Reducing Provisions of the 2018
Requirements (Explicit Carve-Outs of
Activities From the Definition of
Research [§ ll.102(I)]; Eliminating the
Requirement That the Grant Application
Undergo IRB Review and Approval [Pre2018 Rule at § ll.103(f)]; Elimination
of Continuing Review of Research
Under Specific Conditions
[§§ ll.109(f) and ll.115(a)(3)]
We assume that 50 percent of
regulated entities will take advantage of
the option proposed in this NPRM to
implement three burden-reducing
provisions of the 2018 Requirements
early. We assume this because an
institution’s decision about whether to
transition a study to the 2018
requirements to take advantage of the
three burden-reducing provisions might
vary depending on the nature and
progress of the study, including any
elements of the study to be conducted
after January 21, 2019. For example,
studies planning to recruit some
subjects after January 21, 2019 would
have to meet the new requirements for
obtaining the informed consent of those
subjects. In contrast, for studies whose
remaining activities consist only of
completing data analyses, the new
requirements for informed consent
would generally not be applicable.
Therefore, we assume that there are
situations where an institution would
want to take advantage of the three
burden-reducing provisions, and
situations where an institution would
not want to take advantage of this
flexibility. We note that we intend to
publish guidance on the carve-outs from
the definition of research prior to July
2018, which may also impact an
institution’s decision to elect to
implement the three burden-reducing
provisions or not.
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Thus, these entities will still obtain
the benefits and costs described in the
RIA for the 2018 Requirements,
implying no effects of this rule for 50
percent of regulated entities. For the
regulated entities that do not take
advantage of these flexibilities, we
assume that the foregone benefits (costs)
of delaying implementation of these
provisions are what would have been
the benefits of implementing these
provisions in January of 2018. Similarly,
we assume that the benefits (costsavings) associated with delaying the
implementation of these provisions are
what would have been the costs of
implementing these provisions in July
of 2018. We assume that these regulated
entities account for 50 percent of the
costs and benefits that would have been
experienced in 2018 absent this delay.
We also assume that institutional staff
at the IRB Administrative staff level 6
will spend 5 minutes per protocol
documenting the voluntary election to
use the three burden-reducing 2018
provisions during the time period of
July 19, 2018 to January 21, 2019.
We request comment on our
assumption that 50 percent of regulated
entities will take advantage of the
option proposed in this NPRM to
implement three burden-reducing
provisions of the 2018 Requirements
early.
Some members of the regulated
community have indicated that even
though the 2018 Requirements yield
cost savings, these institutions are still
hesitant to transition ongoing research
to the 2018 Requirements, largely
because of the burden of making studies
already in compliance with the pre-2018
requirements comply with the 2018
requirements. Also, some institutions
seem inclined to make all of the
transitions at once. This
interconnectedness is key to some of the
assumptions noted elsewhere in this
analysis. For example, if the three
burden-reducing provisions are
considered on their own, a reasonable
assumption would be that 100 percent
of affected entities would realize the
associated cost savings as soon as
possible. The use, instead, of a 50
percent estimate reflects entities’
possible inclinations to make all
transitions at once. We request comment
that would provide insight into entities’
views regarding the interconnectedness
of the 2018 Requirements’ provisions
and thus allow for refinement of the 50
percent estimate.
6 See
the RIA to the 2018 Requirements (82 FR
7149) for more information about the labor
categories used in this analysis.
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17601
c. Expansion of Research Activities
Exempt From Full IRB Review
(§ ll.104(d))
The 2018 Requirements include five
new exemption categories, and modify
all but one exemption that exist in the
pre-2018 Requirements. We have
received feedback from SACHRP that
guidance will be useful for regulated
entities to implement many of the
exemption categories.7 Areas where
significant guidance will be helpful
include: Applying the categories of the
new exemptions themselves, conducting
limited IRB review (as required in four
exemptions), developing and using
broad consent (as required in two
exemptions), utilizing the exemption for
certain HIPAA covered activities, and
understanding which federally
supported or conducted nonresearch
information collections qualify for
exemption.
Because the guidance documents that
would be helpful to assist regulated
entities in implementing these 2018
Common Rule provisions have not yet
been developed, we assume that 50
percent of the regulated entities would
not have taken advantage of the
expansion in exemptions during this six
month-delay. For these entities, we
assume that there are no benefits and
costs of the proposed delay, because
they would not have changed their
operations. We assume that 50 percent
of the regulated entities would have
gone forward with using the new or
expanded exemption categories under
the 2018 Requirements; for these
entities, there are costs of delaying the
implementation of this provision during
the six-month delay proposed in this
NPRM.
We do not have data to support our
assumption of what percent of regulated
entities would have gone forward with
the implementation of these provisions
in the absence of additional guidance,
and what percent would not have gone
forward. We request comments on these
assumptions and solicit data that can be
used to quantify these effects.
3. Analysis of NPRM Alternative
This NPRM includes a primary
alternative proposal of delaying the
general effective and compliance date to
January 2019.
Table 3 summarizes the quantified
benefits and costs of the alternative
proposal of delaying the general
implementation of 2018 Requirements
without the option to implement certain
7 See for example, SACHRP Recommendations of
August 2, 2017: https://www.hhs.gov/ohrp/sachrpcommittee/recommendations/sachrprecommendations/.
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2018 Requirements. Over the period of
July 2018 to January 2019, annualized
benefits of $7.4 million are estimated
using a 3 percent discount rate;
annualized benefits of $6.9 million are
estimated using a 7 percent discount
rate. Annualized costs of $50.8 million
are estimated using a 3 percent discount
rate; annualized costs of $47.0 million
are estimated using a 7 percent discount
rate. Note that all values are represented
in millions of 2016 dollars, and 2016 is
used as the frame of reference for
discounting.
TABLE 3—ALL BENEFITS AND COSTS OF DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS UNDER THE
ALTERNATIVE PROPOSAL
Annualized value
by discount rate
(millions of 2016 dollars)
3 Percent
Benefits (Cost–Savings):
Quantified Benefits ...........................................................................................................................................
Costs (Foregone Benefits):
Quantified Costs ...............................................................................................................................................
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B. Paperwork Reduction Act (PRA)
This proposed rule contains
collections of information that are
subject to review and approval by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act (PRA), as amended (44 U.S.C. 3501–
3520). A description of these provisions
is given in this document with an
estimate of the annual reporting and
recordkeeping burden.
Title: Federal Policy for the Protection
of Human Subjects.
Description: In this document is a
discussion of the regulatory provisions
we believe are subject to the PRA and
the probable information collection
burden associated with these
provisions. In general, the following
actions trigger the PRA: (i) Reporting;
(ii) Recordkeeping.
Description of Respondents: The
reporting and recordkeeping
requirements in this document are
imposed on institutions, institutional
review boards, and investigators
involved in human subjects research
conducted or supported or otherwise
subject to regulation by any federal
department or agency that takes
administrative action that makes the
policy applicable to such research.
§ ll.101(l)(4). Compliance Date and
Transition Provision (OMB Control No
0990–0260)
Section 101(l)(4)(i) would permit
studies to transition to the 2018
Requirements between July 19, 2018
and January 21, 2019 (which would be
the new general compliance date of the
2018 Requirements). Between July 19,
2018 and January 21, 2019, institutions
that elect to transition studies to the
2018 Requirements would, after the
decision to transition has been
documented, be able to take advantage
of the three burden-reducing 2018
Requirements.
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This option is described in a proposed
revision to § ll.101(l)(4)(i). As
described, studies taking advantage of
this option would be subject to the three
burden-reducing 2018 Requirements
instead of, or in addition to, the
comparable provisions of the pre-2018
Requirements. As discussed above, the
three burden-reducing 2018
Requirements are (1) the 2018
Requirements’ definition of ‘‘research’’
at § ll.102(l) (instead of § ll.102(d)
of the pre-2018 Requirements), which
deems certain activities not to be
research, (2) the elimination of the
requirement that an IRB review the
grant application or proposal related to
the research at § ll.103(d) of the 2018
Requirements (instead of § ll.103(f) of
the pre-2018 Requirements), and (3) the
allowance for no annual continuing
review of certain categories of research
at § ll.109(f)(1)(i) and (iii) of the 2018
Requirements (instead of § ll.103(b),
as related to the requirement for
continuing review, and in addition to
§ ll.109 of the pre-2018
Requirements).
We estimate that approximately
92,084 protocols would take advantage
of the voluntary election described in
§ ll.101(l)(4)(i). We estimate that
institutional staff would spend 5
minutes per protocol documenting that
the study will be subject to the three
burden-reducing 2018 Requirements
during the time period of July 19, 2018
through January 21, 2019. We estimate
that this provision includes 7,673
burden hours.
C. Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.) (RFA) and the Small
Business Regulatory Enforcement and
Fairness Act of 1996, which amended
the RFA, require agencies that issue a
regulation to analyze options for
regulatory relief for small businesses. If
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7.4
6.9
50.8
47.0
a rule has a significant economic 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 (SBA); (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.
If finalized, this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. 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
proposed rule would not impose a
regulatory burden for regulated small
entities because it would delay the
general compliance date of the 2018
Requirements, allowing the status quo
to be retained for the period of delay,
and also would allow regulated small
entities to elect to implement the 2018
Requirements as scheduled if the
entities so choose. We have therefore
concluded that this action will have no
net regulatory burden for all directly
regulated small entities. We request
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comment on this conclusion, including
specific data and information to support
commenters’ views.
D. Unfunded Mandates Reform Act
(UMRA)
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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. We have determined that
the proposed rule would not contain
policies that would 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. The changes in
the proposed rule represent the Federal
Government regulating its own program.
Accordingly, we conclude that the rule
does not propose policies that have
federalism implications as defined in
Executive Order 13132 and,
consequently, a federalism summary
impact statement is not required.
For the reasons set forth in the
preamble, the Federal Policy for the
Protection of Human Subjects, as
published in the Federal Register on
January 19, 2017 (82 FR 7149) and as
adopted in a final rule published by the
CPSC on September 18, 2017 (82 FR
43459), and as amended in a final rule
published in the Federal Register on
January 22, 2018 (83 FR 2885) and
adopted by HUD through a final rule
published on January 26, 2018 (83 FR
3589), is proposed to be amended as
follows:
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PART ll—PROTECTION OF HUMAN
SUBJECTS
1. Amend § ll.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
Section 202(a) of the Unfunded
Mandates Reform Act 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
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $148
million, using the most current (2016)
implicit price deflator for the gross
domestic product. We do not expect this
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.
VerDate Sep<11>2014
Text of the Amended Common Rule
§ ll.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part/subpart. The general compliance
date for the 2018 Requirements is
January 21, 2019. The compliance date
for § ll.114(b) (cooperative research)
of the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § ll.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under
§ ll.101(b) of the pre-2018
Requirements before January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section ll.102(l) of the 2018
Requirements (definition of research)
(instead of § ll.102(d) of the pre-2018
Requirements),
(2) Section ll.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ ll.103(f) of the pre-2018
Requirements), and
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17603
(3) Section ll.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ ll.103(b), as related to the
requirement for continuing review, and
in addition to § ll.109, of the pre2018 Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
Department of Homeland Security
List of Subjects in 6 CFR Part 46
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Homeland
Security proposes to further amend 6
CFR part 46 as published in the Federal
Register on January 19, 2017 (82 FR
7149), and as amended in a final rule
published in the Federal Register on
January 22, 2018 (83 FR 2885), as
follows:
PART 46—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 46
continues to read as follows:
■
Authority: 5 U.S.C. 301; P.L. 107–296, sec.
102, 306(c); P.L. 108–458, sec. 8306.
2. Amend § 46.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 46.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 46.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
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following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 46.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 46.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 46.102(l) of the 2018
Requirements (definition of research)
(instead of § 46.102(d) of the pre-2018
Requirements),
(2) Section 46.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 46.103(f) of the pre-2018
Requirements), and
(3) Section 46.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 46.103(b), as related to the
requirement for continuing review, and
in addition to § 46.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
VerDate Sep<11>2014
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Jkt 244001
Elaine C. Duke,
Deputy Secretary, Department of Homeland
Security.
Department of Agriculture
List of Subjects in 7 CFR Part 1c
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Agriculture
proposes to further amend 7 CFR part 1c
as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in a final rule published in the
Federal Register on January 22, 2018
(83 FR 2885), as follows:
PART 1c—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 1c
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 1c.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 1c.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 1c.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 1c.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 1c.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
PO 00000
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Fmt 4701
Sfmt 4702
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 1c.102(l) of the 2018
Requirements (definition of research)
(instead of § 1c.102(d) of the pre-2018
Requirements),
(2) Section 1c.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 1c.103(f) of the pre-2018
Requirements), and
(3) Section 1c.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 1c.103(b), as related to the requirement
for continuing review, and in addition
to § 1c.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Chavonda Jacobs-Young,
Acting Deputy Under Secretary for Research,
Education, and Economics, USDA.
Department of Energy
List of Subjects in 10 CFR Part 745
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Energy
proposes to further amend 10 CFR part
745 as published in the Federal Register
on January 19, 2017 (82 FR 7149), and
as amended in a final rule published in
the Federal Register on January 22,
2018 (83 FR 2885), as follows:
PART 745—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 745
continues to read as follows:
■
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Authority: 5 U.S.C. 301; 42 U.S.C. 7254;
42 U.S.C. 300v–1(b).
2. Amend § 745.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 745.101
To what does this policy apply?
sradovich on DSK3GMQ082PROD with PROPOSALS2
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 745.114(b) (cooperative research) of
the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 745.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 745.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 745.102(l) of the 2018
Requirements (definition of research)
(instead of § 745.102(d) of the pre-2018
Requirements),
(2) Section 745.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 745.103(f) of the pre-2018
Requirements), and
(3) Section 745.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
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19:24 Apr 19, 2018
Jkt 244001
§ 745.103(b), as related to the
requirement for continuing review, and
in addition to § 745.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Dan Brouillette,
Deputy Secretary of Energy.
National Aeronautics and Space
Administration
List of Subjects in 14 CFR Part 1230
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, National Aeronautics and
Space Administration proposes to
further amend 14 CFR part 1230 as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in a final rule published in the
Federal Register on January 22, 2018
(83 FR 2885), as follows:
PART 1230—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 1230
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 1230.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 1230.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 1230.114(b) (cooperative research) of
the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
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17605
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 1230.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under
§ 1230.101(b) of the pre-2018
Requirements before January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 1230.102(l) of the 2018
Requirements (definition of research)
(instead of § 1230.102(d) of the pre-2018
Requirements),
(2) Section 1230.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 1230.103(f) of the pre-2018
Requirements), and
(3) Section 1230.109(f)(1)(i) and (iii)
of the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 1230.103(b), as related to the
requirement for continuing review, and
in addition to § 1230.109, of the pre2018 Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
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(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
James D. Polk,
Chief Health & Medical Officer, National
Aeronautics and Space Administration.
Department of Commerce
List of Subjects in 15 CFR Part 27
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Commerce
proposes to further amend 15 CFR part
27 as published in the Federal Register
on January 19, 2017 (82 FR 7149), and
as amended in a final rule published in
the Federal Register on January 22,
2018 (83 FR 2885), as follows:
PART 27—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 27
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 27.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 27.101
To what does this policy apply?
sradovich on DSK3GMQ082PROD with PROPOSALS2
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 27.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 27.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 27.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
VerDate Sep<11>2014
19:24 Apr 19, 2018
Jkt 244001
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 27.102(l) of the 2018
Requirements (definition of research)
(instead of § 27.102(d) of the pre-2018
Requirements),
(2) Section 27.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 27.103(f) of the pre-2018
Requirements), and
(3) Section 27.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 27.103(b), as related to the
requirement for continuing review, and
in addition to § 27.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Wilbur L. Ross,
Secretary of Commerce.
Consumer Product Safety Commission
List of Subjects in 16 CFR Part 1028
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Consumer Product Safety
Commission proposes to further amend
16 CFR part 1028 as published in the
Federal Register on January 19, 2017
(82 FR 7149) and as adopted in a final
rule published by the CPSC on
September 18, 2017 (82 FR 43459), and
as amended in a final rule published in
the Federal Register on January 22,
2018 (83 FR 2885), as follows:
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Fmt 4701
Sfmt 4702
PART 1028—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 1028
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 1028.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 1028.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 1028.114(b) (cooperative research) of
the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 1028.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under
§ 1028.101(b) of the pre-2018
Requirements before January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 1028.102(l) of the 2018
Requirements (definition of research)
(instead of § 1028.102(d) of the pre-2018
Requirements),
(2) Section 1028.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
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§ 1028.103(f) of the pre-2018
Requirements), and
(3) Section 1028.109(f)(1)(i) and (iii)
of the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 1028.103(b), as related to the
requirement for continuing review, and
in addition to § 1028.109, of the pre2018 Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
Social Security Administration
List of Subjects in 20 CFR Part 431
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Social Security
Administration proposes to further
amend 20 CFR part 431 as published in
the Federal Register on January 19,
2017 (82 FR 7149), and as amended in
a final rule published in the Federal
Register on January 22, 2018 (83 FR
2885), as follows:
PART 431—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 431
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
2. Amend § 431.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
sradovich on DSK3GMQ082PROD with PROPOSALS2
§ 431.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
VerDate Sep<11>2014
19:24 Apr 19, 2018
Jkt 244001
§ 431.114(b) (cooperative research) of
the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 431.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 431.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 431.102(l) of the 2018
Requirements (definition of research)
(instead of § 431.102(d) of the pre-2018
Requirements),
(2) Section 431.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 431.103(f) of the pre-2018
Requirements), and
(3) Section 431.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 431.103(b), as related to the
requirement for continuing review, and
in addition to § 431.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
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Fmt 4701
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17607
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Nancy Berryhill,
Deputy Commissioner for Operations,
performing the duties and functions not
reserved to the Commissioner of Social
Security.
Agency for International Development
List of Subjects in 22 CFR Part 225
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Agency for International
Development proposes to further amend
22 CFR part 225 as published in the
Federal Register on January 19, 2017
(82 FR 7149), and as amended in a final
rule published in the Federal Register
on January 22, 2018 (83 FR 2885), as
follows:
PART 225—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 225
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b), unless otherwise noted.
2. Amend § 225.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 225.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 225.114(b) (cooperative research) of
the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 225.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
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research was exempt under § 225.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 225.102(l) of the 2018
Requirements (definition of research)
(instead of § 225.102(d) of the pre-2018
Requirements),
(2) Section 225.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 225.103(f) of the pre-2018
Requirements), and
(3) Section 225.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 225.103(b), as related to the
requirement for continuing review, and
in addition to § 225.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
sradovich on DSK3GMQ082PROD with PROPOSALS2
Kerry Pelzman,
Acting Senior Deputy Assistant
Administrator for Global Health, U.S. Agency
for International Development.
Department of Housing and Urban
Development
List of Subjects in 24 CFR Part 60
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Housing and
VerDate Sep<11>2014
19:24 Apr 19, 2018
Jkt 244001
Urban Development proposes to further
amend 24 CFR part 60 as published in
the Federal Register on January 19,
2017 (82 FR 7149), and as amended in
a final rule published in the Federal
Register on January 22, 2018 (83 FR
2885) and adopted by HUD through a
final rule published on January 26, 2018
(83 FR 3589), as follows:
PART 60—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 60
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b) and 3535(d).
2. Amend § 60.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 60.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 60.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 60.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 60.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
PO 00000
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Fmt 4701
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Requirements, except that the research
shall comply with the following:
(1) Section 60.102(l) of the 2018
Requirements (definition of research)
(instead of § 60.102(d) of the pre-2018
Requirements),
(2) Section 60.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 60.103(f) of the pre-2018
Requirements), and
(3) Section 60.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 60.103(b), as related to the
requirement for continuing review, and
in addition to § 60.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Todd M. Richardson,
Acting General Deputy Assistant Secretary
for Policy Development and Research, U.S.
Department of Housing and Urban
Development.
Department of Labor
List of Subjects in 29 CFR Part 21
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Labor proposes
to further amend 29 CFR part 21 as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in a final rule published in the
Federal Register on January 22, 2018
(83 FR 2885), as follows:
PART 21—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 21
continues to read as follows:
■
Authority: 5 U.S.C. 301; 29 U.S.C. 551.
2. Amend § 21.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
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§ 21.101
To what does this policy apply?
sradovich on DSK3GMQ082PROD with PROPOSALS2
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 21.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 21.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 21.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 21.102(l) of the 2018
Requirements (definition of research)
(instead of § 21.102(d) of the pre-2018
Requirements),
(2) Section 21.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 21.103(f) of the pre-2018
Requirements), and
(3) Section 21.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 21.103(b), as related to the
requirement for continuing review, and
in addition to § 21.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
VerDate Sep<11>2014
19:24 Apr 19, 2018
Jkt 244001
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Dated: April 2, 2018.
R. Alexander Acosta,
Secretary of Labor.
Department of Defense
List of Subjects in 32 CFR Part 219
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Defense
proposes to further amend 32 CFR part
219 as published in the Federal Register
on January 19, 2017 (82 FR 7149), and
as amended in a final rule published in
the Federal Register on January 22,
2018 (83 FR 2885), as follows:
PART 219—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 219
continues to read as follows:
■
Authority: 5 U.S.C. 301.
2. Amend § 219.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 219.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 219.114(b) (cooperative research) of
the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 219.101(i) of
PO 00000
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Fmt 4701
Sfmt 4702
17609
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 219.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 219.102(l) of the 2018
Requirements (definition of research)
(instead of § 219.102(d) of the pre-2018
Requirements),
(2) Section 219.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 219.103(f) of the pre-2018
Requirements), and
(3) Section 219.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 219.103(b), as related to the
requirement for continuing review, and
in addition to § 219.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Mary J. Miller,
Principal Deputy, Assistant Secretary of
Defense for Research and Engineering, U.S.
Department of Defense.
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Department of Education
List of Subjects in 34 CFR Part 97
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Education
proposes to further amend 34 CFR part
97 as published in the Federal Register
on January 19, 2017 (82 FR 7149), and
as amended in a final rule published in
the Federal Register on January 22,
2018 (83 FR 2885), as follows:
PART 97—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 97
continues to read as follows:
■
Authority: 5 U.S.C. 301; 20 U.S.C.
1221e–3, 3474.
2. Amend § 97.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 97.101
To what does this policy apply?
sradovich on DSK3GMQ082PROD with PROPOSALS2
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
subpart. The general compliance date
for the 2018 Requirements is January 21,
2019. The compliance date for
§ 97.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 97.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 97.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
VerDate Sep<11>2014
19:24 Apr 19, 2018
Jkt 244001
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 97.102(l) of the 2018
Requirements (definition of research)
(instead of § 97.102(d) of the pre-2018
Requirements),
(2) Section 97.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 97.103(f) of the pre-2018
Requirements), and
(3) Section 97.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 97.103(b), as related to the
requirement for continuing review, and
in addition to § 97.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Betsy DeVos,
Secretary of Education.
Department of Veterans Affairs
List of Subjects in 38 CFR Part 16
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Veterans
Affairs proposes to further amend 38
CFR part 16 as published in the Federal
Register on January 19, 2017 (82 FR
7149), and as amended in a final rule
published in the Federal Register on
January 22, 2018 (83 FR 2885), as
follows:
PART 16—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 16
continues to read as follows:
■
Authority: 5 U.S.C. 301; 38 U.S.C. 501,
7331, 7334; 42 U.S.C. 300v–1(b).
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Fmt 4701
Sfmt 4702
2. Amend § 16.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 16.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 16.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 16.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 16.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 16.102(l) of the 2018
Requirements (definition of research)
(instead of § 16.102(d) of the pre-2018
Requirements),
(2) Section 16.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 16.103(f) of the pre-2018
Requirements), and
(3) Section 16.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 16.103(b), as related to the
requirement for continuing review, and
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in addition to § 16.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Jacquelyn Hayes-Byrd,
Deputy Chief of Staff, Department of
Veterans Affairs.
Environmental Protection Agency
List of Subjects in 40 CFR Part 26
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Environmental Protection
Agency proposes to further amend 40
CFR part 26 as published in the Federal
Register on January 19, 2017 (82 FR
7149), and as amended in a final rule
published in the Federal Register on
January 22, 2018 (83 FR 2885), as
follows:
PART 26—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 26
continues to read as follows:
■
Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a)
and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec.
201, Pub. L. 109–54, 119 Stat. 531; 42 U.S.C.
300v–1(b).
2. Amend § 26.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 26.101
To what does this policy apply?
sradovich on DSK3GMQ082PROD with PROPOSALS2
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
subpart. The general compliance date
for the 2018 Requirements is January 21,
2019. The compliance date for
§ 26.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
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Jkt 244001
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 26.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 26.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 26.102(l) of the 2018
Requirements (definition of research)
(instead of § 26.102(d) of the pre-2018
Requirements),
(2) Section 26.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 26.103(f) of the pre-2018
Requirements), and
(3) Section 26.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 26.103(b), as related to the
requirement for continuing review, and
in addition to § 26.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
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17611
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
E. Scott Pruitt,
Administrator, Environmental Protection
Agency.
Department of Health and Human
Services
List of Subjects in 45 CFR Part 46
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Health and
Human Services proposes to further
amend 45 CFR part 46 as published in
the Federal Register on January 19,
2017 (82 FR 7149), and as amended in
a final rule published in the Federal
Register on January 22, 2018 (83 FR
2885), as follows:
PART 46—PROTECTION OF HUMAN
SUBJECTS
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).
2. Amend § 46.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 46.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
subpart. The general compliance date
for the 2018 Requirements is January 21,
2019. The compliance date for
§ 46.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 46.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 46.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Proposed Rules
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 46.102(l) of the 2018
Requirements (definition of research)
(instead of § 46.102(d) of the pre-2018
Requirements),
(2) Section 46.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 46.103(f) of the pre-2018
Requirements), and
(3) Section 46.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 46.103(b), as related to the
requirement for continuing review, and
in addition to § 46.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Alex M. Azar II,
Secretary, U.S. Department of Health and
Human Services.
National Science Foundation
sradovich on DSK3GMQ082PROD with PROPOSALS2
List of Subjects in 45 CFR Part 690
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, National Science Foundation
proposes to further amend 45 CFR part
690 as published in the Federal Register
on January 19, 2017 (82 FR 7149), and
as amended in a final rule published in
the Federal Register on January 22,
2018 (83 FR 2885), as follows:
VerDate Sep<11>2014
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Jkt 244001
PART 690—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 690
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 690.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 690.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
§ 690.114(b) (cooperative research) of
the 2018 Requirements is January 20,
2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 690.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 690.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 690.102(l) of the 2018
Requirements (definition of research)
(instead of § 690.102(d) of the pre-2018
Requirements),
(2) Section 690.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
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Fmt 4701
Sfmt 4702
§ 690.103(f) of the pre-2018
Requirements), and
(3) Section 690.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 690.103(b), as related to the
requirement for continuing review, and
in addition to § 690.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Lawrence Rudolph,
General Counsel, National Science
Foundation.
Department of Transportation
List of Subjects in 49 CFR Part 11
Human research subjects, Reporting
and recordkeeping requirements,
Research.
For the reasons stated in the
preamble, Department of Transportation
proposes to further amend 49 CFR part
11 as published in the Federal Register
on January 19, 2017 (82 FR 7149), and
as amended in a final rule published in
the Federal Register on January 22,
2018 (83 FR 2885), as follows:
PART 11—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for Part 11
continues to read as follows:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b).
2. Amend § 11.101 by revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as
follows:
■
§ 11.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(2) For purposes of this section, the
2018 Requirements means the Federal
Policy for the Protection of Human
Subjects requirements contained in this
part. The general compliance date for
the 2018 Requirements is January 21,
2019. The compliance date for
E:\FR\FM\20APP2.SGM
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Proposed Rules
sradovich on DSK3GMQ082PROD with PROPOSALS2
§ 11.114(b) (cooperative research) of the
2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 11.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 11.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
engaged in research otherwise covered
by paragraph (l)(3) of this section
determines that such ongoing research
instead will transition to comply with
VerDate Sep<11>2014
19:24 Apr 19, 2018
Jkt 244001
the 2018 Requirements, the institution
or an IRB must document and date such
determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation until January 20, 2019,
comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 11.102(l) of the 2018
Requirements (definition of research)
(instead of § 11.102(d) of the pre-2018
Requirements),
(2) Section 11.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 11.103(f) of the pre-2018
Requirements), and
(3) Section 11.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 11.103(b), as related to the
requirement for continuing review, and
PO 00000
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Fmt 4701
Sfmt 9990
17613
in addition to § 11.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019,
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019, and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Elaine L. Chao,
Secretary of Transportation.
[FR Doc. 2018–08231 Filed 4–19–18; 8:45 am]
BILLING CODE 4150–36–P
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]]>Agencies
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Proposed Rules]
[Pages 17595-17613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08231]
[[Page 17593]]
Vol. 83
Friday,
No. 77
April 20, 2018
Part II
Department of Homeland Security
-----------------------------------------------------------------------
6 CFR Part 46
Department of Agriculture
-----------------------------------------------------------------------
7 Part 1c
Department of Energy
-----------------------------------------------------------------------
10 CFR Part 745
National Aeronautics and Space Administration
-----------------------------------------------------------------------
14 CFR Part 1230
Department of Commerce
-----------------------------------------------------------------------
15 CFR Part 27
Consumer Product Safety Commission
-----------------------------------------------------------------------
16 CFR Part 1028
Social Security Administration
-----------------------------------------------------------------------
20 CFR Part 431
[[Page 17594]]
Agency for International Development
-----------------------------------------------------------------------
22 CFR Part 225
Department of Housing and Urban Development
-----------------------------------------------------------------------
24 CFR Part 60
Department of Labor
-----------------------------------------------------------------------
29 CFR Part 21
Department of Defense
-----------------------------------------------------------------------
32 CFR Part 219
Department of Education
-----------------------------------------------------------------------
34 CFR Part 97
Department of Veterans Affairs
-----------------------------------------------------------------------
38 CFR Part 16
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 26
Department of Health and Human Services
-----------------------------------------------------------------------
45 CFR Part 46
National Science Foundation
-----------------------------------------------------------------------
45 CFR Part 690
Department of Transportation
-----------------------------------------------------------------------
49 CFR Part 11
Federal Policy for the Protection of Human Subjects: Proposed Six Month
Delay of the General Compliance Date While Allowing the Use of Three
Burden-Reducing Provisions During the Delay Period; Proposed Rule
Federal Register / Vol. 83 , No. 77 / Friday, April 20, 2018 /
Proposed Rules
[[Page 17595]]
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DEPARTMENT OF HOMELAND SECURITY
6 CFR Part 46
DEPARTMENT OF AGRICULTURE
7 Part 1c
DEPARTMENT OF ENERGY
10 CFR Part 745
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
14 CFR Part 1230
DEPARTMENT OF COMMERCE
15 CFR Part 27
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1028
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 431
AGENCY FOR INTERNATIONAL DEVELOPMENT
22 CFR Part 225
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
24 CFR Part 60
DEPARTMENT OF LABOR
29 CFR Part 21
DEPARTMENT OF DEFENSE
32 CFR Part 219
DEPARTMENT OF EDUCATION
34 CFR Part 97
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 16
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 26
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 46
NATIONAL SCIENCE FOUNDATION
45 CFR Part 690
DEPARTMENT OF TRANSPORTATION
49 CFR Part 11
Federal Policy for the Protection of Human Subjects: Proposed Six
Month Delay of the General Compliance Date While Allowing the Use of
Three Burden-Reducing Provisions During the Delay Period
AGENCY: Department of Homeland Security; Department of Agriculture;
Department of Energy; National Aeronautics and Space Administration;
Department of Commerce; Consumer Product Safety Commission; Social
Security Administration; Agency for International Development;
Department of Housing and Urban Development; Department of Labor;
Department of Defense; Department of Education; Department of Veterans
Affairs; Environmental Protection Agency; Department of Health and
Human Services; National Science Foundation; and Department of
Transportation.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: In a final rule published on January 19, 2017, federal
departments and agencies made revisions to the Federal Policy for the
Protection of Human Subjects (hereafter the ``2018 Requirements''). The
Consumer Product Safety Commission (CPSC) adopted the same regulatory
changes in a separate final rule published on September 18, 2017. The
2018 Requirements were scheduled to become effective on January 19,
2018, with a general compliance date of January 19, 2018 (with the
exception of the revisions to the cooperative research provision). The
departments and agencies listed in this document have also published an
interim final rule delaying the effective date and general compliance
date for the 2018 Requirements for six months, to cover the time period
of January 19, 2018 until July 19, 2018.
As per the interim final rule, the effective date of the 2018
Requirements is now July 19, 2018. The departments and agencies listed
in this document propose delaying the general compliance date for the
2018 Requirements for an additional six months, for the time period of
July 19, 2018 until January 21, 2019. This proposed rule is intended to
provide additional time to regulated entities for the preparations
necessary to implement the 2018 Requirements. This proposed rule, if
finalized, would require regulated entities to continue to comply with
the requirements of the current Federal Policy for the Protection of
Human Subjects (hereafter the ``pre-2018 Requirements'') until January
21, 2019.
This proposal also takes comment on whether to permit institutions
to implement, for certain research studies, the following provisions in
the 2018 Requirements during the period from July 19, 2018, until
January 21, 2019, that the general compliance date is delayed. Those
three provisions, intended to reduce burdens on regulated entities, are
the 2018 Requirements' definition of ``research,'' which deems certain
activities not to be research, the allowance for no annual continuing
review of certain categories of research, and the elimination of the
requirement that institutional review boards (IRBs) review grant
applications related to the research. The way that this option is
proposed, regulated entities would be required to comply with all pre-
2018 Requirements during the period that the general compliance date is
delayed, except for provisions substituted by the three burden-reducing
provisions of the 2018 Requirements.
As described in section III, below, this flexibility is proposed
only for studies for which an institution makes a choice to transition
to comply with the 2018 Requirements, beginning on July 19, 2018. In
order to clearly describe this proposed flexibility, including how it
would impact institutions choosing to transition research to comply
with the 2018 Requirements, this document proposes a redrafted
transition provision.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 11:59 p.m. Eastern Standard
Time on May 21, 2018.
ADDRESSES: You may submit comments, identified by docket ID number HHS-
OPHS-2018-0007 by one of the following methods:
Federal eRulemaking Portal (https://www.regulations.gov):
[cir] Enter the following link into your web browser's address bar:
https://www.regulations.gov/document?D=HHS-OPHS-2018-0007.
[cir] Click the blue ``Comment Now!'' button in the upper right
hand corner and follow the instructions on how to submit a comment.
[cir] Alternatively, you can enter the docket ID number into the
``search'' box on the main page of the Federal eRulemaking Portal
(https://www.regulations.gov) to find the electronic docket.
[[Page 17596]]
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852.
Comments received, including any personal information,
will be posted without change to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Office for
Human Research Protections (OHRP), Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852;
telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071;
email [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On September 8, 2015, HHS and 15 other federal departments and
agencies published a notice of proposed rulemaking (NPRM) proposing
revisions to each agency's codification of the Federal Policy for the
Protection of Human Subjects, originally promulgated as a Common Rule
in 1991. 80 FR 53931. On January 19, 2017, HHS and other federal
departments and agencies published a final rule revising the Federal
Policy for the Protection of Human Subjects. 82 FR 7149. The CPSC
adopted the same regulatory changes, also with a scheduled effective
date of January 19, 2018, in a separate final rule published on
September 18, 2017. 82 FR 43459. For this reason, references in this
document to the January 2017 final rule also extend to the CPSC's
September 2017 final rule. The revised policy, reflected in both final
rules, is hereafter referred to as the ``2018 Requirements.'' The 2018
Requirements were originally scheduled to become effective on January
19, 2018, with a general compliance date of January 19, 2018 (with the
exception of the revisions to the cooperative research provision at
Sec. __.114(b), for which the compliance date is January 20, 2020).
After publication of the 2018 Requirements, some representatives of
the regulated community, including organizations representing
recipients of federal human subjects research awards, expressed concern
regarding the regulated community's ability to implement all of the
2018 Requirements by the scheduled general compliance date.\1\ One of
the two letters asked for a delay in the general compliance date of the
2018 Requirements, with the option to adopt burden-reducing provisions
of the 2018 Requirements during the delay period, including certain
carve-outs from the definition of ``research,'' exemptions, elimination
of the continuing review requirement for certain categories of
research, and the elimination of the requirement that institutional
review boards (IRBs) review grant applications. The HHS Secretary's
Advisory Committee on Human Research Protections (SACHRP) also
recommended in August 2017 that the required implementation of the 2018
Requirements should be delayed.\2\ On January 17, 2018, HHS and other
federal departments and agencies placed on display in the Federal
Register an interim final rule delaying the effective date and general
compliance date of the 2018 requirements to July 19, 2018. 83 FR 2885
(published January 22, 2018). On January 26, 2018, HUD published an
interim final rule adopting the January 17, 2018 interim final rule. 83
FR 3589.
---------------------------------------------------------------------------
\1\ Two unsolicited comments were received. See the June 21,
2017 letter to Jerry Menikoff from the Association of American
Medical Colleges, Association of American Universities, Association
of Public & Land-grant Universities, and Council on Governmental
Relations, available at https://www.cogr.edu/sites/default/files/AAMC_AAU_APLU_COGR%20Common%20Rule%20Delay%20Letter%206-21-2017.pdf.
See the June 9, 2017 letter to Secretary Thomas Price from the
American Medical Informatics Association at https://www.amia.org/sites/default/files/AMIA%20Letter%20Regarding%20the%20Common%20Rule.pdf.
\2\ August 2, 2017 SACHRP Letter to HHS Secretary, Attachment A-
Recommendations on Compliance Dates and Transition Provisions,
https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-august-2-2017/.
---------------------------------------------------------------------------
This NPRM proposes to delay the general compliance date of the 2018
Requirements by an additional six months, during the time period of
July 19, 2018 to January 21, 2019.
II. Proposed Delay of the General Compliance Date
We propose to delay the general compliance date of the 2018
Requirements for six months after the effective date of July 19, 2018
until January 21, 2019. Given the degree of complexity involved with
implementing the revised rule, we believe the delay we are proposing in
this action is both an appropriate action to take at this juncture, and
a reasonable time period to allow the regulated community to be
prepared for compliance with the 2018 Requirements and for HHS and the
other Common Rule agencies to develop implementation guidance. The 2018
requirements include new exemptions, new IRB review procedures, and new
provisions pertaining to informed consent, among other revisions, and
guidance would be helpful to the regulated community in understanding
and complying with these requirements. As described below, we propose
to revise Sec. __.101(l)(2) to specify that the general compliance
date for the 2018 Requirements is January 21, 2019. We also propose to
revise the dates in the transition provision at Sec. __.101(l)(3),(4)
and (5) to reflect this revised general compliance date.
As proposed, regulated entities would be required to comply with
the pre-2018 Requirements prior to January 21, 2019, and the pre-2018
Requirements would be applied by the Common Rule departments and
agencies during this period. To clarify, under this proposal, regulated
entities would not be allowed, prior to January 21, 2019, to comply
with all provisions of the 2018 Requirements in lieu of all provisions
of the pre-2018 Requirements. As described below in section III, an
exception would exist during the six-month period between July 19,
2018, and January 21, 2019, with respect to three specified burden-
reducing provisions contained in the 2018 Requirements.
Research initiated (i.e., initially approved by an IRB, or for
which IRB review was waived pursuant to Sec. __.101(i), or determined
to be exempt) before the general compliance date of the 2018
Requirements (which would now become January 21, 2019) would, as a
default, continue to be subject to the pre-2018 Requirements for their
duration. This will maintain the ability of institutions to hold such
studies to the same set of standards throughout the studies' duration,
and will avoid a requirement that such research be subject to two sets
of rules.
Research initiated (i.e., initially approved by an IRB, or for
which IRB review was waived pursuant to Sec. __.101(i), or determined
to be exempt) on or after January 21, 2019 (proposed as the new general
compliance date), would need to be conducted entirely in compliance
with the 2018 Requirements. This document proposes to restructure Sec.
__.101(1)(3) and (4) (now numbered (5)) to aid readability. A new
section Sec. __.101(l)(4) is proposed to be inserted to explain how
the requirements would apply to research transitioning to take
advantage of the burden-reducing provisions.
We do not propose delaying the compliance date for the cooperative
research provision of the 2018 Requirements (Sec. _.114(b)), which
will remain January 20, 2020.
[[Page 17597]]
III. Proposed Flexibility for Taking Advantage of Certain Burden-
Reducing Provisions Without a Delay
This proposed rule also proposes to permit institutions, during the
period from July 19, 2018, until January 21, 2019, that the general
compliance date is proposed to be delayed, to take advantage of three
provisions in the 2018 Requirements intended to minimize burdens on
regulated entities (hereinafter ``three burden-reducing 2018
Requirements'').
As under the January 2017 final rule, under this proposed rule,
studies initiated prior to the general compliance date of the 2018
Requirements, would, as a default, remain subject to the pre-2018
Requirements for their duration unless and until a decision to
transition to the 2018 Requirements (i.e., the institution chooses to
have a study be subject to the 2018 Requirements) is made and
documented.
The January 2017 final rule provided an option for institutions to
transition ongoing studies from compliance with the pre-2018
Requirements to compliance with the 2018 Requirements for the studies'
duration. This proposed rule would preserve that option, and proposes
an additional flexibility for ongoing studies to transition to the 2018
Requirements if the decision to transition is documented prior to
January 21, 2019, which would be the new general compliance date of the
2018 Requirements. Between July 19, 2018 and January 21, 2019,
institutions that elect to transition studies to the 2018 Requirements
would, after the decision to transition has been documented, be able to
take advantage of the three burden-reducing 2018 Requirements. This
option is available for ongoing studies, as well as for studies newly
initiated after July 19, 2018.
This option is described in a proposed revision to Sec. __.101(l).
In order to clearly outline the operation of this proposed flexibility,
we propose to redraft Sec. __.101(l) to describe how the transition
provision applies to research subject to the pre-2018 Requirements,
research transitioned from the pre-2018 Requirements to the 2018
Requirements, and research subject to the 2018 Requirements. The
revised Sec. __.101(l) describes how the pre-2018 Requirements and the
2018 Requirements apply to research initiated (i.e., initially approved
by an IRB, waived under Sec. __.101(i), or determined to be exempt),
during three time periods: Prior to July 19, 2018, between July 19,
2018 and January 21, 2019, and on or after January 21, 2019.
As described, studies taking advantage of this option would be
subject to the three burden-reducing 2018 Requirements instead of, or
in addition to, the comparable provisions of the pre-2018 Requirements.
The three burden-reducing 2018 Requirements are (1) the 2018
Requirements' definition of ``research'' at Sec. __.102(l) (instead of
Sec. __.102(d) of the pre-2018 Requirements), which deems certain
activities not to be research, (2) the elimination of the requirement
that an IRB review the grant application related to the research at
Sec. __.103(d) of the 2018 Requirements (instead of Sec. __.103(f) of
the pre-2018 Requirements), and (3) the allowance for no annual
continuing review of certain categories of research at Sec.
__.109(f)(1)(i) and (iii) of the 2018 Requirements (instead of Sec.
__.103(b), as related to the requirement for continuing review, and in
addition to Sec. __.109, of the pre-2018 Requirements).
Given that studies taking advantage of this flexibility would, if
this proposal is adopted, temporarily be subject to the three burden-
reducing 2018 Requirements, but not other provisions in the 2018
Requirements, we are clarifying our intended interpretations of these
provisions during a transition period. First, the definition of
``research'' in the 2018 Requirements references a ``public health
authority,'' a term defined in the 2018 Requirements, but not included
in the pre-2018 Requirements. The reference to a ``public health
authority'' in Sec. __.102(l)(3) of the 2018 Requirements would be
interpreted consistent with the definition of ``public health
authority'' included in the 2018 Requirements (Sec. __.102(k)).
Second, Sec. __.103(d) of the 2018 Requirements refers to research
``exempted under Sec. __.104.'' Because the exemptions that will be in
place during any transition period are set forth in Sec. __.101(b) of
the pre-2018 Requirements, this reference to research ``exempted under
Sec. __.104'' would be interpreted, during this transition period and
prior to the general compliance date of the 2018 Requirements, as a
reference to research exempted under Sec. __.101(b) of the pre-2018
Requirements. Third, the reference in Sec. __.109(f)(1)(i) of the 2018
Requirements to research eligible for expedited review under Sec.
__.110 would be interpreted as a reference to that section in the pre-
2018 Requirements. Moreover, the documentation requirements set forth
in Sec. __.115(a)(3) of the 2018 Requirements (documenting an IRB's
rationale for conducting continuing review that would not otherwise be
required under Sec. __.109(f)(1) of the 2018 Requirements) would not
be applicable during this transition period as proposed.
As proposed above, for institutions electing to transition a
research study to compliance with the 2018 Requirements in order to
take advantage of the three burden-reducing provisions, Sec. __.103(d)
of the 2018 Requirements would be substituted for Sec. __.103(f) of
the pre-2018 Requirements. Both sections address the requirement for
certification of research supported by a Federal department or agency.
In addition to removing the requirement that IRBs review grant
applications or proposals, Sec. __.103(d) of the 2018 Requirements
reflects other minor wording changes necessary to accommodate the
removal of the grant application or proposal review requirement or to
provide additional clarifications.
Except for the three burden-reducing 2018 Requirements identified
in proposed Sec. __.101(l)(4)(i)(A), institutions that elect to
transition a research study to comply with the 2018 Requirements and
document that decision, at any time between July 19, 2018, and January
21, 2019, would be required to comply with the pre-2018 Requirements
until January 21, 2019. This approach would afford institutions
additional time before they are required to comply with all provisions
of the 2018 Requirements, while enabling them to take advantage of the
three burden-reducing 2018 Requirements more quickly. The option of
applying the three burden-reducing 2018 Requirements would only be
available for studies that institutions decided to transition to comply
with the 2018 Requirements on or after July 19, 2018. If an institution
so chooses to apply the three burden-reducing 2018 Requirements to
certain research, those studies would be required to comply with all of
the 2018 Requirements beginning on January 21, 2019.
An institution's decision about whether to transition a study to
the 2018 requirements to take advantage of the three burden-reducing
provisions might vary depending on the nature and progress of the
study, including any elements of the study to be conducted on or after
January 21, 2019. For example, studies planning to recruit some
subjects on or after January 21, 2019 would have to meet the new
requirements for obtaining the informed consent of those subjects. In
contrast, for studies whose remaining activities
[[Page 17598]]
consist only of completing data analyses, the new requirements for
informed consent generally would not be applicable.
We considered stakeholder suggestions to extend this approach to
other burden-reducing sections of the 2018 Requirements, such as the
revised exemption categories. We do not propose adding the revised
exemption categories to Sec. __.101(l)(4)(i)(A) because implementation
of these categories would involve significantly greater complications.
For example, these categories use terms that are newly defined or for
which revised definitions have been included in the 2018 Requirements,
and permitting compliance with these categories without also
selectively adopting revised definitions could be problematic. To
minimize confusion, this proposed rule limits those provisions for
which early adoption would be permitted to those that would minimize
burdens without creating significant complexities. We also considered a
delay to the effective and general compliance dates without proposing
this additional option in the interim period. Such an approach would be
simple to implement. We decided against proposing this alternative to
be responsive to public comments received and in an effort to minimize
burdens with respect to new provisions that will not be difficult to
implement prior to the general compliance date of the 2018
Requirements.
As proposed for Sec. __.101(l)(4)(ii), if the determination to
transition previously initiated studies to the 2018 Requirements is not
made until on or after January 21, 2019, such studies would not benefit
from the additional flexibilities created for the period between July
19, 2018 and January 21, 2019. Such studies would be required to comply
with the 2018 Requirements after the date of transition.
The regulatory provisions are not prescriptive regarding how an
institution chooses to make its transition decisions. An institution
may elect to transition research protocols to the 2018 Requirements on
a protocol-by-protocol basis, or for a class of protocols (e.g., all
minimal risk research), or for the institution's entire research
portfolio. While these three burden reducing provisions are a
regulatory package, an institution that took advantage of the
flexibility proposed in this NPRM, as a matter of institutional policy,
could adopt a more stringent standard (such as that of the pre-2018
rule) for any or all of these three provisions.
We also propose a revision to Sec. __.101(l)(4) regarding
documentation of an institution's decision to transition research begun
under the pre-2018 Requirements to the 2018 Requirements. This proposal
is intended to offer institutions greater flexibility regarding who
documents that decision. Under the January 19, 2017, final rule, if an
institution determines that ongoing research will transition to comply
with the 2018 Requirements, this determination must be documented by an
IRB before the transition can take effect. We now propose that, to
allow ease in implementing this documentation requirement, the
documentation of an institution's transition determination may be
performed either by an institution (through officials who have the
authority to make such determinations on behalf of the institution) or
an IRB. As proposed, this documentation must include the date of the
transition determination. Records documenting the transition decision
must be retained as per Sec. __.115(b).
Once the institution makes the determination to transition the
research to the revised rule and that determination is documented, the
date of documentation will serve as the de facto compliance date as
applied to the research. For a study that is transitioned in accordance
with Sec. __.101(l)(4)(i), between July 19, 2018, and January 20,
2019, one set of rules would apply until the general compliance date of
the final rule and another would apply beginning on such general
compliance date. As of the date the decision to transition is
documented until January 20, 2019, the pre-2018 Requirements would be
applicable, except that the three burden-reducing 2018 Requirements
would apply instead of or in addition to the pre-2018 Requirements
specified in Sec. __.101(l)(4)(i)(A). Beginning on January 21, 2019,
the 2018 Requirements would apply for the duration of the study.
As proposed, all studies that are transitioned in accordance with
Sec. __.101(l)(4)(ii) on or after January 21, 2019, and all studies
that are newly initiated on and after January 21, 2019, would be
required to follow all of the 2018 Requirements.
In summary, the proposed rule would create three options that would
be available beginning July 19, 2018, that institutions may choose to
follow for research studies initiated before January 21, 2019. The
first option, and default, is to continue to follow all of the pre-2018
Requirements for the duration of the study. The second option is to
choose to follow the pre-2018 Requirements, except for the three
burden-reducing 2018 Requirements, until January 21, 2019, when all of
2018 Requirements would become applicable. The third option would be to
follow the pre-2018 requirements until January 21, 2019, and at some
point thereafter choose to follow all of the 2018 Requirements for the
duration of the study.
We also solicit comments about the advisability of the alternative
of delaying the effective date and general compliance date until
January 21, 2019, but without the option to implement certain 2018
Requirements during that delay period.
In addition, we solicit comments on the desirability of the
alternative of delaying the effective date and general compliance date
beyond January 21, 2019. We do not believe the regulated community will
require this additional time to come into compliance with the revised
rule, but we are interested in receiving public comments on this
alternative.
While we considered the alternative of proposing to amend the
transition provision to permit institutions to voluntarily comply with
the revised rule beginning on July 19, 2018, and not requiring
compliance with the new rule until January 21, 2019 or later, we
believe this approach could result in confusion regarding
implementation of the revised Common Rule that could be minimized with
the issuance of guidance from the Common Rule departments and agencies.
By making the changes proposed above, we believe the Common Rule
departments and agencies will be able to issue relevant guidance
documents that will better enable the regulated community to comply
with the revised rule.
We also solicit comments about the advisability of not making the
changes proposed in this NPRM (i.e., allowing the effective date and
general compliance date to remain as July 19, 2018). Finally, we note
that we will consider public comments submitted in response to the
interim final rules described above.
IV. Legal Authorities
The legal authorities for the departments and agencies that are
signatories to this action are as follows:
Department of Homeland Security, 5 U.S.C. 301; Public Law 107-296,
sec. 102, 306(c); Public Law 108-458, sec. 8306. Department of
Agriculture, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Energy, 5
U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b). National Aeronautics
and Space Administration, 5 U.S.C. 301; 42 U.S.C.
[[Page 17599]]
300v-1(b). Department of Commerce, 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Consumer Product Safety Commission, 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Social Security Administration, 5 U.S.C. 301; 42 U.S.C. 289(a). Agency
for International Development, 5 U.S.C. 301; 42 U.S.C. 300v-1(b),
unless otherwise noted. Department of Housing and Urban Development, 5
U.S.C. 301; 42 U.S.C. 300v-1(b); 3535(d). Department of Labor, 5 U.S.C.
301; 29 U.S.C. 551. Department of Defense, 5 U.S.C. 301. Department of
Education, 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474. Department of
Veterans Affairs, 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C.
300v-1(b). Environmental Protection Agency, 5 U.S.C. 301; 7 U.S.C.
136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Public Law
109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b). Department of Health
and Human Services, 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-
1(b). National Science Foundation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
Department of Transportation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
V. Regulatory Impact Analyses
We have examined the effects of this proposed 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 13771 on Reducing Regulation and
Controlling Regulatory Costs (January 30, 2017), the Paperwork
Reduction Act of 1995 (Pub. L. 104-13), the Regulatory Flexibility Act,
(Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism
(August 4, 1999).
A. Executive Orders 12866, 13563, and 13771
Executive Orders 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). Executive
Order 13563 is supplemental to and reaffirms the principles,
structures, and definitions governing regulatory review as established
in Executive Order 12866, emphasizing the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. In accordance with the provisions of
Executive Order 12866, this proposed rule was submitted to the Office
of Management and Budget (OMB) for review, and has been determined to
be a ``significant'' regulatory action. The designation, as regulatory
or deregulatory under Executive Order 13771 (Reducing Regulation and
Controlling Regulatory Costs, issued on January 30, 2017), of any final
rule resulting from this notice of proposed rulemaking will be informed
by comments received on the costs and cost savings of delaying the 2018
Requirements. Details on the preliminary estimated costs of this
proposed rule can be found in the economic analysis below.
1. Need for This NPRM and Summary
On January 19, 2017, HHS and 15 other federal departments and
agencies published the 2018 Requirements designed to more thoroughly
address the broader types of research conducted or otherwise supported
by all of the Common Rule departments and agencies. In addition, the
CPSC adopted the same regulatory changes on September 18, 2017.
This proposed rule, if finalized, would allow regulated entities to
continue to comply with the pre-2018 requirements until January 21,
2019. As discussed above, this proposed rule also proposes to permit
institutions, during the period between July 19, 2018, and January 21,
2019, to take advantage of three provisions in the 2018 Requirements
intended to minimize burdens on regulated entities. Those three burden-
reducing 2018 Requirements are (1) the 2018 Requirements' definition of
``research,'' which deems certain activities not to be research, (2)
the allowance for no annual continuing review of certain categories of
research, and (3) the elimination of the requirement that IRBs review
grant applications related to the research. As described in section III
above, this flexibility is proposed for studies for which an
institution makes a choice to have those studies be subject to the 2018
Requirements.
2. Analysis of Benefits (Cost-Savings) and Costs (Foregone Benefits)
\3\
---------------------------------------------------------------------------
\3\ Note, that the terms ``benefits'' and ``cost-savings'' are
used interchangeably in this RIA. Similarly, the terms ``costs'' and
``foregone benefits'' are also used interchangeably.
---------------------------------------------------------------------------
The RIA for the 2018 Requirements described the benefits and costs
of 16 broad categories of changes finalized. The RIA for this NPRM uses
the information and calculations described in the preamble to the 2018
Requirements as a base for estimating benefits and costs of delaying
the general implementation of the 2018 Requirements by six months. The
time period for the analysis in this RIA is the six month period from
July 2018 to January 2019.
Table 1 summarizes the quantified benefits and costs of delaying
the general implementation of 2018 Requirements. Over the period of
July 2018 to January 2019, annualized benefits of $6.4 million are
estimated using a 3 percent discount rate; annualized benefits of $5.9
million are estimated using a 7 percent discount rate. Annualized costs
of $37.2 million are estimated using a 3 percent discount rate;
annualized costs of $34.4 million are estimated using a 7 percent
discount rate. Note that all values are represented in millions of 2016
dollars, and 2016 is used as the frame of reference for discounting.
Table 1--All Benefits and Costs of Delaying the General Compliance Date
of the 2018 Requirements by Six Months
[From July 19, 2018 to January 21, 2019]
------------------------------------------------------------------------
Annualized value by discount
rate (millions of 2016 dollars)
---------------------------------
3 Percent 7 Percent
------------------------------------------------------------------------
Benefits (Cost-Savings):
Quantified Benefits............... 6.4 5.9
Costs (Foregone Benefits):
[[Page 17600]]
Quantified Costs.................. 37.4 34.7
------------------------------------------------------------------------
The estimated benefits and costs of delaying the general
implementation date of the 2018 Requirements by six months are shown in
Table 2 below. Note that the categorization shown below includes the
same 16 categories used in the RIA of the 2018 Requirements.
Table 2--Accounting Table of Quantified Benefits (Cost-Savings) and Costs (Foregone Benefits) of Delaying
Compliance With the 2018 Requirements by Six Months \4\
----------------------------------------------------------------------------------------------------------------
Annualized value over 1 year by discount rate (millions of
2016 dollars)
---------------------------------------------------------------
2018 Requirement RIA Category Benefits (cost-savings) (Foregone benefits)
---------------------------------------------------------------
3% 7% 3% 7%
----------------------------------------------------------------------------------------------------------------
Regulated Community Learning New Requirements -- -- -- --
and Developing Training Materials; OHRP
Developing Training and Guidance Materials, and
Implementing the 2018 Requirements.............
Extending Oversight to IRBs Unaffiliated with an 4.47 4.14 -- --
Institution Holding an FWA (impact to IRBs not
operated by an FWA-holding institution)........
Excluding Activities from the Requirements of -- -- 0.95 0.88
the Common Rule because They are not Research..
Clarifying and Harmonizing Regulatory -- -- -- --
Requirements and Agency Guidance...............
Modifying the Assurance Requirements............ -- -- 0.31 0.29
Requirement for Written Procedures and -- -- -- --
Agreements for Reliance on IRBs Not Operated by
the Engaged Institution (impact to FWA-holding
institutions)..................................
Eliminating the Requirement that the Grant -- -- 8.5 7.9
Application Undergo IRB Review and Approval....
Expansion of Research Activities Exempt from 0.01 0.01 20.8 19.3
Full IRB Review................................
Elimination of Continuing Review of Research 1.04 0.96 4.10 3.80
Under Specific Conditions......................
Amending the Expedited Review Procedures........ -- -- 2.66 2.47
Cooperative Research (single IRB mandate in -- -- -- --
multi-institutional research) \5\..............
Changes in the Basic Elements of Consent, -- -- -- --
Including Documentation........................
Obtaining Consent to Secondary Use of -- -- -- --
Identifiable biospecimens and Identifiable
private information............................
Elimination of Pre-2018 Rule Requirement to -- -- 0.07 0.06
Waive Consent in Certain Subject Recruitment
Activities.....................................
Requirement for Posting of Consent Forms for 0.85 0.79 -- --
Clinical Trials Conducted or supported by
Common Rule Departments or Agencies............
Alteration in Waiver for Documentation of -- -- -- --
Informed Consent in Certain Circumstances......
--------------------------------
Cost Savings, as indicated by public comments -- --
(unable to attribute to particular provisions). unquantified
----------------------------------------------------------------------------------------------------------------
We assume that, in almost all categories described in the RIA for
the 2018 Requirements, the foregone benefits (costs) of delaying the
2018 Requirements by six months are what would have been the benefits
of implementing the 2018 Requirements during the period of July 2018
through January of 2019. Similarly, we assume that, in almost all
categories described in the RIA for the 2018 Requirements, the benefits
(cost-savings) associated with delaying the 2018 Requirements by six
months are what would have been the costs of implementing the 2018
Requirements during the period of July 2018 through January of 2019. We
assume this because regulated entities likely would not have difficulty
implementing these provisions in the absence of guidance from Common
Rule departments or agencies, and thus could have been implemented as
assumed in the economic analysis contained in the RIA for the 2018
Requirements. We seek comment on these assumptions.
---------------------------------------------------------------------------
\4\ Zeroes in Table 2 (represented by ``--'') signify that the
category has been unaffected by the six month delay of the 2018
Requirements. The category could be unaffected for one of two
reasons: (1) No costs or benefits were associated with the category
in the RIA for the 2018 Requirements; or (2) the costs and benefits
of the provision during the six month delay are the same as those
estimated in the RIA for the 2018 Requirements.
\5\ Because compliance with this provision is not required until
2020, benefits and costs here are not included.
---------------------------------------------------------------------------
Categories with different assumptions are described below:
[[Page 17601]]
a. Regulated Community Learning New Requirements and Developing
Training Materials; OHRP Developing Training and Guidance Materials,
and Implementing the 2018 Requirements
We assume that even with the proposed six month delay, regulated
entities and OHRP would still assume costs related to learning the new
requirements and developing training materials. Thus, there are no
effects estimated here.
We expect that some entities would experience cost savings as a
result of this proposed rule, and some entities would experience costs
as a result of this proposed rule, but we lack data to quantify these
effects. We request comments which provide data that can be used to
quantify these effects.
b. Early Implementation of the Three Burden-Reducing Provisions of the
2018 Requirements (Explicit Carve-Outs of Activities From the
Definition of Research [Sec. __.102(I)]; Eliminating the Requirement
That the Grant Application Undergo IRB Review and Approval [Pre-2018
Rule at Sec. __.103(f)]; Elimination of Continuing Review of Research
Under Specific Conditions [Sec. Sec. __.109(f) and __.115(a)(3)]
We assume that 50 percent of regulated entities will take advantage
of the option proposed in this NPRM to implement three burden-reducing
provisions of the 2018 Requirements early. We assume this because an
institution's decision about whether to transition a study to the 2018
requirements to take advantage of the three burden-reducing provisions
might vary depending on the nature and progress of the study, including
any elements of the study to be conducted after January 21, 2019. For
example, studies planning to recruit some subjects after January 21,
2019 would have to meet the new requirements for obtaining the informed
consent of those subjects. In contrast, for studies whose remaining
activities consist only of completing data analyses, the new
requirements for informed consent would generally not be applicable.
Therefore, we assume that there are situations where an institution
would want to take advantage of the three burden-reducing provisions,
and situations where an institution would not want to take advantage of
this flexibility. We note that we intend to publish guidance on the
carve-outs from the definition of research prior to July 2018, which
may also impact an institution's decision to elect to implement the
three burden-reducing provisions or not.
Thus, these entities will still obtain the benefits and costs
described in the RIA for the 2018 Requirements, implying no effects of
this rule for 50 percent of regulated entities. For the regulated
entities that do not take advantage of these flexibilities, we assume
that the foregone benefits (costs) of delaying implementation of these
provisions are what would have been the benefits of implementing these
provisions in January of 2018. Similarly, we assume that the benefits
(cost-savings) associated with delaying the implementation of these
provisions are what would have been the costs of implementing these
provisions in July of 2018. We assume that these regulated entities
account for 50 percent of the costs and benefits that would have been
experienced in 2018 absent this delay.
We also assume that institutional staff at the IRB Administrative
staff level \6\ will spend 5 minutes per protocol documenting the
voluntary election to use the three burden-reducing 2018 provisions
during the time period of July 19, 2018 to January 21, 2019.
---------------------------------------------------------------------------
\6\ See the RIA to the 2018 Requirements (82 FR 7149) for more
information about the labor categories used in this analysis.
---------------------------------------------------------------------------
We request comment on our assumption that 50 percent of regulated
entities will take advantage of the option proposed in this NPRM to
implement three burden-reducing provisions of the 2018 Requirements
early.
Some members of the regulated community have indicated that even
though the 2018 Requirements yield cost savings, these institutions are
still hesitant to transition ongoing research to the 2018 Requirements,
largely because of the burden of making studies already in compliance
with the pre-2018 requirements comply with the 2018 requirements. Also,
some institutions seem inclined to make all of the transitions at once.
This interconnectedness is key to some of the assumptions noted
elsewhere in this analysis. For example, if the three burden-reducing
provisions are considered on their own, a reasonable assumption would
be that 100 percent of affected entities would realize the associated
cost savings as soon as possible. The use, instead, of a 50 percent
estimate reflects entities' possible inclinations to make all
transitions at once. We request comment that would provide insight into
entities' views regarding the interconnectedness of the 2018
Requirements' provisions and thus allow for refinement of the 50
percent estimate.
c. Expansion of Research Activities Exempt From Full IRB Review (Sec.
__.104(d))
The 2018 Requirements include five new exemption categories, and
modify all but one exemption that exist in the pre-2018 Requirements.
We have received feedback from SACHRP that guidance will be useful for
regulated entities to implement many of the exemption categories.\7\
Areas where significant guidance will be helpful include: Applying the
categories of the new exemptions themselves, conducting limited IRB
review (as required in four exemptions), developing and using broad
consent (as required in two exemptions), utilizing the exemption for
certain HIPAA covered activities, and understanding which federally
supported or conducted nonresearch information collections qualify for
exemption.
---------------------------------------------------------------------------
\7\ See for example, SACHRP Recommendations of August 2, 2017:
https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/.
---------------------------------------------------------------------------
Because the guidance documents that would be helpful to assist
regulated entities in implementing these 2018 Common Rule provisions
have not yet been developed, we assume that 50 percent of the regulated
entities would not have taken advantage of the expansion in exemptions
during this six month-delay. For these entities, we assume that there
are no benefits and costs of the proposed delay, because they would not
have changed their operations. We assume that 50 percent of the
regulated entities would have gone forward with using the new or
expanded exemption categories under the 2018 Requirements; for these
entities, there are costs of delaying the implementation of this
provision during the six-month delay proposed in this NPRM.
We do not have data to support our assumption of what percent of
regulated entities would have gone forward with the implementation of
these provisions in the absence of additional guidance, and what
percent would not have gone forward. We request comments on these
assumptions and solicit data that can be used to quantify these
effects.
3. Analysis of NPRM Alternative
This NPRM includes a primary alternative proposal of delaying the
general effective and compliance date to January 2019.
Table 3 summarizes the quantified benefits and costs of the
alternative proposal of delaying the general implementation of 2018
Requirements without the option to implement certain
[[Page 17602]]
2018 Requirements. Over the period of July 2018 to January 2019,
annualized benefits of $7.4 million are estimated using a 3 percent
discount rate; annualized benefits of $6.9 million are estimated using
a 7 percent discount rate. Annualized costs of $50.8 million are
estimated using a 3 percent discount rate; annualized costs of $47.0
million are estimated using a 7 percent discount rate. Note that all
values are represented in millions of 2016 dollars, and 2016 is used as
the frame of reference for discounting.
Table 3--All Benefits and Costs of Delaying Compliance With the 2018
Requirements Under the Alternative Proposal
------------------------------------------------------------------------
Annualized value by discount
rate (millions of 2016 dollars)
---------------------------------
3 Percent 7 Percent
------------------------------------------------------------------------
Benefits (Cost-Savings):
Quantified Benefits............... 7.4 6.9
Costs (Foregone Benefits):
Quantified Costs.................. 50.8 47.0
------------------------------------------------------------------------
B. Paperwork Reduction Act (PRA)
This proposed rule contains collections of information that are
subject to review and approval by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act (PRA), as amended (44 U.S.C.
3501-3520). A description of these provisions is given in this document
with an estimate of the annual reporting and recordkeeping burden.
Title: Federal Policy for the Protection of Human Subjects.
Description: In this document is a discussion of the regulatory
provisions we believe are subject to the PRA and the probable
information collection burden associated with these provisions. In
general, the following actions trigger the PRA: (i) Reporting; (ii)
Recordkeeping.
Description of Respondents: The reporting and recordkeeping
requirements in this document are imposed on institutions,
institutional review boards, and investigators involved in human
subjects research conducted or supported or otherwise subject to
regulation by any federal department or agency that takes
administrative action that makes the policy applicable to such
research.
Sec. __.101(l)(4). Compliance Date and Transition Provision (OMB
Control No 0990-0260)
Section 101(l)(4)(i) would permit studies to transition to the 2018
Requirements between July 19, 2018 and January 21, 2019 (which would be
the new general compliance date of the 2018 Requirements). Between July
19, 2018 and January 21, 2019, institutions that elect to transition
studies to the 2018 Requirements would, after the decision to
transition has been documented, be able to take advantage of the three
burden-reducing 2018 Requirements.
This option is described in a proposed revision to Sec.
__.101(l)(4)(i). As described, studies taking advantage of this option
would be subject to the three burden-reducing 2018 Requirements instead
of, or in addition to, the comparable provisions of the pre-2018
Requirements. As discussed above, the three burden-reducing 2018
Requirements are (1) the 2018 Requirements' definition of ``research''
at Sec. __.102(l) (instead of Sec. __.102(d) of the pre-2018
Requirements), which deems certain activities not to be research, (2)
the elimination of the requirement that an IRB review the grant
application or proposal related to the research at Sec. __.103(d) of
the 2018 Requirements (instead of Sec. __.103(f) of the pre-2018
Requirements), and (3) the allowance for no annual continuing review of
certain categories of research at Sec. __.109(f)(1)(i) and (iii) of
the 2018 Requirements (instead of Sec. __.103(b), as related to the
requirement for continuing review, and in addition to Sec. __.109 of
the pre-2018 Requirements).
We estimate that approximately 92,084 protocols would take
advantage of the voluntary election described in Sec. __.101(l)(4)(i).
We estimate that institutional staff would spend 5 minutes per protocol
documenting that the study will be subject to the three burden-reducing
2018 Requirements during the time period of July 19, 2018 through
January 21, 2019. We estimate that this provision includes 7,673 burden
hours.
C. Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the
Small Business Regulatory Enforcement and 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 economic 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 (SBA); (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.
If finalized, this action will not have a significant economic
impact on a substantial number of small entities under the RFA. 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 proposed rule would not impose a
regulatory burden for regulated small entities because it would delay
the general compliance date of the 2018 Requirements, allowing the
status quo to be retained for the period of delay, and also would allow
regulated small entities to elect to implement the 2018 Requirements as
scheduled if the entities so choose. We have therefore concluded that
this action will have no net regulatory burden for all directly
regulated small entities. We request
[[Page 17603]]
comment on this conclusion, including specific data and information to
support commenters' views.
D. Unfunded Mandates Reform Act (UMRA)
Section 202(a) of the Unfunded Mandates Reform Act 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 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the most current (2016) implicit
price deflator for the gross domestic product. We do not expect this
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. We have determined that the proposed rule
would not contain policies that would 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. The changes in the proposed rule
represent the Federal Government regulating its own program.
Accordingly, we conclude that the rule does not propose policies that
have federalism implications as defined in Executive Order 13132 and,
consequently, a federalism summary impact statement is not required.
For the reasons set forth in the preamble, the Federal Policy for
the Protection of Human Subjects, as published in the Federal Register
on January 19, 2017 (82 FR 7149) and as adopted in a final rule
published by the CPSC on September 18, 2017 (82 FR 43459), and as
amended in a final rule published in the Federal Register on January
22, 2018 (83 FR 2885) and adopted by HUD through a final rule published
on January 26, 2018 (83 FR 3589), is proposed to be amended as follows:
Text of the Amended Common Rule
PART __--PROTECTION OF HUMAN SUBJECTS
0
1. Amend Sec. __.101 by revising paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5), to read as follows:
Sec. __.101 To what does this policy apply?
* * * * *
(l) * * *
(2) For purposes of this section, the 2018 Requirements means the
Federal Policy for the Protection of Human Subjects requirements
contained in this part/subpart. The general compliance date for the
2018 Requirements is January 21, 2019. The compliance date for Sec.
__.114(b) (cooperative research) of the 2018 Requirements is January
20, 2020.
(3) Research subject to pre-2018 requirements. The pre-2018
Requirements shall apply to the following research, unless the research
is transitioning to comply with the 2018 Requirements in accordance
with paragraph (l)(4) of this section:
(i) Research initially approved by an IRB under the pre-2018
Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to Sec.
__.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research
was exempt under Sec. __.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution engaged in research otherwise covered by paragraph (l)(3)
of this section determines that such ongoing research instead will
transition to comply with the 2018 Requirements, the institution or an
IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation until January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section __.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. __.102(d) of the pre-2018 Requirements),
(2) Section __.103(d) of the 2018 Requirements (revised
certification requirement that eliminates IRB review of application or
proposal) (instead of Sec. __.103(f) of the pre-2018 Requirements),
and
(3) Section __.109(f)(1)(i) and (iii) of the 2018 Requirements
(exceptions to mandated continuing review) (instead of Sec. __.103(b),
as related to the requirement for continuing review, and in addition to
Sec. __.109, of the pre-2018 Requirements); and
(B) Beginning on January 21, 2019, comply with the 2018
Requirements.
(ii) If the determination to transition is documented on or after
January 21, 2019, the research shall, beginning on the date of such
documentation, comply with the 2018 Requirements.
(5) Research subject to 2018 Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an IRB on or after January 21,
2019,
(ii) Research for which IRB review is waived pursuant to paragraph
(i) of this section on or after January 21, 2019, and
(iii) Research for which a determination is made that the research
is exempt on or after January 21, 2019.
Department of Homeland Security
List of Subjects in 6 CFR Part 46
Human research subjects, Reporting and recordkeeping requirements,
Research.
For the reasons stated in the preamble, Department of Homeland
Security proposes to further amend 6 CFR part 46 as published in the
Federal Register on January 19, 2017 (82 FR 7149), and as amended in a
final rule published in the Federal Register on January 22, 2018 (83 FR
2885), 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; P.L. 107-296, sec. 102, 306(c); P.L.
108-458, sec. 8306.
0
2. Amend Sec
