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Home No. 25: What do PIs overlook the most when seeking IACUC approval of their protocols?

Sep 27

No. 25: What do PIs overlook the most when seeking IACUC approval of their protocols?

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What do PIs overlook the most when seeking IACUC approval of their protocols?

Reader Question: I'm a new PI about to submit my first animal protocol to the Institutional Animal Care and Use Committee (IACUC) and am hoping to have it approved quickly. I've completed the application, but am afraid of overlooking something that will slow the process. Is there anything frequently overlooked to which I should give special attention?

Expert Comments: Watch out for hang-ups in safety reviews. That's perhaps the most common. For example, say you want to test a drug therapy in an animal or you expect to use a radioisotope. You'd likely need to pass a safety test in both cases and must do that before your IACUC will give your protocol its final approval.

We’ve found that many PIs don't research all of the preliminary requirements before submitting their proposals to the IACUC. Often there's more than one compliance administration within the institution whose blessing you need — for example, radiation or chemical-hazard safety.

Sometimes PIs aren't aware of this. As a result, the IACUC might have completed its review but the PI hasn't completed these additional steps. The IACUC usually won't put its final stamp on the project until there is proof of compliance across the board.

Your best bet is to take the following steps:

  1. Draw up a list of all the safety checks you’re going to need. If you have questions about any of them, contact the administrator for that area beforehand.
  2. Decide whether it’s wiser to submit them to each panel all at once or one at a time and build your time frame accordingly. For example, if handling the radiation-safety issue could alter your procedures so as to impact other parts of the process, then you’d want to take care of them individually. But it’s more likely that you’ll be able to secure all your safety approvals concurrently.

Expert comments: Judy Lassiter Schledorn, Regulatory Compliance Administrator, Institutional Animal Care and Use Committee, Sponsored Programs, and Regulatory Compliance, North Carolina State University.

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Comments (2)
written by past ACUC chair, September 23, 2010
endpoints--what are the endpoints of your study or studies and what will trigger early euthanasia,
how people will be trained to perform the studies,
rationale for your animal numbers (we have always used X, is NOT an acceptable rationale).
Ask for help
written by Attending Veterinarian, September 30, 2010
The best method to assure fastest approval is to just speak with your attending veterinarian, IACUC chair, other institutional representative that can discuss your research desires and provide guidance on institutional policies. No institutions protocol forms are perfect and they can often provide guidance on key sticking points in the review process. PIs not providing all the information requested in each section is a common issue for us. If we ask for dosage, route of administration, needle size, etc., be sure to provide it. Alternatives searches must have all the required elements. Your IACUCs goal is to have as best possible all processes and contingencies determined prior to beginning the experiment so they can evaluate the legally required portions of IACUC review, the impact on the animals, and the protocol personnel's ability to conduct the research.

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