Calculating Risk/Benefit in X-Linked Severe Combined Immune Deficiency Disorder (X-SCID) Gene Therapy Trials: The Task of Ethical Evaluation  

Oleh:

Swazo, Norman K.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The Journal of Medicine and Philosophy vol. 31 no. 5 (Oct. 2006), page 533-564 .
Topik: Biomedical Ethics; Retroviral Gene Therapy; X-SCID
Fulltext: MM80V31N5P533.pdf (183.3KB)

Ketersediaan

Perpustakaan Pusat (Semanggi) Nomor Panggil: MM80.16 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

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.

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