Re application by Catherine O'Brien
[2023] QCAT 204
QUEENSLAND CIVIL AND
ADMINISTRATIVE TRIBUNAL
CITATION:
Re application by Catherine O’Brien [2023] QCAT 204
APPLICANT:
CATHERINE O’BRIEN (applicant)
APPLICATION NO:
CRL007-23
MATTER TYPE:
Clinical research matters
DELIVERED ON:
16 May 2023
HEARING DATE:
16 May 2023
HEARD AT:
Brisbane
DECISION OF:
Member Kanowski
ORDER:
The application by Catherine O’Brien for the approval of clinical research, namely the SELECT Study: clinical effectiveness and cost of peripheral intravenous device selection and insertion by a vascular access specialist, is dismissed.
CATCHWORDS:
HEALTH LAW – TREATMENT AND CARE OF PERSONS WITH IMPAIRED CAPACITY – where approval sought for study comparing systems for inserting catheters – whether clinical research as defined
Guardianship and Administration Act 2000 (Qld), s 65, s 66, s 74A, s 74C, Schedule 2, s 6, s 7, s 12
Avent [2011] QCAT 598
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) (‘QCAT Act’)
REASONS FOR DECISION
Introduction
An application has been made to the tribunal for approval of clinical research namely the SELECT Study: Clinical effectiveness and cost of peripheral intravenous device selection and insertion by a vascular access specialist. The application was made by Ms Catherine O’Brien of the Nursing and Midwifery Research Centre at the Royal Brisbane and Women's Hospital.
I have decided to dismiss the application, for the reasons that follow.
Background
The research project is about peripheral intravenous catheters (PIVCs). These are tubes inserted into veins to allow medicines, fluids or blood transfusions to be given. The project will compare the clinical effectiveness and cost of two different systems for inserting catheters: a generalist system and a specialist system. The generalist system, which is most commonly used in Queensland hospitals, is that the catheters are selected and inserted by junior doctors or generalist nurses. The specialist system uses vascular access specialists who are ‘predominantly nurses with advanced PIVC insertion and maintenance skills’.[1] The specialist system has been used in Queensland hospitals, but vascular access specialist teams ‘have been disbanded in many hospitals due to budgetary constraints’.[2] The researchers hypothesise that the specialist system provides better clinical results and patient satisfaction. The project aims to establish whether the hypothesis is correct.
[1]Study protocol, page 1.
[2]Ibid.
Legislative criteria
The tribunal may approve clinical research if the criteria in section 74C of the Guardianship and Administration Act 2000 (Qld) (‘Guardianship and Administration Act’) are met.
Clinical research is defined in section 74A of the Guardianship and Administration Act:
74AWhat is clinical research
(1)Clinical research is—
(a) medical research intended to diagnose, maintain or treat a condition affecting the participants in the research; or
(b) a trial of drugs, devices, biologicals or techniques involving the carrying out of health care that may include giving placebos to some of the participants in the trial.
(2) However, a comparative assessment of health care already proven to be beneficial is not medical research.
Examples—
• a comparative assessment of the effects of different forms of administration of a drug proven to be beneficial in the treatment of a condition, for example, a continuous infusion, as opposed to a once-a-day administration of the drug
• a comparative assessment of the angle at which to set a tilt-bed to best assist an adult’s breathing
Why has the application been dismissed?
In her application form, Ms O'Brien ticked boxes to indicate, in effect, that the study does not come within either paragraph (a) or (b) of section 74A(1). However, I consider that it does come within paragraph (a): it is intended to treat a condition – or more accurately, a multitude of conditions – affecting the participants in the research.
Ms O'Brien also ticked a box to indicate that the study involves a comparative assessment of health care already proven to be beneficial. Ms O'Brien added:
While initial pilot data of general versus expert inserter suggests there may be a benefit to patients, there has been no definitive trial to prove overall efficacy. This will be the first trial to also enable expert inserters the ability to select alternative devices (not only short PIVCs).[3]
[3]Application form, page 2.
I accept that the research is a comparative assessment of health care already proven to be beneficial. Both the generalist and the specialist systems have been widely used, and I infer that they been proven to be beneficial treatment methods. The study hopes to prove that the specialist system is more beneficial. The study will explore differences in outcomes to better inform a cost/benefit analysis.
It follows that the research is not medical research as defined. Nor is it a trial that may involve giving placebos. Accordingly, it is not clinical research as defined in section 74A. It therefore cannot be the subject of approval by the tribunal under section 74C, as that section applies only to clinical research as defined. I will therefore dismiss Ms O'Brien’s application, under section 47 of the QCAT Act, as misconceived.
Effect of dismissal
In Avent,[4] the tribunal dismissed an application on the same basis, when it found that a research project comparing types of antibiotic therapy, both known to be beneficial, was not clinical research as defined. The tribunal commented:
This does not mean of course that the trial can not proceed. It simply means that the approval of this Tribunal is not necessary.
The enrolment of people with impaired decision making capacity can still occur with the approval of an attorney under an Enduring Power of Attorney for personal matters or a guardian appointed by this Tribunal or a statutory health attorney as defined in the Powers of Attorney Act 1998.[5]
[4][2011] QCAT 598.
[5]Ibid, [5-6].
I agree, but wish to add some explanation and context.
For most health matters for adults with impaired capacity, section 66 of the Guardianship and Administration Act sets up a hierarchy:
66Adult with impaired capacity—order of priority in dealing with health matter
(1) If an adult has impaired capacity for a health matter, the matter may only be dealt with under the first of the following subsections to apply.
(2) If the adult has made an advance health directive giving a direction about the matter, the matter may only be dealt with under the direction.
(3) If subsection (2) does not apply and the tribunal has appointed 1 or more guardians for the matter or made an order about the matter, the matter may only be dealt with by the guardian or guardians or under the order.
…
(4) If subsections (2) and (3) do not apply and the adult has made 1 or more enduring documents appointing 1 or more attorneys for the matter, the matter may only be dealt with by the attorney or attorneys for the matter appointed by the most recent enduring document.
(5) If subsections (2) to (4) do not apply, the matter may only be dealt with by the statutory health attorney.
(6) This section does not apply to a health matter relating to health care that may be carried out without consent under division 1.
Section 66 would have been the section contemplated by the tribunal in Avent. The tribunal did not mention advance health directives, but that would be because experience shows that it is rare for people to include directions in advance health directives about participation in research.
‘Special health matters’ are dealt with differently, under section 65 of the Guardianship and Administration Act. Under section 65, again, a direction in an advance health directive takes priority. If there is no such direction, though, then an order by the tribunal or another relevant entity such as the Mental Health Review Tribunal is required. One type of special health matter is ‘participation by the adult in special medical research or experimental health care’.[6] That term is defined in section 12 of Schedule 2 to the Guardianship and Administration Act:
[6]Guardianship and Administration Act, Schedule 2, s6, s 7(d).
12Special medical research or experimental health care
(1) Special medical research or experimental health care, for an adult, means—
(a) medical research or experimental health care relating to a condition the adult has or to which the adult has a significant risk of being exposed; or
(b) medical research or experimental health care intended to gain knowledge that can be used in the diagnosis, maintenance or treatment of a condition the adult has or has had.
(2)Special medical research or experimental health care does not include—
(a) psychological research; or
(b) approved clinical research.
It can be seen that ‘special medical research or experimental health care’ is defined broadly in subsection (1), but then research that is psychological research or approved clinical research is excluded under subsection (2).
In practice, the approval of clinical research under section 74C is a streamlining mechanism. It removes the need for multiple time-consuming applications to the tribunal: one for each adult with impaired capacity where the research falls within the broad definition in subsection (1) of section 12 in Schedule 2 and is not psychological research. Instead, a single application can be made to the tribunal for the research project. Approval can be given under section 74C if the criteria in that section are met. Those criteria focus on the research not being unduly risky. If approval is given for the research, then for any individual participant with impaired capacity, consent can be sought in accordance with the hierarchy under section 66: advance health directive / guardian / attorney / statutory health attorney.
As previously noted, a comparative assessment of health care already proven to be beneficial is not medical research.[7] Accordingly, such an assessment will not be medical research within subsection 1 of section 12 of Schedule 2. That leaves the question of whether it is experimental health care within that subsection. ‘Experimental health care’ is not separately defined in the legislation. It is not necessary for me to attempt a definition, because it is clear that health care already proven to be beneficial will not be experimental in nature.
[7]Guardianship and Administration Act, s 74A(2).
Therefore, a comparative assessment of health care already proven to be beneficial, such as the SELECT Study, is not a special health matter to be dealt with under section 65. It is, rather, simply a health matter to be dealt with under section 66. Whether an adult with impaired capacity participates in the study is to be decided in the manner set out in section 66, using the hierarchy advance health directive / guardian / attorney / statutory health attorney.
Although the SELECT Study is not clinical research as defined, it is worth adding that the title of the tribunal’s application form, which is Application for approval to conduct clinical research, may give an impression that the tribunal’s approval is a prerequisite to the carrying out of clinical research as defined. That impression would be incorrect. Whether the tribunal has given approval is irrelevant to the conduct of clinical research to the extent that it involves participants with decision-making capacity. Such persons will make their own choices whether to participate. Approval by the tribunal only becomes relevant for the participation of adults with impaired capacity.
Conclusion
Ms O'Brien’s application is dismissed.
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