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Science 24 March 2000:
Vol. 287. no. 5461, pp. 2163 - 2165
DOI: 10.1126/science.287.5461.2163
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Policy Forum

MEDICAL ETHICS:
Principles for Human Gene Therapy Studies

Theodore Friedmann

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.

The author is director of the Program in Human Gene Therapy, University of California at San Diego School of Medicine, La Jolla, CA 92093-0634. E-mail: tfriedmann{at}ucsd.edu

The author is a member of the Recombinant DNA Advisory Committee (RAC). These comments are not intended to reflect the views of that Committee or of the National Institutes of Health.

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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES:
Concise Review: Scientific and Ethical Roadblocks to Human Embryonic Stem Cell Therapy.
L. Gruen and L. Grabel (2006)
Stem Cells 24, 2162-2169
   Abstract »    Full Text »    PDF »
Risks, benefits, and consent in the age of gene therapy.
J. R. Mendell and K. R. Clark (2006)
Neurology 66, 964-965
   Full Text »    PDF »
Protection at the cutting edge: the case for central review of human gene transfer research.
J. Kimmelman (2003)
Can. Med. Assoc. J. 169, 781-782
   Full Text »
What next for human gene therapy?.
E. T Juengst (2003)
BMJ 326, 1410-1411
   Full Text »    PDF »
Mouse Genetic Evidence That Tranilast Reduces Smooth Muscle Cell Hyperplasia via a p21WAF1-Dependent Pathway.
M. Sata, A. Takahashi, K. Tanaka, M. Washida, N. Ishizaka, J. Ako, M. Yoshizumi, Y. Ouchi, T. Taniguchi, Y. Hirata, et al. (2002)
Arterioscler. Thromb. Vasc. Biol. 22, 1305-1309
   Abstract »    Full Text »    PDF »
The Orthopaedic Genome: What Does the Future Hold and Are We Ready?.
J. E. Puzas, R. J. O'Keefe, and J. R. Lieberman (2002)
J. Bone Joint Surg. Am. 84, 133-141
   Full Text »
Harm, ethics committees and the gene therapy death.
J. Savulescu (2001)
J. Med. Ethics 27, 148-150
   Full Text »    PDF »
Moving From Compliance to Conscience: Why We Can and Should Improve on the Ethics of Clinical Research.
J. P. Kahn and A. C. Mastroianni (2001)
Arch Intern Med 161, 925-928
   Full Text »    PDF »
Conflict-of-Interest Policies for Investigators in Clinical Trials.
B. Lo, L. E. Wolf, and A. Berkeley (2000)
N. Engl. J. Med. 343, 1616-1620
   Abstract »    Full Text »    PDF »

E-Letters:

Read all E-Letters

Three Criteria for Patient Protection
John C. Fletcher
Science Online, 27 Mar 2000 [Full text]

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Science. ISSN 0036-8075 (print), 1095-9203 (online)