October 19, 2023
- November 21, 2024 - Reminder that Multiple Changes Affecting Extramural Applications and Review are Coming for Application Due Dates on or After January 25, 2025. See Notice NOT-OD-25-035.
- October 16, 2024 - Notice of Intent to Publish a Funding Opportunity Announcement for CCRP Initiative: Countermeasures Against Chemical Threats (CounterACT) Therapeutics Discovery and Early-Stage Development (UG3/UH3 Clinical Trial Not Allowed). See Notice NOT-NS-24-126
- April 4, 2024 - Simplified Review Framework for NIH Research Project Grant Applications - Update and Implementation Plans. See Notice NOT-OD-24-085
- April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
- March 20, 2024 - Registration Open for Webinar on NIH Simplified Review Framework for NIH Research Project Grants (RPGs): Implementation and Impact on Funding Opportunities. See Notice NOT-OD-24-081
- October 19, 2023 - Online Briefing on NIH’s Simplified Peer Review Framework for NIH Research Project Grant (RPG) Applications: for Applicants and Reviewers. See NOT-OD-24-012.
- December 8, 2022 - Request for Information (RFI) on Proposed Simplified Review Framework for NIH Research Project Grant Applications. See Notice NOT-OD-23-034.
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?”
Background
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.
Implementation
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.
Review Framework
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.
- 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 with a selection from a drop-down menu
- Appropriate (no written explanation needed)
- Identify need for additional expertise and/or resources (requires reviewer to briefly address specific gaps in expertise or resources needed 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.
Additional Changes
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.
Review Criteria
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.
Resources
- Simplifying Review of Research Project Grant Applications
- Simplifying Review FAQs
- Register to attend an online briefing from 1:00 pm to 2:00 pm Eastern Time on November 3, 2023 which will provide an initial overview of upcoming changes.
and Human Services (HHS)
