Gene Therapy Oversight: Lessons for Nanobiotechnology

Journal of Law, Medicine and Ethics 37 (4):659-684 (2009)
  Copy   BIBTEX

Abstract

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 94,749

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

RAC Oversight of Gene Transfer Research: A Model Worth Extending?Nancy M. P. King - 2002 - Journal of Law, Medicine and Ethics 30 (3):381-389.
The oversight of human Gene transfer research.LeRoy Walters - 2000 - Kennedy Institute of Ethics Journal 10 (2):171-174.
Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.

Analytics

Added to PP
2010-09-13

Downloads
58 (#274,193)

6 months
16 (#218,262)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Susan Wolf
University of North Carolina, Chapel Hill

Citations of this work

Gain-of-Function Research: Ethical Analysis.Michael J. Selgelid - 2016 - Science and Engineering Ethics 22 (4):923-964.
Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):802-808.
Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):802-808.
Theological Anthropology and Human Germ-Line Intervention.N. Koios - 2012 - Christian Bioethics 18 (2):187-200.
Corporate social responsibility for nanotechnology oversight.Jennifer Kuzma & Aliya Kuzhabekova - 2011 - Medicine, Health Care and Philosophy 14 (4):407-419.

View all 8 citations / Add more citations