JONA s Healthcare Law Ethics and Regulation · 2002 · 62 citations · 5 references
Public HealthBiotechnologyGeneticsBioethicsGene TherapyMedical EthicsAnimal Research EthicsBiotechnology EthicsClinical Trial EthicsGenetic EthicsGenetic Research EthicsSafety Of Gene TherapyCellular Gene TherapyCompliance With Federal RegulationsGene Therapy EthicsGene-targeted TherapyGenetic Research Ethics ReviewResearch Ethics CommitteesResearch Ethics Review
As gene therapy research races to a first cure of a genetic-based disease, the research community has struggled with the aftermath of the well-publicized death of Jesse Gelsinger from complications of an experimental treatment. In a wrongful death lawsuit against the University of Pennsylvania and its researchers, Jesse Gelsinger's family alleged violations of federal regulations and research ethics. This article reviews gene therapy research, examines the role of the key players in this tragedy, and provides suggestions for preventing future misfortunes.
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Eliot Marshall · Science · 2000 · 194 citations
Challenges to Human Subject Protections in US Medical Research
Beverly Woodward · JAMA · 1999 · 117 citations
Principles for Human Gene Therapy Studies
Theodore Friedmann · Science · 2000 · 64 citations
Biotechnology on the RAC--FDA/NIH regulation of human gene therapy.
Rainsbury Jm · PubMed · 2000 · 17 citations
NIH tightens up monitoring of gene-therapy mishaps
Paul Smaglik · Nature · 2000 · 12 citations · Full text