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"IACUC 101 for Scientists" Summary

PROTOCOL REVIEW: In his talk, Stallone reviewed the basics of protocol review requirements as required under the AWA, PHS Policy, and U.S. Government Principles. He provided a series of issues to be addressed, IACUC approval criteria and questions that should be answered to the IACUC's satisfaction before a protocol is approved. He provided two handouts developed by Greene to assist IACUCs. The first was a side-by-side comparison of the respective Protocol Review Content Requirements of the AWA regulations, PHS Policy, the Guide, and the U.S. Government Principles. The second was a model Protocol Review Checklist Greene designed to help IACUCs make certain that the protocol has addressed all relevant issues satisfactorily.

DISCUSSION TOPICS: The question-and-answer sessions between talks covered a wide range of topics. One questioner wanted to know how to determine when significant and unexpected animal loss has occurred that should be reported to OLAW or USDA. OLAW Director Nelson Garnett, DVM explained that although it is difficult to give detailed guidance, it is generally expected that institutions with PHS Assurances will report cases where an approved activity has to be suspended or when there has been an instance of serious non-compliance with the PHS Policy or a deviation from the NRC Guide that result in the preventable deaths of animals.

Training requirements were also discussed. Garnett noted that training should be oriented toward the activities an individual engages in. The requirement for training specifies that training must be available but does not prescribe its frequency or intensity. Richard Van Sluyters, OD, PhD, a Professor of Optometry and IACUC Chair from the University of California, Berkeley, who was representing AAALAC, noted that investigators at his institution are asked to take a training refresher course at least every five years. This requirement is typically fulfilled through periodic seminars given to each department by the attending veterinarian. Jodie Kulpa, DVM, of the APHIS Animal Care staff at USDA recommended that training should be offered in a variety of lectures, workshops, hands-on clinics and on-line courses tailored to areas where researchers want and need further information. The website www.iacuc.org was recommended as a resource because it provides a list of training programs and model policies. The Medical Research Service of the Department of Veterans Affairs has also made available free web-based animal research training resources for investigators and IACUC members.

The panel was asked whether there are ethical standards in place for research involving animal exercise. At the moment, the only standard regarding exercise is the AWA requirement that dogs be provided with opportunities to exercise. AAALAC's Van Sluyters indicated that it is important for scientists involved in specific types of research to provide written guidelines that IACUCs can use when reviewing protocols. Garnett said that OLAW is interested in supporting the development of such guidelines, as is the National Academy of Sciences, possibly in the form of an ILAR committee report similar to the Guide.

Another question that provoked a lively interchange involved protocols for animal models that cause pain and distress. The questioner was concerned about instances in which the attending veterinarian has decided to euthanize an animal without notifying the investigator so the data were lost and the animal's life was wasted. Andrea Barnes, DVM, of the APHIS Animal Care staff commented that the issue may be one of specifying a humane end point for the experiment, and pilot studies may be needed to refine or define that end point. Barnes pointed out that the animal study proposal serves as a contract between the principal investigator and the animal care staff so it is important to indicate what are the end points for each group of animals and to spell out whether the investigator is to be notified before animals are euthanized. Van Sluyters noted that veterinarians have an obligation to euthanize animals that are suffering so provisions should also be made about how to proceed if the lab personnel are unavailable. Greene underscored the need for the IACUC to ensure that these procedures have been established before animal use begins.

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