It has been NIH grants policy that applications submitted to NIH, which include research involving human participants, are required to have IRB approval at the time of submission or within 60 days after application receipt date. Since fewer than half of all applications submitted to NIH are funded, and in order to reduce burden on applicants and IRBs, the NIH is modifying this policy.

Beginning with applications submitted for the January 2001 Council round (generally, those applications submitted for the June/July 2000 receipt dates), IRB approval is not required prior to NIH peer review of an application. As part of the peer review process, the peer review group carefully considers whether the application includes the necessary safeguards to protect the rights and welfare of research participants.

This change in policy is intended to provide flexibility at the institutional level. The institution may still determine that certain lines of research (e.g., scientifically or ethically controversial research) or mechanisms of research (e.g., multicenter clinical trials) should receive IRB review prior to submission of the application.

No grant award can be made without IRB approval. Therefore, following NIH peer review and notification of priority score/percentile, institutions should proceed with IRB review for those applications that have not yet received IRB approval and that appear to be in a fundable range. The term "fundable range" does not signify a certainty of funding. Guidance is currently being developed that will assist applicants in determining their status related to a particular Institute or Center's fundable range.

This change in NIH policy is intended to provide institutions with the flexibility to reduce the workload burdens that many IRBs are currently facing. This change is consistent with the requirements of 45 CFR 46 (The Common Rule).