Notice Number: NOT-OD-16-034

Key Dates
Release Date: December 17, 2015

Issued by
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)

Purpose

This Notice informs the biomedical and health services research communities of NIH and AHRQ plans to require formal instruction in scientific rigor and transparency to enhance reproducibility for all individuals supported by institutional training grants, institutional career development awards, or individual fellowships. Implementation of these requirements will be as early as FY 2017 but will not be in 2016 as indicated in NOT-OD-16-004. An extension of the anticipated implementation date is to ensure that applicants for NIH or AHRQ institutional training grants, institutional career development awards, and individual fellowships have time to access resources and develop substantive instructional plans to ensure that all supported individuals receive in-depth training in rigorous experimental design and data interpretation. NIH and AHRQ will issue a Notice at a future date to provide an updated timeline for implementing this requirement.

Background

In October 2015, NIH and AHRQ introduced new requirements for rigor and transparency for most research grant and individual mentored career development award applications (see NOT-OD-16-004, NOT-OD-16-011 and NOT-OD-16-012). Originally this requirement was to be implemented for institutional training and individual fellowship applications submitted for the May 25th 2016 due date and beyond. We recognized however, that the development of substantive and effective instructional plans and curricula to ensure in-depth, transformative education and training in rigorous experimental design across the many different fields and disciplines supported by institutional training grants, institutional career development awards, and individual fellowships would require time and resources on the applicant’s part; therefore, the timeline for implementing this requirement has been extended.

Definition

Scientific rigor is the strict application of the scientific method to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of results. Scientific rigor also includes transparency in reporting full experimental details so that others may reproduce and extend the findings.

Implementation

NIH and AHRQ intend to implement the formal instructional requirements for all institutional training, institutional career development, and individual fellowship applications as early as FY 2017. When implemented, applications will be expected to provide the following:

Institutional training grant applications will be required to include within the training program plan a summary of the instruction planned for all predoctoral and postdoctoral trainees to ensure the knowledge and skills required to design and conduct rigorous, well-controlled experiments that consider all relevant biological variables, use authenticated biological and chemical resources, and apply appropriate statistical tests for data analyses. In addition, a separate attachment will be required to describe in more detail the instructional content and curricular content. The impacted programs will include the following training grants: D43, T15, T32/TL1, T34, T35, T36, T37, T90/R90, and U2R.

Institutional career development applications will be required to include within the career development program plan a summary of the instruction planned for all scholars to ensure the knowledge and skills required to design and conduct rigorous, well-controlled experiments that consider all relevant biological variables, use authenticated biological and chemical resources, and apply appropriate statistical tests for data analyses. In addition, a separate attachment will be required to describe in more detail the instructional content and curricular content. The impacted programs will include the following career development awards: K12/KL2.

Individual fellowship applications will be required to summarize in the research strategy section plans to ensure rigorous, well-controlled experiments that consider all relevant biological variables, use authenticated biological and chemical resources, and apply appropriate statistical tests for data analyses. In addition more detailed description of instruction in rigorous experimental design to ensure reproducibility will be required in the section on Institutional Environment and Commitment to Training. The impacted programs will include the following individual fellowships: F05, F30, F31, F32, F37, F38, and FI2.

Resources

Future applicants are recommended to seek resources to ensure they will be prepared to include their content describing instruction in rigorous experimental design and transparency to ensure reproducibility. Some existing resources provided by the NIH are as follows:

• The NIH website on Rigor and Reproducibility.
• The NIH Office of Extramural Research website on Rigor and Reproducibility.
• NIH institute and center supported training modules being developed for use in instruction to enhance students abilities to conduct rigorous and reproducible research:
  https://www.nigms.nih.gov/training/Pages/training-modules-to-enhance-data-reproducibility.aspx
• Availability of Administrative Supplements to NIGMS Predoctoral Training Grants (Admin Supp):
  https://grants.nih.gov/grants/guide/pa-files/PA-16-060.html
• NIGMS blog, Catalyzing the Modernization of Graduate Education:
  http://loop.nigms.nih.gov/2015/11/catalyzing-the-modernization-of-graduate-education/

Inquiries

Please direct all inquiries to:

Division of Biomedical Research Workforce
Office of Extramural Programs
National Institutes of Health
Email: [email protected]