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Guidance: Rigor and Reproducibility in Grant Applications

The NIH is committed to promoting rigorous and transparent research in all areas of science supported by a variety of grant programs. Grant application instructions and the criteria by which reviewers are asked to evaluate the scientific merit of the application include components that address reproducibility, rigor, and transparency. Learn how to address rigor and reproducibility in your grant application and discover what reviewers are looking for as they evaluate the application for scientific merit.

Overview of Guidelines for Rigor in Your Application

Infographics on new grant guidelines, including information on the four key areas of rigor, and details the updates to research strategy guidance, authentication, and new reviewer guidelines.

infographic thumbnail image fpr rigor infographic
Infographic courtesy of Ms. Nichole Swan, Dr. Shana Spindler, and Dr. Yvette Pittman of the
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
 
infographic thumbnail image for rigor and reproducibility chart
Enhancing Reproducibility in NIH Applications: Resource Chart
Infographic courtesy of OER
   



Research Grants and Mentored Career Development Awards

Beginning with applications due on January 25, 2019 the application instructions and review criteria will be clarified to replace the term “scientific premise” with the term "rigor of the prior research". Applicants will also be instructed to describe plans to address any weaknesses in the rigor of prior research within the Research Strategy. For additional details, see NOT-OD-18-228 and NOT-OD-18-229.

NIH research grant and career development award application instructions
and review language focus on four key areas:


1. The rigor of the prior research
  • A careful assessment of the rigor of the prior research that serves as the key support for a proposed project helps to identify weakness or gaps in a line of research. NIH expects applicants to describe the general strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project. It is expected that this consideration includes attention to the rigor of the previous experimental designs, as well as the incorporation of relevant biological variables and authentication of key resources. Applicants are expected to include plans to address any weaknesses or gaps identified.
  • See related FAQs    Blog Post
2. Rigorous experimental design for robust and unbiased results
  • Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. NIH expects full transparency in proposing and reporting experimental details so that reviewers may assess the proposed research and others may reproduce and extend the findings.
     
  • See related FAQs    Blog Post    Resources
3. Consideration of relevant biological variables
  • Biological variables, such as sex, age, weight, and underlying health conditions, are often critical factors affecting health or disease. In particular, sex is a biological variable that is frequently ignored in animal study designs and analyses, leading to an incomplete understanding of potential sex-based differences in basic biological function, disease processes and treatment response.
  • 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.
     
  • See related FAQs   Blog Posts   Reviewer Guidance   Article Link to Non-U.S. Government Site - Click for Disclaimer 
4. Authentication of key biological and/or chemical resources
  • Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. Key biological and/or chemical resources may or may not be generated with NIH funds and:
    • may differ from laboratory to laboratory or over time;
    • may have qualities and/or qualifications that could influence the research data;
    • are integral to the proposed research.
  • The quality of resources used to conduct research is critical to the ability to reproduce the results. Each investigator will have to determine which resources used in their research fit these criteria and are therefore key to the proposed research.
     
  • See related FAQs   Blog Post   Resources
     

 

Institutional Training Grants, Institutional Career Development, Individual Career Development, and Individual Fellowships

The NIH plans to require formal instruction in rigorous experimental design and transparency to enhance reproducibility for institutional training, institutional career development, individual career development, and individual fellowship applications with due dates on or after May 25, 2020. In addition, the requirements for rigor and transparency already in place for other research grants will be extended to fellowship research grants. See NOT-OD-20-033

When implemented, applications will be expected to provide the following:

Institutional research training and institutional career development  applications
  • The Program Plan section of the application will be expected to include a description of how the program and faculty will provide training in rigorous research design and relevant data science and quantitative approaches.
  • The requirement to include a Plan for Instruction in Methods for Enhancing Reproducibility attachment will be expanded to all applicants. 
Individual career development applications 
  • In describing their career development plans in the Program Plan attachment, candidates for career development awards will be expected to address, as applicable, any new research skills they plan to acquire in the areas of rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation. 
Individual fellowship applications 
  • In describing their training goals and objectives in the Program Plan attachment, fellowship candidates will be expected to address, as applicable, any new research skills they plan to acquire in the areas of rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation.
  • In the Research Strategy section of the Program Plan attachment, fellowship candidates will be expected to describe (a) the strengths and weaknesses in the rigor of the prior research that serves as the key support for the proposed project, (b) plans to address any weaknesses in the rigor of the prior research, (c) how the experimental objectives proposed will achieve robust and unbiased results, and (d) how relevant biological variables are factored into research designs and analyses.
  • If applicable, fellowship candidates will be required to include the Authentication of Key Biological and/or Chemical Resources attachment.