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Gene editing clinical trials could slip through Australian regulatory cracks
Citation
Eckstein, L and Nicol, D, Gene editing clinical trials could slip through Australian regulatory cracks, Journal of Law and Medicine, 27 Article 274. ISSN 1320-159X (2019) [Refereed Article]
Copyright Statement
Copyright 2019 Thomson Reuters (Professional) Australia Limited
Official URL: https://www.westlaw.com.au/maf/wlau/app/document?d...
Abstract
In this column we explore the regulatory environment within which clinical trials involving new genome editing techniques are undertaken. Ostensibly, there is regulatory congestion in this area, with overlapping obligations through the national scheme for regulating gene technology, the national scheme for regulating the supply of therapeutic goods, and the human research ethics system, predominantly administered at the institutional level. In practice, however, the oversight of gene editing clinical trials is left almost entirely to human research ethics committees. Given the uncertain risks associated with such novel technologies, we conclude that it is opportune to reconsider the rigor of current Australian processes for assessing clinical trials involving gene-editing technology.
Item Details
Item Type: | Refereed Article |
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Keywords: | gene editing, CRISPR, gene technology regulation, therapeutic goods administration, human research ethics committees |
Research Division: | Law and Legal Studies |
Research Group: | Law in context |
Research Field: | Medical and health law |
Objective Division: | Law, Politics and Community Services |
Objective Group: | Justice and the law |
Objective Field: | Law reform |
UTAS Author: | Eckstein, L (Dr Lisa Eckstein) |
UTAS Author: | Nicol, D (Professor Dianne Nicol) |
ID Code: | 136963 |
Year Published: | 2019 |
Funding Support: | Australian Research Council (DP180101262) |
Deposited By: | Law |
Deposited On: | 2020-01-23 |
Last Modified: | 2020-03-20 |
Downloads: | 1 View Download Statistics |
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