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Letters

Comment: Privacy legislation and research

Kerry J Breen and Sandra M Hacker
MJA 2002 177 (9): 523-524

Comment: It is unfortunate that a valuable research project has apparently been made more difficult or delayed by the combination of complex new privacy law and longer-standing inefficiencies in the ethical review of multicentre research proposals. Both are issues with which the Australian Health Ethics Committee (AHEC) is grappling at present.

Multicentre research was identified as a significant issue in the review that led to the revised 1999 National Statement on Ethical Conduct in Research Involving Humans.1 The Statement makes it clear that researchers have a role in negotiating with human research ethics committees and institutions to seek agreement that the ethical and scientific assessment of one committee or institution will be accepted by other sites. The National Statement equally empowers ethics committees to minimise unnecessary duplication.

Ethics committees have been very slow to grasp the opportunities offered by the 1999 National Statement for reasons that may include the past practice of insisting that each committee make its own assessment. Initiatives are now in train in New South Wales, Victoria, Western Australia and Queensland to develop different forms of centralised assessment, but the benefits may take time to be realised. AHEC, through its bulletins and workshops for ethics committee members, has repeatedly reminded committees how to simplify multicentre review, but traditional practices appear to have obstructed this message. This letter is yet another opportunity to remind ethics committees and institutions that the National Statement permits and encourages them to exercise initiative, judgement and common sense in facilitating effective and timely review of multicentre research.

With regard to the difficulties associated with the new privacy regimes being put in place by a combination of federal and State laws, AHEC anticipated some introductory problems in relation to human research. It is understandable that ethics committees and researchers will take time to adjust some of their established practices to comply with the law and associated guidelines. During the period of adjustment, some flexibility needs to be exercised by all parties. AHEC conducted a series of workshops in all capital cities earlier this year to assist researchers and ethics committees in this phase. An explanatory guide to the use of privacy law and the associated guidelines from the National Health and Medical Research Council was used at these workshops and will be made more widely available shortly.

Finally, the federal legislation will be the subject of a systematic review after two years. Unintended consequences of the law should be addressed at that time. AHEC understands that, in Victoria, the Health Services Commissioner, whose office has responsibilty for supervising the application of the health privacy law, is in the process of producing a practical guide for Victorian healthcare researchers.

  1. National statement on ethical conduct in research involving humans. Canberra: National Health and Medical Research Council, 1999. http://www.nhmrc.gov.au/publications/synopses/e35syn.htm

(Received 8 Aug 2002, accepted 21 Aug 2002)

Australian Health Ethics Committee, National Health and Medical Research Council, Canberra, ACT.

Kerry J Breen, Chair; Sandra M Hacker, Chair, Privacy Working Party.

Correspondence: Dr Kerry J Breen, Australian Health Ethics Committee, National Health and Medical Research Council, GPO Box 9848, Canberra, ACT 2601. kbreenATaccess.net.au

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