Washington Update

FASEB Provides Recommendations to OLAW for Congruency Review

By: Naomi Charalambakis
Wednesday, October 14, 2020

On October 6, FASEB responded to a National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) Request for Information (RFI) seeking stakeholder feedback on clarifying guidance to institutions regarding grant to protocol congruency. According to Public Health Service policy, institutions conducting animal research are responsible for ensuring that research described in NIH grant applications matches corresponding protocols approved by Institutional Animal Care and Use Committees (IACUCs).

This is the second in a series of RFIs issued as part of OLAW’s ongoing efforts to reduce regulatory burden associated with animal research, per the 21st Century Cures Act. A time- and labor-intensive process for investigators, OLAW identified grant to protocol congruency review as an area for which guidance could be simplified.

Because congruency review requires the comparison of two documents — research grants and IACUC protocols — written at separate times, FASEB recommended eliminating the congruency review requirement to reflect the dynamic nature of the scientific process. This recommendation was previously highlighted in the FASEB 2017 report, “Reforming Animal Research Regulations,” and is consistent with the revised 2018 Common Rule for research with human subjects. As a potential compromise, FASEB also proposed an option in which OLAW could waive congruency review for investigators without noncompliance citations during the prior two years.

To further streamline guidance, FASEB also encouraged OLAW to extend the current three-year duration of IACUC protocols to align with the duration of research grants. For example, for investigators with both R03 (up to two years) and R01 grants (four or five years), FASEB recommended extending protocol approval based on the longer-lasting grant mechanism. FASEB also emphasized the availability of existing mechanisms such as post-approval monitoring and semiannual inspections to ensure optimal animal care, effectively rendering premature IACUC renewals a duplicative policy that slows research progress.