Journal of Law, Medicine and Ethics 30 (3):381-389 (2002)

Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration.
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DOI 10.1111/j.1748-720X.2002.tb00407.x
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References found in this work BETA

Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
Phase I Cancer Trials: A Collusion of Misunderstanding.Matthew Miller - 2000 - Hastings Center Report 30 (4):34-43.

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The Diverse Ethics of Translational Research.Neema Sofaer & Nir Eyal - 2010 - American Journal of Bioethics 10 (8):19-30.
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Valuing Risk: The Ethical Review of Clinical Trial Safety.Jonathan Kimmelman - 2004 - Kennedy Institute of Ethics Journal 14 (4):369-393.

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