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:	Refereed Article
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
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