On October 9, 2015, the National Institutes of Health (NIH) and the Agency for Health Research Quality (AHRQ) issued notices with updated grant submission and review instructions (Notice Numbers: NOT-OD-16-011, NOT-OD-16-012 and NOT-OD-17-068). These changes are intended to enhance the reproducibility of research findings and are required with applications due January 25, 2016, and thereafter.
These new instructions and revised review criteria focus on four areas deemed important for enhancing rigor and transparency:
- Scientific premise of the proposed research
- Authentication of key biological and/or chemical resources
- Consideration of relevant biological variables
- Rigorous experimental design for robust and unbiased results
Authentication of Key Biological and/or Chemical Resources Samples
The sample documents provided below address the second criteria on the list, authentication of key biological and/or chemical resources, and are currently pending study section review. An authentication plan is required as an appendix to grant applications. Although the “Authentication of Key Biological and/or Chemical Resources” appendix is unscored, NIH study section reviewers have been instructed to comment on proposed plans for identifying and ensuring the validity of biological and/or chemical resources. On May 31, 2017, the NIH released a reminder (NOT-OD-17-068) of the need for grant applicants to meet this requirement, providing additional guidance. Applicants may also wish to review the NIH Frequently Asked Questions concerning the authentication of key biological and/or chemical resources plan.
We sincerely thank our colleagues for sharing their content, especially in advance of review. They are provided here to serve as a guide until post-review samples are available. While we encourage you to emulate these fine examples, please remain mindful of the difference between imitation and plagiarism.
We invite other investigators to share their experience with the new requirements as they are implemented during the 2016 grant cycles. For assistance with meeting rigor, reproducibility, and transparency requirements in your grant, or to submit a sample of how these requirements were met in a grant that has been awarded, contact the CCTS Research Commons (