Clarification from NIH on recent grant policy changes

On Jan. 28, NIH Deputy Director for Extramural Affairs Mike Lauer published the first in a series of blog posts addressing recent NIH policy changes related to rigor and transparency. The Open Mike series will focus on four key areas related to reproducible research: scientific premise, rigorous experimental design, consideration of relevant biological variables, and authentication of key biological and chemical resources.

The first post examines scientific premise and why it warrants special consideration in grant review. Lauer speaks to the importance of a sound scientific premise, “the strengths and weakness of the data and previously performed work upon which the proposal is built,” citing examples, both real and hypothetical. While one of the examples illustrates the problems that can arise from failure to closely examine previous work (e.g. “ethically unjustifiable trials, wasted resources, incorrect conclusions, and unnecessary risks for trial participants”), Lauer offers little guidance on specific NIH expectations for incorporating this examination into grant applications.

Updated instructions state that as part of the Significance section of the Research Strategy, applicants must “Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.” But Lauer doesn’t shed light on how extensive this description must be considering space limitations of this section nor how far back the examination of published should data go.

A lively discussion about how effective this new requirement will be at improving scientific and health outcomes followed Lauer’s posting. If you’d like to make your voices heard, weigh in here.