NIH Updates: Rigor and Reproducibility

You've probably heard the discussion around NIH projects and the questions around rigor and responsibility taking place in the last few years. But what does this mean for your next grant application?

The updates around rigor and reproducibility focus in four areas: premise, design, variables, and authentication.

Premise: Sure, PIs have always needed to show preliminary data or results when applying to the NIH, but now you need to take it a bit further. In addition to discussing your preliminary work, you must also discuss the strengths and weaknesses of it. You must now vet the foundation of your project in your grant application.

Design: The NIH is expecting more rigorous experimental design; their definition of rigorous includes the use of methods that are reproducible. As they state, "Robust results are obtained using methods designed to avoid bias and can be reproduced under well-controlled and reported experimental conditions." (NIH website, 2016)

Variables: A couple years ago, Sally Rocky, former Director of Extramural Research at the NIH, reported that a good majority of projects funded by the NIH did not include female animal models. In response to this particular overarching bias, the NIH now expects that sex as well as other relevant variables be accounted for in project design in funded grant applications.

Authentication: According to Hughes (2007), "between 18-36% of cell lines might be misidentified or cross-contaminated." Thus the NIH "expects that key biological and/or chemical resources will be regularly authenticated to ensure their identity and validity for use in the proposed studies" (NIH website, 2016). For AMC researchers, the Barbara Davis Center's Molecular Biology Service Center
does offer authentication services.

The NIH put the following diagram together to look at the various reasons and implications for their new rigor and reproducibility. The link and other resources are available below.

Resources:
NIH New Grant Guidelines Diagram
Updated Application Instructions
Presentation from the Department of Medicine - Jenny Kemp, PhD