Office of Research Integrity

Reporting Guidelines

Guidelines for Handling Reportable Events

Investigators using animals for research should be aware that failure to comply with regulations pertaining to the care and use of the animals are considered reportable events that must be reported by the IACUC to the Office of Laboratory Animal Welfare (OLAW) in the NIH. Prompt reporting of these events is mandated by OLAW.

From NIH Report No. NOT-OD-05-034:

The PHS Policy on Humane Care and Use of Laboratory Animals identifies three areas that require prompt reporting to OLAW (Section IV.F., paragraph 3): (a) any serious or continuing noncompliance with the PHS Policy; (b) any serious deviation from the provisions of the Guide for Care and Use of Laboratory Animals; and (c) any suspension of an activity by the IACUC.

The MUSC IACUC, as advised by OLAW, includes the following reportable events as well as anything else specified in the OLAW Reporting Guidelines:

  1. Modification of an approved protocol without prior IACUC approval to include:
    1. Change in anesthesia;
    2. Change in analgesia;
    3. Change in euthanasia method;
    4. Change in dosages or procedures;
    5. Inclusion of additional test substances;
    6. Inclusion of additional timepoints;
    7. Utilization of core facility/service;
    8. Any other modification as clarified by OLAW;
  2. Handling of animals by personnel who are not specifically approved on the protocol;
  3. Improper survival surgery procedure;
  4. Failure to use aseptic procedures;
  5. Significant postoperative complication rate that is not reported to IACUC and corrected by modifications in the procedure;
  6. Removal of live animals from DLAR without IACUC approval;
  7. Failure to euthanize an animal in pain/distress which cannot be relieved by analgesia;
  8. Use of animals without IACUC approval;
  9. Failure to correct previously identified deficiencies;
  10. Inhumane use or treatment of research animals.

At the discretion of the IACUC, in consultation with OLAW, situations other than those listed may also qualify as reportable events. The IACUC has the option to require mandatory training of personnel involved in any situation that results in a reportable event, and to monitor the progress of the research laboratory in correcting the problem.

The IACUC will provide written notification of any reportable event to the investigator, in conjunction with adherence to prompt reporting guidelines requiring immediate notification of OLAW. When an activity has been identified as a reportable event, the preliminary notification to OLAW is made via email by authorized IACUC or DLAR personnel under prompt reporting guidelines. A complete final report, including all corrective actions, will be submitted in writing to OLAW by the Institutional Official. At MUSC, the Institutional Official is the Vice President of Academic Affairs & Provost. More details on prompt reporting guidelines, timelines and consequences are available on our FAQs.

If you have any questions, please contact Cyndi Rosenblatt, IACUC Program Manager (792-0021).

Revised 10/2009