Addressing Rigor and Reproducibility in NIH Grant Applications

If you are writing your first NIH R01 proposal for the upcoming deadline, chances are that a well-meaning senior faculty member has given you a copy of one of their funded grants to use as a model for developing your application. This is a kind gesture that can be helpful for those who would like to see an example of a well-explained scientific plan, so I do recommend that you accept these types of offers. However, things change quickly in the grants world. If you follow a previously funded grant as a guide without reading the updated application instructions, you might miss key information or include outdated sections.

For example, there was a brief period of time back in the mid-2010s when Scientific Premise was a required component of the application. However, this terminology changed with a 2019 update that changed the requirement from Scientific Premise to Rigor and Reproducibility. Per policy, most research grants and career development awards submitted for January 25, 2016 and beyond as well as training grants and fellowships as of May 25, 2020 and beyond must address specific aspects of rigor and reproducibility in the text of their application.

Addressing rigor and reproducibility in your grant proposal requires addressing four key areas:

1. The rigor of the prior research. 
• Provide a careful assessment of the rigor of the prior research that helps to identify weakness or gaps in a line of research to provide support for the proposed project. Describe general strengths and weaknesses in the rigor of the prior research that lays the groundwork for the proposed project. Critique the rigor of previous experimental designs, incorporation of relevant biological variables, and authentication of key resources. Describe your plans to address any weaknesses or gaps.
2. Rigorous experimental design for robust and unbiased results. 
• NIH defines scientific rigor as "the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results". Clearly state planned experimental details to enable reviewers to assess the proposed research. Enough detail should be provided that other researchers can reproduce and extend the findings.
3. Consideration of relevant biological variables.
• Describe the extent to which biological variables including sex, age, weight, and underlying health conditions will be factored into study design and analyses. In particular, provide strong justification for studies proposing to study only one sex, including animal studies.
4. Authentication of key biological and/or chemical resources.
• Key biological and/or chemical resources such as cell lines, specialty chemicals, antibodies and other biologics should be clearly described. Include the origin of each resource and any steps to ensure quality of the resources that will be used for the project.

As you work to complete your application, be sure to leave time for a final read-through and make sure you address each of these components.