This clarification is being provided in part due to the 21st Century Cures Act (21CCA). As a reminder, the Cures Act is a law that was enacted in 2016 authorizing billions of dollars in funding in order to, among other things, eliminate bureaucratic red tape and reduce regulatory burden in research. This includes those in animal research. For more information, read our previous post TOPAZ and the 21st Century Cures Act. Additional information can also be found in the 21CCA Final Report published by NIH, USDA, and FDA in August of 2019.
The notice includes some clarifications regarding grant to protocol congruency from the Office of Laboratory Animal Welfare (OLAW).
Performing and establishing grant to protocol congruency is an
Meaning, it doesn’t necessarily have to be executed by the IACUC or the IACUC office.
A congruence review is only required prior to receiving a grant or contract award
The NIH Grants Policy Statement (GPS) only requires a congruence review be conducted before the institution can receive a grant or contract award. The status of the review must be submitted as part of a “Just In Time” request. Thus, it’s recommended that an IACUC protocol be prepared if the application receives a potentially fundable score and that the congruence review be conducted only for applications that are likely to be funded.
A side-by-side comparison of the grant and IACUC protocol is not the only
way to conduct a grant congruence review.
Similarly, a grant can be deemed congruent with multiple protocols and a protocol can be deemed congruent with multiple grants. A one-to-one relationship is not required.
Once the review is completed, additional documentation is needed only in
Once a congruency review is completed and the NIH is informed of the successful review, no additional documentation needs to be submitted to the NIH unless (a) requested to do so by the NIH or (b) to request a significant change in scope to the original application in accordance with NIH GPS Section 220.127.116.11. For example, a change from one species to another would be considered a significant change in scope.
A Request for Input
As an RFI, the purpose of the notice is to request input from the public and others in the industry on the “NIH expectations and flexibilities of grant to protocol congruency” (NOT-OD-20-153). A 90-day comment period is being provided, ending on October 29, 2020 at 11:59 PM EDT. To submit a comment, you can visit the RFI webpage. After the comment period closes and the NIH has a chance to review the comments provided, we can expect the Office of Laboratory Animal Welfare (OLAW) to issue official guidance to clarify institutional responsibilities regarding grant to protocol congruency.