Appointing Research Decision-Makers for Represented Persons

Introduction

A research decision-maker may be appointed by the State Administrative Tribunal (Tribunal) under the Guardianship and Administration Act 1990 (WA) (GA Act) to make decisions about a represented person's participation in medical research. This appointment power was introduced by the Guardianship and Administration Amendment (Medical Research) Act 2020 (WA), which inserted Part 9E into the GA Act to regulate decision-making about medical research participation.

The Tribunal has jurisdiction to appoint a research decision-maker where it is satisfied that the represented person lacks capacity to make their own decisions about participation in medical research and that there is a need to appoint a substitute decision-maker to make such decisions in the represented person's best interests (see DAH [2023] WASAT 102 at [13], [43], [138]-[139]).

This blog examines the statutory framework governing the appointment of research decision-makers and the principles derived from the leading Tribunal decision on research decision-maker appointments, DAH [2023] WASAT 102.

Statutory Framework

Part 9E of the GA Act establishes a regime for substitute decision-making regarding medical research participation. Key aspects of the legislative scheme are:

  • The Tribunal may appoint a research decision-maker with the function of making 'research decisions' on behalf of a represented person who lacks capacity to make their own decisions about participation in medical research (see GA Act ss 43, 45(2)(i), 46(2)(i); DAH at [28]-[35]).

  • A 'research decision' means a decision to consent or refuse consent to a person's participation in 'medical research' (see GA Act s 3).

  • 'Medical research' is defined broadly, with limited exceptions, as research conducted with or about individuals in the field of medicine or health (see GA Act s 3AA; DAH at [38]-[41]).

  • Certain criteria must be satisfied before a research decision-maker can consent to a represented person's participation in medical research (see GA Act ss 110ZR, 110ZU, 110ZW; DAH at [42]-[57]). These include:

  • The research must be approved by a Human Research Ethics Committee (GA Act s 110ZR(1)(a));

  • The represented person must be unable to make reasonable judgments about research participation (GA Act s 110ZR(1)(b));

  • The research decision-maker must obtain a medical opinion that the represented person is unlikely to regain capacity within the research timeframe (GA Act s 110ZR(1)(c));

  • An independent medical practitioner must determine that participation will be in the represented person's best interests or not adverse to their interests (GA Act ss 110ZR(2)(b), 110ZU); and

  • The research decision-maker must be satisfied about the nature and risks of the research (GA Act s 110ZR(2)(c)).

Principles from DAH

The leading Tribunal decision on the appointment of research decision-makers is DAH [2023] WASAT 102. Some key principles derived from DAH regarding the appointment of research decision-makers are:

Jurisdiction

  • The Tribunal has jurisdiction to appoint a research decision-maker where the represented person proposes to participate in medical research concerning a condition from which they do not suffer. While some provisions in Part 9E assume the research concerns a condition affecting the represented person, those provisions can be applied even if that is not the case (DAH at [58]-[75]).

  • The definitions of 'research decision' and 'medical research' in the GA Act are broad and not limited to particular types of medical research. The absence of words limiting research to the represented person's own medical conditions indicates Parliament did not intend to impose such a limit (DAH at [63]-[65]).

  • Construing Part 9E to apply even where the represented person does not have the relevant medical condition facilitates the protective purpose of guardianship laws (DAH at [75]).

Capacity

  • The represented person must be unable to make reasonable judgments in their own best interests regarding participation in medical research in order for the Tribunal to appoint a research decision-maker (DAH at [125]-[127]).

  • Informed consent requires the ability to understand complex information, ask appropriate questions, weigh alternatives and appreciate risks and benefits (DAH at [126]). Intellectual disability, comprehension and communication deficits may impede capacity for informed consent (DAH at [128]-[137]).

  • The presumption of capacity in GA Act s 4 can be displaced by evidence of intellectual disability affecting functions like language, memory and concentration that are critical for research participation decisions (DAH at [128]-[137]).

Need

  • The appointment of a research decision-maker must be needed to make decisions in the represented person's best interests about research participation. Need may arise where the represented person actively wishes to participate in research, has an intellectual disability, and is financially vulnerable such that participation may exploit that vulnerability (DAH at [140]-[144]).

  • Appointment of a research decision-maker has a protective purpose by legally preventing participation where the represented person lacks capacity, even if they express willingness to participate (DAH at [143]).

Who may be appointed

  • Consistent with guardianship laws, the Public Advocate may only be appointed as research decision-maker if there is no one else suitable and willing (DAH at [145]-[147]).

Best interests

  • The independent medical practitioner advising on best interests is limited to considering medical interests, not financial interests (DAH at [78]-[84]).

  • The research decision-maker should also give limited or no weight to financial benefits when deciding if participation is in the represented person's best interests (DAH at [80]-[84]).

Facts of the case

The applicant in this case was the support coordinator for DAH, a represented person under the Guardianship and Administration Act 1990 (WA) (GA Act). DAH, who was 23 years old at the time, had been subject to guardianship orders since she was 18 appointing the Public Advocate as her limited guardian to make decisions about the services she accesses.

The application concerned DAH's proposal to participate in medical research in return for payment. DAH had applied to take part in a trial conducted by a medical research company. The trial would involve 11 days of confinement in a clinic with medical testing and examinations. DAH was interested in participating to earn the payment offered, which was a substantial sum.

However, it emerged that DAH did not suffer from the medical condition that was the subject of the research. The applicant was concerned that DAH lacked capacity to make a decision in her own best interests regarding involvement in the trial. The applicant sought review of DAH's guardianship orders, requesting the Tribunal appoint the Public Advocate as DAH's research decision-maker with the function of making decisions about her participation in medical research.

The application required the Tribunal to consider whether DAH had capacity to decide on research participation herself and, if not, whether there was a need to appoint a substitute research decision-maker to make such decisions for DAH. The Tribunal had to interpret the scope of the provisions in Part 9E of the GA Act, which govern the appointment of research decision-makers, given DAH's situation.

Conclusion

The appointment of research decision-makers for represented persons who lack capacity is now an important aspect of guardianship law in Western Australia. DAH [2023] WASAT 102 provides authoritative guidance on the interpretation of Part 9E of the GA Act and how the Tribunal should approach the appointment of research decision-makers. Key considerations include whether the represented person has capacity for informed consent, whether there is a need for substitute decision-making, who is the appropriate decision-maker, and what factors determine the represented person's best medical interests.