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 guidance:

In our analysis of the scenario, two instances of noncompliance occurred. First, the researchers committed the original noncompliance for which the Principal Investigator (PI) was suspended. Then the PI changed key personnel without IACUC approval, a second noncompliance. Under section 2.31 (d) (4) of the Animal Welfare Act Regulations (AWARs), a research activity is approved to be performed under the PI specified in the proposal1. OLAW considers the transfer of PI authority for the activity a significant change requiring IACUC approval2.

The AWARs describe standards for compliance regarding research activities and specifies that such activities can be suspended by the IACUC; they do not address direct actions against a PI1. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) also permits the suspension of animal activities rather than the suspension of a PI (section IV.C.7)3. Therefore, the IACUC facilitated the second noncompliance by failing to provide an accurate explanation of the suspension in its notification to the PI.

The IACUC should consider the reasons for its initial sanction and determine that procedures to prevent a reoccurrence have been enacted before reinstating the PI. Under section 2.31 (d) (6-7) of the AWARs, suspension of an animal activity requires the Institutional Official (IO), in consultation with the IACUC, to review the reasons for the suspension and take appropriate corrective action1. The PHS Policy uses nearly identical language (section IV.C.7)3. In addition, the underlying foundation of the PHS Policy is one of institutional self-evaluation, self-monitoring and self-reporting and not one of punitive sanctions4. As such, the IACUC may wish to require additional training or other educational activities as a corrective measure during the suspension period.

According to federal requirements, suspended animal activities must be reported. Under section 2.31 (d) (6-7) of the AWARs, in the instance of suspension of an animal activity, the IO must submit a full written explanation to APHIS and to any federal agency funding that activity1. If the study was funded by the PHS, the suspension must be reported to OLAW and to the funding component of NIH that supported the grant award4,5. The noncompliant actions of the PI that led to the suspension and the conduct of research by the lab staff without IACUC approval of the change in PI must be described in the report by the IACUC. The report must include corrective and preventive measures taken. In addition, no costs for the activities conducted without IACUC approval may be charged to NIH. In cases where charges have been made for unauthorized animal activities, appropriate adjustments must be made to the grant to remove charges5.

Whether approved or unapproved by the IACUC, change of PI constitutes a change in key personnel, which requires NIH approval of alternate arrangements for or replacement of the suspended individual. Change in status, including absence of the PI, requires the grantee to notify the Grants Management Officer in writing5. NIH must approve any alternate arrangement proposed by the grantee, including any replacement of the PI named in the Notice of Grant Award (NGA). The requirement to obtain NIH prior approval for a change in status pertains only to the PI and those key personnel NIH names in the NGA, regardless of whether the applicant organization designates others as key personnel for its own purposes5. The PI may delegate daily responsibilities for overseeing the lab and its activities to someone else when he or she is travelling or during other absences while retaining overall responsibility for the conduct of the funded research.

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