RAC Oversight of Gene Transfer Research: A Model Worth Extending?

Author:

King Nancy M. P.

Abstract

Clinical gene transfer research (GTR) has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee (RAC). 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 (IRB) 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 (FDA).

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference76 articles.

1. 43. 65 Fed. Reg. 60328–60332 (Oct. 10, 2000).

2. 25. Sources of concern range from the original Asilomar moratorium on recombinant DNA research to discussions of germ-line interventions, both deliberate and inadvertent. See, e.g., the many sources cited in the Human Gene Therapy Scope Note, supra note 10.

3. 53. which had a stake in the success of the trial's liver-directed gene transfer methodology, developed by his laboratory at Penn. See Nelson, D. Weiss, R. , “Hasty Decisions in the Race to a Cure?,” Washington Post, Sunday, Nov. 1999; at A01, for a review of the potential financial conflicts of interest and how they were viewed before Mr. Gelsinger's death.

4. 34. RAC meeting, at (last visited September 17, 2002).

5. 52. Dr. Wilson, James , then-director of the University of Pennsylvania's Institute for Human Gene Therapy, where the ornithine transcarbamylase deficiency trial took place, and a co-investigator, had a financial interest in a company he founded, Genovo Inc.

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