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NIH rDNA HUMAN GENE THERAPY "POINTS TO CONSIDER" DRAFT DOCUMENT

Executive Summary

NIH rDNA HUMAN GENE THERAPY "POINTS TO CONSIDER" DRAFT DOCUMENT under development at the Natl. Institutes of Health would require investigators to submit information on possible side effects of the treatment and the cost of gene therapy in comparison to alternative therapies. The draft document was discussed at an Oct. 12 meeting of NIH's Recombinant DNA Advisory Cmte. (RAC) working group on human gene therapy. Cmte. chairman LeRoy Walters, Georgetown University, explained that when the document is completed it will serve as "advice to investigators and local IRBs [institutional review boards]" preparing rDNA gene therapy experiments for submission to NIH. Under the draft document, investigators would be required to submit information on their research methods, including the characterization of vector and inserted DNA, and techniques to be used to demonstrate the "absence of contaminants" in the culture. In addition, investigators would be required to consider "general social issues" not covered by HHS human subject research regs. For example, they would be requested to account for both public and private financial support for the proposed research and their intent to patent "either the products or procedures developed," the document notes. Researchers would be asked to consider any "likely or possible" impact of the therapy on the patient's germ-line and the implications such work would hold for "clinical research or the practice of medicine, if it were successful," the draft states. RAC is not expected to review any human gene therapy proposals at its upcoming Oct. 29 meeting. However, there are gene therapy proposals in the NIH pipeline. Human gene therapy "protocols are already [at NIH] or will be in two to four weeks," Maurice Mahoney, Yale University, said. NIH is working on a similar draft policy statement for experiments involving the environmental release of rDNA microbes but is currently enjoined from approving any federally-funded experiments that involve deliberate release. After further revision by the RAC working group, the document will be published in the Federal Register sometime in December. The group plans to submit a final draft to the full RAC at the cmte.'s winter meeting.

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