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Will anonymous report adversely affect future IACUC reviews of protocol?

Reader Question: I am seven months into my research on a new technique in bone grafting. One of our lab animals recently developed a severe infection. After consulting with the attending veterinarian, the animal was removed from the study and will receive antibiotic therapy, but someone decided to make an anonymous report to the IACUC, prompting an inspection. We passed the inspection, but I'm concerned this anonymous report will be seen as a “black mark” against my protocol. Will it adversely affect any future reviews of this or other protocols I might submit?

Expert Comments:

The short answer is probably not, but the ultimate answer will be specific to the institution and its policies.

Generally speaking, though, there should not be anything attached to your protocol. The anonymous report and follow-up inspection should remain independent of the protocol review.

If I were you, I would list infection as an expected adverse event on the form submitted to the IACUC as part of the protocol to preclude any surprises.

If the IACUC finds something during an inspection, it should provide increased oversight for those procedures. At our institution, we have a post-approval monitoring (PAM) officer who would come in and observe. This is how it would work for us, and how it could work at your institution in a situation like yours:

If infection is the issue, the PAM officer might look for sterility breaks. That could include observing the procedure itself or any members of the research team who are doing the procedure. Depending on how you sterilize your instruments, the PAM officer could verify the autoclave is calibrated and that you're using autoclave tape to ensure the instruments get through the sterilization process effectively. I've actually seen things that have been autoclaved sit on shelf for six months and then be used in a procedure instead of being re-autoclaved.

One thing that you could consider is pre-implantation antibiotics. These would start the day or two before the procedure. Use high-level antibiotics during the surgery and then for 10 days after the procedure. You may already be taking this course, but if the infection developed using your current antibiotics you should consult with your veterinarian about possibly changing antibiotics.

There are many steps that need to be followed to prevent infection during any bone-marrow transplantation. These types of procedures will lower the animals' immunity. Whatever the specifics of your particular protocol, strict autoclaving and adherence to sterile procedure is always advised. These proactive steps, and PAM inspections, often preclude any problems with the IACUC.

Expert comments by Larry Iten, DVM, associate director, Office of Research Integrity, University of Kentucky.

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