An adverse event (AE) is an unanticipated occurrence that results in increased pain, distress, or health risk to an animal(s) or human(s). Reporting AEs assists the research team, provider or veterinary staff, to determine the cause and to prevent re-occurrence.
A protocol deviation is any departure from the procedures approved in the IACUC or IRB protocol.
Research teams are required to promptly report adverse events and protocol deviations to the IACUC or IRB, as appropriate.
Use the resources below for additional help.
The Office of Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) both conduct site inspections to ensure compliance with the regulations that govern human subject research. OHRP has jurisdiction over all Public Health Service funded human subjects research, while the FDA’s Bioresearch Monitoring Program (BIMO) focuses on research that involves drugs, biologics, and devices used in the diagnosis, cure, mitigation, treatment, or prevention of disease. The links below document common findings of noncompliance discovered during routine and for cause audits.
In addition to helping the staff prevent the AE from happening in the future, it also helps the IACUC meet the federal requirement to monitor all animal activities.
WFU personnel are strongly encouraged to report any concern about the care and treatment of animals used in research or teaching at WFU. Should you have a concern or question, please contact your supervisor and/or the principal investigator of the research project. If the issues are not resolved to your satisfaction, you can contact the below numbers.
For confidential reporting, you may also leave a message on the WFU Concern Line at 1-877-880-7888 or www.tnwinc.com/Reportline. You may leave your name or remain anonymous. All concerns are investigated. You will not be subject to discrimination or reprisal for good faith reports.