Calculating risk/benefit in X-linked severe combined immune deficiency disorder (X-SCID) Gene therapy trials: The task of ethical evaluation
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medicine and Philosophy 31 (5):533 – 564 (2006)
In response to adverse events in retroviral gene therapy clinical trials conducted in France to correct for X-linked severe combined immune deficiency disorder (X-SCID), an advisory committee of the Food and Drug Administration convened in October 2002, February 2003, and March 2005, to deliberate and provide recommendations for similarly sponsored research in the United States. A similar National Institutes of Health committee met in February 2003. In this article, I review the transcripts and/or minutes of these meetings to evaluate the extent to which the ethical dimension of the research was engaged even as the molecular and clinical evidence was reviewed. I then provide representative ethical arguments to demonstrate the sort of ethical reasoning that should be included as part of the agenda of such committee meetings.
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
Hallvard Lillehammer (2004). Who Needs Bioethicists? Studies in History and Philosophy of Science Part C 35 (1):131-144.
Citations of this work BETA
No citations found.
Similar books and articles
Jeremy Sugarman (2004). Using Empirical Data to Inform the Ethical Evaluation of Placebo Controlled Trials. Science and Engineering Ethics 10 (1):29-35.
Isaac Rabino (2003). Gene Therapy: Ethical Issues. Theoretical Medicine and Bioethics 24 (1):31-58.
Thomas C. Jones (2005). A Call to Restructure the Drug Development Process: Government Over-Regulation and Non-Innovative Late Stage (Phase III) Clinical Trials Are Major Obstacles to Advances in Health Care. Science and Engineering Ethics 11 (4):575-587.
Celia B. Fisher, Susan Z. Kornetsky & Ernest D. Prentice (2007). Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations. American Journal of Bioethics 7 (3):5 – 10.
Gerd Richter & Matthew D. Bacchetta (1998). Interventions in the Human Genome: Some Moral and Ethical Considerations. Journal of Medicine and Philosophy 23 (3):303 – 317.
Richard F. Kitchener (1991). The Ethical Foundations of Behavior Therapy. Ethics and Behavior 1 (4):221 – 238.
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
W. French Anderson (1985). Human Gene Therapy: Scientific and Ethical Considerations. Journal of Medicine and Philosophy 10 (3):275-292.
John C. Fletcher (1985). Ethical Issues in and Beyond Prospective Clinical Trials of Human Gene Therapy. Journal of Medicine and Philosophy 10 (3):293-310.
Added to index2009-01-28
Total downloads7 ( #440,687 of 1,911,616 )
Recent downloads (6 months)1 ( #458,010 of 1,911,616 )
How can I increase my downloads?