IACUC Policy 330 - Protocol Suspension Procedures

IACUC Policy 330 - Protocol Suspension Procedures

Effective Date: October 18, 2023

I. Policy Purpose

To specify actions taken for protocol suspension.

II. Policy Definitions

AAALAC: American Association for Accreditation of Laboratory Animal Care

IO: Institutional Officer

OSPA:  SIU Office of Sponsored Project Administration

PHS: Public Health Service

III. Procedures

The IACUC may receive information indicating that work previously approved is not being conducted in accordance with PHS regulation. An IACUC ad hoc subcommittee, appointed by the IACUC chair, will investigate the complaint and report to the IACUC, as outlined by Policy #110, Managing Reports of Animal Welfare or Noncompliance concerns. The IACUC will recommend actions to be taken by the researcher to remedy the situation and will monitor the response of the PI.

According to the Public Health Service Policy on the Humane Care and Use of Laboratory Animals IV(C)(6), “the IACUC may suspend an activity which it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide to the Care and Use of Laboratory Animals, the institution’s PHS Assurance, or provisions” IV(C)(1)¹. This can only be done after review of the matter at a convened meeting of the IACUC with a quorum of members present, and a majority vote of the quorum to suspend activity.

When the IACUC suspends an activity involving animals, the IO in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW, APHIS (for USDA-covered species), AAALAC, and the funding agency for the activity. The SIU OSPA office will be included in distribution of the report, since certain grant-funded activity may not be charged to the grant during protocol suspension.

A memo with the outcome of the IACUC investigation detailing the issues of non-compliance and potential corrective actions will be submitted to the PI.

To reinstate the protocol, the PI must describe in writing a plan to implement all corrective actions requested by the IACUC; describe any other actions to prevent non-compliance and address the points included in the memo to the PI. The IACUC will decide how and when to lift the suspension.

IV. References

Public Health Service Policy on the Humane Care and Use of Laboratory Animals, https://olaw.nih.gov/policies-laws/phs-policy.htm#ReviewofPHS-ConductedorSupportedResearchProjects

Animal Welfare Act and Regulations. 9 CFR Ch. 1, Part 2, Subpart C.

Office of Laboratory Animal Welfare. Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals. Notice NOT-OD-05-034. National Institutes of Health, Washington, DC

Office of Laboratory Animal Welfare. Guidance Addressing the NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld. Notice NOT-OD-07-044. National Institutes of Health, Washington, DC.