Australia: regulating genomic data sharing to promote public trust

Author(s)

Eckstein, Lisa; Chalmers, Donald; Critchley, Christine; Jeanneret, Ruthie; McWhirter, Rebekah; Nielsen, Jane; Otlowski, Margaret; Nicol, Dianne

Abstract

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.

Publication year

2018

Publication type

Journal article

Source

Human Genetics, Vol. 137, no. 8 (Aug 2018), pp. 583-591

ISSN

0340-6717

Publisher

Springer Verlag

Copyright

Copyright © The Author(s) 2018. (Corrected publication September 2018) Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Additional information

Note: Correction published 23 August 2018. https://doi.org/10.1007/s00439-018-1930-z - original paper is now released for Open Access, see Publisher URL.

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