Principles for Human Gene Therapy Studies

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Science  24 Mar 2000:
Vol. 287, Issue 5461, pp. 2163-2165
DOI: 10.1126/science.287.5461.2163

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The recent revelations of problems in gene therapy trials have clearly indicated that the current federal mechanisms for review, regulation, and oversight of human gene transfer studies require modification. This policy forum discusses the basic principles that form the foundation of clinical research, with the most important being patient protection, and makes recommendations for changes in oversight that will ensure that the highest standards are met.