Re application by Professor Nora Shields
[2022] QCAT 186
QUEENSLAND CIVIL AND
ADMINISTRATIVE TRIBUNAL
CITATION:
Re application by Professor Nora Shields [2022] QCAT 186
APPLICANT:
PROFESSOR NORA SHIELDS APPLICATION NO/S:
CRL004-22
MATTER TYPE:
Clinical research matters
DELIVERED ON:
27 May 2022
HEARING DATE:
24 May 2022
HEARD AT:
Brisbane
DECISION OF:
Member Kanowski
ORDERS:
1. The clinical trial Improving muscle strength in young people with Prader-Willi syndrome: a phase II randomised trial is approved.
2. This approval remains current for three years or until expiry or revocation of the ethics approval, whichever is the sooner.
CATCHWORDS:
HEALTH LAW – TREATMENT AND CARE OF PERSONS WITH IMPAIRED CAPACITY – where approval sought for clinical research – where clinical trial will study effects of exercise in people with Prader-Willi syndrome – whether clinical research should be approved
Guardianship and Administration Act 2000 (Qld), s 65, s 66, s 74A, s 74B, s 74C, Schedule 2 s 6, s 7, s 12
Powers of Attorney Act 1998 (Qld), s 63
APPEARANCES & REPRESENTATION:
This matter was heard and determined on the papers pursuant to section 32 of the Queensland Civil and Administrative Tribunal Act 2009 (Qld)
REASONS FOR DECISION
Introduction
On 10 March 2022 Professor Nora Shields filed an ‘Application for approval to conduct clinical research – Guardianship and Administration Act 2000’, relating to the clinical trial Improving muscle strength in young people with Prader-Willi syndrome: a phase II randomised trial.
I have decided to approve the clinical research.
Before explaining my reasons, it is important to clarify something. In the covering email with her application, Professor Shields described the application as one for consent for a named individual, who lives in Queensland, to participate in the trial. Presumably the individual is a person with impaired decision-making capacity.
It is important to note, though, that when the tribunal approves clinical research, the approval relates to the research and not to participation by any individual in the research.
The tribunal can approve clinical research under section 74C of the Guardianship and Administration Act 2000 (Qld) (‘G&A Act’). Section 74C goes on to say that ‘the tribunal’s approval of clinical research does not operate as a consent to the participation in the clinical research of any particular person’.[1]
[1]G&A Act, s 74C(3).
In Queensland, most decision-making about health matters for people with impaired decision-making capacity is done by statutory health attorneys. A statutory health attorney is a person such as a close friend or relation of the adult.[2] They do not require appointment by a court or tribunal. Sometimes, decision-making is done by a guardian appointed by the tribunal for health matters.
[2]Powers of Attorney Act 1998 (Qld), s 63.
However, if the health matter is a ‘special health matter’, neither a statutory health attorney nor a guardian has a decision-making role. A special health matter is a matter relating to special health care, such as participation in ‘special medical research’.[3] Whether an adult with impaired capacity can participate in a special health matter depends on the terms of their advance health directive (if they have one), or a decision of the tribunal or another relevant entity such as the Mental Health Review Tribunal relating to that individual.[4]
[3]G&A Act, Schedule 2, s 6, s 7.
[4]G&A Act, s 65.
It is not necessary to explore the definition of ‘special medical research’ here, other than to note that it expressly does not include ‘approved clinical research’.[5] Approved clinical research is clinical research approved by the tribunal.[6]
[5]Ibid, Schedule 2, s 12(2)(b).
[6]G&A Act, 74B.
So, when the tribunal has approved particular clinical research, this removes the research from the category of ‘special health matter’. It means that consent to participate in the research can be given, for an adult with impaired capacity, by their guardian or, in the absence of a guardian, by their statutory health attorney. It removes the need for multiple applications to the tribunal, each in respect of a different individual.
The clinical trial
Professor Shields has supplied copies of the trial protocol, information sheets and consent forms, and the ethics approval letter from the Royal Children’s Hospital Melbourne.
Based on that material, I find as follows. Muscle weakness is a feature of Prader-Willi syndrome. The trial is a double-blind, randomised controlled trial. Participants will be people with Prader-Willi syndrome. The trial will compare the outcomes between two groups of participants. Each participant will participate in guided exercise at a gym over a period of six months, but each group will have a different exercise program. The program for one group – the experimental group – will involve progressive resistance training. The program for the other group – the control group – will involve low intensity exercise. The purpose of the research is to determine whether progressive resistance training is effective in increasing muscle strength in people with the syndrome. The principal risks are typical and relatively low risks of exercising such as getting sore muscles. Some participants may experience some anxiety. Further, there is exposure to a very small amount of radiation during scanning. There are potential benefits for participants, such as increased muscle strength, better health, and social interaction.
Does the research meet the requirements for approval?
‘Clinical research’ is defined as including medical research intended to treat a condition affecting participants in the research.[7] I am satisfied that the clinical trial in question is such research.
[7]G&A Act, s 74A(1)(a).
I note that ‘a comparative assessment of health care already proven to be beneficial is not medical research’.[8] However, that exclusion is not operative here. There will be a comparison of the outcomes in the experimental group and the outcomes in the control group, but this does not involve comparison of two types of care already proven to be beneficial for people with the syndrome.
[8]Ibid, s 74A(2).
Clinical research may be approved by the tribunal if it meets the requirements of section 74C(1) of the G&A Act. I am satisfied that the clinical trial in question meets those requirements:
(a)it has been approved by an ethics committee;
(b)the techniques to be trialled are intended to treat Prader-Willi syndrome;
(c)the research does not involve any known substantial risks to participants;
(d)the techniques to be used in the trial are at a stage where safety and ethical considerations make it appropriate for them to be made available to relevant participants despite their inability to consent; and
(e)having regard to the potential benefits and risks of participation, on balance it is not adverse to the interests of participants to participate in the research.
Conclusion
Accordingly, I have approved the clinical research.
The next step for Professor Shields’ team, in relation to the individual she identified (assuming he has impaired decision-making capacity), will be to seek the consent of that person’s guardian or statutory health attorney to his participation in the clinical trial.
0
0
0