February 2000 News

NIH Continues to Support In Vitro Mab Production in Most Cases

February 7, 2000

The National Institutes of Health (NIH) has reconfirmed that it expects investigators to use in vitro methods for the production of monoclonal antibodies (Mabs) whenever possible, and that it expects Institutional Animal Care and Use Committees (IACUCs) to require strong justification for those who wish to use the ascites method instead.

A guidance document, published in the NIH Guide to Grants and Contracts for the first week of February, directs IACUCs to examine their practices concerning the review and approval of proposals to produce Mabs. Any IACUCs that still routinely approve the ascites method may not be in compliance with U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals.

The guidance document, together with last years' report by the National Research Coucil's Institute for Laboratory Animal Research (ILAR), provides detailed guidance for IACUCs uncertain how they should assess proposals for Mab production. The ILAR report presents the advantages and disadvantages of both in vitro and in vivo Mab production, and provides examples of instances when the ascites method may still be necessary. It also provides guidelines for minimizing pain and distress in those cases. The report concludes by encouraging the development of new core centers for Mab production and other cost-effective approaches that should allow in vitro methods to replace the ascites method in most cases.

The policy outlined in the guidance document is not new, but merely a restatement of the NIH's position. The NIH Office for the Prevention of Research Risks (OPRR) sent a "Dear Colleague Letter" to all IACUCs in November 1997, recommending that all IACUCs consider in vitro methods of Mab production as the rule, and ascites production as the exception. Full-text of the guidance document, the ILAR report, and the original "Dear Colleague Letter" can be found on the OPRR website here.