By Shannon Reynolds, BA, CPIA, RLAT
Shannon Reynolds, regulatory compliance specialist at the Allen Institute for Brain Science, recently shared her experience at the Northwest Association for Biomedical Research (NWABR) 2015 IACUC Conference on NWABR’s official blog, "Thank Research!". We are pleased to share her thoughts and observations about a recent OLAW Notice Number NOT-OD-14-126, which was a topic of discussion at the conference.
The Office of Laboratory Animal Welfare (OLAW) oversees the care and use of animals in research funded by the National Institutes of Health (NIH). IACUCs are responsible for oversight at the institutional level, which includes the review of research protocols and their compliance.
This past summer, OLAW issued guidance formally known as "Notice Number NOT-OD-14-126" (in government-speak), and it was a hot topic during the 2015 NWABR IACUC Conference.
In short, now some changes to an original research plan (or protocol) submitted by a researcher can be approved by a more efficient process. Instead of researchers resubmitting to the IACUC from scratch, a select group of changes can be reviewed against policies previously approved by the IACUC, through a process called Veterinary Verification and Consultation (VVC), with caveats.Why would institutions want to do this? Mainly because it offers a new, more efficient method for IACUCs to approve small changes in the researcher’s roadmap that would otherwise need to be submitted to the IACUC for a lengthier review. This change will increase efficiency for IACUCs and researchers. VVC is a common sense approach to support the forward motion of research, while continuing to protect animals involved. So, "This guidance sounds great, but how can I USE it?" Well, if you’re a researcher or administrator looking to escape red tape, you’re in luck.
OLAW has done its part to open the door to make compliance easier. Dr. Brent Morse, an Animal Welfare Program Specialist with the Division of Compliance Oversight at OLAW, recently provided a practical overview of the new guidance at the 2015 NWABR IACUC Conference, along with an explanation of the various options that IACUCs have for approving the supporting policies. The bottom line – institutions will need to do their part.Your institution’s preparation of clear and specific policies will determine the extent to which this new guidance can be leveraged. While the guidance is fairly straightforward, the extent to which it can be implemented is not. It’s a move both respectful and smart. The veterinarian performing VVC is only verifying that the requested change is consistent with your existing IACUC-approved policies. It’s up to your individual institution working with your IACUC to support making the process easier still.
If you missed Dr. Morse’s talk, or if you still have questions about this guidance, I would encourage you to review the transcript of the OLAW Online Seminar on this topic which originally aired on August 21, 2014.
Of note for the strictly administrative among us, certain types of significant changes are still required to go through the "classic" IACUC review and approval methods (i.e., FCR or DMR). A subset of specific significant changes may now be administratively "handled" (not approved) through VVC. In addition, the description of the changes that qualify for administrative review has been expanded to include increases in animal numbers when the institution’s IACUC has supporting policies in place.
We’d like to thank Shannon for allowing us to share her thoughts from the 2015 NWABR Conference.
The 2016 NWABR Conference will be held in conjunction with PRIM&R’s 2016 IACUC Conference , March 30-April 2, 2016, in Bellevue, WA.