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Gene editing clinical trials could slip through Australian regulatory cracks
journal contribution
posted on 2023-05-20, 10:06 authored by Lisa EcksteinLisa Eckstein, Dianne NicolDianne NicolIn 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.
Funding
Australian Research Council
History
Publication title
Journal of Law and MedicineVolume
27Article number
274Number
274Pagination
274-283ISSN
1320-159XDepartment/School
Faculty of LawPublisher
Thompson ReutersPlace of publication
AustraliaRights statement
Copyright 2019 Thomson Reuters (Professional) Australia LimitedRepository Status
- Restricted