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Johns Hopkins Bloomberg School of Public HealthCAAT

CAAT Newsletter: Vol. 13, No. 2, Winter 1996

IACUC Review: An Investigator's Perspective

By Bill D. Roebuck, Ph.D.

"Well, I'll be damned! They don't know anything about what I'm doing!"

More than once I have had this reaction to the questioning and criticisms of my own Institutional Animal Care and Use Committee (IACUC). Over several years, I have heard variations upon this reaction from many of my associates. Why does this reaction occur? Need it be this way? How could the communication between the IACUC and the investigators submitting the protocols be improved?

Why Does this Reaction Occur?

I believe that there are two basic reasons for the reaction expressed above. First, the IACUC review process represents something else to do--another form in an endless series of forms that cross our desks. Second, I think that many of us look upon this review as an insult--questioning us from afar or perhaps "big brother" looking over our shoulder.

While the first issue may be irritating, it is rather minor. What tends to make it more important is that the timing may not be particularly good with deadlines for grants, teaching, and meetings. Additionally, the time it takes from submission of a protocol to revising that protocol may be upwards to a month or more. This tends to draw the whole process out. Nonetheless, I believe it is a minor irritation.

I believe that most of the negative reaction to IACUC review results from the investigator's perception of the review as an insult. "A committee is questioning my ideas and methods!" Perhaps the idea of review by a committee, some or most of whom are unknown to the investigator, is more upsetting than if the reviewer were a knowledgeable and respected associate suggesting that the investigator do an experiment differently. Adding to the insult is the almost certain knowledge that the investigator knows far more about the grant or project than anyone on the IACUC.

Need it Be this Way?

Clearly, the answer is no! The trick is to get the investigator to view the IACUC review as an opportunity--a research opportunity. IACUC review offers the investigator the opportunity to review his or her research plans, the opportunity to confront the some difficult scientific choices, and the opportunity to evaluate some new or alternative choices.

My grants and many other grant applications progress from observations and limited data sets to the generation of a new hypothesis. Next, experiments are designed to test that new hypothesis. The design of the experiments comes last. The opportunity provided by an animal protocol review is that the first item is the animal, giving the investigator the opportunity to view the project from a very different perspective. This is like looking at a building from a different angle. Instead of formulating a hypothesis and trying to adequately test it, we ask our first questions about the type and number of animals, and how they will be used and treated. Concerns and positive answers to these questions can only improve the quality of experiments. It is possible that the adequacy of the hypothesis and experiments will be questioned once again. Such a re-examination is an opportunity.

A second opportunity is the opportunity to confront and accept or reject different scientific choices. For example, the use of alternative models, new approaches or new products in the marketplace, or perhaps ways to to generate higher quality data can be discovered, thus reducing the number of animals. If the justification questions posed in protocol review forms are viewed as an opportunity, they become much more interesting and ultimately more useful.

A third opportunity is the opportunity to view (or defend) standard or usual ways of understanding a task. In grappling with this, one must always weigh these tried-and-true procedures with newer ways of generating similar data. In comparison shopping between methods and experimental approaches, some new and better approaches may arise. More often, refinements of existing approaches will develop. The key point is that opportunities to enhance the scientific value of the experiment can be found in such a review process, while meeting the institutional and societal obligations.

How Can Communications between the IACUC and the Investigator Be Improved?

There are several approaches to make the process into an opportunity. I believe that the first approach should be to create a dialogue between the committee and the investigator. When completing the protocol review forms, I have often felt that I was being asked to guess the "right" answer on the form, or that little respect was being afforded to the intricacies of my research. I believe that this is largely due to the impersonal nature of committees and forms. Personal interactions among associates would be of considerable aid. Requests from the committee such as "could I come over and help you understand some aspects of the committee's problems with your protocol?" would be better than simply receiving a form letter rejecting the protocol and/or enumerating problems.

I believe that the investigator and his/her team are the best source for solutions to problems raised on IACUC forms. Trust and respect for their knowledge is critical. Committees and the veterinary staff must cultivate these relationships. One approach to this end is to invite investigators to share their ideas and knowledge with the IACUC in the form of informal seminars. Another approach would be to provide support to investigators in need. For example, statistical questions related to a number of animals and replication of experiments are common. Power tests to justify the number of animals are another common need of investigators. Cultivation of statistical services to help with these common needs would be helpful.

I raise a caution here. Intellectual engagement is the key to developing these relationships. Half-hearted efforts or simplistic approaches will not work. For example, experimental alternatives can be a problem. How one searches the literature and formulates the question in searches will determine the outcome. Usually, only the investigator can pose the critical questions in a search. Although investigators commonly undertake searches, the insight of an experienced librarian is most useful.

Finally, it is important to recognize that veterinarians have an awkward role. They work for the institution and are obligated to protect both the institution and its investigators from bad situations. A relationship of trust and respect between veterinarians and investigators is important. As with all relationships, this takes work. I believe that one of the best ways to build such relationships of trust is for the veterinary staff to serve as keepers of important knowledge of techniques and procedures involving animals. This knowledge can only be acquired by working actively with investigators, manually and intellectually.

Dr. Roebuck is Professor of Toxicology, Dartmouth Medical School.