IMPORTANT UPDATE: Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications
This notice (link below) informs the biomedical research community of updates to application instructions and review language intended to enhance the reproducibility of research findings through increased scientific rigor and transparency. These updates will take effect for most research grant applications (including small business and complex research grant applications) submitted for due dates on or after January 25, 2016. For research contracts, this policy will be effective for proposals received on/after January 25, 2016 and expected to result in contract awards in Fiscal Year 2017 and beyond.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html
At an NIH Regional seminar this year the session on “Rigor and Reproducibility” received conspicuous attention. According to the NIH, the advancement of science is based on “rigor in designing and performing scientific research, and the ability to reproduce biomedical research findings.”
Addressing the rigor and reproducibility of a research plan will become mandatory for applications submitted after January 25, 2016. The seminar also reported the expectation for careful consideration of “relevant biological variables, such as sex, age, weight and any other factors affecting health or disease” and the requirement for “authentication of key biological and/or chemical resources.”
There are revised instructions for applications due on and after January 25, 2016:
1. The scientific premise of the proposed research (research plan)
Applicants must state the scientific premise that forms the basis for the proposed research question(s). NIH expects applicants to describe the general strengths and weaknesses of prior research cited by the applicant, including the rigor of previous experimental designs, their examination of relevant biological variables and their authentication of key resources
2. Rigorous experimental design for robust and unbiased results (research plan)
Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting. This requires full disclosure of experimental details so that others may reproduce and extend the findings.
3. Consideration of relevant biological variables (human and/or animal subjects)
Biological variables, such as sex, age, weight, and underlying health conditions are often critical factors affecting health or disease. 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 must be provided for applications proposing to study only one sex.
4. Authentication of key biological and/or chemical resources (other attachments)
Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. These may differ between laboratories or over time, and may influence the research data and the ability to reproduce the results. Investigators must determine which resources used in their research fit these criteria and are therefore key to the proposed research.
The links below provide additional information on the principals and guidelines governing Rigor and Reproducibility, a training module and application instructions for your upcoming grant proposals.
