Reporting Adverse Events

May 24, 2018

Reporting adverse events iconIn order to ensure the continuity of animal care, investigators must report adverse events.

An adverse event is an unexpected incident that negatively impacts animal welfare and is related to research activities. Other unexpected incidents related to clinical care or general animal well-being should be reported to ULAM. Adverse consequences that can be expected as part of the research model, which are included on each IACUC approved protocol, do NOT need to be reported.
 
Examples of adverse events that should be reported to the Animal Care & Use Office (ACUO) include but are NOT limited to:

  • A cohort of animals dies during experiments because of an equipment or power failure;
  • An animal’s indwelling catheter is dislodged and the animal, or animals, is injured or dies;
  • A cohort of animals experiences unexpected and/or higher than expected morbidity or mortality following a procedure

Reports will be reviewed by the ACUO, and any additional required information or follow-up questions will be collected and resolved as needed. Adverse events can be a one-time occurrence or indicative of broader programmatic concerns. Accordingly, resolutions to adverse events may include:

  • A change in the procedure to avoid reoccurrence of the event
  • Revision of the protocol to include new adverse consequences
  • Reports to regulatory agencies

Please use the following to help guide your reporting:

If... Report to:
Immediate care is needed for an animal and/or the
incident relates to husbandry or clinical care of animals

Veterinary care staff. Refer to the specific contact information posted on the animal housing room door.

Veterinary care can be requested:

  • During normal business hours (Monday – Friday, 8:00 AM – 5:00 PM) by calling ULAM at (734) 764-0277
  • After hours (Monday – Friday, 5:00 PM – 8:00 AM) by calling DPSS at (734) 763-1131
  • Weekends and holidays by calling the on-site Veterinary Technician at (734) 936-1037
No immediate intervention is needed Email your Research Compliance Associate (RCA) and include the following:
  • The IACUC protocol number(s) and species
  • The nature of the event (briefly describe what occurred)
  • Who should be contacted for follow-up
Anonymous reporting is necessary Use the Animal Concern Hotline (animalcare.umich.edu/hotline)

Questions?

If you have any questions or concerns about reporting adverse events, please contact the Animal Care & Use Office at (734) 763-8028.