December 18, 2019
Rigor and reproducibility has been a major topic in biomedical, physical, and social science research as scientist have recognized the importance of thoroughness and independent reproducibility. Beginning January 2019, the NIH began including rigor and reproducibility in grant application instructions and review criteria. There are four main areas of focus:
- Rigor of the prior research
Applicants must describe the strengths and weaknesses of their preliminary data. Elements that should be described include experimental design, biological variables, and authentication of key resources.
2. Rigorous experimental design for robust and unbiased results
Applicants must utilize the scientific method to ensure robust and unbiased experimental design, methodology, analysis and interpretation of results. See https://grants.nih.gov/policy/reproducibility/resources.htm#tools for resources on rigorous experimental design.
3. Consideration of relevant biological variables
Applicants must consider biological variables, including age, sex, weight, and underlying health conditions. Biological variables must be factored into the research design, analysis, and interpretation of vertebrate animal and human studies. Applicants may propose studies with only one sex if appropriately justified with scientific literature and preliminary data. See https://www.fasebj.org/doi/full/10.1096/fj.15-279554 for guidance on sex as a biological variable.
4. Authentication of key biological and/or chemical resources
Applicants must demonstrate validation of key biological and chemical resources, including cell lines, specialty chemicals, antibodies, and other biologics. Since these resources may differ between laboratories and over time and may have qualities that influence the results, the applicant must ensure their research material is appropriately validated. See https://grants.nih.gov/policy/reproducibility/resources.htm#authentication for examples of authentication plans.
Please see https://grants.nih.gov/policy/reproducibility/guidance.htm for more information on NIH’s Rigor and Reproducibility requirements.
NIGMS has made NIH Rigor and Reproducibility Training Modules available. These modules, developed by NIH, focus on integral aspects of rigor and reproducibility in the research endeavor, such as bias, blinding and exclusion criteria. The modules are not meant to be comprehensive, but rather are intended as a foundation to build on and a way to stimulate conversations, which may be facilitated by the accompanying discussion materials.