10
Sep2019

USDA, OLAW, and AAALAC provide varying guidance with respect to defining noncompliance and determining how IACUCs should best handle and report incidents of noncompliance. Despite increasing efforts toward harmonization and communication, IACUCs may struggle to identify noncompliance, which cases to report, and how to best correct and prevent it from occurring in the future. Non-typical research, such as activities involving wildlife, may be especially challenging in this regard.

On June 20, PRIM&R hosted a webinar, Advanced Noncompliance Scenarios for IACUCs: Laboratory Animals and Wildlife, which presented interactive scenarios to assist IACUCs in navigating the challenges associated with identifying, investigating, reporting, and correcting noncompliance at their institution. The speaker panel consisted of Stacy Pritt, DVM, MS, MBA, CPIA, CHRC, DACAW, assistant vice president for conflict of interest and the IACUC at the University of Texas (UT) Southwestern Medical Center and Tracy Thompson, DVM, veterinary medical officer in the wildlife health branch of the National Park Service.

In this blog post, Stacy Pritt offers input on a protocol review process called veterinary verification and consultation (VVC), and explores a scenario from the webinar in which this method may be employed by the IACUC to prevent noncompliance as well as to reduce regulatory burden. We’re pleased to share her insight with the readers of Ampersand.

Stacy Pritt: In 2014, OLAW introduced a new method of approving certain types of protocol changes called veterinary verification and consultation. The gist of this new method is that the IACUC may put in place certain policies that will then allow a veterinarian designated by the IACUC, also called the “authorized veterinarian,” to confirm that the submitted protocol changes meet policy guidelines. With this confirmation, the IACUC may then administratively handle and process the protocol change. Goals of this method include decreasing regulatory burden by decreasing the number of protocol changes that must be reviewed by the IACUC as well as potentially decreasing the turnaround time for protocol changes that are eligible for VVC.

The USDA acknowledges this method of processing certain protocol changes in chapter seven of the Animal Welfare Inspection Guide.

During the webinar, we discussed a scenario where there was a change in the number of blood collections needed during the course of a study. This is a good example of where VVC may be used by an IACUC to decrease regulatory burden. In this scenario, if an IACUC has an approved policy for the number of blood collections it deems to be acceptable for each species, then a change to the number of blood collections in a protocol could be reviewed by VVC. An authorized veterinarian can review the change for congruence to the already existing policy. With that confirmation, the protocol change can be processed without further review by the IACUC. This is admittedly a simplistic view of VVC, and a lot more nuance may be involved depending on the situation, but there are some checks and balances built in. For example, the authorized veterinarian has the ability to route the proposed protocol change to the full committee for review if they feel that the change is not consistent with an already approved policy.

Since the implementation of VVC, I have seen a steady increase in the number of programs using the method. At PRIM&R’s 2019 IACUC Conference, I surveyed one workshop audience and found that 50% of attendees were using VVC, which is a definite increase from previous years.

At UT Southwestern Medical Center, we adopted VVC within two months of OLAW’s notice. Our metrics consistently show that we are able to handle about 5% of our submitted protocol changes via VVC. The primary reason why that figure is not higher is because we see investigators submit changes that we think will be VVC eligible, but they add other changes that make the submitted change not eligible. However, given our volume of amendments, a 5% reduction in the number of amendments going to the IACUC for review definitely decreases our regulatory burden.


PRIM&R thanks Dr. Pritt for sharing her expertise.

The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to registration@primr.org.

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