Notice2022-26603
Request for Information on Proposed Simplified Review Framework for NIH Research Project Grant Applications
Primary source
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Published
December 7, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The purpose of this Request for Information (RFI) is to solicit public input on a proposed revised framework for evaluating and scoring peer review criteria for National Institutes of Health (NIH) research project grant (RPG) applications. NIH is proposing a revised simplified framework that will reorganize five major regulatory criteria under three scored categories and reduce the number of non- score driving review considerations that reviewers evaluate in judging the scientific merit of RPG applications. The proposed changes pertain to those RPGs with standard review criteria. All the factors required by regulation will continue to be evaluated. NIH is not proposing to revise the regulatory criteria. Rather, NIH is proposing to revise its policy of how peer reviewers score the criteria, and how NIH organizes the criteria for review purposes. NIH believes that these changes will allow peer reviewers to refocus on the critical task of judging scientific merit and will improve those judgements by reducing bias.
Full Text
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<title>Federal Register, Volume 87 Issue 234 (Wednesday, December 7, 2022)</title>
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[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Pages 75056-75057]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information on Proposed Simplified Review Framework
for NIH Research Project Grant Applications
AGENCY: National Institutes of Health, HHS.
ACTION: Request for information.
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SUMMARY: The purpose of this Request for Information (RFI) is to
solicit public input on a proposed revised framework for evaluating and
scoring peer review criteria for National Institutes of Health (NIH)
research project grant (RPG) applications. NIH is proposing a revised
simplified framework that will reorganize five major regulatory
criteria under three scored categories and reduce the number of non-
score driving review considerations that reviewers evaluate in judging
the scientific merit of RPG applications. The proposed changes pertain
to those RPGs with standard review criteria. All the factors required
by regulation will continue to be evaluated. NIH is not proposing to
revise the regulatory criteria. Rather, NIH is proposing to revise its
policy of how peer reviewers score the criteria, and how NIH organizes
the criteria for review purposes. NIH believes that these changes will
allow peer reviewers to refocus on the critical task of judging
scientific merit and will improve those judgements by reducing bias.
DATES: The RFI is open for public comment for a period of 90 days.
Comments must be received by 11:59:59 p.m. (ET) on March 10, 2023, to
ensure consideration.
ADDRESSES: Submissions can be sent electronically to <a href="https://rfi.grants.nih.gov/?s=638509b5409baa49f803e572">https://rfi.grants.nih.gov/?s=638509b5409baa49f803e572</a>). NIH is specifically
requesting public comment on the Proposed Revised Simplified Review
Framework, a proposed revised framework for evaluating and scoring peer
review criteria for NIH research project grant applications, described
above. Response to this RFI is voluntary.
FOR FURTHER INFORMATION CONTACT: Questions about this request for
information should be directed to Office of Extramural Research, Dr.
Kristin Kramer, Phone number (301) 437-0911, Email
<a href="/cdn-cgi/l/email-protection#8dfee4e0fde1e4ebe4e8e9ffe8fbe4e8facde3e4e5a3eae2fb"><span class="__cf_email__" data-cfemail="23504a4e534f4a454a46475146554a4654634d4a4b0d444c55">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Current Process
The first stage of NIH peer review serves to provide expert advice
to NIH on the scientific and technical merit of grant applications. The
NIH peer review regulations at 42 CFR part 52h.8 state that for
research project grant applications, the scientific peer review group
shall assess the overall impact that the project could have on the
research field involved, taking into account, among other pertinent
factors:
(a) The significance of the goals of the proposed research, from a
scientific or technical standpoint;
(b) Approach: The adequacy of the approach and methodology proposed
to carry out the research;
(c) Innovation: The innovativeness and originality of the proposed
research;
(d) Investigator(s): The qualifications and experience of the
principal investigator and proposed staff;
(e) Environment: The scientific environment and reasonable
availability of resources necessary to the research;
(f) The adequacy of plans to include both genders, minorities,
children and special populations as appropriate for the scientific
goals of the research;
(g) The reasonableness of the proposed budget and duration in
relation to the proposed research; and
(h) The adequacy of the proposed protection for humans, animals,
and the environment, to the extent they may be adversely affected by
the project proposed in the application.
By NIH policy at: <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.4.1_initial_review.htm#">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.4.1_initial_review.htm#</a> Addition, peer reviewers are
currently also required to evaluate Biohazards, Resubmissions, Foreign
Organizations, Select Agents, Resource Sharing Plans, and
Authentication of Key Biological and/or Chemical Resources. NIH
currently gives the first five of the regulatory factors the following
categorical labels: Significance, Approach, Innovation,
Investigator(s), and Environment.
The NIH peer review regulation does not address scoring. Scoring of
all regulatory factors is determined by NIH policy. Currently, peer
reviewers provide an Overall Impact Score (scored 1-9) that reflects
the overall scientific and technical merit of the application and
individual criterion scores for Significance, Investigators,
Innovation, Approach, and Environment. The remaining factors,
Protections for Human Subjects, Inclusion, Vertebrate Animals,
Biohazards, Resubmission, Renewal, and Revision are evaluated and
factored into the Overall Impact Score; however, they are not given
individual scores. When reviewers judge any of these to be
unacceptable, they are asked to provide justification for that
assessment. Beyond these factors, reviewers are asked to assess the
following additional review considerations, but these considerations
are not considered when reviewers determine an Overall Impact Score:
Applications from Foreign Organizations, Select Agents, Resource
Sharing Plans, Authentication of Key Biological and/or Chemical
Resources, Budget & Period of Support.
Proposal Development
NIH gathered input from many sources in forming this proposal.
Unsolicited comments over a period of years, reflecting sustained
concerns from reviewers and applicants regarding complexity of review
criteria, administrative load, and potential biases led the Center for
Scientific Review (CSR) to form a working group to the CSR Advisory
Council. To inform that group, CSR published a Review Matters blog at:
<a href="https://www.csr.nih.gov/reviewmatters/2020/02/27/seeking-your-input-on-simplifying-review-criteria/">https://www.csr.nih.gov/reviewmatters/2020/02/27/seeking-your-input-on-simplifying-review-criteria/</a> which was cross-posted on the Office of
Extramural Research blog, Open Mike at: <a href="https://nexus.od.nih.gov/all/2020/02/27/seeking-your-input-on-simplifying-review-criteria/">https://nexus.od.nih.gov/all/2020/02/27/seeking-your-input-on-simplifying-review-criteria/</a>. The blog
received more than 9,000 views by unique individuals and over 400
comments. The working group presented interim recommendations at:
<a href="https://public.csr.nih.gov/sites/default/files/2019-10/Review_criteria_wg_CSRAC_interim_report_7April2020.pdf">https://public.csr.nih.gov/sites/default/files/2019-10/Review_criteria_wg_CSRAC_interim_report_7April2020.pdf</a> to the CSR
Advisory Council, which adopted the recommendations, at public CSR
Advisory Council meetings (March 2020 video <a href="https://videocast.nih.gov/summary.asp?live=35649&bhcp=1&start=4307">https://videocast.nih.gov/summary.asp?live=35649&bhcp=1&start=4307</a>, slides <a href="https://public.csr.nih.gov/sites/default/files/presentations/200330/Simplifying_Review_Criteria_Workgroup_Interim_Rpt_final.pdf">https://public.csr.nih.gov/sites/default/files/presentations/200330/Simplifying_Review_Criteria_Workgroup_Interim_Rpt_final.pdf</a>; March 2021
video <a href="https://videocast.nih.gov/watch=41574&start=4816">https://videocast.nih.gov/watch=41574&start=4816</a>, slides <a href="https://public.csr.nih.gov/sites//files/2021-04/Simplifying_Review_Criteria_29_March_2021.pdf">https://public.csr.nih.gov/sites//files/2021-04/Simplifying_Review_Criteria_29_March_2021.pdf</a>). Final recommendations
from the CSR Advisory Council (report <a href="https://public.csr.nih.gov/sitest/files/2021-04/Recommendations_of_the_CSRAC_Working_Group_on_Simplifying_Review-non-CT_and_CT.pdf">https://public.csr.nih.gov/sitest/files/2021-04/Recommendations_of_the_CSRAC_Working_Group_on_Simplifying_Review-non-CT_and_CT.pdf</a>) were considered by the CSR Director, as well as major
internal NIH extramural-focused committees that included leadership
from across NIH
[[Page 75057]]
institutes and centers. This process produced many modifications and
the final proposal presented below. Additional background information
can be found here <a href="https://grants.nih.gov/policyroposed-Framework/index.htm">https://grants.nih.gov/policyroposed-Framework/index.htm</a>.
Proposed Revised Simplified Review Framework
An Overall Impact Score (scored 1-9) will reflect the overall
scientific and technical merit of the application. Reviewers will take
into account their assessments of the three factors below and the
following additional criteria in determining an Overall Impact Score.
Of the three factors, only Factor 1: Importance of the Research and
Factor 2: Feasibility and Rigor, will receive individual scores. In the
revised framework, Factor 3: Expertise and Resources will not receive
an individual score. The additional review criteria below will not
receive individual scores but will be considered in arriving at the
Overall Impact Score. Two review considerations will be evaluated but
have no effect on the Overall Impact Score. Detailed descriptions of
the three factors can be found here <a href="https://grants.nih.gov/policyroposed-Framework/reviewer-guidance.htm">https://grants.nih.gov/policyroposed-Framework/reviewer-guidance.htm</a>.
Factor 1: Importance of the Research (scored 1-9).
Factor 1 is based on the criteria Significance and Innovation.
Factor 2: Feasibility and Rigor (scored 1-9).
Factor 2 is based on the criteria Approach.
Factor 3: Expertise and Resources (rated as ``fully capable'',
``appropriate'' or ``additional capability/expertise needed'' or
``additional resources needed'')
Factor 3 is based on the criteria Investigator and Environment. If
``additional expertise/capability needed'' or ``additional resources
needed'' is selected, justification must be provided.
Additional Criteria (not scored, but affecting Overall Impact):
<bullet> Human Subject Protections
<bullet> Inclusion of Women, Minorities, and Individuals Across the
Lifespan
<bullet> Vertebrate Animals
<bullet> Biohazards
<bullet> Resubmission/Renewal/Revisions
Each of the Additional Criteria except the last will be rated as
``Appropriate'', with no comments required, or as ``Concerns'', which
must be briefly justified. Resubmission/Renewal/Revisions will be given
brief written evaluations.
Additional Review Considerations (not scored and having no effect
on Overall Impact):
<bullet> Authentication of Key Biological and/or Chemical Resources
<bullet> Rated as ``Appropriate'' with no comments required, or as
``Concerns'', which must be briefly described.
<bullet> Budget and Period of Support
<bullet> Rated as ``Appropriate'', ``Excessive'', or
``Inadequate''; the latter two ratings requiring a brief account of
concerns.
The additional review considerations, including Foreign
Organizations, Select Agents, and Resource Sharing Plans, will no
longer be evaluated by peer reviewers.
Restructuring the categorization and scoring of criteria in this
way reduces the number of scores reviewers need to provide, and policy
considerations reviewers need to take into account when evaluating
scientific merit. It focuses reviewers on the two most important
judgements about a proposed research project; how important the
research is, and how rigorous and feasible the approach is. Evaluation
of the investigators and research environment is framed in terms of
whether the expertise and resources needed to accomplish the project
are available, thus diminishing halo effects-- diffuse judgements of
investigator or institutional reputation that bias judgements of
research importance, rigor, and feasibility.
Submitting a Response
Comments should be submitted electronically to the following web
page at: <a href="https://rfi.grants.nih.gov/?s=638509b5409baa49f803e572">https://rfi.grants.nih.gov/?s=638509b5409baa49f803e572</a>.
This RFI is for planning purposes only and should not be construed
as a policy, solicitation for applications, or as an obligation on the
part of the Government to provide support for any ideas identified in
response to it. Please note that the Government will not pay for the
preparation of any information submitted or for its use of that
information.
Please do not include any proprietary, classified, confidential, or
sensitive information in your response. Responses will be compiled and
a content analysis will be shared publicly after the close of the
comment period. The NIH may use information gathered by this Notice to
inform future policy development.
Dated: December 1, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-26603 Filed 12-6-22; 8:45 am]
BILLING CODE 4140-01-P
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