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Australia: regulating genomic data sharing to promote public trust


Eckstein, L and Chalmers, D and Critchley, C and Jeanneret, R and McWhirter, R and Nielsen, J and Otlowski, M and Nicol, D, Australia: regulating genomic data sharing to promote public trust, Human Genetics, 137, (8) pp. 583-591. ISSN 1432-1203 (2018) [Refereed Article]


Copyright Statement

Copyright 2018 The Authors. Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0)

DOI: doi:10.1007/s00439-018-1914-z


The regulation of genomic data sharing in Australia is a confusing mix of common law, legislation, ethical guidelines, and codes of practice. Beyond privacy laws, which only apply to genomic data that meets the definition of personal information, the key regulatory lever is the National Health and Medical Research Council (NHMRC) National Statement for Ethical Conduct in Human Research ("National Statement") (2007). Compliance with the National Statement is a requirement for institutions to apply to the NHMRC for funding, and includes—among other things—requirements for review of most genomic research by Human Research Ethics Committees. The sections of the National Statement specifying requirements for research with human genomic data are currently under review, including proposed new requirements addressing the return of genetic research findings and oversight of transfer agreements. Ensuring the willingness of Australians to donate their genomic information and participate in medical research will require clarification and harmonisation of the applicable regulatory framework, along with reforms to ensure that these regulations reflect the conditions necessary to promote ongoing public trust in researchers and institutions.

Item Details

Item Type:Refereed Article
Keywords:genomic research, research ethics committees, privacy, information dissemination
Research Division:Law and Legal Studies
Research Group:Public law
Research Field:Privacy and data rights
Objective Division:Law, Politics and Community Services
Objective Group:Justice and the law
Objective Field:Justice and the law not elsewhere classified
UTAS Author:Eckstein, L (Dr Lisa Eckstein)
UTAS Author:Chalmers, D (Professor Don Chalmers)
UTAS Author:Critchley, C (Associate Professor Christine Critchley)
UTAS Author:Jeanneret, R (Ms Ruthie Jeanneret)
UTAS Author:McWhirter, R (Dr Rebekah McWhirter)
UTAS Author:Nielsen, J (Associate Professor Jane Nielsen)
UTAS Author:Otlowski, M (Professor Margaret Otlowski)
UTAS Author:Nicol, D (Professor Dianne Nicol)
ID Code:127932
Year Published:2018
Funding Support:Australian Research Council (DP180100269)
Web of Science® Times Cited:14
Deposited By:Office of the Faculty of Law
Deposited On:2018-08-23
Last Modified:2019-12-03
Downloads:84 View Download Statistics

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