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Reviewer Guidance for the Proposed Simplified Review Framework

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)


Factor 1: Importance of the Research (scored 1-9)

 

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

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.

 

 

The critique template will request:
  • Major Score-Driving Factors
  • Strengths
  • Weaknesses
  • Minor Points (optional)

 


Factor 2 – Rigor and Feasibility (scored 1-9)
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 will contain sufficient representative diversity to address the proposed question(s).
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.

The critique template will request:
  • Major Score-Driving Factors
  • Strengths
  • Weaknesses
  • Minor Points (optional)

Factor 3 – Expertise and Resources (evaluated, not individually scored)
Investigators

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.

Reviewers will be asked to select one from a menu:
  • 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.
Environment

Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Reviewers will be asked to select one from a menu:
  • 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)

Human Subject Protections
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.

 

Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, evaluate the proposed plans for the 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) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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 Animal Section.
Biohazards
Reviewers will assess 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.
Resubmission (if applicable):
Evaluate the full application as now presented.
Renewal (if applicable):
Evaluate the progress made in the last funding period.
Revision (if applicable):
Evaluate the appropriateness of the proposed expansion of the scope of the project.


 

Additional Review Considerations (not factored into 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.