Updated Application Instructions to Enhance Rigor and Reproducibility

The National Institutes of Health (NIH) Office of Extramural Research (OER) clarified and revised application instructions and review criteria to enhance reproducibility of research findings through increased scientific rigor and transparency. These updates took effect for research grants and mentored career development award applications submitted for the January 25, 2016 due date and beyond. Updates to institutional training grants, institutional career development awards (K12/KL2), and individual fellowships will be forthcoming in 2017 or later.  

Newly revised grant application instructions clarify long-standing expectations to ensure that NIH is funding the best and most rigorous science, highlight the need for applicants to describe details that may have been previously overlooked, highlight the need for reviewers to consider such details in their reviews through revised review criteria, and minimize additional burden.  These new instructions and revised review criteria focus on four areas deemed important for enhancing rigor and transparency:

Scientific Premise of Proposed Research

The scientific premise for an application is the research that is used to form the basis for the proposed research question; NIH has always strived to fund projects that are based on a strong foundation. Moving forward, NIH expects applicants to describe the general strengths and weaknesses of the prior research being cited by the investigator as crucial to support the application. It is expected that this consideration of general strengths and weaknesses could include attention to the rigor of the previous experimental designs, as well as the incorporation of relevant biological variables and authentication of key resources.

Rigorous Experimental Design

Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. This includes full transparency in reporting experimental details so that others may reproduce and extend the findings. NIH expects applicants to describe how they will achieve robust and unbiased results when describing the experimental design and proposed methods.  Robust results are obtained using methods designed to avoid bias and can be reproduced under well-controlled and reported experimental conditions.

Consideration of Sex and Other Relevant Biological Variables

NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies.  Appropriate analysis and transparent reporting of data by sex may enhance the rigor, transparency, and applicability of preclinical biomedical research. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided for applications proposing to study only one sex.  Please refer to NOT-OD-15-102 for further consideration of NIH expectations about sex as a biological variable.

Similarly, investigators should consider other biological variables, as appropriate, in the design and analyses of their proposed studies.  Research plans and findings should clearly indicate which biological variables are tested or controlled.  Clear justification should be provided for exclusion of variables that may be relevant but are not considered in the research plan.  For example, studies using young adult animals should clearly describe their study population and not generalize findings to juvenile or aged animals.

Authentication of Key Biological and/or Chemical Resources

The quality of the resources used to conduct research is critical to the ability to reproduce the results. NIH expects that key biological and/or chemical resources will be regularly authenticated to ensure their identity and validity for use in the proposed studies.  Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. Researchers should transparently report on what they have done to authenticate key resources, so that consensus can emerge.

Investigators are strongly encouraged to discuss these revised application instructions with NIH program staff prior to submission of applications. Further information is provided at the following website: http://grants.nih.gov/reproducibility/index.htm

This page last reviewed on April 28, 2016