Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period, 28497-28520 [2018-13187]
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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations
DEPARTMENT OF HOMELAND
SECURITY
DEPARTMENT OF TRANSPORTATION
49 CFR Part 11
6 CFR Part 46
DEPARTMENT OF ENERGY
Federal Policy for the Protection of
Human Subjects: Six Month Delay of
the General Compliance Date of
Revisions While Allowing the Use of
Three Burden-Reducing Provisions
During the Delay Period
10 CFR Part 745
AGENCY:
DEPARTMENT OF AGRICULTURE
7 CFR Part 1c
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
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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 46
RIN 0937–AA05
NATIONAL SCIENCE FOUNDATION
45 CFR Part 690
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In a final rule published on
January 19, 2017, a number of federal
departments and agencies revised to the
Federal Policy for the Protection of
Human Subjects (often referred to as the
‘‘Common Rule’’), which each
department and agency adopted into
regulations in its part of the Code of
Federal Regulations (CFR). The
Consumer Product Safety Commission
(CPSC) adopted the same changes in a
final rule published on September 18,
2017. The revised Common Rule was
scheduled to become effective on
January 19, 2018, with a general
compliance date of the same date. By an
interim final rule issued on January 17,
2018 and published in the Federal
Register on January 22, 2018, federal
departments and agencies delayed the
effective date and the general
compliance date for the revised
Common Rule for a 6-month period,
until July 19, 2018. The Department of
Housing and Urban Development (HUD)
published an interim final rule adopting
the same regulatory changes on January
26, 2018. The revised Common Rule,
including technical amendments made
by the January 22, 2018 interim final
rule, is referred to here as the ‘‘2018
Requirements.’’
On April 20, 2018, the federal
departments and agencies listed here
published a notice of proposed
rulemaking (NPRM) proposing and
seeking comments as to whether the
general compliance date for the 2018
Requirements should be delayed for an
additional 6-month period. The NPRM
also proposed and sought comments on
SUMMARY:
AGENCY FOR INTERNATIONAL
DEVELOPMENT
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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: Final rule.
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whether to allow regulated entities to
implement certain burden-reducing
provisions of the 2018 Requirements in
specified circumstances during such
continued delay period.
Through this final rule, we are
adopting the proposals described in the
April 20, 2018 NPRM. This rule delays
the general compliance date for the 2018
Requirements for an additional 6-month
period, until January 21, 2019. As a
result of this delay, regulated entities
will be required, with an exception, to
continue to comply with the
requirements of the pre-2018 version of
the Federal Policy for the Protection of
Human Subjects (the ‘‘pre-2018
Requirements’’) until January 21, 2019.
The one exception to this general rule
is that institutions will be permitted
(but not required) to implement, for
certain research, three burden-reducing
provisions of the 2018 Requirements
during the delay period (July 19, 2018,
through January 20, 2019). Those three
provisions are: The revised definition of
‘‘research,’’ which deems certain
activities not to be research covered by
the Common Rule; the elimination of
the requirement for annual continuing
review with respect to certain categories
of research; and the elimination of the
requirement that institutional review
boards (IRBs) review grant applications
or other funding proposals related to the
research. Institutions taking advantage
of the three-burden reducing provisions
must comply with all other pre-2018
Requirements during the delay period.
The three burden-reducing provisions of
the 2018 Requirements can only be
implemented during the delay period
with respect to studies initiated prior to
January 21, 2019 that will transition to
compliance with the revised Common
Rule. Any study that implements these
three burden-reducing provisions
during the delay period must, beginning
on January 21, 2019, comply with all of
the 2018 Requirements for the balance
of the study’s duration.
DATES: Effective date: This rule is
effective on July 19, 2018. Compliance
dates: The general compliance date for
the 2018 Requirements in the final rule
published in the Federal Register (82
FR 7149, Jan. 19, 2017) and of the final
rule published by the Consumer Product
Safety Commission in the Federal
Register (82 FR 43459, Sept. 18, 2017),
which were delayed in the interim final
rule published in the Federal Register
(83 FR 2885, Jan. 22, 2018), and adopted
by HUD through an interim final rule
published in the Federal Register (83
FR 3589, Jan. 26, 2018), with the
exception of § lll.114(b), is further
delayed until January 21, 2019. The
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compliance date for § lll.114(b)
(cooperative research) remains January
20, 2020.
ADDRESSES: Jerry Menikoff, M.D., J.D.,
Office for Human Research Protections,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852.
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
Jerry.Menikoff@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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On January 19, 2017, the Department
of Health and Human Services (HHS)
and other federal departments and
agencies published a final rule revising
the Federal Policy for the Protection of
Human Subjects (generally referred to as
‘‘the Common Rule’’). 82 FR 7149. The
CPSC adopted the same regulatory
changes in a separate final rule
published on September 18, 2017. 82 FR
43459. The revised Common Rule was
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
§ lll.114(b), which has a compliance
date of January 20, 2020).
Some representatives of the regulated
community expressed concern regarding
their ability to implement all of the 2018
Requirements by the scheduled general
compliance date.1
On January 17, 2018, HHS and other
federal departments and agencies placed
on display at the Office of 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). This
rule did not impact the compliance date
for the cooperative research provision at
1 See, e.g., 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.aamc.org/download/480840/data/
aamcissuesjointletteroncommonrule.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.
See also 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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§ lll.114(b), which remained
January 20, 2020. On January 26, 2018,
HUD published an interim final rule
adopting the interagency interim final
rule. 83 FR 3589.
On April 20, 2018, federal
departments and agencies published a
notice of proposed rulemaking (NPRM)
soliciting comments on two proposals.
83 FR 17595. The first proposed an
additional 6-month delay for the general
compliance date for the 2018
Requirements (from July 19, 2018 to
January 21, 2019). The second proposed
a flexibility that would allow regulated
entities to take advantage of three
burden-reducing provisions of the 2018
Requirements during the delay period.
Both proposals are described more fully
below, together with a discussion of the
public comments submitted, and our
response to public comments. For the
reasons provided below, this final rule
adopts the proposals set forth in the
NPRM.
II. Public Comments and Response to
Comments
A. 2018 Interim Final Rule and 2018
NPRM Public Comment Summary
Public comment was solicited on the
interim final rule between January 22,
2018 and March 19, 2018. Public
comment was solicited on the NPRM to
delay the implementation of the 2018
Requirements while permitting the use
of three burden-reducing provisions of
the 2018 Requirements between April
20, 2018 and May 21, 2018.
We received 62 public comments on
the interim final rule. Of these, 36
comments were related to the Common
Rule. The remaining 26 comments were
not related to the Common Rule in any
way. We received 73 comments on the
NPRM. Five of these comments were not
related to the Common Rule.
Several common themes emerged
from the public comments on the
interim final rule and the NPRM. These
included:
—The need for the regulated community
to have as much advance notice as
possible about any delay in
implementing the 2018 Requirements.
—The need for guidance to be issued
promptly.
—General support for a delay of the
general compliance date, with more
limited support for a delay beyond
January, 2019. This support, however,
was generally tied to concern with
whether Common Rule departments
and agencies will be able to issue
guidance in a timely fashion prior to
the new general compliance date of
January 21, 2019.
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Both sets of comments tended to
endorse some type of delay beyond July
19, 2018 in the general compliance date
for the 2018 Requirements. Comments
on the interim final rule tended to
suggest that institutions be permitted to
voluntarily implement the 2018
Requirements in their entirety at any
time after July 19, 2018, while
comments on the NPRM indicated broad
support for the narrower approach of
permitting the voluntary use of three
burden-reducing provisions during the
delay period.
B. Public Comments on the January 22,
2018 Interim Final Rule and Response
to Comments
As well as soliciting comments on the
delay of the implementation of the 2018
Requirements, the interim final rule
solicited comments on the following:
—Whether or not the interim final rule
should be considered regulatory or
de-regulatory.
—Whether or not our assumption that
50 percent of regulated entities would
have gone forward using the new or
expanded exemption categories, had
the implementation date of the 2018
Requirements remained January 19,
2018, was correct.
We received no comments on our
assumption that 50 percent of regulated
entities would have gone forward using
the new or expanded exemption
categories had the implementation date
of the 2018 Requirements remained
January 19, 2018. We received one
comment addressing whether or not the
interim final rule should be considered
regulatory or de-regulatory. This
comment indicated that the 2018
Requirements should be considered deregulatory, without commenting on the
regulatory or de-regulatory status of the
interim final rule.
Of the 36 comments received on the
interim final rule related to the Common
Rule (and more specifically on delaying
the effective and general compliance
dates of the 2018 Requirements to July
19, 2018), several themes were present.
Many of these comments discussed
issues with the timing and issuance of
the interim final rule, claiming that the
fact that it was put on public display in
the Federal Register 48 hours before the
original implementation date caused
chaos and confusion in the regulated
community. Several commenters
described what they categorized as
chaos that ensued when the interim
final rule was put on public display 48
hours before the original effective date
and general compliance date for the
2018 Requirements. This rollout created
administrative burdens for institutions,
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as many had changed IT systems,
training programs, and other operational
tasks and then had to hastily undo these
changes. Another commenter described
the issuance of the interim final rule
and the relative silence from Common
Rule departments and agencies in the
period since publication of the 2018
Requirements (in the January 19, 2017
final rule) as a betrayal of IRBs.
Additionally, commenters expressed
concern that given the short timeline
between the closing of the comment
period and the new general
implementation date of July 19, 2018,
any further delay of the 2018
Requirements would similarly create
chaos and confusion in the regulated
community. Commenters also generally
expressed that the 6-month delay
granted by the interim final rule created
a situation in which regulated entities
that were ready to implement the 2018
Requirements in January 2018 had to
spend the personnel hours to ‘‘undo’’
these changes, which seemed
contradictory to the overall goal of the
revisions to the Common Rule of
reducing administrative burden. A few
commenters focused entirely on how
the relative silence by Common Rule
departments and agencies since
publication of the 2018 Requirements
has created a confusing environment for
this regulated community and requested
more transparency from the regulating
departments and agencies in the future.
[Response: We acknowledge that the
timing of the interim final rule was not
ideal and led to frustration within the
regulated community. We believe that
the 2018 NPRM and this final rule to
delay the general compliance date for
the 2018 Requirements while permitting
the use of three burden-reducing
provisions of the 2018 Requirements
provides the regulated community with
sufficient notice about when the 2018
Requirements will go into effect, and
when regulated entities will be required
to comply with the 2018 Requirements.]
Almost half of the comments related
to the Common Rule advocated for the
Common Rule departments and
agencies to retain the July 19, 2018
effective date for the 2018
Requirements, and to delay the general
compliance date. These commenters
argued that during the period between
the effective date and delayed general
compliance date, institutions should be
permitted to voluntarily comply (on a
study-by-study basis) with the 2018
Requirements. A couple of these
comments advocated for institutions to
be able to implement select 2018
Requirements during this voluntary
compliance period, as opposed to
choosing to comply with the entirety of
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the 2018 Requirements, in order to
provide institutions with the most
flexibility. A majority of the comments
described in this paragraph advocated
for delaying the general compliance date
to January 21, 2019, as these
commenters did not believe that full
compliance with the 2018 Requirements
would be possible by July 19, 2018. A
few commenters advocated delaying the
general compliance date beyond January
21, 2019 to permit institutions as much
time as possible to comply with the
2018 Requirements
One commenter suggested that both
the effective and general compliance
dates be delayed by 6 months to one
year after Common Rule departments
and agencies issue critical guidance
documents. Other commenters
suggested that Common Rule
departments and agencies should be
given a date by which they must publish
key guidance documents. Several
comments included a description of
guidance documents that they would
like for Common Rule departments and
agencies to focus on initially.
Suggestions included: OHRP’s decision
charts, key information in informed
consent, broad consent, and continuing
review (§ lll.109(f)).
Some of the comments relevant to the
Common Rule advocated for no
additional delay in the implementation
of the 2018 Requirements beyond July
19, 2018. These comments argued that
institutions and Common Rule
departments and agencies have had
sufficient time to prepare for the
implementation of the Rule. One
comment suggested that while guidance
would certainly be helpful, it is possible
to implement the Rule without such
guidance, as evidenced by the fact that
many institutions were ready to
implement the 2018 Requirements
before the publication of the interim
final rule.
Several commenters also addressed
whether certain aspects of the 2018
Requirements would be difficult to
implement in the absence of agency
guidance. These commenters
acknowledged the importance of
guidance to implement many areas of
the 2018 Requirements but noted that
the confusion and chaos created by latebreaking announcements of delays in
the implementation of the 2018
Requirements ultimately caused more
administrative burden within
institutions. One large public university
system in the United States indicated
that if guidance is issued after
institutions have revised their policies,
procedures, and IT systems, it likely
will create a burdensome situation
where policies, procedures, and IT
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systems will need to be revised again to
comport with department and agency
guidance.
[Response: We agree with interim
final rule comments suggesting that we
keep the effective date of the 2018
Requirements as July 19, 2018, while
delaying the general compliance date.
While we considered the alternative of
amending 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 adopting the changes
proposed in the NPRM, 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 2018 Requirements. As
described in the NPRM, 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 finalizing 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.
We recognize the difficulty in
implementing the 2018 Requirements in
the absence of guidance and will strive
to issue guidance on key aspects of the
2018 Requirements as quickly as
possible, while also engaging
stakeholders.]
A small subset of comments suggested
additional revisions to the Common
Rule. For example, one commenter
discussed the inclusion of a provision
that would permit parents to decline
certain procedures on behalf of their
children.
[Response: This comment listed
several clinical procedures done in the
routine course of medical care. Such
activities are outside of the scope of the
Common Rule, and thus are outside of
the scope of this rulemaking.]
Others discussed concerns with the
waiver provision at § lll.101(i) and
suggested that this provision be
strengthened such that departments and
agencies are only permitted to waive the
Common Rule with regard to certain
research activities when such a waiver
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is consistent with the Belmont Report.2
One commenter also suggested that the
Clinton Memorandum3 concerning
requirements pertaining to classified
research be fully implemented. These
comments also referenced concerns
with the carve-out form the definition of
research pertaining to authorized
operational activities in support of
national security missions.
[Response: The January 19, 2017 final
rule preamble stated ‘‘[t]hese authorized
operational activities, as determined by
each agency, do not include research
activities as defined by the Common
Rule, nor have they ever in the past
been considered regulated by the
Common Rule. This category of activity
is removed from the definition of
research to make explicit that the
requirements of the final rule do not
apply to authorized operational
activities in support of national security
missions. This clarification is not
intended to narrow the scope of the
Common Rule. We do not believe that
this category contradicts President
Clinton’s Memorandum of 1997
regarding classified research, because
this category is merely clarifying what
activities are not considered to meet the
definition of research. The Clinton
Memorandum calls for a number of
requirements to be added to protections
for classified research activities, but it
does not address activities that are not
considered research.’’]
Some commenters expressed concerns
with how the transition provision
essentially creates a dual regulatory
system for human subjects protections.
One commenter explicitly advocated for
the Common Rule to require all research
subject to the Common Rule to comply
with the 2018 Requirements by a certain
date given the additional protections to
subjects that the revised Common Rule
affords research participants.
[Response: We agree that the
transition provision at § lll.101(l)
creates a system in which many
institutions will need to be familiar with
both versions of the Common Rule (if
they elect to keep at least some
previously initiated studies subject to
the pre-2018 Requirements while their
newly initiated studies are subject to the
2018 Requirements). However, we
believe that the flexibility afforded by
2 National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research. Ethical Principles and Guidelines for the
Protection of Human Subjects of Research. April 18,
1979. https://www.hhs.gov/ohrp/regulations-andpolicy/belmont-report/.
3 Clinton, WJ. Strengthened Protections for
Human Subjects of Classified Research. 62 FR
26367–26372. May 13, 1997. https://www.gpo.gov/
fdsys/pkg/FR-1997-05-13/pdf/97-12699.pdf.
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the transition provision is important for
institutions to manage their operations
while implementing the 2018
Requirements. We do not believe that
this compromises the protection of
human subjects.]
A few comments suggested that the
general compliance date of the 2018
Requirements should coincide with
FDA’s revision of its human subjects
protection regulations in order for there
not to be a time period where FDA
regulations are not harmonized with the
other Common Rule departments and
agencies.
[Response: With respect to the
comments suggesting that the general
compliance date of the 2018
Requirements should be tied to the FDA
harmonization efforts with the Common
Rule, we do not believe that this is
necessary. FDA is currently working to
harmonize its human subjects
regulations with the 2018 Requirements,
to the extent permitted by FDA’s
statutory authority and mandate. We do
not believe it is necessary to further
delay the 2018 Requirements’ general
compliance date as a result of a separate
rulemaking effort.]
One commenter argued that the 2018
Requirements should not be
implemented at all, as in their view, the
pre-2018 Requirements adequately
protect human subjects.
[Response: We disagree. We believe
that the 2018 Requirements will provide
a meaningful improvement in human
subjects protection, while reducing
administrative burden on institutions.]
A couple of commenters argued that
the general compliance date for the
cooperative research provision (§ lll
.114) should be delayed to 2022.
[Response: We disagree with the
comments suggesting that the
compliance date for the cooperative
research provision (§ lll.114(b))
needs to be delayed beyond January
2020. Public comments requesting this
change have not provided specific
evidence for why such a delay is
necessary, nor for the assertion that
implementing the single IRB of record
in cooperative research requirement will
not result in a reduction in burden.]
C. Public Comments on the April 20,
2018 NPRM and Response to Comments
The April 20, 2018 NPRM sought
comment on two primary proposals: (1)
The proposal to delay the general
compliance date for the 2018
Requirements to January 21, 2019; and
(2) whether institutions should be
allowed to implement three burdenreducing provisions in the 2018
Requirements during the delay period
from July 19, 2018 to January 21, 2019.
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The NPRM also solicited comment on
the advisability of two alternative
approaches to delaying the 2018
Requirements: (1) 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; and (2) the alternative of
delaying the effective date and general
compliance date beyond January 21,
2019. The NPRM also solicited
comment on whether the general
compliance date for the 2018
Requirements should remain July 19,
2018.
The NPRM proposed to modify the
transition provision at § lll.101(l) to
permit an institution or IRB (and not
just an IRB) to document the
institution’s decision to transition a
study to comply with the 2018
Requirements. (We received no public
comments on this proposal.)
A majority of comments that
discussed the NPRM proposals
supported some kind of delay to the
implementation of the 2018
Requirements. A majority supported the
NPRM proposals as drafted but
indicated that their support was
contingent upon the Common Rule
departments and agencies issuing the
relevant guidance prior to July 19, 2018
for the three burden-reducing
provisions, and all other key guidance
documents before the January 2019
general compliance date. In particular,
commenters noted that critical guidance
documents would need to be available
to the regulated community at least four
months prior to the proposed general
compliance date of January 21, 2019.
These commenters specifically stated
that if critical guidance documents were
not available by September 19, 2019,
they would support an additional delay
of the general compliance date.
Comments in response to the NPRM
generally supported the position that
many institutions need additional time
to prepare to implement the 2018
Requirements, and that the Common
Rule departments and agencies need
more time to develop and issue
guidance. Several commenters
specifically noted that the Department
of Veterans Affairs is not yet ready to
implement the 2018 Requirements and
needs more time.
Commenters suggested guidance
documents that should be provided as
quickly as possible to the regulated
community. These suggestions included
revising existing guidance, or issuing
new guidance, as follows:
—Revised OHRP decision charts
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—Information on the § lll.116
clinical trial consent form posting
location
—Limited IRB review
—Broad consent
—The new requirement that the
informed consent give the prospective
subject the information that a
reasonable person would want to
know in order to make an informed
decision about research participation
—The new requirement that the
informed consent begin with a
concise and focused presentation of
the key information that is most likely
to assist a prospective subject or
legally authorized representative in
understanding the reasons why one
might or might not want to participate
in the research.
—Identifiability
—Privacy and confidentiality
—Benign behavioral interventions
—Continuing review
[Response: This final rule adopts the
April 20, 2018 NPRM proposals, with
minor changes made to the regulatory
text for clarification and accuracy. As
stated above, we agree with the
comments that the issuance of guidance
will be useful for institutions to be able
to implement the 2018 Requirements,
and are working to issue such guidance
promptly. We appreciate the commenter
input on topics for guidance to be
issued by the departments and
agencies.]
One commenter noted that if Common
Rule departments and agencies
envisioned a specific way that
institutions or IRBs should document
the use of the three burden-reducing
provisions in the 2018 Requirements or
document the fact that an ongoing study
has transitioned to comply with the
2018 Requirements, that information
must be communicated to the regulated
community as soon as possible.
[Response: We do not believe that
there is a need to prescribe how
institutions document the decision to
use the three burden-reducing
provisions of the 2018 Requirements or
the decision to transition a study to
comply with the 2018 Requirements (on
or after January 21, 2019), beyond the
requirement that the institution or an
IRB must document and date such
determination. For example, this
institutional determination could be
documented in IRB meeting minutes, or
in an IRB reviewer checklist (if an
institution uses a checklist system). This
institutional determination could also
be documented in an institution’s
existing electronic system, if one exists,
or in a spreadsheet created and
maintained by the institution to keep
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track of which studies have been
transitioned to the 2018 Requirements.]
Several alternatives were suggested
for how a delay might be structured.
These included:
—Permitting voluntary compliance with
the entirety of the 2018 Requirements
between July 19, 2018 and January 21,
2019
—Keeping the NPRM proposals related
to decoupling the effective and
general compliance dates and the
early implementation of the three
burden-reducing provisions of the
2018 Requirements, but delaying the
effective date of the 2018
Requirements until at least one year
after Common Rule departments and
agencies have issued key guidance
documents
—Delaying both the effective and
general compliance dates until
January 21, 2019
—Delaying both the effective and
general compliance dates beyond
January 21, 2019
—Permitting the use of the three
burden-reducing provisions of the
2018 Requirements, but not requiring
that studies taking advantage of this
flexibility comply with the entirety of
the 2018 Requirements on and after
January 21, 2019.
A minority of comments indicated
concern that the NPRM proposals would
be confusing for the regulated
community to implement accurately.
However, several of these comments
indicated that if the Common Rule
departments and agencies determined
that moving forward with a delay was
still appropriate, the structure proposed
in the NPRM would be acceptable.
Regardless of the delay structure
endorsed, commenters noted that no
matter the delay option chosen by
Common Rule departments and
agencies, guidance needed to be issued
in order for the regulated community to
make use of the delay period and
prepare their institutions.
[Response: We acknowledge that there
were multiple ways that an
implementation delay of the 2018
Requirements could be structured. We
believe that the approach proposed in
the NPRM and adopted in this final rule
is the best balance of permitting
institutions to implement several of the
more straightforward provisions of the
2018 Requirements before the general
compliance date, while granting
Common Rule departments and
agencies additional time to develop and
issue key guidance documents, and
granting institutions additional time to
ensure that their operations are ready to
implement the 2018 Requirements.
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We do not believe a delay of the
general compliance date beyond January
21, 2019 is necessary. As discussed in
the NPRM, we continue to believe that
the regulated community will not need
additional time beyond January 2019 to
comply with the 2018 Requirements.
Most NPRM comments supported the
idea that January 2019 would be
sufficient to allow for implementation of
the 2018 Requirements, provided that
the Common Rule departments and
agencies issued key guidance.
We recognize that the implementation
structure in this final rule might be
confusing to some in the regulated
community. We intend to engage in
educational outreach to help the
regulated community better understand
what is permitted and what is not under
the revised transition provision at § ll
.101(l).]
Several commenters indicated that
understanding OHRP’s plan for
modifying the Federalwide Assurance
(‘‘FWA’’) process to comport with the
2018 Requirements would also be
helpful. Specific concerns were raised
about the deletion of the option to
‘‘check the box’’ on the FWA and how
the removal of this option will, in
certain states with separate human
subjects requirements, present
administrative challenges for
institutions. Another commenter
expressed concern about whether, after
January 21, 2019, FWAs would still be
valid given that they would include
statements and elections no longer
required under the 2018 Requirements.
[Response: We intend to provide the
regulated community with information
about how the FWA process will change
well in advance of any modifications
that are implemented. The 2018
Requirements at § lll.103(b) state
that the ‘‘[assurance] shall be filed in
such form and manner as the
department or agency head prescribes.’’
To that end, Common Rule departments
and agencies have significant flexibility
in what information is requested in the
assurance process. Questions about nonOHRP assurances will be addressed by
the relevant Common Rule departments
and agencies. With respect to OHRP
issued FWAs, OHRP wishes to make
clear that assurances on file with the
office will still be valid on and after
January 21, 2019 for their effective
period. Additionally, any changes made
to the assurance process will take
account of the fact that some
institutions might oversee protocols that
comply with the pre-2018 and 2018
Requirements.]
One commenter expressed concern
with how auditors would handle IRBs
reviewing protocols governed by both
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the pre-2018 Requirements and the 2018
Requirements, given that the 2018
Requirements do not require that every
nondiscriminatory effort will be made to
ensure that no IRB consists entirely of
men or entirely of women (pre-2018
Requirements at § lll.107(b)).
[Response: We believe that the § ll
.107(a) requirements for diversity on
IRBs serves the same purpose, and thus
do not see a conflict between the
diversity requirements for IRBs under
the pre-2018 Requirements and the 2018
Requirements.]
While the NPRM did not solicit
comments on the requirement for
cooperative research to be reviewed by
a single IRB (see § lll.114), we
received several comments discussing
this provision. Several asked for an
additional 2-year delay before the
changes at § lll.114(b) become
effective. Others said that this provision
should be amended such that use of a
single IRB is voluntary in cooperative
research. These comments argued that
the 2018 Requirements’ preamble
(published in the January 19, 2017 final
rule) underestimated the costs of the
single IRB mandate and the confusion
that implementing this policy would
create for investigators. Several of these
comments acknowledged that over time,
as institutions become accustomed to
developing reliance agreements and
managing the single IRB process, the
costs currently being experienced would
decrease.
[Response: We appreciate the
comments received on the single IRB of
record requirement in cooperative
research (§ lll.114(b)). We continue
to believe that a compliance date of
January 20, 2020 for this provision gives
institutions sufficient time to prepare
and implement this requirement. While
these commenters anecdotally indicated
that implementing this requirement has
been more costly to institutions than the
January 19, 2017 final rule preamble
estimated, no comment provided data
about the actual costs to implement this
provision. In the absence of specific
data, we retain our cost and benefit
assumptions related to this provision.]
One comment suggested adding the
exemption category for secondary use
where consent is not required (§ lll
.104(d)(4)) to the burden-reducing
provisions. This commenter noted that
because the inability to implement the
revised exemptions during the delay
period (i.e., July 19, 2018 through
January 20, 2018) accounted for the
majority of the costs estimated in the
NPRM for this delay, it would be
preferable for the final rule to permit the
early implementation of this exemption
category.
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[Response: As explained in the April
20, 2018 NPRM, we did not propose
adding the revised exemption categories
to § lll.101(l)(4)(i)(A) because
implementation of these categories
would involve significantly greater
complications. For example, we noted
in the NPRM that 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. Specifically in regard to
§ lll.104(d)(4), this exemption
involves several regulations and statutes
outside of the scope of the Common
Rule. As a result, it is a much more
complicated provision to implement,
and thus was not included as one of the
burden-reducing provisions of the 2018
Requirements that institutions could
voluntarily implement during the delay
period. After consideration of the public
comments received, we continue to
believe that the approach proposed in
the NPRM makes the most sense.]
One commenter argued that the 2018
Requirements should be withdrawn,
and that Common Rule departments and
agencies should issue several smaller
NPRMs to revise specific aspects of the
Common Rule.
[Response: We disagree with this
comment. We believe that the 2018
Requirements will provide a meaningful
improvement in human subjects
protection, while reducing
administrative burden on institutions.]
One commenter proposed that
institutions or other Common Rule
departments and agencies be required to
file interim reports with HHS about
their status with regard to full
implementation and compliance with
the 2018 Requirements. This commenter
suggested that HHS could issue waivers
for full implementation of the rule based
on these interim reports. Additionally,
such a reporting requirement would
give HHS and other Common Rule
departments and agencies the data
necessary to determine if another
adjustment to the 2018 Requirements
might be needed.
[Response: We believe that this
approach is impractical and
unnecessary. We believe that this final
rule will give institutions sufficient time
to implement the 2018 Requirements,
which also precludes the need for such
a phased approach.]
One commenter indicated a desire to
see a final rule containing the flexibility
included in the original publication of
the 2018 Requirements, on January 19,
2017, that institutions be permitted to
implement provisions of the 2018
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Requirements at any time before the
effective date.
[Response: This commenter
misunderstood the transition provision
as written in the first publication of the
2018 Requirements; the transition
provision published in the January 19,
2017 final rule revising the Common
Rule did not include the ability for
institutions to implement all provisions
of the 2018 Requirements before the
effective date and general compliance
date.]
As with the comments on the interim
final rule, a few comments expressed
concern with the waiver provision at
§ lll.101(i) allowing federal
departments and agencies to waive
some or all provisions of the Common
Rule (which could allow research to be
conducted on people without their
informed consent). These comments
additionally expressed concern with
institutions being permitted to
implement the exclusion of certain
operational activities conducted by
intelligence agencies during the delay
period and suggested that this carve-out
from the definition of research be
removed from the 2018 Requirements.
[Response: We are not contemplating
modifying the carve-outs from the
definition of research. Regarding the
carve-out from the definition of research
pertaining to authorized operational
activities in support of national security
missions, the January 19, 2017 final rule
preamble noted that ‘‘[t]hese authorized
operational activities, as determined by
each agency, do not include research
activities as defined by the Common
Rule, nor have they ever in the past
been considered regulated by the
Common Rule. This category of activity
is removed from the definition of
research to make explicit that the
requirements of the final rule do not
apply to authorized operational
activities in support of national security
missions. This clarification is not
intended to narrow the scope of the
Common Rule.’’]
III. Delay of the General Compliance
Date Until January 21, 2019
Through this final rule, the general
compliance date for the 2018
Requirements is delayed for a 6-month
period until January 21, 2019. Section
ll.101(l)(2) is revised to make this
delay explicit. The dates included in the
transition provision, set forth at § lll
.101(l)(3), (4), and (5), are also modified
to reflect this revised general
compliance date.
As a result of this rule, regulated
entities will be required to comply with
the pre-2018 Requirements prior to
January 21, 2019 (putting aside the
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burden-reducing provisions discussed
in section III below). Regulated entities
may not, prior to January 21, 2019,
comply with all provisions of the 2018
Requirements, with the exception of the
three burden-reducing provisions, in
lieu of all provisions of the pre-2018
Requirements. Of course, regulated
entities are permitted to adopt
provisions that do not conflict with the
pre-2018 Requirements, prior to January
21, 2019. For example, institutions may
choose to incorporate additional
elements of informed consent that
happen to be found in the 2018
Requirements, or elsewhere, so long as
such implementation does not conflict
with the pre-2018 Requirements. In
other words, institutions have the same
flexibility they have always had (i.e., to
exceed the minimum requirements set
by the regulations).
The compliance date for the
cooperative research provision of the
2018 Requirements (§ lll.114(b))
remains January 20, 2020.
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IV. Optional Flexibility:
Implementation of Certain BurdenReducing Provisions During the Delay
Period
As detailed in revised § lll
.101(l)(4) and as set forth below in more
detail, during the additional 6-month
period that the general compliance date
for the 2018 Requirements is delayed
(July 19, 2018 through January 20,
2019), institutions may transition a
research study to the 2018 Requirements
in order to take advantage of three
burden-reducing provisions of the 2018
Requirements. This final rule also
restructures § lll.101(l)(3) and (4)
(now numbered (5)) to aid readability. A
new section (now § lll.101(1)(4))
describes how the requirements apply to
research transitioning to take advantage
of the burden-reducing provisions
during different time periods. Below, we
provide an overview of the revised
transition provision to clarify its
application to different types of studies,
including studies taking early advantage
of the three burden-reducing provisions
of the 2018 Requirements.
A. Research Subject to the pre-2018
Requirements (§ lll.101(l)(3))
As a default, studies initiated (i.e.,
initially approved by an IRB, or for
which IRB review was waived by the
government pursuant to § lll.101(i)
or determined to be exempt) before
January 21, 2019 (the new general
compliance date for the 2018
Requirements) will continue to be
subject to the pre-2018 Requirements.
This approach will maintain the ability
of institutions to hold such studies to
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the same set of standards throughout
their duration and will avoid a
circumstance in which such research is
subject to two sets of rules. However, as
described below, institutions may elect
to transition such studies to comply
with the 2018 Requirements.
B. Research Subject to the 2018
Requirements (§ lll.101(l)(5))
Research initiated (i.e., initially
approved by an IRB, or for which IRB
review was waived by the government
pursuant to § lll.101(i), or
determined to be exempt) on or after
January 21, 2019 (the new general
compliance date for the 2018
Requirements) must be conducted in
compliance with the 2018
Requirements.
C. Research That Transitions To Comply
With the 2018 Requirements on or After
January 21, 2019 (§ lll.101(l)(4)(ii))
Section ll.101(l)(4)(ii) applies to
studies following the pre-2018
Requirements that transition to comply
with the 2018 Requirements on or after
January 21, 2019. In such
circumstances, the study must be
conducted in compliance with the 2018
Requirements beginning on the
transition date (i.e., the date the
transition determination is documented,
on or after January 21, 2019) for its
duration.
D. Research That Transitions To
Comply With the 2018 Requirements
During the 6-Month Delay Period (§ ll
.101(l)(4)(i))
As described in § lll
.101(l)(4)(i)(A), the option of applying
the three burden-reducing provisions of
the 2018 Requirements during the 6month delay period is only available
with respect to studies that transition to
comply with the 2018 Requirements
between July 19, 2018 through January
20, 2019.
Beginning on the date that the
transition determination is documented,
through January 20, 2019, such studies
must comply with the pre-2018
Requirements, except that the studies
will comply with the three burdenreducing provisions instead of or in
addition to the comparable pre-2018
Requirements (specified in § lll
.101(l)(4)(i)(A)(1)–(3)).
• Pursuant to § lll
.101(l)(4)(i)(A)(1), § lll.102(l) of the
2018 Requirements (definition of
research) will apply instead of § lll
.102(d) of the pre-2018 Requirements).
• Pursuant to § lll
.101(l)(4)(i)(A)(2), § lll.103(d) of the
2018 Requirements (revised certification
requirement that eliminates IRB review
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28503
of application or proposal) will apply
instead of § lll.103(f) of the pre-2018
Requirements.
• Pursuant to § ll.101(l)(4)(i)(A)(3),
§ lll.109(f)(1)(i) and (iii) of the 2018
Requirements (exceptions to mandated
continuing review) will apply instead of
§ lll.103(b) of the pre-2018
Requirements (as related to the
requirement for continuing review) and
in addition to § lll.109 of the pre2018 Requirements.
This approach is designed to 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 provisions
during the delay period.
In addition, beginning on January 21,
2019, such studies must, for the balance
of their duration, comply with the 2018
Requirements in their entirety.
We believe this rule strikes an
appropriate balance of permitting
voluntary early adoption of provisions
that reduce burdens without creating
significant complexities. 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 in which the remaining
activities consist only of completing
data analyses, the new requirements for
informed consent generally would not
be applicable.
While the three burden-reducing
provisions are a regulatory package, an
institution that takes advantage of this
flexibility may, as a matter of
institutional policy, adopt a more
stringent standard (such as that of the
pre-2018 Requirements) for any or all of
the circumstances addressed by these
three provisions. For example, if an
institution chooses to adopt a policy
that studies that qualify for expedited
review under a certain category should
continue to be subject to annual
continuing review, this rule does not
prevent the institution from adopting
and implementing that policy.
Given that studies taking advantage of
this flexibility will be complying with
provisions from both the pre-2018
Requirements and the 2018
Requirements during the delay period,
we explain how some provisions
interact and clarify our intended
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interpretations of particular regulatory
provisions that will apply during the 6month delay period. For studies electing
to transition to comply with the 2018
Requirements during the 6-month delay
period (July 19, 2018 through January
20, 2019), once the decision to
transition the study is documented:
1. In applying the definition of
research under the 2018 Requirements
(§ lll.102(l)(3)), the reference to a
‘‘public health authority’’ will be given
the meaning provided in the definition
of ‘‘public health authority’’ in the 2018
Requirements (§ lll.102(k)). This
interpretation arises because ‘‘public
health authority’’ is defined in the 2018
Requirements, but not in the pre-2018
Requirements.
2. In applying § lll.103(d) of the
2018 Requirements, the reference to
research ‘‘exempted under § ll.104’’
will be interpreted to refer to research
exempted under § lll.101(b) of the
pre-2018 Requirements. This
interpretation arises given that only the
exemptions set forth in the pre-2018
Requirements will be in effect during
the 6-month delay period.
3. The reference to ‘‘[r]esearch eligible
for expedited review in accordance with
§ lll.110’’ in § lll.109(f)(1)(i) of
the 2018 Requirements will be
interpreted to refer to § lll.110 of the
pre-2018 Requirements.
4. The documentation requirements
described in § lll.115(a)(3) of the
2018 Requirements (documenting an
IRB’s rationale for conducting
continuing review not otherwise
required) are not applicable during this
period.
5. Sectionll.103(d) of the 2018
Requirements will be substituted for
§ lll.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, § lll
.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.
E. General Transition Issues
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.
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Section ll.101(l)(4)(ii) applies to
studies following the pre-2018
Requirements that, at some point on or
after January 21, 2019, transition to
comply with the 2018 Requirements. If
the determination to transition a study
to the 2018 Requirements is
documented on or after January 21,
2019, as of the date of documentation
the study must be conducted in
compliance with the 2018 Requirements
for its duration.
We clarify that the transition
provision at § lll.101(l)(4) of the
2018 Requirements extends to research
newly initiated during the delay period.
Research newly initiated between July
19, 2018 and January 20, 2019 may be
either conducted under the pre-2018
Requirements, in accordance with § ll
.101(l)(3); or, an institution may
transition research newly initiated
during the delay period to the 2018
Requirements, in accordance with § ll
.101(l)(4), in which event the research
would be conducted under the pre-2018
Requirements, with substitution of the
three burden-reducing provisions of the
2018 Requirements for the comparable
provisions of the pre-2018
Requirements. In addition, on or after
January 21, 2019, an institution may
choose to transition research initiated
during the delay period that was
initially conducted under the pre-2018
Requirements, to compliance with the
2018 Requirements. In the NPRM,
proposed § lll.101(l)(4) referenced
application by an institution ‘‘engaged
in research’’ to ‘‘ongoing’’ research. In
order to clarify the Common Rule
departments’ and agencies’ intention
that research newly initiated during the
delay period may transition to the 2018
Requirements, this final rule no longer
includes the qualifier of ‘‘ongoing’’ to
describe research that transitions to the
2018 Requirements in accordance with
§ lll.101(l)(4). The final rule at
§ lll.101(l)(4) also includes the
additional wording ‘‘planning or’’ before
‘‘engaged in research’’ to clarify that
institutions are allowed to take
advantage of the 2018 Requirements’
carve-outs from the definition of
research for studies newly initiated
during the delay period (which would
allow a study that qualifies for one of
the carve-outs to be conducted without
prior IRB review and approval or
application of the other regulatory
requirements).
This final rule revises the
requirement, now set forth at § lll
.101(l)(4), regarding which entity may
document an institution’s decision to
transition research. This change will
offer institutions greater flexibility
regarding who documents the transition
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determination. Under the January 19,
2017 final rule, an institutional
determination that research would
transition to comply with the 2018
Requirements had to be documented by
an IRB. Under this rule, such a
determination may be documented
either by an IRB or an institution
(through officials who have the
authority to make such determinations
on behalf of the institution). Such
documentation must include the date of
the transition determination, and
records documenting the transition
decision must be retained in accordance
with § lll.115(b).
As a general matter, once an
institution decides to transition a study
to the 2018 Requirements and that
determination is documented, the date
of documentation will serve as the de
facto compliance date for either the
three-burden reducing provisions for
transition determinations documented
between July 19, 2018 and January 20,
2019, or the 2018 Requirements as
applied to the study for transition
determinations documented on or after
January 21, 2019.
This final rule has an effective date of
July 19, 2018, to enable regulated
entities to take advantage of the three
burden-reducing provisions during the
delay period. However, as explained in
this rule, the requirements a study must
comply with beginning on July 19, 2018
are detailed in the transition provision
codified at § lll.101(l)(1)–(5).
Finally, for consistency, headings were
added to § lll.101(l)(1) and (2).
V. 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.
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.
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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).
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VI. Regulatory Impact Analyses
We have examined the effects of this
final rule under Executive Order 12866
on Regulatory Planning and Review
(September 30, 1993), Executive Order
13563 on Improving Regulation and
Regulatory Review (January 18, 2011),
Executive Order 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 rule was
submitted to the Office of Management
and Budget (OMB) for review and has
been determined to be a ‘‘significant’’
regulatory action. This regulation has
been designated as ‘‘regulatory’’ under
Executive Order 13771 (Reducing
Regulation and Controlling Regulatory
Costs, issued on January 30, 2017). We
estimate that this rule generates $2.02
million in annualized costs at a 7%
discount rate, discounted relative to
year 2016, over a perpetual time
horizon. Details on the estimated costs
of this final rule can be found in the
economic analysis below.
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1. Need for This Final Rule 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 rule was
amended in a final rule published in the
Federal Register on January 22, 2018
and adopted by HUD through a final
rule published on January 26, 2018.
This final rule allows regulated
entities to continue to comply with the
pre-2018 requirements until January 21,
2019. As discussed above, this final rule
also permits 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 elimination of the
requirement for annual continuing
review of certain categories of research,
and (3) the elimination of the
requirement that IRBs review grant
applications or proposals related to the
research. As described in section III
above, this flexibility is permitted for
studies for which an institution makes
a choice to have those studies be subject
to the 2018 Requirements.
2. Public Comments on the April 20,
2018 NPRM RIA and Response to
Comments
The April 20, 2018 NPRM RIA
solicited comment on the following
assumptions:
—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, the assumption 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.
—That some entities will experience
cost savings as a result of this rule,
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and some entities would experience
costs as a result of this rule.
—That 50 percent of regulated entities
will take advantage of the option to
implement three burden-reducing
provisions of the 2018 Requirements
early. Additionally, the NPRM sought
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.
—That this rulemaking will not have
a significant economic impact on a
substantial number of small entities.
We received several comments on the
costs and benefits associated with the
April 20, 2018 NPRM to delay the 2018
Requirements. None of these comments
provided specific feedback on the cost
and benefit assumptions included in the
NPRM.
These comments indicated that the
timing and implementation of the
interim final rule created additional
administrative burden on institutions
that were prepared to implement the
2018 Requirements on January 19, 2018.
As discussed above, one comment
noted that if we permitted the
exemption at § lll.104(d)(4) for
secondary research where consent is not
required to be implemented prior to the
general compliance date, this delay
would essentially be cost neutral. While
we appreciate that there might be
economic benefits to permitting the
early implementation of one or more of
the new or revised exemption
categories, we did not include the
exemptions as one of the provisions of
the 2018 Requirements institutions can
utilize during the delay period finalized
in this rule because of the added
complexity of implementing the
exemptions in the absence of guidance.
Finally, we received several
comments indicating that the January
19, 2017 final rule preamble
underestimated the costs of
implementing the cooperative research
provision at § lll.114. These
comments argued that, at best, this
provision would represent a shifting of
administrative costs and burdens, but
would not represent an overall cost
savings. We continue to believe that the
original compliance date of this
provision in January 2020 gives
institutions sufficient time to prepare
and implement this requirement. While
these commenters anecdotally indicated
that implementing this requirement has
been more costly to institutions than the
January 19, 2017 final rule preamble
estimated, no commenter provided data
about the actual costs to implement this
provision. In the absence of specific
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data, we continue with our cost and
benefit assumptions related to this
provision.
3. Analysis of Benefits (Cost-Savings)
and Costs (Foregone Benefits) 4
The RIA for the 2018 Requirements
described the benefits and costs of 16
broad categories of changes finalized.
The RIA for this final rule uses the
information and calculations described
in the preamble to the 2018
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.
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
6-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
TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE GENERAL COMPLIANCE DATE FOR THE 2018 REQUIREMENTS BY 6
MONTHS
[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):
Quantified Costs ...............................................................................................................................................
The estimated benefits and costs of
delaying the general implementation
date of the 2018 Requirements by 6
months are shown in Table 2 below.
Note that the categorization shown
below includes the same 16 categories
7 Percent
6.4
5.9
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 6 MONTHS 5
Annualized value over 1 year by discount rate
(millions of 2016 dollars)
2018 Requirement RIA Category
Benefits (cost-savings)
Costs (foregone benefits)
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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 or Proposal 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) 6
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 ..................................................................................................
4 Note, that the terms ‘‘benefits’’ and ‘‘costsavings’’ are used interchangeably in this RIA.
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7%
3%
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
........................
........................
........................
........................
........................
........................
Similarly, the terms ‘‘costs’’ and ‘‘foregone benefits’’
are also used interchangeably.
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TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF
DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS BY 6 MONTHS 5—Continued
Annualized value over 1 year by discount rate
(millions of 2016 dollars)
2018 Requirement RIA Category
Benefits (cost-savings)
3%
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 benefits
(costs) of delaying the 2018
Requirements by 6 months are what
would have been the benefits of
implementing the 2018 Requirements
during the period of July 2018 through
January 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
6 months are what would have been the
costs of implementing the 2018
Requirements during the period of July
2018 through January 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.5 6
Categories with different assumptions
are described below.
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 6-month delay, regulated
entities and OHRP will 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 final rule, and some entities will
experience costs as a result of this rule,
but we lack data to quantify these
effects.
5 Zeroes in Table 2 (represented by —) signify that
the category has been unaffected by the 6-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 6-month delay
are the same as those estimated in the RIA for the
2018 Requirements.
6 Because compliance with this provision is not
required until 2020, benefits and costs here are not
included.
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3%
7%
........................
Unquantified
b. Early Implementation of the Three
Burden-Reducing Provisions of the 2018
Requirements (Explicit Carve-Outs of
Activities From the Definition of
Research [§ lll.102(l)]; Eliminating
the Requirement That the Grant
Application or Other Funding Proposal
Undergo IRB Review and Approval [Pre2018 Rule at § lll.103(f)];
Elimination of Continuing Review of
Research Under Specific Conditions
[§§ lll.109(f) and lll.115(a)(3)]
We assume that 50 percent of
regulated entities will take advantage of
the option included in this final rule to
implement three burden-reducing
provisions of the 2018 Requirements
prior to the general compliance date. 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 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
consist only of completing data
analyses, the new requirements for
informed consent would generally not
be applicable. Therefore, we assume
that there are situations in which an
institution would want to take
advantage of the three burden-reducing
provisions, and situations in which 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 19, 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
Costs (foregone benefits)
........................
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 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
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 or
IRB staff at the IRB Administrative staff
level 7 will spend 5 minutes per
protocol documenting the voluntary
election to use the three burdenreducing 2018 provisions during the
time period of July 19, 2018 to January
21, 2019.
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.
c. Expansion of Research Activities
Exempt From Full IRB Review (§ lll
.104(d))
The 2018 Requirements include five
new exemption categories and modify
7 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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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.8 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
provisions of the 2018 Requirements
have not yet been issued, 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.
4. Analysis of Final Rule Alternative
An alternative to the proposal
finalized in this rule was to delay the
effective date and general compliance
date to January 21, 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
provisions of the 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 final 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
8 See for example, SACHRP Recommendations of
August 2, 2017: https://www.hhs.gov/ohrp/sachrp-
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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.
§ lll.101(l)(4) Compliance Date and
Transition Provision (OMB Control No
0990–0260)
Section 101(l)(4)(i) permits studies to
transition to the 2018 Requirements
between July 19, 2018 and January 21,
2019 (which would be the new general
compliance date for 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 revision
to § lll.101(l)(4)(i). As described,
studies taking advantage of this option
would be subject to the three burden-
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7.4
6.9
50.8
47.0
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 § lll.102(l) (instead of § lll
.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 § lll.103(d) of the
2018 Requirements (instead of § lll
.103(f) of the pre-2018 Requirements),
and (3) the elimination of the
requirement for annual continuing
review of certain categories of research
at § lll.109(f)(1)(i) and (iii) of the
2018 Requirements (instead of § lll
.103(b), as related to the requirement for
continuing review, and in addition to
§ lll.109 of the pre-2018
Requirements).
committee/recommendations/sachrprecommendations/.
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We estimate that approximately
92,084 protocols would take advantage
of the voluntary election described in
§ lll.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 provisions of the 2018
Requirements during the time period of
July 19, 2018 through January 21, 2019.
We estimate that this provision includes
7,674 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.
We have determined that this final
rule 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 final rule would
not impose a regulatory burden for
regulated small entities because it
would delay the general compliance
date for the 2018 Requirements,
allowing the status quo to be retained
for the period of delay. Additionally,
regulated small entities are permitted to
comply voluntarily with those aspects
of the 2018 Requirements that do not
conflict with the pre-2018
Requirements, prior to January 21, 2019.
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We have therefore concluded that this
action will have no net regulatory
burden for all directly regulated small
entities.
adding paragraph (l)(5) to read as
follows:
D. Unfunded Mandates Reform Act
(UMRA)
*
28509
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.’’ In 2018, that threshold
is approximately $150 million. 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.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
this 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
this 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 further amended as follows:
Text of the Amended Common Rule
PARTll—PROTECTION OF HUMAN
SUBJECTS
1. Amend § lll.101 by adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
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§ lll.101 To what does this policy
apply?
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this [part/
subpart]. The general compliance date
for the 2018 Requirements is January 21,
2019. The compliance date for § lll
.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 § lll.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 § .101(b) of
the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section lll.102(l) of the 2018
Requirements (definition of research)
(instead of § lll.102(d) of the pre2018 Requirements);
(2) Section lll.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ lll.103(f) of the pre-2018
Requirements); and
(3) Section lll.109(f)(1)(i) and (iii)
of the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ lll.103(b), as related to the
requirement for continuing review, and
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in addition to § lll.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 further amends 6 CFR part 46
as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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; Pub. L. 107–296,
sec. 102, 306(c); Pub. L. 108–458, sec. 8306.
2. Amend § 46.101 by adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 46.101
To what does this policy apply?
daltland on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 46.102(l) of the 2018
Requirements (definition of research)
(instead of § 46.102(d) of the pre-2018
Requirements);
(2) Section 46.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 46.103(f) of the pre-2018
Requirements); and
(3) Section 46.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 46.103(b), as related to the
requirement for continuing review, and
in addition to § 46.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019;
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019; and
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Fmt 4701
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(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Claire M. Grady,
Deputy Secretary (Acting), 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
further amends 7 CFR part 1c as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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 adding a
heading for paragraph (l)(1), 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) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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)
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of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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.
daltland on DSKBBV9HB2PROD with RULES2
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 further
amends 10 CFR part 745 as published in
VerDate Sep<11>2014
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Jkt 244001
the Federal Register on January 19,
2017 (82 FR 7149), and as amended in
an interim 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:
■
Authority: 5 U.S.C. 301; 42 U.S.C. 7254;
42 U.S.C. 300v–1(b).
2. Amend § 745.101 by adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 745.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
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Fmt 4701
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28511
(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
§ 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 further amends
14 CFR part 1230 as published in the
Federal Register on January 19, 2017
(82 FR 7149), and as amended in an
interim 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 adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
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§ 1230.101
Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations
To what does this policy apply?
daltland on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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.
VerDate Sep<11>2014
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Jkt 244001
(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.
*
*
*
*
*
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
further amends 15 CFR part 27 as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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 adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 27.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
PO 00000
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Fmt 4701
Sfmt 4700
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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
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(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 further amends 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 an interim final rule published in the
Federal Register on January 22, 2018
(83 FR 2885), as follows:
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 adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 1028.101
To what does this policy apply?
daltland on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
VerDate Sep<11>2014
18:16 Jun 18, 2018
Jkt 244001
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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
§ 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
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28513
Administration further amends 20 CFR
part 431 as published in the Federal
Register on January 19, 2017 (82 FR
7149), and as amended in an interim
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 adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 431.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this part. The
general compliance date for the 2018
Requirements is January 21, 2019. The
compliance date for § 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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
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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;
(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,
Acting 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 further amends 22 CFR
part 225 as published in the Federal
Register on January 19, 2017 (82 FR
7149), and as amended in an interim
final rule published in the Federal
Register on January 22, 2018 (83 FR
2885), as follows:
daltland on DSKBBV9HB2PROD with RULES2
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 adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
■
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Jkt 244001
adding paragraph (l)(5) to read as
follows:
§ 225.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
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Frm 00020
Fmt 4701
Sfmt 4700
(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.
*
*
*
*
*
Irene Koek,
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
Urban Development further amends 24
CFR part 60 as published in the Federal
Register on January 19, 2017 (82 FR
7149), and as amended in an interim
final rule published in the Federal
Register on January 22, 2018 (83 FR
2885), and adopted by HUD through an
interim 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. 300v1(b) and 3535(d).
2. Amend § 60.101 by adding a
heading for paragraph (l)(1), 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) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this part. The
general compliance date for the 2018
Requirements is January 21, 2019. The
compliance date for § 60.114(b)
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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations
(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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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;
VerDate Sep<11>2014
18:16 Jun 18, 2018
Jkt 244001
(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 further
amends 29 CFR part 21 as published in
the Federal Register on January 19,
2017 (82 FR 7149), and as amended in
an interim 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 adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 21.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
PO 00000
Frm 00021
Fmt 4701
Sfmt 4700
28515
(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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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,
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.
*
*
*
*
*
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
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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations
further amends 32 CFR part 219 as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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; 42 U.S.C. 300v–
1(b).
2. Amend § 219.101 by adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 219.101
To what does this policy apply?
daltland on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
VerDate Sep<11>2014
18:16 Jun 18, 2018
Jkt 244001
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.
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
further amends 34 CFR part 97 as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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; 42 U.S.C. 300v–1(b).
2. Amend § 97.101 by adding a
heading for paragraph (l)(1), revising
■
PO 00000
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Fmt 4701
Sfmt 4700
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
§ 97.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this subpart.
The general compliance date for the
2018 Requirements is January 21, 2019.
The compliance date for § 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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
E:\FR\FM\19JNR2.SGM
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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations
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 further amends 38 CFR part 16
as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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).
2. Amend § 16.101 by adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 16.101
To what does this policy apply?
daltland on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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.
VerDate Sep<11>2014
18:16 Jun 18, 2018
Jkt 244001
(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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
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
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28517
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Jacquelyn Hayes-Byrd,
Acting 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 further amends 40 CFR part 26
as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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; and 42
U.S.C. 300v–1(b).
2. Amend § 26.101 by adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 26.101
To what does this policy apply?
*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this subpart.
The general compliance date for the
2018 Requirements is January 21, 2019.
The compliance date for § 26.114(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 § 26.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
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(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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
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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.
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For the reasons stated in the
preamble, Department of Health and
Human Services further amends 45 CFR
part 46 as published in the Federal
Register on January 19, 2017 (82 FR
7149), and as amended in an interim
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 adding a
heading for paragraph (l)(1), 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) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this subpart.
The general compliance date for the
2018 Requirements is January 21, 2019.
The compliance date for § 46.114(b)
(cooperative research) of the 2018
Requirements is January 20, 2020.
(3) Research subject to pre-2018
requirements. The pre-2018
Requirements shall apply to the
following research, unless the research
is transitioning to comply with the 2018
Requirements in accordance with
paragraph (l)(4) of this section:
(i) Research initially approved by an
IRB under the pre-2018 Requirements
before January 21, 2019;
(ii) Research for which IRB review
was waived pursuant to § 46.101(i) of
the pre-2018 Requirements before
January 21, 2019; and
(iii) Research for which a
determination was made that the
research was exempt under § 46.101(b)
of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or
after July 19, 2018, an institution
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
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(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 46.102(l) of the 2018
Requirements (definition of research)
(instead of § 46.102(d) of the pre-2018
Requirements);
(2) Section 46.103(d) of the 2018
Requirements (revised certification
requirement that eliminates IRB review
of application or proposal) (instead of
§ 46.103(f) of the pre-2018
Requirements); and
(3) Section 46.109(f)(1)(i) and (iii) of
the 2018 Requirements (exceptions to
mandated continuing review) (instead of
§ 46.103(b), as related to the
requirement for continuing review, and
in addition to § 46.109, of the pre-2018
Requirements); and
(B) Beginning on January 21, 2019,
comply with the 2018 Requirements.
(ii) If the determination to transition
is documented on or after January 21,
2019, the research shall, beginning on
the date of such documentation, comply
with the 2018 Requirements.
(5) Research subject to 2018
Requirements. The 2018 Requirements
shall apply to the following research:
(i) Research initially approved by an
IRB on or after January 21, 2019;
(ii) Research for which IRB review is
waived pursuant to paragraph (i) of this
section on or after January 21, 2019; and
(iii) Research for which a
determination is made that the research
is exempt on or after January 21, 2019.
*
*
*
*
*
Alex M. Azar II,
Secretary, U.S. Department of Health and
Human Services.
NATIONAL SCIENCE FOUNDATION
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
further amends 45 CFR part 690 as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim final rule
published in the Federal Register on
January 22, 2018 (83 FR 2885), as
follows:
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).
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2. Amend § 690.101 by adding a
heading for paragraph (l)(1), revising
paragraphs (l)(2), (3), and (4), and
adding paragraph (l)(5) to read as
follows:
■
§ 690.101
To what does this policy apply?
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*
*
*
*
*
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this 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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
§ 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
VerDate Sep<11>2014
18:16 Jun 18, 2018
Jkt 244001
§ 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
further amends 49 CFR part 11 as
published in the Federal Register on
January 19, 2017 (82 FR 7149), and as
amended in an interim 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 adding a
heading for paragraph (l)(1), 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) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes
of this section, the 2018 Requirements
means the Federal Policy for the
Protection of Human Subjects
requirements contained in this part. The
general compliance date for the 2018
Requirements is January 21, 2019. The
compliance date for § 11.114(b)
PO 00000
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Fmt 4701
Sfmt 4700
28519
(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
planning or engaged in research
otherwise covered by paragraph (l)(3) of
this section determines that such
research instead will transition to
comply with the 2018 Requirements, the
institution or an IRB must document
and date such determination.
(i) If the determination to transition is
documented between July 19, 2018, and
January 20, 2019, the research shall:
(A) Beginning on the date of such
documentation through January 20,
2019, comply with the pre-2018
Requirements, except that the research
shall comply with the following:
(1) Section 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
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;
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(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. 2018–13187 Filed 6–18–18; 8:45 am]
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BILLING CODE 4150–36–P
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]]>Agencies
[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Rules and Regulations]
[Pages 28497-28520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13187]
[[Page 28495]]
Vol. 83
Tuesday,
No. 118
June 19, 2018
Part II
Department of Homeland Security
-----------------------------------------------------------------------
6 CFR Part 46
Department of Agriculture
-----------------------------------------------------------------------
7 CFR 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 28496]]
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: Six Month Delay of
the General Compliance Date of Revisions While Allowing the Use of
Three Burden-Reducing Provisions during the Delay Period; Final Rule
Federal Register / Vol. 83 , No. 118 / Tuesday, June 19, 2018 / Rules
and Regulations
[[Page 28497]]
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
6 CFR Part 46
DEPARTMENT OF AGRICULTURE
7 CFR 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
RIN 0937-AA05
NATIONAL SCIENCE FOUNDATION
45 CFR Part 690
DEPARTMENT OF TRANSPORTATION
49 CFR Part 11
Federal Policy for the Protection of Human Subjects: Six Month
Delay of the General Compliance Date of Revisions 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: Final rule.
-----------------------------------------------------------------------
SUMMARY: In a final rule published on January 19, 2017, a number of
federal departments and agencies revised to the Federal Policy for the
Protection of Human Subjects (often referred to as the ``Common
Rule''), which each department and agency adopted into regulations in
its part of the Code of Federal Regulations (CFR). The Consumer Product
Safety Commission (CPSC) adopted the same changes in a final rule
published on September 18, 2017. The revised Common Rule was scheduled
to become effective on January 19, 2018, with a general compliance date
of the same date. By an interim final rule issued on January 17, 2018
and published in the Federal Register on January 22, 2018, federal
departments and agencies delayed the effective date and the general
compliance date for the revised Common Rule for a 6-month period, until
July 19, 2018. The Department of Housing and Urban Development (HUD)
published an interim final rule adopting the same regulatory changes on
January 26, 2018. The revised Common Rule, including technical
amendments made by the January 22, 2018 interim final rule, is referred
to here as the ``2018 Requirements.''
On April 20, 2018, the federal departments and agencies listed here
published a notice of proposed rulemaking (NPRM) proposing and seeking
comments as to whether the general compliance date for the 2018
Requirements should be delayed for an additional 6-month period. The
NPRM also proposed and sought comments on whether to allow regulated
entities to implement certain burden-reducing provisions of the 2018
Requirements in specified circumstances during such continued delay
period.
Through this final rule, we are adopting the proposals described in
the April 20, 2018 NPRM. This rule delays the general compliance date
for the 2018 Requirements for an additional 6-month period, until
January 21, 2019. As a result of this delay, regulated entities will be
required, with an exception, to continue to comply with the
requirements of the pre-2018 version of the Federal Policy for the
Protection of Human Subjects (the ``pre-2018 Requirements'') until
January 21, 2019. The one exception to this general rule is that
institutions will be permitted (but not required) to implement, for
certain research, three burden-reducing provisions of the 2018
Requirements during the delay period (July 19, 2018, through January
20, 2019). Those three provisions are: The revised definition of
``research,'' which deems certain activities not to be research covered
by the Common Rule; the elimination of the requirement for annual
continuing review with respect to certain categories of research; and
the elimination of the requirement that institutional review boards
(IRBs) review grant applications or other funding proposals related to
the research. Institutions taking advantage of the three-burden
reducing provisions must comply with all other pre-2018 Requirements
during the delay period. The three burden-reducing provisions of the
2018 Requirements can only be implemented during the delay period with
respect to studies initiated prior to January 21, 2019 that will
transition to compliance with the revised Common Rule. Any study that
implements these three burden-reducing provisions during the delay
period must, beginning on January 21, 2019, comply with all of the 2018
Requirements for the balance of the study's duration.
DATES: Effective date: This rule is effective on July 19, 2018.
Compliance dates: The general compliance date for the 2018 Requirements
in the final rule published in the Federal Register (82 FR 7149, Jan.
19, 2017) and of the final rule published by the Consumer Product
Safety Commission in the Federal Register (82 FR 43459, Sept. 18,
2017), which were delayed in the interim final rule published in the
Federal Register (83 FR 2885, Jan. 22, 2018), and adopted by HUD
through an interim final rule published in the Federal Register (83 FR
3589, Jan. 26, 2018), with the exception of Sec. ___.114(b), is
further delayed until January 21, 2019. The
[[Page 28498]]
compliance date for Sec. ___.114(b) (cooperative research) remains
January 20, 2020.
ADDRESSES: Jerry Menikoff, M.D., J.D., Office for Human Research
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
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 January 19, 2017, the Department of Health and Human Services
(HHS) and other federal departments and agencies published a final rule
revising the Federal Policy for the Protection of Human Subjects
(generally referred to as ``the Common Rule''). 82 FR 7149. The CPSC
adopted the same regulatory changes in a separate final rule published
on September 18, 2017. 82 FR 43459. The revised Common Rule was
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),
which has a compliance date of January 20, 2020).
Some representatives of the regulated community expressed concern
regarding their ability to implement all of the 2018 Requirements by
the scheduled general compliance date.\1\
---------------------------------------------------------------------------
\1\ See, e.g., 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.aamc.org/download/480840/data/aamcissuesjointletteroncommonrule.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.
See also 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/.
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On January 17, 2018, HHS and other federal departments and agencies
placed on display at the Office of 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). This rule did not impact the compliance date for the
cooperative research provision at Sec. ___.114(b), which remained
January 20, 2020. On January 26, 2018, HUD published an interim final
rule adopting the interagency interim final rule. 83 FR 3589.
On April 20, 2018, federal departments and agencies published a
notice of proposed rulemaking (NPRM) soliciting comments on two
proposals. 83 FR 17595. The first proposed an additional 6-month delay
for the general compliance date for the 2018 Requirements (from July
19, 2018 to January 21, 2019). The second proposed a flexibility that
would allow regulated entities to take advantage of three burden-
reducing provisions of the 2018 Requirements during the delay period.
Both proposals are described more fully below, together with a
discussion of the public comments submitted, and our response to public
comments. For the reasons provided below, this final rule adopts the
proposals set forth in the NPRM.
II. Public Comments and Response to Comments
A. 2018 Interim Final Rule and 2018 NPRM Public Comment Summary
Public comment was solicited on the interim final rule between
January 22, 2018 and March 19, 2018. Public comment was solicited on
the NPRM to delay the implementation of the 2018 Requirements while
permitting the use of three burden-reducing provisions of the 2018
Requirements between April 20, 2018 and May 21, 2018.
We received 62 public comments on the interim final rule. Of these,
36 comments were related to the Common Rule. The remaining 26 comments
were not related to the Common Rule in any way. We received 73 comments
on the NPRM. Five of these comments were not related to the Common
Rule.
Several common themes emerged from the public comments on the
interim final rule and the NPRM. These included:
--The need for the regulated community to have as much advance notice
as possible about any delay in implementing the 2018 Requirements.
--The need for guidance to be issued promptly.
--General support for a delay of the general compliance date, with more
limited support for a delay beyond January, 2019. This support,
however, was generally tied to concern with whether Common Rule
departments and agencies will be able to issue guidance in a timely
fashion prior to the new general compliance date of January 21, 2019.
Both sets of comments tended to endorse some type of delay beyond
July 19, 2018 in the general compliance date for the 2018 Requirements.
Comments on the interim final rule tended to suggest that institutions
be permitted to voluntarily implement the 2018 Requirements in their
entirety at any time after July 19, 2018, while comments on the NPRM
indicated broad support for the narrower approach of permitting the
voluntary use of three burden-reducing provisions during the delay
period.
B. Public Comments on the January 22, 2018 Interim Final Rule and
Response to Comments
As well as soliciting comments on the delay of the implementation
of the 2018 Requirements, the interim final rule solicited comments on
the following:
--Whether or not the interim final rule should be considered regulatory
or de-regulatory.
--Whether or not our assumption that 50 percent of regulated entities
would have gone forward using the new or expanded exemption categories,
had the implementation date of the 2018 Requirements remained January
19, 2018, was correct.
We received no comments on our assumption that 50 percent of
regulated entities would have gone forward using the new or expanded
exemption categories had the implementation date of the 2018
Requirements remained January 19, 2018. We received one comment
addressing whether or not the interim final rule should be considered
regulatory or de-regulatory. This comment indicated that the 2018
Requirements should be considered de-regulatory, without commenting on
the regulatory or de-regulatory status of the interim final rule.
Of the 36 comments received on the interim final rule related to
the Common Rule (and more specifically on delaying the effective and
general compliance dates of the 2018 Requirements to July 19, 2018),
several themes were present. Many of these comments discussed issues
with the timing and issuance of the interim final rule, claiming that
the fact that it was put on public display in the Federal Register 48
hours before the original implementation date caused chaos and
confusion in the regulated community. Several commenters described what
they categorized as chaos that ensued when the interim final rule was
put on public display 48 hours before the original effective date and
general compliance date for the 2018 Requirements. This rollout created
administrative burdens for institutions,
[[Page 28499]]
as many had changed IT systems, training programs, and other
operational tasks and then had to hastily undo these changes. Another
commenter described the issuance of the interim final rule and the
relative silence from Common Rule departments and agencies in the
period since publication of the 2018 Requirements (in the January 19,
2017 final rule) as a betrayal of IRBs.
Additionally, commenters expressed concern that given the short
timeline between the closing of the comment period and the new general
implementation date of July 19, 2018, any further delay of the 2018
Requirements would similarly create chaos and confusion in the
regulated community. Commenters also generally expressed that the 6-
month delay granted by the interim final rule created a situation in
which regulated entities that were ready to implement the 2018
Requirements in January 2018 had to spend the personnel hours to
``undo'' these changes, which seemed contradictory to the overall goal
of the revisions to the Common Rule of reducing administrative burden.
A few commenters focused entirely on how the relative silence by Common
Rule departments and agencies since publication of the 2018
Requirements has created a confusing environment for this regulated
community and requested more transparency from the regulating
departments and agencies in the future.
[Response: We acknowledge that the timing of the interim final rule
was not ideal and led to frustration within the regulated community. We
believe that the 2018 NPRM and this final rule to delay the general
compliance date for the 2018 Requirements while permitting the use of
three burden-reducing provisions of the 2018 Requirements provides the
regulated community with sufficient notice about when the 2018
Requirements will go into effect, and when regulated entities will be
required to comply with the 2018 Requirements.]
Almost half of the comments related to the Common Rule advocated
for the Common Rule departments and agencies to retain the July 19,
2018 effective date for the 2018 Requirements, and to delay the general
compliance date. These commenters argued that during the period between
the effective date and delayed general compliance date, institutions
should be permitted to voluntarily comply (on a study-by-study basis)
with the 2018 Requirements. A couple of these comments advocated for
institutions to be able to implement select 2018 Requirements during
this voluntary compliance period, as opposed to choosing to comply with
the entirety of the 2018 Requirements, in order to provide institutions
with the most flexibility. A majority of the comments described in this
paragraph advocated for delaying the general compliance date to January
21, 2019, as these commenters did not believe that full compliance with
the 2018 Requirements would be possible by July 19, 2018. A few
commenters advocated delaying the general compliance date beyond
January 21, 2019 to permit institutions as much time as possible to
comply with the 2018 Requirements
One commenter suggested that both the effective and general
compliance dates be delayed by 6 months to one year after Common Rule
departments and agencies issue critical guidance documents. Other
commenters suggested that Common Rule departments and agencies should
be given a date by which they must publish key guidance documents.
Several comments included a description of guidance documents that they
would like for Common Rule departments and agencies to focus on
initially. Suggestions included: OHRP's decision charts, key
information in informed consent, broad consent, and continuing review
(Sec. ___.109(f)).
Some of the comments relevant to the Common Rule advocated for no
additional delay in the implementation of the 2018 Requirements beyond
July 19, 2018. These comments argued that institutions and Common Rule
departments and agencies have had sufficient time to prepare for the
implementation of the Rule. One comment suggested that while guidance
would certainly be helpful, it is possible to implement the Rule
without such guidance, as evidenced by the fact that many institutions
were ready to implement the 2018 Requirements before the publication of
the interim final rule.
Several commenters also addressed whether certain aspects of the
2018 Requirements would be difficult to implement in the absence of
agency guidance. These commenters acknowledged the importance of
guidance to implement many areas of the 2018 Requirements but noted
that the confusion and chaos created by late-breaking announcements of
delays in the implementation of the 2018 Requirements ultimately caused
more administrative burden within institutions. One large public
university system in the United States indicated that if guidance is
issued after institutions have revised their policies, procedures, and
IT systems, it likely will create a burdensome situation where
policies, procedures, and IT systems will need to be revised again to
comport with department and agency guidance.
[Response: We agree with interim final rule comments suggesting
that we keep the effective date of the 2018 Requirements as July 19,
2018, while delaying the general compliance date. While we considered
the alternative of amending 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 adopting the changes proposed in the NPRM,
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 2018 Requirements. As described in the
NPRM, 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 finalizing 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.
We recognize the difficulty in implementing the 2018 Requirements
in the absence of guidance and will strive to issue guidance on key
aspects of the 2018 Requirements as quickly as possible, while also
engaging stakeholders.]
A small subset of comments suggested additional revisions to the
Common Rule. For example, one commenter discussed the inclusion of a
provision that would permit parents to decline certain procedures on
behalf of their children.
[Response: This comment listed several clinical procedures done in
the routine course of medical care. Such activities are outside of the
scope of the Common Rule, and thus are outside of the scope of this
rulemaking.]
Others discussed concerns with the waiver provision at Sec.
___.101(i) and suggested that this provision be strengthened such that
departments and agencies are only permitted to waive the Common Rule
with regard to certain research activities when such a waiver
[[Page 28500]]
is consistent with the Belmont Report.\2\ One commenter also suggested
that the Clinton Memorandum\3\ concerning requirements pertaining to
classified research be fully implemented. These comments also
referenced concerns with the carve-out form the definition of research
pertaining to authorized operational activities in support of national
security missions.
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\2\ National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. Ethical Principles and
Guidelines for the Protection of Human Subjects of Research. April
18, 1979. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/.
\3\ Clinton, WJ. Strengthened Protections for Human Subjects of
Classified Research. 62 FR 26367-26372. May 13, 1997. https://www.gpo.gov/fdsys/pkg/FR-1997-05-13/pdf/97-12699.pdf.
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[Response: The January 19, 2017 final rule preamble stated
``[t]hese authorized operational activities, as determined by each
agency, do not include research activities as defined by the Common
Rule, nor have they ever in the past been considered regulated by the
Common Rule. This category of activity is removed from the definition
of research to make explicit that the requirements of the final rule do
not apply to authorized operational activities in support of national
security missions. This clarification is not intended to narrow the
scope of the Common Rule. We do not believe that this category
contradicts President Clinton's Memorandum of 1997 regarding classified
research, because this category is merely clarifying what activities
are not considered to meet the definition of research. The Clinton
Memorandum calls for a number of requirements to be added to
protections for classified research activities, but it does not address
activities that are not considered research.'']
Some commenters expressed concerns with how the transition
provision essentially creates a dual regulatory system for human
subjects protections. One commenter explicitly advocated for the Common
Rule to require all research subject to the Common Rule to comply with
the 2018 Requirements by a certain date given the additional
protections to subjects that the revised Common Rule affords research
participants.
[Response: We agree that the transition provision at Sec.
___.101(l) creates a system in which many institutions will need to be
familiar with both versions of the Common Rule (if they elect to keep
at least some previously initiated studies subject to the pre-2018
Requirements while their newly initiated studies are subject to the
2018 Requirements). However, we believe that the flexibility afforded
by the transition provision is important for institutions to manage
their operations while implementing the 2018 Requirements. We do not
believe that this compromises the protection of human subjects.]
A few comments suggested that the general compliance date of the
2018 Requirements should coincide with FDA's revision of its human
subjects protection regulations in order for there not to be a time
period where FDA regulations are not harmonized with the other Common
Rule departments and agencies.
[Response: With respect to the comments suggesting that the general
compliance date of the 2018 Requirements should be tied to the FDA
harmonization efforts with the Common Rule, we do not believe that this
is necessary. FDA is currently working to harmonize its human subjects
regulations with the 2018 Requirements, to the extent permitted by
FDA's statutory authority and mandate. We do not believe it is
necessary to further delay the 2018 Requirements' general compliance
date as a result of a separate rulemaking effort.]
One commenter argued that the 2018 Requirements should not be
implemented at all, as in their view, the pre-2018 Requirements
adequately protect human subjects.
[Response: We disagree. We believe that the 2018 Requirements will
provide a meaningful improvement in human subjects protection, while
reducing administrative burden on institutions.]
A couple of commenters argued that the general compliance date for
the cooperative research provision (Sec. ___.114) should be delayed to
2022.
[Response: We disagree with the comments suggesting that the
compliance date for the cooperative research provision (Sec.
___.114(b)) needs to be delayed beyond January 2020. Public comments
requesting this change have not provided specific evidence for why such
a delay is necessary, nor for the assertion that implementing the
single IRB of record in cooperative research requirement will not
result in a reduction in burden.]
C. Public Comments on the April 20, 2018 NPRM and Response to Comments
The April 20, 2018 NPRM sought comment on two primary proposals:
(1) The proposal to delay the general compliance date for the 2018
Requirements to January 21, 2019; and (2) whether institutions should
be allowed to implement three burden-reducing provisions in the 2018
Requirements during the delay period from July 19, 2018 to January 21,
2019. The NPRM also solicited comment on the advisability of two
alternative approaches to delaying the 2018 Requirements: (1) 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; and (2) the alternative of
delaying the effective date and general compliance date beyond January
21, 2019. The NPRM also solicited comment on whether the general
compliance date for the 2018 Requirements should remain July 19, 2018.
The NPRM proposed to modify the transition provision at Sec.
___.101(l) to permit an institution or IRB (and not just an IRB) to
document the institution's decision to transition a study to comply
with the 2018 Requirements. (We received no public comments on this
proposal.)
A majority of comments that discussed the NPRM proposals supported
some kind of delay to the implementation of the 2018 Requirements. A
majority supported the NPRM proposals as drafted but indicated that
their support was contingent upon the Common Rule departments and
agencies issuing the relevant guidance prior to July 19, 2018 for the
three burden-reducing provisions, and all other key guidance documents
before the January 2019 general compliance date. In particular,
commenters noted that critical guidance documents would need to be
available to the regulated community at least four months prior to the
proposed general compliance date of January 21, 2019. These commenters
specifically stated that if critical guidance documents were not
available by September 19, 2019, they would support an additional delay
of the general compliance date.
Comments in response to the NPRM generally supported the position
that many institutions need additional time to prepare to implement the
2018 Requirements, and that the Common Rule departments and agencies
need more time to develop and issue guidance. Several commenters
specifically noted that the Department of Veterans Affairs is not yet
ready to implement the 2018 Requirements and needs more time.
Commenters suggested guidance documents that should be provided as
quickly as possible to the regulated community. These suggestions
included revising existing guidance, or issuing new guidance, as
follows:
--Revised OHRP decision charts
[[Page 28501]]
--Information on the Sec. ___.116 clinical trial consent form posting
location
--Limited IRB review
--Broad consent
--The new requirement that the informed consent give the prospective
subject the information that a reasonable person would want to know in
order to make an informed decision about research participation
--The new requirement that the informed consent begin with a concise
and focused presentation of the key information that is most likely to
assist a prospective subject or legally authorized representative in
understanding the reasons why one might or might not want to
participate in the research.
--Identifiability
--Privacy and confidentiality
--Benign behavioral interventions
--Continuing review
[Response: This final rule adopts the April 20, 2018 NPRM
proposals, with minor changes made to the regulatory text for
clarification and accuracy. As stated above, we agree with the comments
that the issuance of guidance will be useful for institutions to be
able to implement the 2018 Requirements, and are working to issue such
guidance promptly. We appreciate the commenter input on topics for
guidance to be issued by the departments and agencies.]
One commenter noted that if Common Rule departments and agencies
envisioned a specific way that institutions or IRBs should document the
use of the three burden-reducing provisions in the 2018 Requirements or
document the fact that an ongoing study has transitioned to comply with
the 2018 Requirements, that information must be communicated to the
regulated community as soon as possible.
[Response: We do not believe that there is a need to prescribe how
institutions document the decision to use the three burden-reducing
provisions of the 2018 Requirements or the decision to transition a
study to comply with the 2018 Requirements (on or after January 21,
2019), beyond the requirement that the institution or an IRB must
document and date such determination. For example, this institutional
determination could be documented in IRB meeting minutes, or in an IRB
reviewer checklist (if an institution uses a checklist system). This
institutional determination could also be documented in an
institution's existing electronic system, if one exists, or in a
spreadsheet created and maintained by the institution to keep track of
which studies have been transitioned to the 2018 Requirements.]
Several alternatives were suggested for how a delay might be
structured. These included:
--Permitting voluntary compliance with the entirety of the 2018
Requirements between July 19, 2018 and January 21, 2019
--Keeping the NPRM proposals related to decoupling the effective and
general compliance dates and the early implementation of the three
burden-reducing provisions of the 2018 Requirements, but delaying the
effective date of the 2018 Requirements until at least one year after
Common Rule departments and agencies have issued key guidance documents
--Delaying both the effective and general compliance dates until
January 21, 2019
--Delaying both the effective and general compliance dates beyond
January 21, 2019
--Permitting the use of the three burden-reducing provisions of the
2018 Requirements, but not requiring that studies taking advantage of
this flexibility comply with the entirety of the 2018 Requirements on
and after January 21, 2019.
A minority of comments indicated concern that the NPRM proposals
would be confusing for the regulated community to implement accurately.
However, several of these comments indicated that if the Common Rule
departments and agencies determined that moving forward with a delay
was still appropriate, the structure proposed in the NPRM would be
acceptable.
Regardless of the delay structure endorsed, commenters noted that
no matter the delay option chosen by Common Rule departments and
agencies, guidance needed to be issued in order for the regulated
community to make use of the delay period and prepare their
institutions.
[Response: We acknowledge that there were multiple ways that an
implementation delay of the 2018 Requirements could be structured. We
believe that the approach proposed in the NPRM and adopted in this
final rule is the best balance of permitting institutions to implement
several of the more straightforward provisions of the 2018 Requirements
before the general compliance date, while granting Common Rule
departments and agencies additional time to develop and issue key
guidance documents, and granting institutions additional time to ensure
that their operations are ready to implement the 2018 Requirements.
We do not believe a delay of the general compliance date beyond
January 21, 2019 is necessary. As discussed in the NPRM, we continue to
believe that the regulated community will not need additional time
beyond January 2019 to comply with the 2018 Requirements. Most NPRM
comments supported the idea that January 2019 would be sufficient to
allow for implementation of the 2018 Requirements, provided that the
Common Rule departments and agencies issued key guidance.
We recognize that the implementation structure in this final rule
might be confusing to some in the regulated community. We intend to
engage in educational outreach to help the regulated community better
understand what is permitted and what is not under the revised
transition provision at Sec. __.101(l).]
Several commenters indicated that understanding OHRP's plan for
modifying the Federalwide Assurance (``FWA'') process to comport with
the 2018 Requirements would also be helpful. Specific concerns were
raised about the deletion of the option to ``check the box'' on the FWA
and how the removal of this option will, in certain states with
separate human subjects requirements, present administrative challenges
for institutions. Another commenter expressed concern about whether,
after January 21, 2019, FWAs would still be valid given that they would
include statements and elections no longer required under the 2018
Requirements.
[Response: We intend to provide the regulated community with
information about how the FWA process will change well in advance of
any modifications that are implemented. The 2018 Requirements at Sec.
___.103(b) state that the ``[assurance] shall be filed in such form and
manner as the department or agency head prescribes.'' To that end,
Common Rule departments and agencies have significant flexibility in
what information is requested in the assurance process. Questions about
non-OHRP assurances will be addressed by the relevant Common Rule
departments and agencies. With respect to OHRP issued FWAs, OHRP wishes
to make clear that assurances on file with the office will still be
valid on and after January 21, 2019 for their effective period.
Additionally, any changes made to the assurance process will take
account of the fact that some institutions might oversee protocols that
comply with the pre-2018 and 2018 Requirements.]
One commenter expressed concern with how auditors would handle IRBs
reviewing protocols governed by both
[[Page 28502]]
the pre-2018 Requirements and the 2018 Requirements, given that the
2018 Requirements do not require that every nondiscriminatory effort
will be made to ensure that no IRB consists entirely of men or entirely
of women (pre-2018 Requirements at Sec. ___.107(b)).
[Response: We believe that the Sec. __.107(a) requirements for
diversity on IRBs serves the same purpose, and thus do not see a
conflict between the diversity requirements for IRBs under the pre-2018
Requirements and the 2018 Requirements.]
While the NPRM did not solicit comments on the requirement for
cooperative research to be reviewed by a single IRB (see Sec.
___.114), we received several comments discussing this provision.
Several asked for an additional 2-year delay before the changes at
Sec. ___.114(b) become effective. Others said that this provision
should be amended such that use of a single IRB is voluntary in
cooperative research. These comments argued that the 2018 Requirements'
preamble (published in the January 19, 2017 final rule) underestimated
the costs of the single IRB mandate and the confusion that implementing
this policy would create for investigators. Several of these comments
acknowledged that over time, as institutions become accustomed to
developing reliance agreements and managing the single IRB process, the
costs currently being experienced would decrease.
[Response: We appreciate the comments received on the single IRB of
record requirement in cooperative research (Sec. ___.114(b)). We
continue to believe that a compliance date of January 20, 2020 for this
provision gives institutions sufficient time to prepare and implement
this requirement. While these commenters anecdotally indicated that
implementing this requirement has been more costly to institutions than
the January 19, 2017 final rule preamble estimated, no comment provided
data about the actual costs to implement this provision. In the absence
of specific data, we retain our cost and benefit assumptions related to
this provision.]
One comment suggested adding the exemption category for secondary
use where consent is not required (Sec. ___.104(d)(4)) to the burden-
reducing provisions. This commenter noted that because the inability to
implement the revised exemptions during the delay period (i.e., July
19, 2018 through January 20, 2018) accounted for the majority of the
costs estimated in the NPRM for this delay, it would be preferable for
the final rule to permit the early implementation of this exemption
category.
[Response: As explained in the April 20, 2018 NPRM, we did 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, we noted in
the NPRM that 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.
Specifically in regard to Sec. ___.104(d)(4), this exemption involves
several regulations and statutes outside of the scope of the Common
Rule. As a result, it is a much more complicated provision to
implement, and thus was not included as one of the burden-reducing
provisions of the 2018 Requirements that institutions could voluntarily
implement during the delay period. After consideration of the public
comments received, we continue to believe that the approach proposed in
the NPRM makes the most sense.]
One commenter argued that the 2018 Requirements should be
withdrawn, and that Common Rule departments and agencies should issue
several smaller NPRMs to revise specific aspects of the Common Rule.
[Response: We disagree with this comment. We believe that the 2018
Requirements will provide a meaningful improvement in human subjects
protection, while reducing administrative burden on institutions.]
One commenter proposed that institutions or other Common Rule
departments and agencies be required to file interim reports with HHS
about their status with regard to full implementation and compliance
with the 2018 Requirements. This commenter suggested that HHS could
issue waivers for full implementation of the rule based on these
interim reports. Additionally, such a reporting requirement would give
HHS and other Common Rule departments and agencies the data necessary
to determine if another adjustment to the 2018 Requirements might be
needed.
[Response: We believe that this approach is impractical and
unnecessary. We believe that this final rule will give institutions
sufficient time to implement the 2018 Requirements, which also
precludes the need for such a phased approach.]
One commenter indicated a desire to see a final rule containing the
flexibility included in the original publication of the 2018
Requirements, on January 19, 2017, that institutions be permitted to
implement provisions of the 2018 Requirements at any time before the
effective date.
[Response: This commenter misunderstood the transition provision as
written in the first publication of the 2018 Requirements; the
transition provision published in the January 19, 2017 final rule
revising the Common Rule did not include the ability for institutions
to implement all provisions of the 2018 Requirements before the
effective date and general compliance date.]
As with the comments on the interim final rule, a few comments
expressed concern with the waiver provision at Sec. ___.101(i)
allowing federal departments and agencies to waive some or all
provisions of the Common Rule (which could allow research to be
conducted on people without their informed consent). These comments
additionally expressed concern with institutions being permitted to
implement the exclusion of certain operational activities conducted by
intelligence agencies during the delay period and suggested that this
carve-out from the definition of research be removed from the 2018
Requirements.
[Response: We are not contemplating modifying the carve-outs from
the definition of research. Regarding the carve-out from the definition
of research pertaining to authorized operational activities in support
of national security missions, the January 19, 2017 final rule preamble
noted that ``[t]hese authorized operational activities, as determined
by each agency, do not include research activities as defined by the
Common Rule, nor have they ever in the past been considered regulated
by the Common Rule. This category of activity is removed from the
definition of research to make explicit that the requirements of the
final rule do not apply to authorized operational activities in support
of national security missions. This clarification is not intended to
narrow the scope of the Common Rule.'']
III. Delay of the General Compliance Date Until January 21, 2019
Through this final rule, the general compliance date for the 2018
Requirements is delayed for a 6-month period until January 21, 2019.
Section __.101(l)(2) is revised to make this delay explicit. The dates
included in the transition provision, set forth at Sec. ___.101(l)(3),
(4), and (5), are also modified to reflect this revised general
compliance date.
As a result of this rule, regulated entities will be required to
comply with the pre-2018 Requirements prior to January 21, 2019
(putting aside the
[[Page 28503]]
burden-reducing provisions discussed in section III below). Regulated
entities may not, prior to January 21, 2019, comply with all provisions
of the 2018 Requirements, with the exception of the three burden-
reducing provisions, in lieu of all provisions of the pre-2018
Requirements. Of course, regulated entities are permitted to adopt
provisions that do not conflict with the pre-2018 Requirements, prior
to January 21, 2019. For example, institutions may choose to
incorporate additional elements of informed consent that happen to be
found in the 2018 Requirements, or elsewhere, so long as such
implementation does not conflict with the pre-2018 Requirements. In
other words, institutions have the same flexibility they have always
had (i.e., to exceed the minimum requirements set by the regulations).
The compliance date for the cooperative research provision of the
2018 Requirements (Sec. ___.114(b)) remains January 20, 2020.
IV. Optional Flexibility: Implementation of Certain Burden-Reducing
Provisions During the Delay Period
As detailed in revised Sec. ___.101(l)(4) and as set forth below
in more detail, during the additional 6-month period that the general
compliance date for the 2018 Requirements is delayed (July 19, 2018
through January 20, 2019), institutions may transition a research study
to the 2018 Requirements in order to take advantage of three burden-
reducing provisions of the 2018 Requirements. This final rule also
restructures Sec. ___.101(l)(3) and (4) (now numbered (5)) to aid
readability. A new section (now Sec. ___.101(1)(4)) describes how the
requirements apply to research transitioning to take advantage of the
burden-reducing provisions during different time periods. Below, we
provide an overview of the revised transition provision to clarify its
application to different types of studies, including studies taking
early advantage of the three burden-reducing provisions of the 2018
Requirements.
A. Research Subject to the pre-2018 Requirements (Sec. ___.101(l)(3))
As a default, studies initiated (i.e., initially approved by an
IRB, or for which IRB review was waived by the government pursuant to
Sec. ___.101(i) or determined to be exempt) before January 21, 2019
(the new general compliance date for the 2018 Requirements) will
continue to be subject to the pre-2018 Requirements. This approach will
maintain the ability of institutions to hold such studies to the same
set of standards throughout their duration and will avoid a
circumstance in which such research is subject to two sets of rules.
However, as described below, institutions may elect to transition such
studies to comply with the 2018 Requirements.
B. Research Subject to the 2018 Requirements (Sec. ___.101(l)(5))
Research initiated (i.e., initially approved by an IRB, or for
which IRB review was waived by the government pursuant to Sec.
___.101(i), or determined to be exempt) on or after January 21, 2019
(the new general compliance date for the 2018 Requirements) must be
conducted in compliance with the 2018 Requirements.
C. Research That Transitions To Comply With the 2018 Requirements on or
After January 21, 2019 (Sec. ___.101(l)(4)(ii))
Section __.101(l)(4)(ii) applies to studies following the pre-2018
Requirements that transition to comply with the 2018 Requirements on or
after January 21, 2019. In such circumstances, the study must be
conducted in compliance with the 2018 Requirements beginning on the
transition date (i.e., the date the transition determination is
documented, on or after January 21, 2019) for its duration.
D. Research That Transitions To Comply With the 2018 Requirements
During the 6-Month Delay Period (Sec. __.101(l)(4)(i))
As described in Sec. ___.101(l)(4)(i)(A), the option of applying
the three burden-reducing provisions of the 2018 Requirements during
the 6-month delay period is only available with respect to studies that
transition to comply with the 2018 Requirements between July 19, 2018
through January 20, 2019.
Beginning on the date that the transition determination is
documented, through January 20, 2019, such studies must comply with the
pre-2018 Requirements, except that the studies will comply with the
three burden-reducing provisions instead of or in addition to the
comparable pre-2018 Requirements (specified in Sec.
___.101(l)(4)(i)(A)(1)-(3)).
Pursuant to Sec. ___.101(l)(4)(i)(A)(1), Sec. ___.102(l)
of the 2018 Requirements (definition of research) will apply instead of
Sec. ___.102(d) of the pre-2018 Requirements).
Pursuant to Sec. ___.101(l)(4)(i)(A)(2), Sec. ___.103(d)
of the 2018 Requirements (revised certification requirement that
eliminates IRB review of application or proposal) will apply instead of
Sec. ___.103(f) of the pre-2018 Requirements.
Pursuant to Sec. __.101(l)(4)(i)(A)(3), Sec.
___.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to
mandated continuing review) will apply instead of Sec. ___.103(b) of
the pre-2018 Requirements (as related to the requirement for continuing
review) and in addition to Sec. ___.109 of the pre-2018 Requirements.
This approach is designed to 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 provisions during the delay period.
In addition, beginning on January 21, 2019, such studies must, for
the balance of their duration, comply with the 2018 Requirements in
their entirety.
We believe this rule strikes an appropriate balance of permitting
voluntary early adoption of provisions that reduce burdens without
creating significant complexities. 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 in which the
remaining activities consist only of completing data analyses, the new
requirements for informed consent generally would not be applicable.
While the three burden-reducing provisions are a regulatory
package, an institution that takes advantage of this flexibility may,
as a matter of institutional policy, adopt a more stringent standard
(such as that of the pre-2018 Requirements) for any or all of the
circumstances addressed by these three provisions. For example, if an
institution chooses to adopt a policy that studies that qualify for
expedited review under a certain category should continue to be subject
to annual continuing review, this rule does not prevent the institution
from adopting and implementing that policy.
Given that studies taking advantage of this flexibility will be
complying with provisions from both the pre-2018 Requirements and the
2018 Requirements during the delay period, we explain how some
provisions interact and clarify our intended
[[Page 28504]]
interpretations of particular regulatory provisions that will apply
during the 6-month delay period. For studies electing to transition to
comply with the 2018 Requirements during the 6-month delay period (July
19, 2018 through January 20, 2019), once the decision to transition the
study is documented:
1. In applying the definition of research under the 2018
Requirements (Sec. ___.102(l)(3)), the reference to a ``public health
authority'' will be given the meaning provided in the definition of
``public health authority'' in the 2018 Requirements (Sec.
___.102(k)). This interpretation arises because ``public health
authority'' is defined in the 2018 Requirements, but not in the pre-
2018 Requirements.
2. In applying Sec. ___.103(d) of the 2018 Requirements, the
reference to research ``exempted under Sec. __.104'' will be
interpreted to refer to research exempted under Sec. ___.101(b) of the
pre-2018 Requirements. This interpretation arises given that only the
exemptions set forth in the pre-2018 Requirements will be in effect
during the 6-month delay period.
3. The reference to ``[r]esearch eligible for expedited review in
accordance with Sec. ___.110'' in Sec. ___.109(f)(1)(i) of the 2018
Requirements will be interpreted to refer to Sec. ___.110 of the pre-
2018 Requirements.
4. The documentation requirements described in Sec. ___.115(a)(3)
of the 2018 Requirements (documenting an IRB's rationale for conducting
continuing review not otherwise required) are not applicable during
this period.
5. Section__.103(d) of the 2018 Requirements will 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.
E. General Transition Issues
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.
Section __.101(l)(4)(ii) applies to studies following the pre-2018
Requirements that, at some point on or after January 21, 2019,
transition to comply with the 2018 Requirements. If the determination
to transition a study to the 2018 Requirements is documented on or
after January 21, 2019, as of the date of documentation the study must
be conducted in compliance with the 2018 Requirements for its duration.
We clarify that the transition provision at Sec. ___.101(l)(4) of
the 2018 Requirements extends to research newly initiated during the
delay period. Research newly initiated between July 19, 2018 and
January 20, 2019 may be either conducted under the pre-2018
Requirements, in accordance with Sec. __.101(l)(3); or, an institution
may transition research newly initiated during the delay period to the
2018 Requirements, in accordance with Sec. __.101(l)(4), in which
event the research would be conducted under the pre-2018 Requirements,
with substitution of the three burden-reducing provisions of the 2018
Requirements for the comparable provisions of the pre-2018
Requirements. In addition, on or after January 21, 2019, an institution
may choose to transition research initiated during the delay period
that was initially conducted under the pre-2018 Requirements, to
compliance with the 2018 Requirements. In the NPRM, proposed Sec.
___.101(l)(4) referenced application by an institution ``engaged in
research'' to ``ongoing'' research. In order to clarify the Common Rule
departments' and agencies' intention that research newly initiated
during the delay period may transition to the 2018 Requirements, this
final rule no longer includes the qualifier of ``ongoing'' to describe
research that transitions to the 2018 Requirements in accordance with
Sec. ___.101(l)(4). The final rule at Sec. ___.101(l)(4) also
includes the additional wording ``planning or'' before ``engaged in
research'' to clarify that institutions are allowed to take advantage
of the 2018 Requirements' carve-outs from the definition of research
for studies newly initiated during the delay period (which would allow
a study that qualifies for one of the carve-outs to be conducted
without prior IRB review and approval or application of the other
regulatory requirements).
This final rule revises the requirement, now set forth at Sec.
___.101(l)(4), regarding which entity may document an institution's
decision to transition research. This change will offer institutions
greater flexibility regarding who documents the transition
determination. Under the January 19, 2017 final rule, an institutional
determination that research would transition to comply with the 2018
Requirements had to be documented by an IRB. Under this rule, such a
determination may be documented either by an IRB or an institution
(through officials who have the authority to make such determinations
on behalf of the institution). Such documentation must include the date
of the transition determination, and records documenting the transition
decision must be retained in accordance with Sec. ___.115(b).
As a general matter, once an institution decides to transition a
study to the 2018 Requirements and that determination is documented,
the date of documentation will serve as the de facto compliance date
for either the three-burden reducing provisions for transition
determinations documented between July 19, 2018 and January 20, 2019,
or the 2018 Requirements as applied to the study for transition
determinations documented on or after January 21, 2019.
This final rule has an effective date of July 19, 2018, to enable
regulated entities to take advantage of the three burden-reducing
provisions during the delay period. However, as explained in this rule,
the requirements a study must comply with beginning on July 19, 2018
are detailed in the transition provision codified at Sec.
___.101(l)(1)-(5). Finally, for consistency, headings were added to
Sec. ___.101(l)(1) and (2).
V. 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. 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.
[[Page 28505]]
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).
VI. Regulatory Impact Analyses
We have examined the effects of this final rule under Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), Executive Order 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 rule was submitted to the Office of
Management and Budget (OMB) for review and has been determined to be a
``significant'' regulatory action. This regulation has been designated
as ``regulatory'' under Executive Order 13771 (Reducing Regulation and
Controlling Regulatory Costs, issued on January 30, 2017). We estimate
that this rule generates $2.02 million in annualized costs at a 7%
discount rate, discounted relative to year 2016, over a perpetual time
horizon. Details on the estimated costs of this final rule can be found
in the economic analysis below.
1. Need for This Final Rule 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
rule was amended in a final rule published in the Federal Register on
January 22, 2018 and adopted by HUD through a final rule published on
January 26, 2018.
This final rule allows regulated entities to continue to comply
with the pre-2018 requirements until January 21, 2019. As discussed
above, this final rule also permits 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 elimination of the
requirement for annual continuing review of certain categories of
research, and (3) the elimination of the requirement that IRBs review
grant applications or proposals related to the research. As described
in section III above, this flexibility is permitted for studies for
which an institution makes a choice to have those studies be subject to
the 2018 Requirements.
2. Public Comments on the April 20, 2018 NPRM RIA and Response to
Comments
The April 20, 2018 NPRM RIA solicited comment on the following
assumptions:
--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, the assumption 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.
--That some entities will experience cost savings as a result of this
rule, and some entities would experience costs as a result of this
rule.
--That 50 percent of regulated entities will take advantage of the
option to implement three burden-reducing provisions of the 2018
Requirements early. Additionally, the NPRM sought 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.
--That this rulemaking will not have a significant economic impact
on a substantial number of small entities.
We received several comments on the costs and benefits associated
with the April 20, 2018 NPRM to delay the 2018 Requirements. None of
these comments provided specific feedback on the cost and benefit
assumptions included in the NPRM.
These comments indicated that the timing and implementation of the
interim final rule created additional administrative burden on
institutions that were prepared to implement the 2018 Requirements on
January 19, 2018.
As discussed above, one comment noted that if we permitted the
exemption at Sec. ___.104(d)(4) for secondary research where consent
is not required to be implemented prior to the general compliance date,
this delay would essentially be cost neutral. While we appreciate that
there might be economic benefits to permitting the early implementation
of one or more of the new or revised exemption categories, we did not
include the exemptions as one of the provisions of the 2018
Requirements institutions can utilize during the delay period finalized
in this rule because of the added complexity of implementing the
exemptions in the absence of guidance.
Finally, we received several comments indicating that the January
19, 2017 final rule preamble underestimated the costs of implementing
the cooperative research provision at Sec. ___.114. These comments
argued that, at best, this provision would represent a shifting of
administrative costs and burdens, but would not represent an overall
cost savings. We continue to believe that the original compliance date
of this provision in January 2020 gives institutions sufficient time to
prepare and implement this requirement. While these commenters
anecdotally indicated that implementing this requirement has been more
costly to institutions than the January 19, 2017 final rule preamble
estimated, no commenter provided data about the actual costs to
implement this provision. In the absence of specific
[[Page 28506]]
data, we continue with our cost and benefit assumptions related to this
provision.
3. Analysis of Benefits (Cost-Savings) and Costs (Foregone Benefits)
\4\
---------------------------------------------------------------------------
\4\ 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 final
rule 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 6-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
for the 2018 Requirements by 6 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):
Quantified Costs.................... 37.4 34.7
------------------------------------------------------------------------
The estimated benefits and costs of delaying the general
implementation date of the 2018 Requirements by 6 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 6 Months \5\
----------------------------------------------------------------------------------------------------------------
Annualized value over 1 year by discount rate (millions of
2016 dollars)
---------------------------------------------------------------
2018 Requirement RIA Category Benefits (cost-savings) Costs (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 or Proposal 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) \6\..............
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......
-------------------------------------------------
[[Page 28507]]
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 6 months are what would have been the benefits of
implementing the 2018 Requirements during the period of July 2018
through January 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 6
months are what would have been the costs of implementing the 2018
Requirements during the period of July 2018 through January 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.\5\ \6\
---------------------------------------------------------------------------
\5\ Zeroes in Table 2 (represented by --) signify that the
category has been unaffected by the 6-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 6-month delay are the same as those
estimated in the RIA for the 2018 Requirements.
\6\ Because compliance with this provision is not required until
2020, benefits and costs here are not included.
---------------------------------------------------------------------------
Categories with different assumptions are described below.
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 6-month delay, regulated
entities and OHRP will 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 final rule, and some entities will experience costs as a
result of this rule, but we lack data 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(l)]; Eliminating the Requirement
That the Grant Application or Other Funding Proposal 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 included in this final rule to implement three burden-
reducing provisions of the 2018 Requirements prior to the general
compliance date. 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 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 consist only of completing data analyses, the new
requirements for informed consent would generally not be applicable.
Therefore, we assume that there are situations in which an institution
would want to take advantage of the three burden-reducing provisions,
and situations in which 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 19, 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 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 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 or IRB staff at the IRB
Administrative staff level \7\ 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.
---------------------------------------------------------------------------
\7\ See the RIA to the 2018 Requirements (82 FR 7149) for more
information about the labor categories used in this analysis.
---------------------------------------------------------------------------
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.
c. Expansion of Research Activities Exempt From Full IRB Review (Sec.
___.104(d))
The 2018 Requirements include five new exemption categories and
modify
[[Page 28508]]
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.\8\
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.
---------------------------------------------------------------------------
\8\ 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 provisions of the 2018
Requirements have not yet been issued, 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.
4. Analysis of Final Rule Alternative
An alternative to the proposal finalized in this rule was to delay
the effective date and general compliance date to January 21, 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 provisions of the
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 final 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) permits studies to transition to the 2018
Requirements between July 19, 2018 and January 21, 2019 (which would be
the new general compliance date for 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 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
elimination of the requirement for 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).
[[Page 28509]]
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 provisions of the 2018 Requirements during the
time period of July 19, 2018 through January 21, 2019. We estimate that
this provision includes 7,674 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.
We have determined that this final rule 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 final rule would not
impose a regulatory burden for regulated small entities because it
would delay the general compliance date for the 2018 Requirements,
allowing the status quo to be retained for the period of delay.
Additionally, regulated small entities are permitted to comply
voluntarily with those aspects of the 2018 Requirements that do not
conflict with the pre-2018 Requirements, prior to January 21, 2019. We
have therefore concluded that this action will have no net regulatory
burden for all directly regulated small entities.
D. Unfunded Mandates Reform Act (UMRA)
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.'' In 2018, that threshold is approximately $150 million. 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.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 this 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 this 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 further amended as follows:
Text of the Amended Common Rule
PART__--PROTECTION OF HUMAN SUBJECTS
1. Amend Sec. ___.101 by adding a heading for paragraph (l)(1),
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) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this [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 planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section ___.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
[[Page 28510]]
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 further amends 6 CFR part 46 as published in the Federal
Register on January 19, 2017 (82 FR 7149), and as amended in an interim
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; Pub. L. 107-296, sec. 102, 306(c);
Pub. L. 108-458, sec. 8306.
0
2. Amend Sec. 46.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 46.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 46.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 46.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 46.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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.
* * * * *
Claire M. Grady,
Deputy Secretary (Acting), 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
further amends 7 CFR part 1c as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as amended in an interim final rule
published in the Federal Register on January 22, 2018 (83 FR 2885), as
follows:
PART 1c--PROTECTION OF HUMAN SUBJECTS
0
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).
0
2. Amend Sec. 1c.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 1c.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 1c.101(b)
[[Page 28511]]
of the pre-2018 Requirements before January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 1c.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 1c.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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
further amends 10 CFR part 745 as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as amended in an interim final rule
published in the Federal Register on January 22, 2018 (83 FR 2885), as
follows:
PART 745--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for part 745 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 745.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 745.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 745.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 745.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec.
745.103(b), as related to the requirement for continuing review, and in
addition to Sec. 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 further amends 14 CFR part 1230 as published in
the Federal Register on January 19, 2017 (82 FR 7149), and as amended
in an interim final rule published in the Federal Register on January
22, 2018 (83 FR 2885), as follows:
PART 1230--PROTECTION OF HUMAN SUBJECTS
0
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).
0
2. Amend Sec. 1230.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
[[Page 28512]]
Sec. 1230.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 1230.114(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.
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 Sec. 1230.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 1230.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec.
1230.103(b), as related to the requirement for continuing review, and
in addition to Sec. 1230.109, 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.
* * * * *
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
further amends 15 CFR part 27 as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as amended in an interim final rule
published in the Federal Register on January 22, 2018 (83 FR 2885), as
follows:
PART 27--PROTECTION OF HUMAN SUBJECTS
0
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).
0
2. Amend Sec. 27.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 27.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 27.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 27.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 27.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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
[[Page 28513]]
(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 further amends 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 an interim final rule published in the Federal Register on
January 22, 2018 (83 FR 2885), as follows:
PART 1028--PROTECTION OF HUMAN SUBJECTS
0
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).
0
2. Amend Sec. 1028.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 1028.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 1028.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 1028.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec.
1028.103(b), as related to the requirement for continuing review, and
in addition to Sec. 1028.109, 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.
* * * * *
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 further amends 20 CFR part 431 as published in the
Federal Register on January 19, 2017 (82 FR 7149), and as amended in an
interim final rule published in the Federal Register on January 22,
2018 (83 FR 2885), as follows:
PART 431--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for part 431 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
0
2. Amend Sec. 431.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 431.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 431.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018
[[Page 28514]]
Requirements, except that the research shall comply with the following:
(1) Section 431.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec.
431.103(b), as related to the requirement for continuing review, and in
addition to Sec. 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;
(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,
Acting 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 further amends 22 CFR part 225 as published in the Federal
Register on January 19, 2017 (82 FR 7149), and as amended in an interim
final rule published in the Federal Register on January 22, 2018 (83 FR
2885), as follows:
PART 225--PROTECTION OF HUMAN SUBJECTS
0
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.
0
2. Amend Sec. 225.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 225.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
225.101(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. 225.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 225.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec.
225.103(b), as related to the requirement for continuing review, and in
addition to Sec. 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.
* * * * *
Irene Koek,
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
Urban Development further amends 24 CFR part 60 as published in the
Federal Register on January 19, 2017 (82 FR 7149), and as amended in an
interim final rule published in the Federal Register on January 22,
2018 (83 FR 2885), and adopted by HUD through an interim final rule
published on January 26, 2018 (83 FR 3589), as follows:
PART 60--PROTECTION OF HUMAN SUBJECTS
0
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).
0
2. Amend Sec. 60.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 60.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 60.114(b)
[[Page 28515]]
(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.
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 Sec. 60.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 60.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 60.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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 further
amends 29 CFR part 21 as published in the Federal Register on January
19, 2017 (82 FR 7149), and as amended in an interim final rule
published in the Federal Register on January 22, 2018 (83 FR 2885), as
follows:
PART 21--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for part 21 continues to read as follows:
Authority: 5 U.S.C. 301; 29 U.S.C. 551.
0
2. Amend Sec. 21.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 21.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 21.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 21.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 21.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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, 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.
* * * * *
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
[[Page 28516]]
further amends 32 CFR part 219 as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as amended in an interim final rule
published in the Federal Register on January 22, 2018 (83 FR 2885), as
follows:
PART 219--PROTECTION OF HUMAN SUBJECTS
0
1. The authority citation for part 219 continues to read as follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 219.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 219.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
219.101(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. 219.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 219.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec.
219.103(b), as related to the requirement for continuing review, and in
addition to Sec. 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.
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
further amends 34 CFR part 97 as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as amended in an interim final rule
published in the Federal Register on January 22, 2018 (83 FR 2885), as
follows:
PART 97--PROTECTION OF HUMAN SUBJECTS
0
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; 42 U.S.C.
300v-1(b).
0
2. Amend Sec. 97.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 97.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this subpart. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 97.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 97.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 97.103(b),
as related to the requirement for continuing review, and
[[Page 28517]]
in addition to Sec. 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 further amends 38 CFR part 16 as published in the Federal
Register on January 19, 2017 (82 FR 7149), and as amended in an interim
final rule published in the Federal Register on January 22, 2018 (83 FR
2885), as follows:
PART 16--PROTECTION OF HUMAN SUBJECTS
0
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).
0
2. Amend Sec. 16.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 16.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 16.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 16.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 16.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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,
Acting 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 further amends 40 CFR part 26 as published in the Federal
Register on January 19, 2017 (82 FR 7149), and as amended in an interim
final rule published in the Federal Register on January 22, 2018 (83 FR
2885), as follows:
PART 26--PROTECTION OF HUMAN SUBJECTS
0
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; and
42 U.S.C. 300v-1(b).
0
2. Amend Sec. 26.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 26.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this subpart. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 26.114(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.
26.101(i) of the pre-2018 Requirements before January 21, 2019; and
[[Page 28518]]
(iii) Research for which a determination was made that the research
was exempt under Sec. 26.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 26.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 26.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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
(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 further amends 45 CFR part 46 as published in the
Federal Register on January 19, 2017 (82 FR 7149), and as amended in an
interim 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; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
0
2. Amend Sec. 46.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 46.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this subpart. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 46.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 46.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 46.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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
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
further amends 45 CFR part 690 as published in the Federal Register on
January 19, 2017 (82 FR 7149), and as amended in an interim final rule
published in the Federal Register on January 22, 2018 (83 FR 2885), as
follows:
PART 690--PROTECTION OF HUMAN SUBJECTS
0
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).
[[Page 28519]]
0
2. Amend Sec. 690.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 690.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 690.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 690.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec.
690.103(b), as related to the requirement for continuing review, and in
addition to Sec. 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 further amends 49 CFR part 11 as published in the
Federal Register on January 19, 2017 (82 FR 7149), and as amended in an
interim final rule published in the Federal Register on January 22,
2018 (83 FR 2885), as follows:
PART 11--PROTECTION OF HUMAN SUBJECTS
0
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).
0
2. Amend Sec. 11.101 by adding a heading for paragraph (l)(1),
revising paragraphs (l)(2), (3), and (4), and adding paragraph (l)(5)
to read as follows:
Sec. 11.101 To what does this policy apply?
* * * * *
(l) * * *
(1) Pre-2018 Requirements. * * *
(2) 2018 Requirements. For purposes of this section, the 2018
Requirements means the Federal Policy for the Protection of Human
Subjects requirements contained in this part. The general compliance
date for the 2018 Requirements is January 21, 2019. The compliance date
for Sec. 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 Sec.
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 Sec. 11.101(b) of the pre-2018 Requirements before
January 21, 2019.
(4) Transitioning research. If, on or after July 19, 2018, an
institution planning or engaged in research otherwise covered by
paragraph (l)(3) of this section determines that such research instead
will transition to comply with the 2018 Requirements, the institution
or an IRB must document and date such determination.
(i) If the determination to transition is documented between July
19, 2018, and January 20, 2019, the research shall:
(A) Beginning on the date of such documentation through January 20,
2019, comply with the pre-2018 Requirements, except that the research
shall comply with the following:
(1) Section 11.102(l) of the 2018 Requirements (definition of
research) (instead of Sec. 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 Sec. 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 Sec. 11.103(b),
as related to the requirement for continuing review, and in addition to
Sec. 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;
[[Page 28520]]
(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. 2018-13187 Filed 6-18-18; 8:45 am]
BILLING CODE 4150-36-P
