APS Comments on Grant-to-Protocol Congruency

APS Response to NOT-OD-20-153

Submitted via webform October 29, 2020

The American Physiological Society (APS) is grateful for the opportunity to comment on NOT-OD-20-153 on behalf of our more than 10,000 members, many of whom submit NIH grants and serve on their institutions’ IACUCs.

OLAW’s responsibilities include “evaluat[ing] the effectiveness of PHS policies and programs for the humane care and use of laboratory animals” and “provid[ing] clarification and guidance for both the Federal and non-Federal sectors with respect to the use of animals in research.” APS appreciates OLAW’s willingness to engage with its stakeholders as it seeks to clarify NIH’s grant-to-protocol congruency requirement. Our comments are directed at obtaining further clarity.

The 21st Century Cures Act in Sec. 2034.d called upon NIH in consultation with USDA and FDA to “reduce administrative burden on investigators while maintaining the integrity of research findings and protection of research animals.” Grant to protocol congruency is an area that was identified by the scientific community as disproportionately burdensome in terms of the benefits it bestows. This process should be eliminated, as suggested in “Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden.” This process has already been eliminated in human subject research via the Common Rule amendment of 2018. If this process is too burdensome for human subject researchers and did not add any additional protection to the human subjects, it is unclear why this is not the case for animal subjects research.

The NIH Grants Policy Statement states that verifying grant to protocol congruency is an institutional responsibility, and this RFI reiterates prior OLAW statements that the IACUC is not required to conduct this review. Rather, institutions may delegate this review to another office (e.g., compliance or sponsored programs) whose personnel have appropriate qualifications. Nevertheless, the vast majority of institutions have assigned this task to the IACUC. We have not collected data, but it seems likely that the reason for this is that personnel in the IACUC office have the appropriate qualifications. There would be no reduction in institutional burden or cost if it became necessary to hire staff with comparable qualifications in another office.

The RFI also reiterates that there is no explicit requirement to do a side-by-side comparison of the grant and any related IACUC protocol(s). It further states that other options are available. However, it is not clear how congruency can be ascertained without a side-by-side comparison. Moreover, the process of obtaining NIH funding complicates the execution of this review given that the grant application is submitted long before the animal protocol is written.

Our members who submit grants and serve on IACUCs would greatly appreciate it if OLAW could provide additional information on these topics:

• What kinds of processes other than a side-by-side document review would enable institutions to establish grant-to-protocol congruency?
• What elements of the grant and protocol must be congruent?
• Please provide examples of how institutions verify grant-to-protocol congruency without the participation of the IACUC.