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REGULATORY COMPLIANCE

What challenges do I face in getting my IACUC to approve a controversial study?

Reader Question: I am planning a Category E animal study. I believe I can provide the required justification but I am not sure it will be accepted. Is there anything I can say or do to facilitate approval by my Institutional Animal Care and Use Committee (IACUC)? Will an IACUC ever push the envelope a bit to approve a valid but controversial study?

Editor's note: The U.S. Department of Agriculture (USDA) has established categories C, D, and E for research-animal pain and distress. Category C animals undergo essentially pain-free experiments, those in Category D receive pain medication, and those in Category E undergo significant pain and distress without medication, but it must be scientifically justified.

Experts Comments: We can't push the envelope if that means bending the rules. When there is a controversial project, the key to approval is going to be scientific justification.

You are right that usually it’s the pain and distress issues that are controversial. That's when the IACUC must weigh an extremely strong scientific justification against the pain and distress of the animals.  It's not impossible to get a Category E experiment approved by an IACUC, but you must give a powerful argument as to why you cannot use any palliative therapy, such as pain relievers and anesthetics. In most cases, the principal investigator works with the IACUC to reach a compromise that leads to IACUC approval.

For instance, you may have to modify your end point if your IACUC feels the justification is not strong enough.  If you're inducing a certain disease and can obtain the data you need before the death of the animal, you might gain approval by not allowing the animal to go all the way to death. Death as an end point is rarely approved.

Some committees will decide that an earlier end point takes a project out of Category E and moves it into Category D. Of course, the majority of protocols approved in an academic environment are Category C, i.e., involving not more than momentary pain or distress. Whenever there is pain and distress at all, I have never known a proposal to get through our IACUC without some kind of modification.

Every PI must understand that working with animals is a privilege, not a right. Even if there's $2 million in funding at stake, the institution has the responsibility to make sure that the project is completed in compliance with the Animal Welfare Act and all other federal and state regulations. There are fewer and fewer Category E projects being approved these days. Ultimately what we're trying to achieve is the best possible animal welfare along with the best possible science.

Expert comments: by Judy Lassiter, IACUC Regulatory Compliance Administrator, North Carolina State University, Raleigh, NC

Additional Expert Comments: There are certain studies that would be controversial in the public eye and protocols that could be spun into a negative light. In such instances, a PI needs to come to an IACUC meeting and talk to the members face-to-face. They need to discuss what’s potentially controversial so that these issues are resolved in a manner agreeable to everyone.

But the ultimate decision lies with the IACUC.

We work very hard to ask the right questions up front on our protocol-approval forms. We work to get a lot of information and do a lot of pre-review before a project even reaches us formally. For example, we have our veterinarians look at the work at this earlier stage and help the PI write a more likely to be approved.

We don't bend any rules. Everyone seems willing to go the extra distance to come up with a good protocol; we really haven't had any battles in that regard.

Expert comments:an anonymous Certified Professional IACUC Administrator (CPIA) from a midwestern research university.

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