much influence the Council of Europe guidelines, Appendix A of ETS 123, would have on the global research community and how that document would drive the need for revisions to the Guide. The ILAR International Committee concluded that this was an important juncture where new COE guidelines and the need to revise the Guide now presented an opportunity where we should examine some of these issues.

At the same time, many pharmaceutical companies, some academics, and certainly government agencies were performing research in international laboratories and doing animal research on a global scale. I want to emphasize in a positive way that when we were doing studies in different laboratories in different countries with varying standards, the interpretation and the integrity of those studies came into question. Science appeared to offer the unifying solution.

So these two issues—the European activities and what potentially was occurring in the United States and certainly in the global community—were drivers for examining the need to harmonize some of the standards and guidelines. There was some uncertainty about how to do this. The Council felt that it would be rational to convene a meeting and confer on what seemed to be a common lineage among all parties: science-based standards, which joined animal care and use with the research community. In other words, we were talking about science-based guidelines and a conference to bring together and harmonize directions among the different parties.

We prepared a conference agenda that would explore and benchmark best practices not only on the regulatory side but also on the scientific side, covering the issues that drove a common understanding and some common guidelines for animal care and use. The conference was convened with a group of people from at least 13 different countries; they were scientific experts, veterinary medical experts, and people from the political administrations. The proceedings of the meeting, The Development of Science-Based Guidelines for Laboratory Animal Care and Use, was the final product published in 2003; it presents many of the scientific and regulatory issues discussed during the conference.

The goal of the workshop was to look specifically at the conditions of laboratory animal care and the science behind it, and more importantly to look at the gaps in our understanding based on what appears in the scientific literature and encourage future research to close those gaps, so that we would have a good science-based understanding of what we were doing for the animals while also trying to help the research community conduct its research in a thoughtful and meaningful way. I will address some of the outcomes of the conference.

After several days of discussion we were able to come to some concrete conclusions. One was that more scientific studies were needed to foster a better understanding of the best conditions for animals in the laboratory and to make sure that the research was conducted in the best possible manner. There were major gaps in our knowledge and the science behind animal care. We also came to a clear understanding—especially with representation from 13 different countries—that this was not only an American problem but an international problem.



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