Response to Protocol Review Scenario: A Word from OLAW

In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) offers the following clarification and guidance:

This scenario raises a number of issues. Can the IACUC administratively extend approval of a project that has expired? No¹. For animal activities funded by the Public Health Service (PHS), the PHS Policy on Humane Care and Use of Laboratory Animals IV.C.5. states that “the IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1-4. at least once every three years”². In order to extend the project, the IACUC must conduct a complete review and approve the protocol either at a full committee meeting or by designated member review². If a protocol is allowed to expire, all animal activities conducted under that protocol must cease. Continuation of animal activities in the absence of a valid approval is a serious violation of both the PHS Policy and the terms and conditions of the grant³. These violations must be reported to OLAW and the funding component³. If the project is PHS-supported, funds may not be drawn from the grant for animal activities during the expired period⁴.

Should the IACUC consider the transfer of animals from one project to another as a significant change? This is a more complex question with implications in several areas. The IACUC has some latitude in defining what it considers a significant change, or it can establish a mechanism for determining significance on a case-by-case basis⁵. Significant changes require IACUC approval by either (1) full-committee review by a convened quorum of the IACUC or (2) designated member review by one or more members in accordance with the Policy at IV.C.2. and as previously clarified by OLAW⁵. The IACUC must clearly define its policy and mechanism for determining significance and communicate this to its investigators.

In the scenario described, it is clear that the investigator's proposal to 'amend' an ongoing protocol to accommodate work described in an expired protocol represents a change in the approved objectives of the ongoing study that would require IACUC review⁶. It is also clear that the reason for the investigator's proposal, including the transfer of mice, has no scientific basis and is actually based on his failure to submit a request for protocol renewal to the IACUC in a timely manner. OLAW expects IACUCs to adhere to the letter and spirit of provisions of the PHS Policy and Animal Welfare Act regulations and recommends that they refuse to consider disingenuous proposals such as the one described. The IACUC has set a precedent for flouting federal regulations by allowing investigators to have additional time before suspending animal activities on an expired protocol. The IACUC needs to conduct a comprehensive review of its practices and revise its policies and procedures so that it is conducting business in accordance with federal requirements.

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