Understanding & Reporting Adverse Events: Definitions, Decisions, and Regulatory Responsibilities
Webinar Objectives
This session is designed to support clear, practical discussion around identifying, managing, and reporting adverse events in animal research. The faculty presenter will highlight key regulatory requirements and guidance from the Animal Welfare Act Regulations, the Guide for the Care and Use of Laboratory Animals, the PHS Policy, and FAQs from OLAW and AAALAC International. Participants will explore how institutions define adverse events, differentiate them from expected outcomes or refinements, and ensure appropriate IACUC oversight. The session will include opportunities for participants to share practices, ask questions, and engage in collaborative problem-solving. Attendees are encouraged to submit questions in advance to wggreer@umich.edu to help shape the conversation.
Program Summary, Discussion Points, and Brief Agenda Topics
Animal research programs are expected to identify, respond to, and report adverse events affecting animal subjects. While federal regulations, policies, and accreditation standards may use different language to describe these incidents, their shared intent is clear: institutions must ensure humane animal care, timely intervention, and appropriate oversight through the IACUC.
This session will explore the practical aspects of defining and managing adverse events, as outlined in:
- The Animal Welfare Act Regulations
- The Guide for the Care and Use of Laboratory Animals
- The Public Health Service (PHS) Policy
- FAQs from OLAW and AAALAC International relevant to Adverse Events
Key discussion points:
- Distinguishing between adverse events, protocol refinements, and clinical cases
- Is an "unexpected" event related to an approved protocol a "significant" reportable event
- The IACUC’s role in reviewing, documenting, and reporting adverse events
- Institutional strategies for timely communication and corrective action
- How to evaluate and document an adverse event
This session is ideal for IACUC administrators, veterinarians, compliance staff, and investigators seeking clarity on how to implement effective response mechanisms that meet regulatory expectations while supporting humane outcomes.
Participants are encouraged to submit questions or scenarios in advance to wggreer@umich.edu to shape an interactive and practical discussion.
Programs Support
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We encourage you to join or renew your membership annually. As a member, you can attend webinars for free and receive discounted attendance fees at both online and in person meetings.
IACUC Administrators Alliance:
We’re excited to share that we have successfully identified the Alliance members, along with a dedicated advisory group that will partner with the efforts of the IACUC Administrators Association’s. We are deeply grateful to everyone who expressed interest in participating, there is a place for all, and if we haven’t yet reached out to you directly, we will be doing so shortly.
As we move into the next phase later this summer, the IACUC Administrators Association will begin working closely with the Alliance to gradually increase its involvement in the community. The Alliance will serve as a vital advisory resource, highlighting emerging issues, recommending priority topics, and shaping the conversations that matter most to our field. In addition to informing strategic direction, Alliance members will actively contribute to the planning, facilitation, and delivery of future IAA events.
The IACUC Administrators Association will sponsor and support the efforts of the Alliance, helping to ensure its success in strengthening collaboration and advancing our shared goals across the IACUC community.
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Presenter(s) Biographies:
Standing IAA Faculty and Facilitators
Bill Greer, Assistant Vice President for Research, University of Michigan: Bill graduated from The Pennsylvania State University in 1985 with a degree in Microbiology. He oversees research compliance programs for animal care and use, biosafety, lab safety, controlled substances, and autonomous systems. Over his 30+ year career, Bill has held roles including Associate Director for Research Compliance, IACUC Vice-Chair, and Biosafety Committee Chair at Penn State, as well as production manager and safety director at Intervet (formerly Tri Bio Laboratories).
In 2005, Bill organized the first Research Administrators Best Practice Meeting, creating a platform for research oversight professionals to discuss programmatic concerns. He continues to facilitate at least five annual Best Practice Meetings focused on biosafety and animal care and use programs. In 2010, he chaired the founding committee of the IACUC Administrators Association (IAA), a nonprofit organization dedicated to education and serves as its president and board chair.
Since 2007, Bill has been an ad hoc consultant to the AAALAC Council, conducting institutional program reviews and assessments. He also served on the Council of Certified Professional IACUC Administrators (CCPIA). As an educator, Bill regularly lectures at conferences including PRIM&R, AALAS, BTAA, and C3, and facilitates IBC and IACUC Best Practice Meetings, continuing to support the IBC and IACUC administrative communities.
Ron E. Banks, DVM: received his veterinary degree from Auburn University’s School of Veterinary Medicine, and retired a Colonel from the United States Army Veterinary Corps. After postings as the Director, Center for Comparative Medicine, University of Colorado Health Sciences Center, Denver, Colorado; and Director, Office of Animal Welfare Assurance at Duke University, Durham, North Carolina; and the Director, Division of Comparative Medicine, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; he is currently retired. Along his professional journey he has contributed as Council Member on AAALAC’s Council on Accreditation; Chairman of the American Veterinary Medical Association’s Institutional Animal Care & Use Committee; Board Member for the IACUC Administrator’s Association; and Fellow of the National Academies of Practice. Dr. Banks is board certified with the American College of Laboratory Animal Medicine; the American College of Veterinary Preventive Medicine; and he is a Charter Diplomate of the American College of Animal Welfare.
United States
NON-Members | $75.00 |
Members | $0.00 |