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How should I handle minor or innocuous post-op changes?

Reader Question: I am both a veterinarian and the PI on a research project involving mice. I changed the post-op analgesic and dosage following a procedure but the animals showed minimal change. One of the techs thought they looked "different" and seemed "lethargic," so she contacted the attending veterinarian who ordered a return to the initial analgesic. The AV also reported me to the IACUC because the change was made without his consent and because I didn't amend my protocol. I made a decision in the best interest of the research, and the animals were never in distress. How do I handle this in the future?

Expert comments:

First, the research animals’ welfare is paramount. Since the lab tech contacted the AV regarding the animals’ state, the AV and the IACUC had a duty to investigate the tech's concerns. Without knowing the procedure’s specifics or exactly what followed, determining how the animals reacted to your change in the post-op analgesic is difficult. The AV was correct to have you return to the original protocol until he could properly evaluate the change. At most institutions, the PI consults with the AV before making any treatment changes, and the IACUC approves an amended protocol. Following this course of action in the future would be best.

Last minute changes happen more often than they should. We see changes due to new information (either published or generated by the prior experimental set), loss of a specific drug supply, new drug availability for analgesia or treatment, accessibility to different transplantable cell lines, and unforeseen problems in the approved protocol’s methods. Although these changes may be in the animal subjects’ best interest, you should remember that the approved protocol is a contract between you and the institution. Making an unapproved change is breaking that contract.

Often, someone familiar with the protocol finds out about the changes and then reports them, as in your case. Under our system, someone can submit this information to the IACUC chair or administrative office, the AV, or anonymously. We take all reports seriously.

If there are any compliance issues, we appoint an investigative subcommittee within 72 hours of the report. It reviews records and interviews individuals it identifies as being involved. Then the committee reports its findings back to the IACUC along with recommendations, which can range from training in specific species care to suspending animal activities. The full IACUC committee then makes a decision on the matter.

There are several ways to avoid finding yourself in this situation:

• The best is to anticipate any potential changes. Our IACUC encourages PIs to build some flexibility into the original protocol by using broader terminology when appropriate or having alternative methods. Check with your IACUC regarding its stance on this. If allowed, then you can engage the AV to determine those terms and methods.


• The most frequent solution at our institution is to amend the protocol prior to the change. This ensures a proper review and typically can be handled easily.


• A third method may be to contact the AV directly before changing a protocol to see if he will allow it in the animal’s best interest. This route is the fastest, but not all IACUCs allow it, and it may still narrowly restrict the change.

Also, the lines of authority seem to be blurring at your institution. AVs and veterinarians alike have many roles and responsibilities, especially at a combined research and teaching school such as ours. As a veterinarian, your first instincts are to assess an animal’s need and treat that need. As a PI on a strict protocol, however, you also have other responsibilities, not only to your research animals, but also to your institution, research and protocol. Carefully reviewing your institution's policy should help determine your responsibilities. If you are still not satisfied, seek assistance from your IACUC, AV or compliance office.

Expert comments by Dr. Robert L. Donnell, IACUC chair, University of Tennessee.

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