NIH research project grants (RPGs) submitted on or after January 25, 2025 will be evaluated using the new NIH Simplified Peer Review Framework.
If you want the history and rationale for NIH’s implementation, check out this blog post. We also have a blog post where we discuss Factor 1. Also, in the Factor 1 blog post, we summarized the difference between criterion scores and impact scores.
Below is a side-by-side, color-coded comparison of the old review criteria and where they will fall under the new paradigm. It’s important to note that the five items under the old review criteria are all scored. Under the new simplified review framework, investigators and environment will be considered but not scored.[1]
| Current Review Criteria | Simplified Review Framework |
|---|---|
| Significance – scored Innovation – scored | Factor 1: Importance of the Research Significance, Innovation Scored 1 – 9 |
| Approach – scored | Factor 2: Rigor and Feasibility Approach (includes Inclusion and Clinical Trial (CT) Study Timeline) Scored 1 – 9 |
| Investigator(s) – scored Environment – scored | Factor 3: Expertise and Resources Investigators, Environment Evaluated as appropriate or gaps identified; gaps require explanation Considered in overall impact; no individual score |
In this post, we’ll go more in-depth regarding Factor 2, Rigor and Feasibility.
Below is a side-by-side comparison of the old and new scoring criteria. Notice the very heavy emphasis in the new framework on scientific rigor! This is not surprising: NIH has been requiring more and more language on rigor in more mechanisms in the past 5-8 years (the rigor scoring criteria were implemented in 2016.) Notice also that under the new framework, human subjects researchers will be required to include information that they typically include in the PHS Human Subjects and Clinical Trial Info Form, such as recruitment and retention and study timeline.
As you prepare your 2025 grant applications, carefully study these scoring criteria and think about how you will structure your subheaders to match the new framework. Remember that reviewers read your application with a scoring sheet in front of them. Make it easy for them to find what they are looking for by matching your subheaders to what will be on their scoring sheet.
Review CriteriaThe table below compares the review criteria of the old review framework and the simplified framework.
| Old Framework | Under the Simplified Review Framework Factor 2. Rigor and Feasibility |
|---|---|
| Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? | 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 v] 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. |
