127932 - AustraliaRegulatingGenomicData.pdf (825.39 kB)
Australia: regulating genomic data sharing to promote public trust
journal contribution
posted on 2023-05-19, 20:41 authored by Lisa EcksteinLisa Eckstein, Donald ChalmersDonald Chalmers, Christine Critchley, Ruthie Jeanneret, Rebekah McWhirterRebekah McWhirter, Jane NielsenJane Nielsen, Margaret OtlowskiMargaret Otlowski, Dianne NicolDianne NicolThe 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.
Funding
Australian Research Council
History
Publication title
Human GeneticsVolume
137Issue
8Pagination
583-591ISSN
1432-1203Department/School
Faculty of LawPublisher
Springer Berlin HeidelbergPlace of publication
GermanyRights statement
Copyright 2018 The Authors. Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/Repository Status
- Open