Ethics Governance
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| Article - Abstract. To view full article click on the article title. | |
eMJA: Ethics committees and guardianship legislation Ethics committees and guardianship legislation. To the Editor: In addition to a complicated ethical approval process, new privacy laws have presented challenges for multicentre research studies.1 In Victoria, an amendment to the Guardianship and Administration Act 1986 came into effect on 1 January 2003. We wish to highlight its unanticipated ramifications. We proposed to conduct a pilot study on the feasibility of ascertaining cases of Murray Valley encephalitis (MVE) in Victorian hospitals. Currently, there is no routine human surveillance for MVE, and we intended to perform diagnostic tests for several encephalitis aetiological agents on routinely collected samples. A study protocol was developed and submitted in November 2002 to five Human Research Ethics Committees (HRECs), one at the Department of Human Services and four at hospitals where the study was to be conducted. The case definition for encephalitis included the criterion that the patient had an “altered conscious state”, and could not therefore give informed consent. Informed consent was to be provided by the patient’s next-of-kin, but, in late December, an HREC representative alerted us to an imminent amendment to the Act which stipulated that only a guardian appointed by the Victorian Civil and Administrative Tribunal (VCAT) could provide consent to participate in “any procedure carried out for the purposes of medical research” on behalf of a disabled patient (in this instance, a patient with an altered conscious state). Full Article: http://www.mja.com.au/public/issues/179_07_061003/letters_061003_fm-1.html |
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2006 Ethics-Governance.com |
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