Below is a draft of the guidance reviewers would receive, under the proposed simplified peer review framework. Comments related to the language below may be submitted under the related RFI by March 10, 2023.
Note: An NIH-wide committee is currently considering how to incorporate this proposed simplified review framework with rigorous review of RPGs involving clinical trials (~ 10% of RPGs involve clinical trials) as well as incorporation of a Plan for Enhancing Diverse Perspectives (PEDP). Incorporation of those elements will result in modifications or additions to the reviewer guidance.
On this Page:
- Review Criteria (all are factored into the Overall Impact Score)
- Additional Review Criteria (not individually scored, may affect Overall Impact Score)
- Additional Review Considerations (not factored into Overall Impact Score)
Review Criteria (all are factored into the Overall Impact Score)
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.
Assess the influence of scientific innovation on the importance of the proposed research. Note that while technical or conceptual innovation can influence the importance of undertaking the work, a project that is not applying novel concepts or approaches may be of critical importance for the field.
Assess whether the proposed work applies novel concepts, methods or technologies in ways that will enhance the overall impact of the project.
- Major Score-Driving Factors
- Strengths
- Weaknesses
- Minor Points (optional)
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).
- 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 will contain sufficient representative diversity to address the proposed question(s).
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.
- Major Score-Driving Factors
- Strengths
- Weaknesses
- Minor Points (optional)
Evaluate whether the investigator(s) have the demonstrated background, training, and expertise, as appropriate for their career stage, to successfully conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
- Fully capable (no comments needed from reviewer).
- Identify need for additional expertise/capability and/or modification of leadership plan, then briefly address specific gaps in expertise needed to carry out the project.
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
- Appropriate (no comments needed from reviewer)
- Identify need for additional resources, then briefly address specific gaps in resources needed to carry out the project.
Additional Review Criteria (not individually scored, may affect Overall Impact Score)
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.
Additional Review Considerations (not factored into Overall Impact Score)