Medical research - Victorian Law Reform Commission

More documents

Recommendations

Info

Chapter 14 Medical research Ethics approval 14.24 Some people emphasised the important role played by human research ethics committees in approving and monitoring research. 23 The Catholic Archdiocese of Melbourne suggested that the process of substitute consent for participation could be strengthened by requiring human research ethics committee approval to be in accordance with the National Statement. 24 14.25 The Catholic Archdiocese said: The National Statement limits research on a person who is unable to consent to low or negligible research procedures and requires that such research be for the benefit of the participant or at least a group to which the participant belongs. It would be helpful if these requirements were included in the G&A Act. 25 UN Convention and Victorian Charter 14.26 Both the United Nations’ Convention on the Rights of Persons with Disabilities (the Convention) 26 and the Charter of Human Rights and Responsibilities Act 2006 (Vic) (the Charter) 27 deal with the issue of participation in medical research without consent. 14.27 The Convention provides that: No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his or her free consent to medical or scientific experimentation. 28 14.28 Similarly, the Charter provides that: A person must not be …. subjected to medical or scientific experimentation or treatment without his or her full, free and informed consent. 29 14.29 The Charter also acknowledges that human rights may be limited in some circumstances. Charter rights ‘may be subject under law only to such reasonable limits as can be demonstrably justified in a free and democratic society’. 30 14.30 There are a number of Victorian laws which authorise medical treatment without the full, free and informed consent of the person. 31 It is arguable, however, that they impose reasonable and justifiable limits upon Charter rights. 32 Other jurisdictions 14.31 Queensland and New South Wales are the only other Australian jurisdictions that have separate legislative provisions concerning substitute consent for participation in medical research. Tribunal approval is required in both states for participation in a medical research procedure by a person who is unable to consent. 33 23 Ibid. 24 Submission CP 27 (Catholic Archdiocese of Melbourne). 25 Ibid. 26 Convention on the Rights of Persons with Disabilities, opened for signature 30 March 2007, 999 UNTS 3 (entered into force 3 May 2008) (‘Convention on the Rights of Persons with Disabilities’). 27 Charter of Human Rights and Responsibilities Act 2006 (Vic). 28 Convention on the Rights of Persons with Disabilities art 15(1). 29 Charter of Human Rights and Responsibilities Act 2006 (Vic) s 10(c). 30 Ibid s 7(2). 31 See, eg, Guardianship and Administration Act 1986 (Vic) pt 4A; Mental Health Act 1988 (Vic); Disability Act 2006 (Vic) pt 8; Severe Substance Dependence Treatment Act 2010 (Vic). 32 For example, involuntary treatment under the Mental Health Act 1986 (Vic), has been found to be Charter compliant: see Kracke v Mental Health Review Board [2009] VCAT 646 (23 April 2009) [775]–[785]. 33 Guardianship and Administration Act 2000 (Qld) s 72; Guardianship Act 1987 (NSW) ss 45AA–45AB. 308 Victorian Law Reform Commission – Guardianship: Final Report 24
14.32 In New South Wales, the Guardianship Tribunal may approve the involvement in a clinical trial of patients who are unable to consent. 34 The Tribunal then determines if it needs to provide individual consent for participation by each patient in the trial, or if the person responsible for each patient can provide consent. 35 14.33 Queensland distinguishes between two categories of medical research: ‘approved clinical research’ 36 and ‘special medical research or experimental health care’. 37 The Queensland Civil and Administrative Tribunal (QCAT) may approve clinical research generally. If this occurs, QCAT is no longer required to provide individual consent for participation in this ‘approved clinical research’. 38 Queensland’s definition of ‘approved clinical research’ specifically excludes ‘a comparative assessment of health care already proven to be beneficial’. 39 14.34 By contrast, participation in ‘special medical research or experimental health care’ requires QCAT consent in each case. 40 14.35 Both the New South Wales and Queensland legislation contain matters for the tribunals to consider when deciding whether to approve the proposed research procedure. 41 The Commission’s views and conclusions 14.36 The 2006 amendments to the G&A Act, which streamlined the process for obtaining substitute consent for participation in a medical research procedure, were important developments in seeking to provide a balance between advancing medical knowledge and protecting vulnerable people from exploitation or unnecessary intrusion. The experience of dealing with these provisions over the past six years demonstrates that the process can be refined and improved. 14.37 As noted above, the consultation paper put forward two reform options in relation to medical research. The first was to retain the existing medical research consent procedures, but simplify them. The second was to apply the same procedures to obtaining consent for medical research as those that apply for obtaining consent for medical treatment. The Commission’s final reform recommendations amalgamate aspects of these options with the aim of simplifying the current procedures and making them more consistent with those used when seeking substitute consent for medical treatment. 14.38 The Commission believes that the current four-step process for authorising participation by a person in a medical research procedure, when that person is unable to consent to the procedure, is unnecessarily cumbersome and inappropriately delegates decision-making authority to researchers in some instances. 14.39 The existing process can be streamlined by distinguishing those medical research procedures that require legal authorisation from those that require authorisation in order to comply with the relevant human research ethical requirements. When a person with appropriate powers has authorised medical treatment for a person who is unable to consent to their own treatment 42 and research is being conducted about 34 Guardianship Act 1987 (NSW) s 45AA. 35 Ibid s 45AB. 36 Guardianship and Administration Act 2000 (Qld) sch 2 pt 2 cl 13. 37 Ibid sch 2 pt 2 cl 12. 38 This is because, once approved, ‘approved clinical research’ is treated like other health matters, which do not require QCAT consent: Guardianship and Administration Act 2000 (Qld) s 72. 39 Guardianship and Administration Act 2000 (Qld) sch 2 pt 2 cl 13(1A). 40 Ibid s 72. 41 See Guardianship Act 1987 (NSW) s 45AA; Guardianship and Administration Act 2000 (Qld) s 72, sch 2 pt 2 cls 13(3)–(5). 42 Under current law, this would include a guardian or an enduring guardian with appropriate powers as well as a registered practitioner relying upon the emergency treatment powers in section 42A of the Guardianship and Administration Act 1986 (Vic). 309
Page 1 and 2: Chapter 14 Medical research 4 303 C
Page 3 and 4: 14.8 A ‘medical research procedur
Page 5: Medical treatment and medical resea
Page 9 and 10: 14.47 The medical treatment provisi
Page 11 and 12: 14.59 The Public Advocate should de
Page 13: 14.66 The National Statement refers

Medical research - Victorian Law Reform Commission

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?