Responding to NIH's Rigor & Reproducibility Requirements

The NIH's new Rigor and Reproducibility requirements are in full swing according to many study section reviewers. Reviewer reports of the discussions and emphasis being given to these requirements are reinvigorating the discussion amongst NIH funded researchers and those aspiring to be funded by NIH around the best way to respond to these requirements.

It's useful to consider the origin of these requirements. This NIH initiative was in part a response to several articles that came out a few years ago that reported a surprising number of research projects published in top journals couldn't be reproduced or had fundamental flaws.

These new requirements fall into four general categories:

Scientific Premise:
Scientific premise refers to the body of completed research and data (by the proposing PI and others) that form the basis or the justification for what the PI is proposing as a next logical step. The NIH wants to make sure that the research they're funding stands on reliable data and/or fills in necessary gaps in the current research.

Rigorous Experimental Design:
According to the NIH website, "Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. This includes full transparency in reporting experimental details so that others may reproduce and extend the findings." Thus, this is where the NIH is hoping to remedy funding research that cannot be reproduced; if experiments are designed rigorously then they remove the question marks that keep other researchers from being able to replicate.

Relevant Biological Variables:
Historically, NIH funded research that used a disproportionately high number of male animals. This had an unintended consequence on the results of such research not taking into account sex in various experiments where it might make a difference. To remedy this, the NIH is now asking for researchers to account for both sexes in research and to provide better justification if only one sex is being used in research. Although better inclusion of females in experiments is a priority, the NIH has identified other variables they want justified in grant proposals.

Authentication of Resources:
Authentication of resources is simply a requirement by the NIH to make sure the chemical and biological resources you use in your experiments are reliable.


Dr. Jennifer Kemp, the Director of the Research Office in our Department of Medicine recently offered some tips on how to address these requirements. Even if your research has always met these requirements, you need to be more explicit about them in your grant proposals. According to Dr. Kemp, each of these requirements should be addressed under a subheading naming it in your proposal. Scientific Premise should be addressed in the Significance section, Rigorous Experimental Design and Relevant Biological Variables should be addressed in Approach, and Authentication of Resources should be addressed in a new attachment.

To learn more about the NIH's requirements and Dr. Kemp's suggestions, please see the resources below:

Resources:
Rigor and Reproducibility - NIH
Update on NIH Grant Proposal Requirements - Dr. Jennifer Kemp