Research noncompliance occurs when researchers (intentionally or unintentionally) fail to comply with established regulations, policies, and/or committee-approved research protocols. Noncompliance comes in many forms. It is study-specific and not always identified by IRBs and IACUCs in the same manner. Some instances of noncompliance may be discovered through post-approval monitoring activities, while others come to the committees via whistleblowers, or reports submitted by the researchers themselves. Whatever the case, committees must decide what happens after noncompliance has been identified. Read more
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How does your organization view noncompliance investigations? Are they seen as an opportunity for learning and growth? If we are honest, many of us would not volunteer to learn or grow our HRPPs through a noncompliance investigation. We want to get through it and hope it does not occur again. That is wishful thinking and is not the wisest approach to addressing and mitigating noncompliance. The AER19 session, “How to Investigate, Mitigate, Report and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement” inspired me to believe that there can be a bright side through the process of noncompliance investigations. Read more
Webinar Follow-Up: Advanced Noncompliance Scenarios for IACUCs – Laboratory Animals and Wildlife
Tags: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. In this blog post, Stacy Pritt, DVM, MS, MBA, CPIA, CHRC, DACAW, assistant vice president for conflict of interest and the IACUC at the University of Texas Southwestern Medical Center, 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. Read more

While it may be a common complaint among researchers that IRBs overregulate, many IRBs opt to “uncheck the box” by building additional flexibility into the regulations that allows them to reduce investigator burden while still ensuring equivalent protections for human subjects. Read more
Webinar Follow-up: Reducing Noncompliance While Facilitating Research – Strategies for IACUCs
Tags:In January 2017, PRIM&R hosted a webinar titled Reducing Noncompliance While Facilitating Research: Strategies for IACUCs, presented by Barbara Garibaldi, DVM, DACLAM, and Emily Hearne, MS. 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. Read more