Response to Protocol Review Scenario: Formalize SOPs

Under the Animal Welfare Act¹ and PHS Policy², investigators are required to provide a description of the methods used to assess and alleviate pain for procedures that may cause more than slight pain or distress. A major surgical procedure would certainly fall within this category. There is nothing in the regulatory language, however, that precludes IACUC approval of several anesthetic and analgesic options in a single protocol, provided that the agents, doses and routes are appropriate for the procedures to be performed. Allowing flexibility in the choice of agents to be administered can be advantageous to both the research lab and the IACUC. Investigators are able to make quick changes between equally effective drugs should the need arise, and the IACUC reduces the number of modifications it must sort through while keeping investigators compliant with their protocol when quick changes are necessary.

Superficially, the IACUC appears to be doing everything right. It is reviewing all drugs and assuring that they are acceptable for the described procedures. Additionally, the labs are keeping nicely detailed surgical records and seem to be compliant. What is worrisome, however, is the underlying anxiety among the veterinarians and the other members of the IACUC. Is everyone just going through the motions? The laboratory animal veterinarians seem to be uncertain that they can fully assess the appropriateness of the drug regimen. If the veterinarians at Great Eastern University feel that they are unable to adequately review a protocol, then they have the authority and the obligation to request more information from the investigator. In this scenario, that may include the specific conditions under which each drug will be used. It is also unclear from the scenario whether or not the veterinarians are communicating at any point with the investigators. The veterinary consult is a required part of the protocol planning process for any potentially painful procedure and is an excellent time for the veterinarian to make recommendations for the latest and greatest drug regimens. If the IACUC has not already implemented this policy at Great Eastern University, it must do so immediately. Ultimately, the responsibility falls upon the IACUC during the protocol review process to assure that methods used to alleviate pain and distress are appropriate and adequate. If it is unable to do so with the given information, it must not be shy about requesting more detail from the investigator.

The IACUC chairman is correct that IACUCs may approve standard operating procedures (SOPs) for routine aspects of research in order to simplify protocol preparation. Although the drug menu provided by the Department of Veterinary Surgery is not a true SOP, the IACUC may consider requesting a formalized version of the document for review. Alternatively, it can create its own anesthesia and analgesia SOPs. The SOP can indicate IACUC-approved drugs, doses, routes of administration, directions for preparation, criteria for which specific drugs are appropriate, etc. In this way, the Department of Veterinary Surgery has an approved list they can easily reference, and the IACUC can better control specifics regarding use.

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