Policy Title: Adverse Event Reporting
Purpose: This policy provides a campus-wide definition of “Adverse Events” and identifies reporting and review requirements for both protocol-related and non-protocol-related adverse events. The purpose of adverse-event reporting is to improve monitoring, focus resources on problem areas, ensure appropriate follow-up when problem areas are identified, and clarify expectations between the ACUCs, the PIs, and the veterinary and animal care staff. The ultimate goal of this policy is to improve animal welfare.
Definition: An adverse event is defined as any event that caused harm to a vertebrate animal and that meets either of the following conditions:
- (a) The event is research-related but is not identified in the approved protocol or occurring at a rate or severity higher than is indicated in the approved protocol; or
- (a) The event is not research-related, but is unanticipated or due to a facility, physical plant, or equipment failure or malfunction, or personnel mistake.
POLICY: Adverse events must be promptly reported to the appropriate Animal Care and Use Committee (ACUC). Any member of the research community (PI, lab staff, veterinary staff, animal care staff) with knowledge of an adverse event may submit a report. Please consult with an RARC veterinarian for assistance with adverse event reporting.
The ACUC will review adverse event reports and may approve proposed corrective plans or require additional actions to ensure animal welfare. The responsible parties will be notified by the ACUC of any actions taken or requirements made regarding an adverse event.
Author: Rob Streiffer, Holly McEntee, Janet Welter, Eric Sandgren, Derrik Duchesneau
ePublication Date: 9/19/2012 (orig.)
History: amended 2/3/2017