Medical research - Victorian Law Reform Commission

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Chapter 14 Medical research Introduction 14.1 In this chapter, the Commission makes recommendations for reform of the law concerning authorisation of participation in medical research by people who are unable to make their own decisions about the matter. 14.2 The Guardianship and Administration Act 1986 (Vic) (G&A Act) was amended in 2006 to establish a four-step process for authorising participation in a ‘medical research procedure’ by a person who is unable to make a decision about their own participation. 1 In all cases, a relevant human research ethics committee must approve the research project. If the patient is unlikely to be capable of giving consent to the procedure within a reasonable time, a ‘person responsible’ may give substitute consent for participation in the research procedure. 2 If a person responsible is not available, the registered practitioner may be able to proceed without any external authorisation. 14.3 Prior to the 2006 amendments, it was necessary to obtain approval from the Victorian Civil and Administrative Tribunal (VCAT) for participation in a medical research procedure by a person who was unable to consent. While the 2006 changes to the G&A Act have streamlined the process of obtaining substitute consent for participation in medical research, improvements can be made without compromising the interests of vulnerable people. 14.4 Two important issues require reform. The first is that in some instances the G&A Act processes for authorising medical treatment and medical research are both applied to the same procedure when standard treatment is being researched. This need for separate authorisation seems unnecessary, especially when the research procedure must also have ethical approval. 14.5 The second issue is that in some instances the substitute decision maker of last resort may be the medical researcher. A disinterested person should authorise participation in any research when it might not be of any benefit to the participant and could be intrusive or exploitative. 14.6 This chapter contains recommendations about the following: • distinguishing between participation in medical research procedures that require separate legal authorisation and those that do not require separate legal authorisation because they form part of medical treatment that has been authorised • distinguishing between routine and significant medical research procedures for the purpose of authorising participation when there is no personal guardian or health decision maker to make the decision • matters for substitute decision makers to consider when deciding whether to authorise participation in a medical research procedure. Current law 14.7 The G&A Act provides for substitute consent to medical research procedures in Division 6 of Part 4A. 1 Guardianship and Administration (Further Amendment) Act 2006 (Vic). This Act inserted Division 6 of Part 4A into the Guardianship and Administration Act 1986 (Vic). 2 In Chapter 5, the Commission recommends changing the term ‘person responsible’ to ‘health decision maker’. 304 Victorian Law Reform Commission – Guardianship: Final Report 24
14.8 A ‘medical research procedure’ is defined in the current Act as: A procedure carried out for the purposes of medical research, including, as part of a clinical trial, the administration of medication or the use of equipment or a device… 3 14.9 The Act specifically excludes some procedures from its definition of a ‘medical research procedure’, such as a non-intrusive examination (including a visual examination of the mouth, throat, nasal cavity, eyes or ears or the measuring of a person’s height, weight or vision), observing a person’s activities, undertaking a survey, or collecting or using information including personal or health information. 4 14.10 The G&A Act establishes a four-step process for authorising a person’s participation in a medical research procedure where they are unable to consent to that procedure. Those steps are: • Step 1: determine whether the research project is approved by the ‘relevant human research ethics committee’. 5 Approval of the project is required before the medical research procedure may be carried out and the procedure must be carried out in accordance with any conditions of the approval. • Step 2: determine whether the patient is likely to be able to consent to the research procedure within a reasonable time. If this is likely, then the research procedure should not go ahead until the patient is able to consent to it. 6 If the patient is not likely to be able to consent within a reasonable time, Step 3 applies. • Step 3: obtain the consent of the ‘person responsible’. 7 The person responsible can consent to the procedure if they believe that it would not be contrary to the patient’s best interests. 8 If it is not possible to comply with this step because the person responsible is not available, Step 4 applies. • Step 4: ‘procedural authorisation’ applies when the person responsible cannot be identified or contacted. It allows a registered practitioner to carry out the research procedure if the practitioner certifies that a number of things have been done and that the practitioner holds a number of beliefs about the research project and the person concerned. The practitioner must hold particular beliefs about: – the best interests of the patient – whether the ethics committee was aware that the research might involve people who are unable to consent – whether the procedure adds to risks the patient faces because of their medical condition – whether there is a reasonable scientific likelihood that the patient will benefit from the research procedure. 9 14.11 The effect of Step 4 is that the person implementing the research procedure becomes the substitute decision maker for a person who is unable to make a decision about their own participation if there is no person responsible available to authorise participation. 3 Guardianship and Administration Act 1986 (Vic) s 3(1). The definition also includes any procedures prescribed by regulations to be medical research procedures. There are no additional procedures in regulations. 4 Guardianship and Administration Act 1986 (Vic) s 3(1). 5 Ibid s 42Q. The term ‘relevant human research ethics committee’ is defined in somewhat circular fashion in section 3 of the Act to mean ‘the human research ethics committee responsible for approving the relevant research project’. 6 Guardianship and Administration Act 1986 (Vic) s 42R. 7 The appointment and role of the person responsible are discussed in Chapter 13. 8 Guardianship and Administration Act 1986 (Vic) s 42S. 9 Ibid s 42T. 305
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Medical research - Victorian Law Reform Commission

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