In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA/APHIS/AC) offer the following clarification and guidance:

The primary question posed in the scenario is whether a voluntary suspension of an animal activity by an investigator needs to be reported to the USDA and to the appropriate federal funding agency.

There are two Animal Welfare regulations (AWRs) that require notification be made to USDA and to any federal agency funding the research activity. These provisions were enacted to provide an effective mechanism to ensure that suffering animals are given prompt relief, and they include the following: (i) an IACUC suspension of a research activity (at a convened meeting, with a majority vote of the quorum present)1 and (ii) an uncorrected significant deficiency2. USDA does not require research facilities to report all serious noncompliances or deviations from the AWRs, as these will be documented by the USDA inspector.

In this particular scenario, the IACUC is investigating a report of a significant protocol violation. The IACUC must still prepare a report to the Institutional Official (IO) identifying the noncompliant items, including a reasonable and specific plan and schedule with dates for correcting each deficiency. This report becomes part of the IACUC records and must be made available to the USDA inspector for review. If the research facility fails to adhere to the plan and schedule and the significant deficiency remains uncorrected, or if the IACUC must take drastic action and suspend the protocol, the IACUC (through the IO) would then be expected to report this in writing to USDA and to any federal funding agency.

In addition to the AWRs, institutions receiving funds from the Public Health Service (PHS) should be aware that the situation described in this scenario falls into the category of conduct of animal activities in the absence of valid IACUC approval, and institutions are required to report such situations to the Institute/Center supporting the award3. The Office of Management and Budget Cost Principles and the National Institutes of Health Grants Policy Statement (NIHGPS) do not permit charges to grant awards for the conduct of animal activities during periods of time that the terms and conditions of the NIHGPS are not upheld, which includes lack of IACUC approval3. NIH expects grantees to continue to maintain and care for animals during the period described.

The IACUC chair's actions were appropriate. Sanctions imposed by the IACUC or by an institutional official due to serious or continuing noncompliance with the PHS Policy4 or serious deviations from the Guide for the Care and Use of Laboratory Animals5 must be reported to OLAW. More detailed guidance on reporting noncompliance can be found in the NIH Guide for Grants and Contracts NOT-OD-05-034 (ref. 6). Institutions should use rational judgment in determining which situations meet the provisions of the PHS Policy, IV.F.3, and should consult with OLAW if in doubt about reporting requirements.

Both USDA and OLAW welcome reporting inquiries and discussion and will provide guidance with regard to specific situations.

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