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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 Type:	Article
Authors/Creators:	Eckstein, L and Nicol, D
Keywords:	gene editing, CRISPR, gene technology regulation, therapeutic goods administration, human research ethics committees
Journal or Publication Title:	Journal of Law and Medicine
Publisher:	Thompson Reuters
ISSN:	1320-159X
Copyright Information:	Copyright 2019 Thomson Reuters (Professional) Australia Limited
Related URLs:	Google Scholar: Eckstein, L UTAS Profile: Eckstein, L Google Scholar: Nicol, D UTAS Profile: Nicol, D
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