Medical research - Victorian Law Reform Commission

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Chapter 14 Medical research 14.52 As the Commission pointed out in Chapter 13, it is not appropriate to regard a guardian with health care powers and a person responsible in the same way. Guardians have been specifically chosen by the person concerned or VCAT to make medical decisions for a person. A person responsible is automatically appointed because of their relationship to the person concerned, rather than following an individual determination of their suitability to make medical treatment decisions. 14.53 New guardianship legislation should continue to require substitute consent for participation in any medical research procedure by a person who is unable to make their own decisions about the matter. It should be possible for a person with capacity to appoint an enduring personal guardian to make decisions about this matter, or for VCAT to appoint an enduring guardian with these powers. In the event that there is no personal guardian with these powers, the automatically appointed health decision maker 44 should be able to make these decisions. Significant procedures 14.54 The existing process can be improved by making the Public Advocate rather than medical researchers the substitute decision maker of last resort when the proposed medical research procedure is significant. The Public Advocate should be permitted to make decisions about participation in a significant medical research procedure for a person who is unable to make their own decisions and who does not have a personal guardian or health decision maker to make the decision for them. At present, researchers themselves make these decisions using the ‘Step 4 – Procedural authorisation’ process in the G&A Act. 45 14.55 Decisions about participation by vulnerable people in research procedures should be made by a public official, who is at arms-length from the research, when the procedures involved are significant because they are potentially harmful, intrusive or exploitative. In some instances, it could be very difficult for committed researchers to be sufficiently dispassionate and attuned to the interests of people who are unable to make their own decisions about participation in a research trial that might produce considerable benefits for the researchers. 14.56 Although the 2006 reforms simplified the unnecessarily cumbersome process of seeking VCAT approval for all participation in research procedures by people who are unable to consent, a public body should be involved in those cases where there is no substitute decision maker and the research procedure is significant because of its possible impact on people who are unable to protect their own interests. 14.57 While medical research should be encouraged, vulnerable people should be protected. As the United Kingdom Parliament said in its equivalent legislation: ‘the interests of the person must be assumed to outweigh those of science and society’ 46 in these circumstances. 14.58 The Commission recommends that new guardianship legislation should distinguish between ‘significant’ and ‘routine’ medical research procedures in the same way and for the same reasons as in substitute consent for medical treatment, discussed in Chapter 13. While the Public Advocate should be the substitute decision maker of last resort when dealing with participation in a significant medical research procedure, the registered practitioners involved in a medical research procedure should continue to be able to rely upon the procedural authorisation process when the procedure is routine. 44 See Chapter 13 for a discussion of this proposed title and role. 45 Guardianship and Administration Act 1986 (Vic) s 42T. 46 Mental Capacity Act 2005 (UK) s 33(3). 312 Victorian Law Reform Commission – Guardianship: Final Report 24
14.59 The Public Advocate should develop and publish guidelines, in consultation with relevant professional bodies and other interested organisations, to assist registered practitioners when determining whether a particular medical research procedure is ‘significant’ or ‘routine’. Recommendations Substituted consent for participation in a medical research procedure 223. It should be possible for a person to appoint an enduring personal guardian to make decisions about their participation in a ‘medical research procedure’ when they do not have the capacity to make their own decisions about participation. 224. It should be possible for the tribunal to appoint a personal guardian with the power to make decisions about participation in a ‘medical research procedure’ for a person who does not have the capacity to make their own decisions about participation. 225. New guardianship legislation should permit a health decision maker to make decisions about participation in a ‘medical research procedure’ for a person who lacks the capacity to make their own decisions and who does not have an enduring personal guardian or a personal guardian with the power to make those decisions for them. 226. A personal guardian or an enduring personal guardian with ‘medical research procedure’ powers or a health decision maker should be permitted to authorise participation in a ‘medical research procedure’ for the principal when the principal lacks the capacity to make their own decision about the matter. 227. The Public Advocate should be permitted to authorise participation in a ‘medical research procedure’ which is a ‘significant procedure’ for a person who does not have the capacity to authorise their own participation and who does not have a personal guardian, an enduring personal guardian or a health decision maker to make that decision for them. 228. The ‘procedural authorisation’ process in the Guardianship and Administration Act 1986 (Vic) should be reproduced in new guardianship legislation for the purpose of authorising participation in a ‘medical research procedure’ which is a ‘routine procedure’ for a person who does not have the capacity to authorise their own participation and who does not have a personal guardian, an enduring personal guardian or a health decision maker to make that decision for them. 229. The Public Advocate should develop and publish guidelines in consultation with relevant professional bodies and other interested organisations to assist registered practitioners when determining whether a particular medical research procedure is ‘significant’ or ‘routine’. 313
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Medical research - Victorian Law Reform Commission

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