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Home No. 28: Must animal protocol be amended if the method of drug administration is changed?

Oct 25

No. 28: Must animal protocol be amended if the method of drug administration is changed?

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Must animal protocol be amended if the method of drug administration is changed?

Reader Question: My protocol approved by the IACUC allows me to administer a drug via IV, but I'm considering switching the method to intramuscular (IM) injection. Is this change big enough that I must ask the IACUC to amend the protocol, or may I simply proceed?

Expert Comments: You absolutely cannot just change the protocol on your own. You must ask the IACUC to approve an amendment. A similar case I recall from a few years ago teaches a lesson as to why this procedure is in place. The PI switched from IV to IM injection without prior approval but didn't know the drug he was testing was not approved for IM injections. He soon learned why: Some of the animals suffered subcutaneous and intramuscular injuries at the injection sites, and a few became so sick they had to be euthanized.

Your best bet: Follow your protocol; if you think you'll need to deviate from it at some point, ask your laboratory veterinarian or IACUC for guidance. During my years as a lab veterinarian, I would ask the PI to tell me what he wanted to accomplish in his experiments and I could explain how to do so within the regulations. Laboratory veterinarians, as well as the IACUC, generally know the plethora of rules, some of which may have "gray" areas.

Often requests such as yours can be granted with a simple protocol change. The process doesn’t always have to be complex or time-consuming, but it might be in some cases. Approach your lab veterinarian and IACUC to get an idea of the likely timelines. Your lab vet may be able to offer you some less difficult alternatives to help you achieve your goals.

Expert comments by Dr. Bill Parlett Jr., a former laboratory veterinarian and current independent laboratory animal medicine consultant in New Hampshire.

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Comments (5)
Stifling regulatory environment
written by A Physiologist, October 28, 2010
The opinion rendered is probably legally correct. However, this kind of restrictive CYA atmosphere is a terrible burden on research. When every tiny change requires paperwork and delays, scientists often don't use optimal protocols because its too much trouble to change. The funding bodies and promotion committees want results. It is easy to imagine that a research protocol will need several changes in the course of a year, and if each requires 3 weeks to submit and hear approval, a lot of research time is lost. A conscientious researcher would check in the literature and with the vet for contraindications before switching to IM injection, and would not require a cumbersome committee to do it for her. If the researcher is not conscientious, she probably wouldn't report this change to the committee anyway.
A Minor Change?
written by A Laboratory Animal Veterinarian, October 28, 2010
The investigator and IACUC do need to ensure that an adequate paper trail exists for a change in procedures, but taking away judgement from the veterinary staff is not what the intent or letter of the Animal Welfare Act or PHS Policy is all about. Depending upon how an institution has their PHS Animal Welfare Assurance written, this could be considered a minor change that could be approved administratively upon consultation with the attending veterinarian. By OLAW's own definitiation, a procedure that results in less pain or distress does not require full IACUC review. Examples such as replacing a difficult and slow IV injection process with a quick IM injection, or switching to an anesthetic method that may work better that is approved by the veterinarian and/or a drug use subcommittee of the IACUC should not have to wait for full or designated member committee review. They are administrative changes to protocols. Increasing animal numbers or performing additional procedures would both increase pain or distress and require committee review. Be smart in how you write your protocols and institutional policies! Leave yourself wiggle room whenever possible.
written by an experimental scientist using mice, October 28, 2010
The comment from "A physiologist" is spot-on and touches on what is a big problem already and one that is growing rapidly; the Lab Animal Vet comment alludes to one facet. I've lost count of the number of PI's (colleagues) who simply don't bother to explore a new avenue that might be of high medical importance or impact because of the excessive regulatory burden from OLAW (with no benefit to experimental animals), amplified by clumsy, scared, CYA IACUC policies, frameworks, and practice for dealing with modifications of an experimental plan in ways that involve totally standard things. For better and worse, the taxpayers footing the bill don't realize how the needless parts of the regulatory burden slow or prevent the discoveries that will lengthen patients' (and animals') lives and mitigate disease burden. As far as the question proper, best first step is to ask your vet staff and also to consider if the change is worth the bother.
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