[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Pages 75056-75057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://rfi.grants.nih.gov/?s=638509b5409baa49f803e572). 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 
[email protected].

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:  https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.4.1_initial_review.htm# 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: 
https://www.csr.nih.gov/reviewmatters/2020/02/27/seeking-your-input-on-simplifying-review-criteria/ which was cross-posted on the Office of 
Extramural Research blog, Open Mike at: https://nexus.od.nih.gov/all/2020/02/27/seeking-your-input-on-simplifying-review-criteria/. The blog 
received more than 9,000 views by unique individuals and over 400 
comments. The working group presented interim recommendations at: 
https://public.csr.nih.gov/sites/default/files/2019-10/Review_criteria_wg_CSRAC_interim_report_7April2020.pdf to the CSR 
Advisory Council, which adopted the recommendations, at public CSR 
Advisory Council meetings (March 2020 video https://videocast.nih.gov/summary.asp?live=35649&bhcp=1&start=4307, slides https://public.csr.nih.gov/sites/default/files/presentations/200330/Simplifying_Review_Criteria_Workgroup_Interim_Rpt_final.pdf; March 2021 
video https://videocast.nih.gov/watch=41574&start=4816, slides https://public.csr.nih.gov/sites//files/2021-04/Simplifying_Review_Criteria_29_March_2021.pdf). Final recommendations 
from the CSR Advisory Council (report https://public.csr.nih.gov/sitest/files/2021-04/Recommendations_of_the_CSRAC_Working_Group_on_Simplifying_Review-non-CT_and_CT.pdf) 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 https://grants.nih.gov/policyroposed-Framework/index.htm.

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 https://grants.nih.gov/policyroposed-Framework/reviewer-guidance.htm.
    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):
     Human Subject Protections
     Inclusion of Women, Minorities, and Individuals Across the 
Lifespan
     Vertebrate Animals
     Biohazards
     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):
 Authentication of Key Biological and/or Chemical Resources

     Rated as ``Appropriate'' with no comments required, or as 
``Concerns'', which must be briefly described.
 Budget and Period of Support

     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: https://rfi.grants.nih.gov/?s=638509b5409baa49f803e572.
    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