Recently the NIH published new guidance on rigor and reproducibility in the NIH application and review process. This new guidance, which goes into effect for applications due January 25, 2016 and later, emphasizes rigor, reproducibility, and transparency in the NIH grant application process. What does this mean for grant applicants? Basically it means paying attention to details and making it clear to reviewers that you have done so.
The new guidance has little effect on the structure and content of the application. However, it does put the onus on the researcher to clearly communicate attention to rigor and reproducibility throughout the application. Additionally, the guidance encourages a robust peer review and gives special consideration to the use of both males and females in biomedical research, as well as to authentication of key biological and chemical resources.
Outlined below are the areas most significantly affected by the new guidance:
Scientific premise of proposed research
While there has always been the expectation that researchers describe the strengths and weaknesses of prior research critical to the application, it is now expected that this description include attention to the rigor of the previous experimental designs as well as to consideration of appropriate biological variables (e.g., sex differences in subject pool) and authentication of key resources (e.g., cell lines, speciality chemicals).
Scientific rigor in experimental design
Not only should previous research be scrutinized for accuracy and precision, but the proposed research should also be robust and unbiased, including full transparency in detailing the experimental design. As always, researchers in the field should be able to read and replicate the experimental design in order to extend the findings and advance the field.
Consideration of relevant biological variables in experimental design
Often overlooked in both animal and human subject study designs are biological differences between females and males. Researchers must justify subject pool demographics and demonstrate understanding of potential sex-based differences in biological function, disease processes, and treatment responses. (Learn more about what it means to consider sex as a relevant biological variable in this post on the NIH blog, Extramural Nexus.) In addition to sex-based differences, other crucial variables include age and weight, as well as current and previous health conditions.
Authentication of key biological and chemical resources
Key biological and chemical resources should be verified since resources can vary over time and between suppliers. Researchers must demonstrate quality and quantity of resources, ensuring design replicability.
To learn more about enhancing rigor and reproducibility in the NIH grant application and review process, visit the NIH Office of Extramural Research.
Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.
Hooded rat photo by Jason Snyder via Wikimedia Commons. SH-SY5Y cell line photo by Reid Offringa via Wikimedia Commons. Both used under Creative Commons license.