On June 9, the National Institutes of Health (NIH) released two notices outlining the agency’s plans to enhance scientific rigor and experimental transparency in grant applications and peer review. Applicable to all funding opportunity announcements for the January 25, 2016 application deadline and beyond, the agency plans to release revised grant application instructions later this year.
To comply with these new policies, applicants will be required to include consideration of scientific premise, rigorous experimental design, and sex and other relevant biological variables in the Research Strategy portion of the application. The scientific premise describes the body of research that forms the basis for the proposed research question. NIH expects applicants to comment on the strengths and weaknesses of this research. Reviewers will evaluate scientific premise as a component of Significance. Rigorous experimental design and consideration of sex and other biological variables will be evaluated as part of the Approach. All three of these areas will factor into reviewers’ assessment of the Overall Impact of an application. In addition, applicants will be required to address authentication of key resources in the Other Research Plan section of the application. Reviewers will be asked to comment on the plan but not consider it when scoring overall impact.
These new policies represent nearly two years of effort by NIH leadership to raise awareness of issues that could contribute to irreproducible research findings. Recognizing that these issues were bigger than the agency alone, NIH actively engaged representatives from across the scientific community, including journal editors, leaders of pharmaceutical companies, and researchers themselves to obtain input on strategies that would be most effective in addressing these concerns. Outcomes from these dialogues, including workshop proceedings, best practices guidelines, and training modules are available on the NIH website, and additional workshops are planned for the summer and fall. During a recent meeting of the NIH Center for Scientific Review (CSR) Advisory Council, Director Richard Nakamura, PhD, acknowledged the critical role of the peer review process in fostering this culture change and noted that CSR is developing training materials for reviewers to reflect the new policies.