Flexibilities for Streamlining IACUC Review RFI

APS’ response to a request for information from the National Institutes of Health Office of Laboratory Animal Welfare on flexibilities for streamlining review of protocols as part of a wider effort to fulfill obligations under the 21st Century Cures Act to reduce regulatory and administrative burden.

The American Physiological Society (APS) thanks OLAW for reinforcing the availability of flexibilities for changes in protocols for animal care and use. Many assured institutions are already utilizing the flexibilities but still find that administrative burden related to animal care and use protocols is excessive. APS encourages OLAW to explore additional areas that would benefit from new flexibilities. One example is the incongruency between the three-year protocol review requirement and the current length of most research grants. OLAW should also consider including existing flexibilities in a comprehensive communications package to current and, especially, new and incoming institutional officials IOs and IACUC chairs. This would ensure that new and existing leadership are aware of all of the flexibilities at their disposal. To increase overall awareness of these flexibilities, OLAW should consider more frequently using the Fast Facts portion of the OLAW website as a place to share these flexibilities.

Proposed Guidance for Streamlining DMR:

Regarding flexibility #1, “the IACUC may determine a reduced, but reasonable, time frame agreed upon by the IACUC to obtain concurrence to call for FCR from all members or concurrence by silent assent once the full time has elapsed (e.g., three instead of seven business days),” OLAW should reiterate that the Guide does not specify a timeframe for obtaining concurrence. This would encourage institutions that strictly adhere to the Guide to take advantage of this flexibility. Regarding flexibility #3, “the IACUC may establish criteria for which some types of research or significant changes may be flagged for DMR. All members must be provided with a reasonable time to call for FCR, but the DMR process may be initiated during that time. Only when there are no requests for FCR at the end of the predetermined time frame, may DMR be finalized,” OLAW should add “change or addition of an Association of Veterinary Medical Association (AVMA)-approved euthanasia methods that minimizes animal pain or distress,” to the existing lists of “examples of criteria based on significant changes.” This would encourage this flexibility to be used for the frequent protocol changes of AVMA-approved euthanasia methods.

Proposed Guidance for Streamlining VVC (Veterinary Verification and Consultation):

To alleviate confusion regarding flexibility #4, “changes handled by VVC do not require subsequent reapproval by, or notification to, the IACUC,” and increase utilization, OLAW should consider developing more descriptive resources for institutions, especially smaller institutions, on what VVC is and how they can utilize it. The guidance provided on VVC in “Significant Changes to Animal Activities,” (NOT-OD-14-126) may not be explicit enough for institutions not well versed in this process.

To increase overall awareness of these flexibilities, OLAW should consider using the Fast Facts portion of the OLAW website as a place to share these flexibilities. If Fast Facts does not seem like an appropriate space for this VVC information, OLAW should consider building out a page for posting all of the VVC resources in one place including the February 2018 presentation on “To VVC or Not to VVC” and the Lab Animal article on “Making changes: when is FFC appropriate?”

Proposed Guidance for Streamlining Administrative Handling of Increase in Previously Approved Animal Numbers:

Regarding the administrative handling of increases in previously approved animal numbers specifically, OLAW should continue to communicate with assured institutions about cases where subsequent reapproval by the IACUC is not necessary. When institutions are confused about the requirements, they may default to reapproval to avoid noncompliance.