In response to the questions posed 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:

In the scenario, the specific reason for suspension of the protocol by the IACUC is not described. In OLAW's and APHIS's experience, repeated noncompliance, implementing significant changes without IACUC approval or other noncompliance with the Animal Welfare Act and Regulations (AWARs)1, the Guide for the Care and Use of Laboratory Animals2 or the institution's Animal Welfare Assurance are all reasons for an IACUC to suspend an approved protocol.

The IACUC may only suspend an activity during a convened IACUC meeting with a quorum present and a majority vote for suspension1,3. If the IACUC does suspend an activity involving animals, the Institutional Official (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 and the funding agency supporting the award1,3,4. The suspension must be reflected in the minutes of the IACUC meeting and in the semiannual report to the IO1,2. During the period of suspension, charges are not to be made to the grant for any research activities involving animals covered by the suspended protocol. However, funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis5.

The suspension may only be lifted by the IACUC. The IO may independently suspend a protocol, but only the IACUC may reinstate or approve an animal activity. IACUCs are at liberty to set stricter institutional requirements for reinstatement than those required by the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy)3 and the AWARs1 but cannot set less restrictive procedures. The AWARs and the PHS Policy provide no specific procedure for protocol reinstatement. APHIS and OLAW expect that the suspended protocol, along with any amendments added as a result of the suspension, will be reinstated only by review and approval according to the IACUC protocol approval process1,3.

The PI may suggest corrective actions, which the IACUC may or may not accept. The IACUC may require additional actions such as staff retraining, enhanced IACUC oversight or protocol changes. It may not be necessary for certain corrective actions to be completed by the time of protocol reinstatement, but it is required that a plan and schedule be developed prior to lifting the suspension. The IACUC may set a time for completion and carry out continued protocol monitoring as necessary until requirements are met1,3. Corrective and preventive measures are to be included in the report of the suspension to OLAW and APHIS.

Return to Protocol Review