New NIH Grant Instructions Effective January 2016

The National Institutes of Health will be revising grant application instructions and review criteria to enhance reproducibility of research findings through increased scientific rigor and transparency. Revisions will focus on four areas: 1) the scientific premise of the proposed research, 2) rigorous experimental design for robust and unbiased results, 3) consideration of relevant biological variables, and 4) authentication of key biological and/or chemical resources.

Pending OMB approval, NIH will incorporate the revisions into the SF424 (Research and Related) Application Guide and funding opportunity announcements in fall of 2015, for applications submitted for the January 25, 2016 due date and beyond.

New Expectations:

1. NIH will expect applicants to describe the general strengths and weaknesses of the prior research being cited by the investigator as crucial to support the application. Failure to identify these weaknesses and propose ways to improve going forward will be considered a proposal weakness.
2. Applicants will be expected to describe how they will achieve robust and unbiased results when describing the experimental design and proposed methods. Researchers will be expected to use methods designed to avoid bias and which can be reproduced under well-controlled and reported experimental conditions.
3. NIH expects that gender 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 gender.
4. Research plans and findings are expected to clearly indicate which biological variables are tested or controlled. Clear justification will need to be provided for exclusion of variables that may be relevant but are not considered in the research plan.
5. Even though there are not clear consensus guidelines on authenticating different types of resources, 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. These include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. In the absence of clear guidelines, researchers should transparently report on what they have done to authenticate key resources, so that consensus can emerge.

Application Preparation/Review Changes:

1. Applicants will be instructed to include their consideration of scientific premise, rigorous experimental design, and consideration of sex and other relevant biological variables in the Research Strategy section. Page limits for this section will not change.
2. Reviewers will be asked to evaluate scientific premise as part of Significance, and rigorous experimental design and consideration of sex and other biological variables as part of the Approach criteria. As such, evaluation of these three areas will be included in the assessment of overall impact.
3. Authentication of Key Resources will be incorporated as a new attachment under the Other Research Plan Sections and reviewers will be asked to comment on the plan but not consider it when scoring overall impact.

NIH will provide more detailed information about the specifics of implementation this fall.

NIH has created a new site to assist applicants and grantees, Rigor and Reproducibility, including a Frequently Asked Questions page.

For more information, see Enhancing Reproducibility through Rigor and Transparency (NOT-OD-15-103), Consideration of Sex as a Biological Variable in NIH-funded Research (NOT-OD-15-102), and Rock Talk article Enhancing Reproducibility in NIH-supported Research through Rigor and Transparency.