NIH Policy on Rigor and Reproducibility

Effective on or after January 25, 2016, most NIH and AHRQ research grant applications are required to comply with the NIH Policy on Rigor and Reproducibility.

For more information, see the official notice:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html

Additional resources that may be helpful to you:

• Example Authentication of Key Biological and/or Chemical Resources

• Slide presentation of the NIH Rigor and Reproducibility policy (PDF):

  • Objectives of the Presentation:
    • Describe reproducibility challenges and NIH focus
    • Summarize changes to application instructions and review criteria
    • Useful resources to help researchers in meeting criteria

Frequently Asked Questions

• Does the policy apply to me?
• How do I apply?
• Why is this important?

Does the policy apply to me?

These updates will take effect for most research grant applications (including small business and complex research grant applications) submitted for due dates on or after January 25, 2016. For research contracts, this policy will be effective for proposals received on/after January 25, 2016 and expected to result in contract awards in Fiscal Year 2017 and beyond.

For information about the NIH Public Access Policy on published results of NIH funded research, see the UCSD Libguide: http://ucsd.libguides.com/nih.

How do I comply?

The requirements for proposals focus on four areas deemed important for enhancing rigor and transparency:

• Significance: Describe the scientific premise forming the basis of the proposed research.
• Design: Describe the rigorous methods proposed for achieving robust and unbiased results.
• Variables: Explain how relevant biological variables, such as sex, age, weight, and underlying health conditions, are factored into research designs and analyses.
• Authentication: Describe methods to ensure the identity and validity of key biological and/or chemical resources to be used in the proposed research.

How do I authenticate my key biological and chemical resources?

• View example: Authentication of Key Biological and/or Chemical Resources (PDF)
• Antibodies:
  • Find and report resource identifiers for antibodies that will be used in the proposed research: https://scicrunch.org/resources/Antibodies/search?q=*
  • Raw data: antibodyregistry.org
  • Authentication guidelines: C. Saper Editorial in J. Comparative Neurology, http://onlinelibrary.wiley.com/doi/10.1002/cne.20839/full
• Cell Lines:
  • Cell lines: https://scicrunch.org/resources/Cell%20Lines/search?q=*
  • Authentication guidelines: http://iclac.org/resources/human-cell-line-authentication
• See NIH's FAQ page on Authentication of Key Biological and/or Chemical Resources: http://grants.nih.gov/reproducibility/faqs.htm

Why is this important?

Reviewers will be asked to consider these additional rigor and transparency criteria when reviewing applications.

(From Table 12, “Review criteria changes: What will be scored and how will it be scored?” in slide presentation of the NIH Rigor and Reproducibility policy (PDF).)