TY - JOUR
T1 - Australia
T2 - regulating genomic data sharing to promote public trust
AU - Eckstein, Lisa
AU - Chalmers, Donald
AU - Critchley, Christine
AU - Jeanneret, Ruthie
AU - McWhirter, Rebekah
AU - Nielsen, Jane
AU - Otlowski, Margaret
AU - Nicol, Dianne
N1 - Publisher Copyright:
© 2018, The Author(s).
PY - 2018/8/1
Y1 - 2018/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85052147876&partnerID=8YFLogxK
U2 - 10.1007/s00439-018-1914-z
DO - 10.1007/s00439-018-1914-z
M3 - Review article
C2 - 30116956
AN - SCOPUS:85052147876
SN - 0340-6717
VL - 137
SP - 583
EP - 591
JO - Human Genetics
JF - Human Genetics
IS - 8
ER -