Dealing with a wayward investigator can be challenging. Although Cole believes that she has cleverly found a loophole in the regulations, she is mistaken. Both the Animal Welfare Act1 and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals2 clearly state that an animal activity can be suspended, but not an investigator. An activity is defined by the Animal Welfare Act as “those elements of research or testing or teaching that involve the care and use of animals”1. Therefore, none of the work on Cole's protocol(s) should have continued, regardless of who did the work.

This distinction should have been made clear to Cole in the letter from the IACUC informing her of the suspension and the provisions thereof. However, Great Eastern's IACUC may have been confused on this issue as well, as the scenario states that it “voted to suspend Cole for six weeks.” In addition, the suspension should have been reported to OLAW, if her research was covered by PHS funds. While the activity was suspended, the animals should have been placed on a holding protocol. Cole's and her personnel's access to the animals and possibly to the animal facility should have been revoked. These steps could have prevented the unapproved use of the animals.

In order for another person to assume responsibilities for work on an IACUC protocol in the absence of the Principal Investigator (PI), this change in responsibilities must be approved by the IACUC. The PI's IACUC protocol should list the personnel working on the protocol and detail their duties. If a change in personnel is necessary, the change must be submitted in an amendment and must be approved by the IACUC prior to the implementation of the change.

During the suspension period, the IACUC should attempt to understand Cole's motivation for noncompliance. By understanding and removing obstacles to compliance, the IACUC could develop a plan for correction. If the problem is a lack of understanding of the rules, additional training and clear communication of expectations may help. If money is the issue, helping the PI to find allowable ways of cutting costs can make a difference. Working with the PI in this manner can allow the suspension period to be a period of reform for the PI rather than just a punitive measure.

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