Reporting Adverse Events
Background
The IACUC is under a federal mandate to monitor all research activities related to animal use. All
suspected Adverse Events (AE) should be reported in a timely manner. AEs can be made to a Harvard
Medical School (HMS) veterinarian at the Harvard Center for Comparative Medicine (HCCM), the
Institutional Animal Care and Use Committee (IACUC) office, or anonymously.
1. Events that are required to be reported as AEs
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html)
Conditions that jeopardize the health or well-being of animals, including natural disasters,
accidents, and mechanical failures, resulting in actual harm or death to animals
2. Examples of events that are not required to be reported as AEs
a. Clinical issues unrelated to approved procedures and being treated by the clinical
veterinarians.
b. Death or morbidity of animals described as expected in the approved IACUC protocol.
3. Applicability
This applies to all research-related animal use under the jurisdiction of the HMA IACUC.
4. Contact Information
Name
Arlene Santos-Diaz
(617) 432-5327
Title
Director, Office of the IACUC
arlene_santos-diaz@hms.harvard.edu
Gerald Pier, PhD
(617) 525-2269
Chair, IACUC
gpier@bwh.harvard.edu
Brian Corning, DVM
(617) 432-1289
Director, HCCM; IACUC Attending Veterinarian
brian_corning@hms.harvard.edu
Harvard Medical Area Standing Committee on Animals (HMA IACUC)
Reporting Adverse Events
Revised October 23, 2015
Appendix 1 – Reporting Form
Adverse Event Report Form
Please fill in all known information
Protocol #:
PI Name:
Location of Adverse Event:
Species of Animal:
Date/Time of Finding
Nature of Event:
Please describe what happened.
Person Reporting Event:
Not required for anonymous reports
Report sent to:
☐ Office of the IACUC
☐ Facility Veterinarian
☐ Attending Veterinarian
☐ Other (
)
Date of Report:
Harvard Medical Area Standing Committee on Animals (HMA IACUC)
Reporting Adverse Events
Revised October 23, 2015