Simplified Peer Review Framework

NIH is simplifying peer review for most research project grants (RPGs) for application due dates of January 25, 2025 or later in order to address the complexity of the peer review process and the potential for reputational bias to affect peer review outcomes. Simplified peer review will apply to the following activity codes: 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, (including the following phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33).

The Simplified Framework for NIH Peer Review Criteria retains the five regulatory criteria (Significance, Investigators, Innovation, Approach, Environment) but reorganizes them 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.

Factor 1: Importance of the Research (Significance, Innovation), scored 1-9
Factor 2: Rigor and Feasibility (Approach), scored 1-9
Factor 3: Expertise and Resources (Investigator, Environment), to be evaluated as either sufficient for the proposed research or not (in which case reviewers must provide an explanation)

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.

Five regulatory criteria reorganized into three factors

(all considered in overall impact score)

Significance - scored
Investigator(s) - scored
Innovation - scored
Approach - scored
Environment - scored

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Factor 1 : Importance of the Research
- Significance, Innovation
- Scored 1 - 9
Factor 2 : Rigor and Feasibility
- Approach (also includes Inclusion and Clinical Trial (CT) Study Timeline )
- Scored 1 - 9
Factor 3 : Expertise and Resources
- Investigators, Environment
- Valuated as appropriate or gaps identified; gaps require explanation
- Considered in overall impact; no individual score

Additional Review Criteria (can affect overall score)

Additional Review Criteria Before Jan 25, 2025

Human Subject (HS) Protections (for HS and CT)
Vertebrate Animal Protections
Bio hazards
Resubmission/Renewal/Revisions
Study Timeline (for CT only)*
Inclusion of Women, Minorities, and Children (for HS and CT)*

▶

Revised Additional Review Criteria

Human Subject Protections (for HS and CT)
Vertebrate Animal Protections
Biohazards
Resubmission/Renewal/Revisions

*Incorporated into Factor 2

Additional Review Considerations (no effect on overall score)

Additional Review Considerations Before Jan 25, 2025

Applications from Foreign Organizations**
Select Agent Research**
Resource Sharing Plans**
Authentication of Key Biological and/or Chemical Resources
Budget and Period of Support

▶

Authentication of Key Biological and/or Chemical Resources
Budget and Period of Support

**Review shifting to NIH staff

Additional Changes

Inclusion criteria and coding (considerations of sex/gender, inclusion across the lifespan, race/ethnicity of the study population), study timelines for clinical trial applications, and plans for valid design and analysis of Phase III clinical trials, previously evaluated under Additional Review Criteria, will be integrated within Factor 2 (Rigor and Feasibility). This change will help to emphasize the importance of these criteria in evaluating scientific merit, rather than as issues of policy compliance.

Peer reviewers will no longer evaluate the following Additional Review Considerations: Applications from Foreign Organizations, Select Agents, Resource Sharing Plans. These considerations will instead be administratively reviewed by NIH prior to funding.

Review Criteria Within the Simplified Framework

Overall Impact

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).

Review Criteria

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

Significance

Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Factor 2. Rigor and Feasibility

Approach

Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

Evaluate the potential to produce unbiased, reproducible, robust data.
Evaluate the rigor of experimental design and whether appropriate controls are in place.
Evaluate whether the sample size is sufficient and well-justified.
Assess the quality of the plans for analysis, interpretation, and reporting of results.
Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
For applications involving human subjects or vertebrate animals, also evaluate:
- the rigor of the intervention or study manipulation (if applicable to the study design).
- whether outcome variables are justified.
- whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
- whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex/gender categories.
For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Factor 3. Expertise and Resources

Investigator(s)
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.

Environment
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 .

Vertebrate Animals

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 .

Biohazards
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.

Resubmissions
As applicable, evaluate the full application as now presented.

Renewals
As applicable, evaluate the progress made in the last funding period.

Revisions
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.