October 19, 2023
NATIONAL INSTITUTES OF HEALTH (NIH)
This notice announces a new framework for the peer review of most research project grant (RPG) applications beginning with submissions for due dates on or after January 25, 2025. The simplified review framework is expected to better focus peer reviewers on the key questions needed to assess the scientific and technical merit of proposed research projects: Should the proposed research project be conducted? Can the proposed research project be conducted?
In recent years, NIH heard sustained frustrations from the extramural community about the complexity of the peer review process for research project grants (RPGs) and the increasing responsibilities of peer reviewers in policy compliance. This may have the unintended effect of diverting the attention of reviewers away from their key task of evaluating the scientific and technical merit of RPG proposals to identify those with the highest potential impact for advancing scientific knowledge. Additionally, NIH has heard concerns that reputational bias, positive or negative, has an undue influence on peer review outcomes.
To help address these problems, NIH developed a series of revisions to the peer review process through the Simplified Framework for NIH Peer Review Criteria initiative. In forming the simplified framework, NIH gathered input from multiple sources over a period of years. This input echoed concerns NIH heard in the past regarding lengthy and unclear review criteria and possible effects of reputational bias. A 2022 Request for Information received more than 800 responses from individuals and scientific societies and underscored the need for communications well in advance of implementation of a new review framework and the need for thoughtful guidance and training resources for investigators, reviewers, and NIH staff. The vast majority of responses were supportive of the proposed changes. After careful deliberation and consideration of all comments, NIH has made the decision to move forward with implementation of the simplified framework.
The Simplified Framework for NIH Peer Review will be effective for receipt deadlines on or after January 25, 2025 for the grants and cooperative agreements with the following RPG activity codes: DP1, DP2, DP3, DP4, DP5, R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4, RF1, RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5.
It is anticipated that additional implementation details will be provided mid-2024.
The mission of NIH is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. In support of this mission, RPG applications to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The Simplified Framework for NIH Peer Review initiative reorganizes the five regulatory criteria (Significance, Investigators, Innovation, Approach, Environment; 42 C.F.R. Part 52h.8) into three factors – two will receive numerical criterion scores and one will be evaluated for sufficiency. All three factors will be considered in arriving at the overall impact score. The reframing of the criteria serves to focus reviewers on three central questions reviewers should be evaluating: How important is the proposed research, how rigorous and feasible are the methods, and whether the investigators and institution have the expertise/resources necessary to carry out the project.
The change to having peer reviewers assess the adequacy of investigator expertise and institutional resources as a binary choice is designed to have reviewers evaluate investigator and environment with respect to the work proposed. It is intended to reduce the potential for general scientific reputation to have an undue influence.
The evaluation of certain clinical trials and inclusions criteria, previously broken out under Additional Review Criteria, will be integrated within Factor 2 (Rigor and Feasibility), to emphasize their importance in evaluating scientific merit, rather than as issues of policy compliance. These include Inclusion criteria and coding (considerations of sex/gender, age across the lifespan, race/ethnicity of the study population), Study Timeline required for clinical trials applications, and plans for valid design and analysis of Phase III clinical trials.
Peer review will no longer evaluate the following Additional Review Considerations: Applications from Foreign Organizations, Select Agents, and Resource Sharing Plans. These considerations will instead be administratively reviewed by NIH prior to funding.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Factor 1. Importance of the Research
Factor 2. Rigor and Feasibility
Factor 3. Expertise and Resources
Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
As applicable, evaluate the full application as now presented.
As applicable, evaluate the progress made in the last funding period.
As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Authentication of Key Biological and/or Chemical Resources
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.