This past fall the NIH published guide notices outlining updates to policies, forms, and instructions for applications due in 2016, including an overview of the changes (NOT-OD-16-004), as well as details about implementing rigor and transparency in grant applications (NOT-OD-16-011) and career development award applications (NOT-OD-16-012). These requirements go into effect with applications submitted on Jan 25, 2016 and beyond. Current grantees should be aware that these requirements also apply to research performance progress reports.
The requirements address four major areas. The first area is the scientific premise of the proposed research. NIH expects applicants to describe the general strengths and weaknesses of the prior research being cited to support the application. General strengths and weaknesses could include the rigor of the previous experimental designs, as well as the consideration of relevant biological variables and authentication of key resources.
The second area is rigorous experimental design for robust and unbiased results in the research proposed. This includes full transparency in reporting experimental details so that others may reproduce and extend the findings. The third area is consideration of relevant biological variables such as sex, age, weight, and underlying health conditions. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex. Peer review will assess these aspects of grant applications, and will factor their assessments into the impact score. Under the significance criteria, reviewers will assess the scientific premise for the proposed project, including consideration of the strengths and weaknesses of relevant published research or preliminary data. Under the approach criteria, reviewers will assess how the experimental design and methods proposed will achieve robust and unbiased results, and how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. It is incumbent upon the applicant to provide the information needed for reviewers to assess these areas of the application.
The last area of rigor and transparency involves authentication of key biological and/or chemical resources. These resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. Information about authentication of research resources will be evaluated by the peer review panel as acceptable or not, but will not be factored into the final impact score. Any potential problems with authentication will be resolved by program staff and the applicant prior to award.
NIH has provided, in addition to the guide notices, a number of on-line resources for applicants and awardees. These include a set of frequently asked questions (grants.nih.gov/reproducibility/faqs.htm) and a page summarizing the requirements, with links to training and workshops (grants.nih.gov/reproducibility/index.htm).
Together, we can improve the rigor and reproducibility of research. If you have questions about your specific research, we encourage you to contact NCCIH program staff to discuss your application.