Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial)

[2015] NSWCATGD 1

NSW Civil and Administrative Tribunal

New South Wales

Medium Neutral Citation:	Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1
Hearing dates:	10 November 2014
Date of orders:	06 January 2015
Decision date:	06 January 2015
Jurisdiction:	Guardianship Division
Before:	Redfern J, Principal Member West C, Senior Member (Professional) Koussa J, General Member (Community)
Decision:	The Amount Rehabilitation Trial approved as a clinical trial in which adults unable to consent may participate. Function of giving or withholding consent to be exercised by ‘person responsible’.
Catchwords:	CLINICAL TRIAL – trial of commercially available technologies for rehabilitation – randomisation of treatment –whether clinical trial – appropriate for approval by ‘person responsible’
Legislation Cited:	Guardianship Act 1987 (NSW) Guardianship Regulation 2010 (NSW)
Cases Cited:	Alcan (NT) Alumnia Pty Ltd v Commissioner of Territory Revenue [2009] HCA 41; (2009) 239 CLR 27, [47]
Texts Cited:	Oxford English Dictionary (Online Edition)
Category:	Principal judgment
Parties:	Dr Leanne Hassett (Applicant)
File Number(s):	8/2014
Publication restriction:	Nil

REASONS FOR DECISION

BACKGROUND

1. On 29 September 2014, the applicant made an application for approval of a trial known as ‘a randomised trial of the effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: The AMOUNT Rehabilitation Trial’.

2. The AMOUNT Rehabilitation Trial (the trial) was approved by the Southern Adelaide Clinical Human Research Ethics Committee on 29 May 2014, with an amended approval on 18 August 2014. It was authorised to be undertaken at Liverpool and Bankstown-Lidcombe Hospitals by the relevant Chief Executive on 4 July 2014.

3. The trial seeks to evaluate whether the use of affordable technology, being commonly used commercially available technologies, improves mobility outcomes for people admitted to hospital for aged care and neurological rehabilitation. The purpose of the trial is to compare mobility outcomes of those patients who are provided with affordable technology as part of their rehabilitation plan with the mobility outcomes of those who are not. The proposed trial is randomised between prospective patients who fall within the relevant criteria for participation. Because of concern that the trial may be a ‘clinical trial’ within the meaning of the Guardianship Act 1987 (NSW) (the Guardianship Act), and therefore requiring approval by this Tribunal, the applicant made this application before commencing the trial.

4. The critical issue for determination was whether this trial was a ‘clinical trial’ and, if so, whether the trial should be approved.

THE TRIBUNAL’S FINDINGS

5. The Tribunal was satisfied that the proposed trial was a clinical trial within the meaning of the Guardianship Act and that the trial meets the criteria established in Section 45AA of the Guardianship Act.

6. The Tribunal determined to approve the proposed trial under Section 45AA of the Guardianship Act as a trial in which it is appropriate for patients who cannot give their own consent to be able to participate.

7. The Tribunal determined that the function of giving or withholding consent for the carrying out of medical treatment on patients in the course of the proposed trial should be exercised by the ‘persons responsible’ for the patients sought to be recruited to the trial pursuant to the provisions of Section 45AB(1)(a).

LEGISLATIVE FRAMEWORK

8. The provisions relating to clinical trials are found in Division 4A of Part 5 of the Guardianship Act. Part 5 applies to patients who are aged 16 years or over and who are incapable of giving consent to the carrying out of medical or dental treatment (s 34(1)).

9. Section 33(2) provides that a person is regarded as being incapable of giving consent to the carrying out of medical or dental treatment for the purposes of Part 5 if the person:

1. is incapable of understanding the general nature and effect of the proposed treatment, or

2. is incapable of indicating whether or not he or she consents or does not consent to the treatment being carried out.

10. The objects of Part 5 are contained in section 32 which provides as follows:

32   Objects

The objects of this Part are:

(a)    to ensure that people are not deprived of necessary medical or dental treatment merely because they lack the capacity to consent to the carrying out of such treatment, and

(b) to ensure that any medical or dental treatment that is carried out on such people is carried out for the purpose of promoting and maintaining their health and well-being.

11. It is a criminal offence to carrying out medical or dental treatment other than in accordance with Part 5 of the Guardianship Act (s 35).

12. The Tribunal may approve a clinical trial as a trial in which patients who are unable to give a valid consent to their own treatment may participate (s 45AA(1)) but only if satisfied as to all of the criteria set out in s 45AA(2) of the Guardianship Act.

13. Section 45AA provides as follows:

45AA Tribunal may approve clinical trials

(1) The Tribunal may approve, in accordance with this section, a clinical trial as a trial in which patients to whom this Part applies may participate.

(2) The Tribunal may give an approval under this section only if it is satisfied that:

(a) the drugs or techniques being tested in the clinical trial are intended to cure or alleviate a particular condition from which the patients suffer, and

(b) the trial will not involve any known substantial risk to the patients (or, if there are existing treatments for the condition concerned, will not involve material risks greater than the risks associated with those treatments), and

(c) the development of the drugs or techniques has reached a stage at which safety and ethical considerations make it appropriate that the drugs or techniques be available to patients who suffer from that condition even if those patients are not able to consent to taking part in the trial, and

(d) having regard to the potential benefits (as well as the potential risks) of participation in the trial, it is in the best interests of patients who suffer from that condition that they take part in the trial, and

(e) the trial has been approved by a relevant ethics committee and complies with any relevant guidelines issued by the National Health and Medical Research Council.

(3) The fact that a clinical trial will or may involve the giving of placebos to some of the participants in the trial does not prevent the Tribunal from being satisfied that it is in the best interests of patients that they take part in the trial.

(4) The Tribunal's approval of a clinical trial under this section does not operate as a consent to the participation in the trial of any particular patient to whom this Part applies. The appropriate consent must be obtained under Division 3 or 4 before any medical or dental treatment in the course of the trial is carried out on the patient.

(5) In this section: ‘ethics committee’ means:

(a) for so long as there is any relevant Institutional Ethics Committee registered by the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992 of the Commonwealth--an Institutional Ethics Committee so registered, or

(b) in the absence of such a committee, an ethics committee established by:

(i) a local health district or a public hospital, or

(ii) a university, being an ethics committee concerned, wholly or partly, with medical research, or

(iii) the National Health and Medical Research Council.

14. Once a trial has been approved, s 45AB(1) provides for consent for participation as follows:

45AB Consent for participation in clinical trials in individual cases

(1) If the Tribunal is satisfied as to the matters specified in section 45AA (2) in relation to a clinical trial, it may, by order, determine:

(a) that the function of giving or withholding consent for the carrying out of medical or dental treatment on patients in the course of the trial is to be exercised by the persons responsible for the patients (in which case Division 3 applies), or

(b) that the Tribunal is to exercise that function itself (in which case Division 4 applies).

(2) Before making a determination referred to in subsection (1) (a), the Tribunal must be satisfied that the form for granting consent and the information available about the trial provide sufficient information to enable the persons responsible to decide whether or not it is appropriate that the patients should take part in the trial.

15. Division 3 of Part 5 establishes the regime for consent to dental and medical treatment by ‘persons responsible’. Relevantly s 40 provides:

(1) Any person may request a person responsible for a patient to whom this Part applies for that person’s consent to the carrying out of medical or dental treatment on the patient.

(2) Such a request shall specify:

(a) the grounds on which it is alleged that the patient is a patient to whom this Part applies,

(b) the particular condition of the patient that requires treatment,

(c) the alternative courses of treatment that are available in relation to that condition,

(d) the general nature and effect of each of those courses of treatment,

(e) the nature and degree of the significant risks (if any) associated with each of those courses of treatment, and

(f) the reasons for which it is proposed that any particular course of treatment should be carried out.

(3) In considering such an application, the person responsible for the patient shall have regard to:

(a) the views (if any) of the patient,

(b) the matters referred to in subsection (2), and

(c) the objects of this Part.

16. Section 33A specifies the person who is the ‘person responsible’ for the purposes of Part 5 and establishes a hierarchy in descending order. In summary, the person responsible for another person is, first, the person’s guardian, secondly, their spouse if any, thirdly, a person with the care of the person and finally, a close friend or relative of the person.

17. Division 4 provides for consent to medical and dental treatment by the Tribunal and is in similar terms to Division 3, although there are additional requirements for consent to minor and major treatments (s 45(1)) and special treatment (s 45(2) and (3)). Only the Tribunal can consent to special treatment.

18. The definitions for a number of the key terms referred to in Part 5 are set out in s 33(1). The definitions relevant to the present case are as follows:

‘clinical trial’ means a trial of drugs or techniques that necessarily involves the carrying out of medical or dental treatment on the participants in the trial.

‘medical or dental treatment’ or ‘treatment’ means:

(a) medical treatment (including any medical or surgical procedure, operation or examination and any prophylactic, palliative or rehabilitative care) normally carried out by or under the supervision of a medical practitioner, or

(b) dental treatment (including any dental procedure, operation or examination) normally carried out by or under the supervision of a dentist, or

(c) any other act declared by the regulations to be treatment for the purposes of this Part,

(and, in the case of treatment in the course of a clinical trial, is taken to include the giving of placebos to some of the participants in the trial), but does not include:

(d) any non-intrusive examination made for diagnostic purposes (including a visual examination of the mouth, throat, nasal cavity, eyes or ears), or

(e) first-aid medical or dental treatment, or

(f) the administration of a pharmaceutical drug for the purpose, and in accordance with the dosage level, recommended in the manufacturer’s instructions (being a drug for which a prescription is not required and which is normally self-administered), or

(g) any other kind of treatment that is declared by the regulations not to be treatment for the purposes of this Part.

‘major treatment’ means treatment (other than special treatment or treatment in the course of a clinical trial) that is declared by the regulations to be major treatment for the purposes of this Part.

‘minor treatment’ means treatment that is not special treatment, major treatment or treatment in the course of a clinical trial.

‘special treatment’ means:

(a) any treatment that is intended, or is reasonably likely, to have the effect of rendering permanently infertile the person on whom it is carried out, or

(b) any new treatment that has not yet gained the support of a substantial number of medical practitioners or dentists specialising in the area of practice concerned, or

(c) any other kind of treatment declared by the regulations to be special treatment for the purposes of this Part,

but does not include treatment in the course of a clinical trial.

19. Thus, if a person does not have capacity to consent to treatment, they will not be able to participate in a clinical trial unless the trial is approved by the Tribunal and the necessary consent is provided in accordance with the Guardianship Act.

20. There is no definition for ‘trial’ in the Guardianship Act and as such this word should be given its ordinary English meaning. According to the Oxford English Dictionary (Online Edition), a trial is an ‘action, method, or treatment adopted in order to ascertain the result; investigation by means of experience; experiment.’ A trial goes beyond research because it involves some active intervention. This is recognised in the definition, which expressly notes that a trial ‘necessarily involves the carrying out of medical or dental treatment’.

21. A clinical trial therefore involves an evaluation of drugs or techniques and, given the broad definition of dental and medical treatment, is not confined to experimental investigations or special medical treatments. Relevantly, it includes rehabilitative care normally carried out by or under the supervision of a medical practitioner.

22. It is relevant to note that Division 4A requires treatments that would otherwise be defined as ‘major’, ‘minor’ or ‘special’ to meet a further legislative threshold if they are being used as part of a clinical trial. This is consistent with the protective nature of the Guardianship Act and the objects of Part 5, which mandate scrutiny by the Tribunal where a person is unable to give informed consent to participate in a clinical trial.

THE EVIDENCE AND THE TRIBUNAL’S REASONING

The proposed trial

23. The Tribunal was provided with the application for ethics approval dated 1 November 2013, approval for the trial by the Southern Adelaide Clinical Human Research Ethics Committee dated 29 May 2014 (as amended 18 August 2014), submissions to the Human Research Ethics Committee of the South-Western Sydney Local Health District dated 5 February 2014, sample participant information sheets and consent forms, correspondence with the South-Western Sydney Local Health District and PowerPoint presentations and a letter dated 25 September 2014 from Professor Cathie Sherrington, the Chief Investigator, the George Institute of Global Health, addressing the application for approval. Professor Sherrington and Dr Leanne Hassett, Research Fellow from the George Institute for Global Health, also participated in the hearing and gave evidence.

24. According to the submission made to the South-Western Sydney Local Health District Human Research Ethics Committee dated 5 February 2014, research has shown that people undertaking rehabilitation in hospitals are ‘quite inactive’ and do not meet the guidelines for activity and exercise levels required to achieve satisfactory outcomes.

25. The hypothesis being tested by the proposed trial is whether rehabilitation outcomes could be improved if a higher dose of repetitive exercise was provided to patients in hospital and after discharge through low-cost video and computer-based technologies.

26. It is recorded in the application for ethics approval that a randomized feasibility study undertaken in South Australia in 2012 found that the use of a commercially available interactive gaming program by physiotherapists with aged care rehabilitation unit inpatients was safe and acceptable to patients and staff. There were similar outcomes recorded for a pilot study undertaken in New South Wales by a number of the proposed trial investigators.

27. The chosen technologies are all currently available low-cost video and computer-based systems that provide feedback on mobility task performance or dose. Participants will be assessed at baseline and then again it three weeks, 12 weeks and 26 weeks to determine any differences in outcome between those who receive the additional exercise through technologies and those who do not.

28. It is proposed to recruit a total of 300 patients over an 18 month period and it is anticipated that the study will be completed in two years. The trial will be conducted at the Brain Injury Rehabilitation Unit, Liverpool Hospital and the Bankstown-Lidcombe Hospital. The trial will establish a control group and a group who receives tailored intervention. The participants in each group will be chosen randomly. Those patients who form part of the control group will receive the usual care provided at the relevant trial sites together with four assessments over six months; being three face-to-face assessments and one assessment over the telephone. Those patients involved in the intervention group will receive a tailored program over a period of six months which will involve five or more sessions per week with duration of 30 to 60 minutes. These patients will also be assessed over three six-month periods through three face-to-face assessments and one telephone assessment.

29. For patients participating in the intervention group, all initial sessions will be supervised by the treating physiotherapist. The patient will only use the technology independently once the physiotherapist is satisfied that the patient is safe and capable to do so. If a patient is not assessed as being able to exercise independently, the patient’s care giver will be instructed on the use of the technology.

30. The trial seeks to recruit patients with no or only mild cognitive impairment and may also include patients admitted to hospital for rehabilitation due to neurological injury such as stroke or traumatic brain injury. Patients with marked cognitive impairment, a medical condition precluding exercise, inadequate vision or a lack of interest will be excluded from the trial. Patients who are admitted to hospital for rehabilitation with reduced mobility and a clinician-assessed capacity for improvement in mobility are eligible to be included in the trial.

31. The primary aim of the trial is to determine the effect of the addition of affordable technology to usual care on physical activity levels and mobility outcomes in people with mobility limitations who have been admitted to hospital for aged care and neurological rehabilitation. A secondary objective of the trial is to assess the cost effectiveness of the intervention compared with usual care, establish predictors of greater use of the technologies and enhance understanding of the patient, family member, carer and staff experiences of technology with qualitative methods.

32. The technologies proposed to be used include commercially available technologies such as the Nintendo Wii, Xbox Kinect and mobile phone applications. Rehabilitation specific technologies such as Humac, stepping tiles and Fysiogaming will also be used.

Is the AMOUNT Rehabilitation Trial a clinical trial?

33. An issue was raised at the outset of the hearing as to whether the AMOUNT Rehabilitation Trial was a clinical trial within the meaning of Division 4A of Part 5 of the Guardianship Act. It is proposed to use commercially available technologies, such as Nintendo Wii and Fitbit, to evaluate the use of technology on rehabilitative care. The trial is low risk and is primarily focused on research and comparison between different techniques for rehabilitation. Treatment is designed and supervised by physiotherapists, although is undertaken in consultation with the patient’s treating team in hospital.

33. As already noted, the definition of clinical trial is very broad. It covers any medical or dental treatment and is not confined to experimental or intrusive procedures. The definition of treatment specifically excludes identified procedures such as non-intrusive examination for diagnosis purposes and first-aid medical and dental treatment. Relevantly, s 33(1)(g) provides for the regulations to exclude certain treatment from the clinical trial regime. It is therefore clear that Division 4A is intended to operate broadly. If the legislature had intended to confine the clinical trial regime it could have easily done so by excluding research or non-intrusive procedures from the definition of treatment. Similarly, such procedures could be excluded by regulation. There is no such exclusion in the Guardianship Regulation 2010 (NSW). The language used in Part 5 is unambiguously wide. Accordingly, there is no need or justification for reading down the provisions or seeking guidance from extrinsic sources (Alcan (NT) Alumnia Pty Ltd v Commissioner of Territory Revenue [2009] HCA 41; (2009) 239 CLR 27, [47]).

34. A rehabilitation specialist may decide to use affordable technologies as part of a person’s tailored rehabilitation plan. This would be minor medical treatment which could be approved by a person responsible if the person who is the subject of the proposed treatment could not themselves consent. It would not be a clinical trial, even if the specialist decided to record the outcome as part of a research project, unless the treatment also involved a test or evaluation of the techniques being used. It is implicit that evaluation involves comparison with other techniques. Randomisation is the most common procedure used to evaluate a drug or technique. Once there is randomisation of treatment, the treatment must necessarily be part of a trial. This is because the health care professional is not recommending that ‘a particular course of treatment should be carried out’, as provided by ss 40(2)(f) and 42(2)(f), but rather that the person participate in the trial. While participation may also involve consent to particular treatment, the administration of a placebo or consent to alternative treatment as randomised, the recommendation is not focussed on a particular course of treatment but on the trial.

35. Having regard to the nature of a clinical trial, it is not surprising, nor indeed inappropriate, that the threshold level of scrutiny prescribed in Division 4A should apply as a protection for people with cognitive impairment.

36. We therefore find that the AMOUNT Rehabilitation Trial is a clinical trial within the meaning of Division 4A of Part 5 of the Guardianship Act.

Should the AMOUNT Rehabilitation Trial be approved?

38. Before the Tribunal may approve this clinical trial as a trial in which patients who are unable to give a valid consent to their own treatment may take part, it must be satisfied as to all of the five criteria set out in Section 45AA(2) of the Guardianship Act.

39. The first criterion is whether the drugs or techniques being tested in the clinical trial are intended to cure or alleviate a particular condition from which the patients suffer. This criterion is satisfied. The trial is directed to improving mobility for patients with limited mobility who are admitted to hospital for rehabilitation.

40. Secondly, the Tribunal must be satisfied the trial will not involve any known substantial risk to the patients or will not involve material risks greater than the risk associated with existing treatments.

41. Based on the evidence provided and the selection criteria for participation in the trial, we are satisfied that the risks of participation in the trial are minimal. The exclusion criteria to the trial preclude recruitment of participants to whom the intervention would not be safe. The risks identified by the pilot are the risk of falls or emotional distress if participants find the technology too difficult. A data safety committee has been established to monitor falls. Furthermore, according to the protocol and the evidence of Dr Hassett, the use of technology will be tailored to match the participants cognitive and physical abilities and the patients will be supported in the use of the technology. If participants become distressed, the treatment will be stopped. It is also relevant to note that the trial seeks to recruit patients with mild cognitive impairment, not with deteriorating cognitive conditions such as dementia.

42. Thirdly, the Tribunal must be satisfied that the development of the treatment has reached a stage at which safety and ethical considerations make it appropriate for the treatment to be available to people who cannot consent to their treatment. We are so satisfied. The technologies being used as part of the trial are commonly used commercially available technologies and technologies that have been commonly used for specifically for rehabilitation purposes.

43. Fourthly, the Tribunal must be satisfied that, having regard to the potential benefits (balanced against potential risks), it is in the best interests of patients who suffer from the condition to participate in the trial. Given the low risk in participating in the trial against the potential benefits of better mobility outcomes, the Tribunal is satisfied that it is in the best interests of patients who suffer from limited mobility to participate in the trial.

44. Fifthly, the trial must have been approved by the relevant ethics committee and it must comply with any relevant guidelines issued by the National Health and Medical Research Council. Based on the correspondence provided from the Southern Adelaide Clinical Human Research Ethics Committee and the South-Western Sydney Local Health District Human Research Ethics Committee, it is clear that the trial has been approved and complies with all relevant guidelines.

‘Person responsible’ to decide

45. The Tribunal is satisfied that this is a trial in which it is appropriate for the ‘person responsible’ for a patient to be delegated the function of giving or withholding consent to that patient’s participation in the trial under the terms of s 45AB(1)(a) of the Guardianship Act. The proposed trial is not complicated and is capable of being adequately explained to enable the person responsible to make an informed decision about consent. There is nothing inherently complex that would necessitate direct approval by the Tribunal under s 45AB(1)(b).

Patient Information and Consent Forms

46. The Tribunal considered the Patient Information and Consent Forms submitted by Liverpool and Bankstown-Lidcombe Hospitals which have been approved by the South-Western Sydney Local Health District Human Research Ethics Committee.

47. The Tribunal was satisfied that the forms provide sufficient information to allow a ‘person responsible’ to assess whether a particular individual should participate in the trial. However, the forms refer to the patient’s ‘next of kin’ and should be amended to refer to the patient’s ‘person responsible’ be consistent with the consent regime set out in Division 3 of Part 5 of the Guardianship Act.

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I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales.

Registrar

Decision last updated: 13 February 2015