The National Institutes of Health (NIH) recently provided guidance to its study section volunteers regarding how they should apply the new rigor and transparency requirements during the upcoming June 5th cycle of grant reviews. The CCTS gathered several reviewers based at UAB to discuss what they had learned from their training with the audience of investigators at its monthly Forum. An overflow room was required to accommodate the number of attendees. Still others participated via GoToMeeting.
Panelists included Yabing Chen, PhD, professor, and Jianhua Zhang, PhD, associate professor, both Division of Molecular & Cellular Pathology; Rita Cowell, PhD, associate professor, Department of Psychiatry & Behavioral Neurobiology; and Mohammad Athar, PhD, professor, Department of Dermatology.
Four areas that the NIH states “require more explicit attention by applicants” were discussed, including (1) scientific premise, (2) scientific rigor, (3) consideration of relevant biological variables, and (4) authentication of key biological/chemical resources. Panelists clarified that only the first three will be scored, but that the fourth requires a new form that must be downloaded and attached to grants for submission.
The panelists helped attendees understand how NIH is defining scientific “premise” and “rigor” and where each needs to be addressed in grant applications. Scientific premise addresses the underlying scientific foundation of a project. Applicants must show sufficient justification for the proposed work, cite appropriate work or preliminary data, identify the strengths and weaknesses of prior work, and describe how they propose to fill a significant gap in the field. It should be addressed under the Significance section.
Rigor pertains to the application of scientific methods to ensure a robust and unbiased design, analysis, interpretation, and reporting of results and that sufficient information about the study is provided for it to be assessed and reproduced. Plans for determining group size, ensuring blinded and independent measurements, improving precision and reducing variability, excluding/including subjects, and managing missing data must be addressed under the Approach section.
Research studies that involve vertebrate animals or humans need to account for relevant biological variables such as sex, age, weight, genetic strain, and race/ethnicity. Applicants must justify the use of only one sex in a study. If little is known about sex differences in the given topic, the applicant must include both, with sufficient numbers to inform the presence or absence of sex differences.
Reviewers will comment on the new Authentication of Key Biological and/or Chemical Resources attachment, rating it acceptable or unacceptable. The goal is to help researchers avoid misidentifying or contaminating resources. Panelists stressed that applicants should not put experimental methods or preliminary data in this section. They also informed investigators that “even applications scored in the fundable range will not receive a Notice of Grant Award in the absence of this document.”
Page limits for NIH grants have not changed. The NIH told reviewers that “page limits, cost, and time are not valid reasons to disregard attention to these issues.”
To learn more and stay up to date on rigor and transparency issues, visit the CCTS Rigor and Transparency web page.