New NIH SCIENTIFIC requirements to enhance the reproducibility of research findings in NIH applications

New requirements include:

  1. Additions to the Research Strategy attachment:
    • Significance: Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.
    • Approach: Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans.
  2. New "Authentication of Key Biological and/or Chemical Resources" attachment. These resources include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. Information in this section must focus only on authentication and/or validation of key resources to be used in the study; all other methods and preliminary data must be included within the page limits of the research strategy. Applications identified as non-compliant with this limitation will be withdrawn from the review process.

These above updates focus on four areas, applying to the full spectrum of research:

  1. the scientific premise forming the basis of the proposed research;
  2. rigorous experimental design for robust and unbiased results;
  3. consideration of relevant biological variables; and
  4. authentication of key biological and/or chemical resources.

Investigators will need to consider how all four areas apply to their proposed research. Likewise, reviewers will assess whether these areas have been appropriately addressed by the applicant through revised language defining the peer review criteria.

Additional Scored Review Criteria and Considerations:

  • Significance
    • Is there a strong scientific premise for the project?
  • Approach
    • Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
    • Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Authentication of Key Biological and/or Chemical Resources
    • For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
    • The review criteria stated in the Funding Opportunity Announcement always prevail in the evaluation of applications submitted under that announcement.

Further guidance is found at the following link: