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Guardianship and consent to participation in clinical trials

In brief: Senior Associate Vasantha Stesin discusses legal issues arising from informed consent and clinical trials. This paper was presented at the ARCS (Association of Regulatory & Clinical Scientists to the Pharmaceutical Industry) Melbourne Group Meeting on 21 May 2002.

• Introduction – consent
• Guardianship
• Consent to medical treatment and clinical trials
• Conclusions – guardianship issues for clinical trials
• Update

Introduction – consent

Before any medical treatment is carried out, the health care professional must obtain consent from the patient. Most patients can consent to treatment for themselves. A person's agreement to undergo a medical procedure or treatment is only valid if the person giving consent has the capacity at law to do so; and the person's agreement is voluntary and covers the act performed.

Some patients have reduced capacity to give informed consent, because they have a mental disorder, intellectual impairment, brain injury, physical disability, dementia or other disability. Because patients have differing abilities to make decisions and express their choices, the concept of 'consent' is variable, and consent to medical treatment can be obtained from a Tribunal or a person other than the patient.

If the patient cannot give valid consent, the medical treatment must not be carried out unless a legally valid consent is obtained from another source. A medical practitioner who performs a medical procedure or treats a patient without obtaining a valid consent may be liable in negligence, and for clinical trials, the pharmaceutical company involved may share some liability.

Guardianship

Where the patient has a disability which currently affects their capacity to make reasonable decisions – such as an intellectual impairment, mental disorder, brain injury, physical disability or dementia – consent must be obtained from an authorised person or decision-making body before the treatment is administered.

The legal ability to make decisions about the medical treatment of another person is set out in the strictly regulated laws of 'guardianship'. Legislation in all Australian States provides that a legal guardian can be appointed for people who have mental incapacities. The powers of a guardian under the Order can be very broad in scope – giving the guardian powers to make decisions about the person's lifestyle (including health care) – or limited to a particular duration, circumstance or treatment.

Note that guardians are appointed by a Government Board or Tribunal, whereas a 'power of attorney' is made by the person him/herself.

In Australia, every State has a different system and different rules about the appointment and powers of guardians, and consent to medical treatment by persons other than the patient. In all the States, the general policy behind the legislation is protection of the rights, welfare, freedom of decision and action, and interests of the person involved.

Consent to medical treatment and clinical trials

Guardians are often empowered to give consent on behalf of the other person to medical treatment. In some States, a relative or close friend can consent to routine medical procedures (without being legally appointed as a guardian).

While all Australian States have legislation which provides for the giving of consent for medical treatment which is necessary or in the person's 'best interests', the position is less straight forward where the proposed treatment is not 'necessary'.

The guardianship rules relevant to clinical trials vary from State to State. Some States have only broad provisions about 'medical treatment', others have specific rules for consent to clinical trials and medical research. Generally, guardians can consent to routine medical procedures, but in order to protect the patient's privacy and autonomy, consent to serious or controversial procedures can only be given by the State guardianship board (or equivalent). In this circumstance, an 'application for consent to medical procedure' is determined at a hearing.

With respect to clinical trials or 'medical research', there are four types of systems in Australian States for consent to clinical trials:

1. In NSW and Queensland, the guardianship board can approve a clinical trial, then consent must be obtained for each participant. In these States, it is relatively straightforward to obtain consent for participation in clinical trials, as a specific application can be made to the relevant board.
2. In Tasmania, the medical treatment in question is classified according to its risk, necessity, prevalence and seriousness. The person's guardian, 'person responsible' and/or the guardianship board can consent to the treatment, depending on its classification. Obtaining consent for clinical trials in Tasmania is relatively simple.
3. In Victoria, the guardian may be able to consent (depending on the treatment involved), or it may be necessary to apply to the Guardianship List.
4. In Western Australia, South Australia and the Northern Territory , the patient's guardian (or in some cases another person) may consent, depending on the limits of their powers and the type of treatment involved, and so on.
   Because the guardianship legislation in these States does not address medical research or clinical trials, it is relatively difficult to obtain consent for participation in a clinical trial unless a guardian has already been appointed for the patient.
5. Presently in the ACT , patients who cannot consent for themselves cannot participate in clinical trials. Neither guardians nor the guardianship board can give consent.

Clearly, it is more straightforward to obtain consent for a mentally incapacitated patient to participate in clinical trials where the State legislation makes express provision for this possibility, that is, in NSW, Queensland, Tasmania and Victoria.

It will be very difficult to include intellectually incapacitated patients in phase II trials (involving healthy volunteers) or trials of treatments which are not likely to benefit the patient, as guardians are usually compelled to make decisions in the patient's best interests.

In some States, where consent is given by someone other than the patient, the health provider is under an obligation to keep records and to inform certain people related to the patient about the treatment; those involved with clinical trials should check the relevant legislation carefully.

Conclusions – guardianship issues for clinical trials

Those involved in the management and administration of clinical trails should keep in mind the following issues:

• Before any medical treatment is carried out on a patient, a valid consent must be obtained from the patient or someone legally authorised to give the consent on behalf of the patient.
• The guardianship system in each State is different and it can take months for the relevant applications to be processed.
• It will be much easier to obtain guardianship consent in those States in which legislation has expressly dealt with the issue, that is, in Victoria, NSW, Queensland or Tasmania.

Therefore the location of the trial may be crucial where the clinical trial involves only or predominantly patients who cannot give informed consent – for example, a trial of a drug for Alzheimer's disease, or a treatment for intellectual disability. But note that the guardian who has powers in the State in which the patient resides may not have those powers in the State in which the trial is to be conducted. The guardian may need to reapply or apply for a guardianship order prior to obtaining consent.

Update

Allens have reviewed the present consent requirements in relation to participation in clinical trials of individuals who are unable to give valid consent themselves. A brief summary of the regime in each jurisdiction is detailed as follows:

Note that this summary is intended as a guide only. The approach taken by particular jurisdictions will depend largely on the nature of the clinical trial proposed. Furthermore, the legislative requirements in a number of jurisdictions are somewhat ambiguous, and the classification of the trial and subsequent determination of the consent requirements can only be undertaken by the relevant body.

For further information, please contact:

• Dr Trevor DaviesPartner, Allens Patent & Trade Mark Attorneys, Sydney
  Ph: +61 2 9230 4007
  Trevor.Davies@allens.com.au