The Guardianship and Administration Act 1986 (Vic) prescribes a process for obtaining consent for medical research procedures conducted on patients who are unable to provide consent.
Under the Guardianship and Administration Act (GAA) the person responsible may consent to the carrying out of a medical research procedure on a patient who cannot provide consent for themselves. If there is no person responsible the practitioner may submit a Section 42T Certificate to the Office of the Public Advocate. The GAA prescribes a 4-step process for authorising the carrying out of a medical research procedure on an incompetent patient. This is described below.
Role of VCAT
VCAT has jurisdiction to hear an application in relation to any matter, question or dispute relating to the best interests of an incompetent patient and their involvement in medical research. Further, the person responsible for a patient may apply to VCAT for directions or an advisory opinion on any matter or question relating to the scope or exercise of his or her authority to consent to a medical research procedure on behalf of the patient.
For the performance of other types of 'special procedures', including sterilisation, termination of pregnancy and removal of tissue, medical practitioners must obtain the authorisation of VCAT. The penalty for performing a special procedure without VCAT's authorisation has increased from 20 penalty units to imprisonment for 2 years or 240 penalty units or both.
Definition of 'medical research procedure'
The definition of 'medical research procedure' is 'a procedure carried out for the purposes of medical research, including, as part of a clinical trial, the administration of medication or the use of equipment or a device' or a procedure prescribed by regulations to be a 'medical research procedure' for the purposes of the GAA (so far no procedures have been so prescribed). Importantly, a 'medical research procedure' does not include:
- any non-intrusive examination (including a visual examination of the mouth, throat, nasal cavity, eyes or ears or the measuring of a person's height, weight or vision)
- observing a person's activities
- undertaking a survey
- collecting or using information, including personal information (within the meaning of the Information Privacy Act 2000) or health information (within the meaning of the Health Records Act 2001)
Process for obtaining consent
The GAA sets out a 4 step process regarding how researchers may obtain consent for the recruitment of incompetent patients into research studies.
Step 1 - Approval of research by Human Research Ethics Committee
The first step is to ensure that the relevant research project has been approved by a Human Research Ethics Committee (HREC).
A medical research procedure must be carried out in accordance with any conditions of the HREC's approval.
Step 2 - Is the patient likely to recover within a reasonable time?
The second step is to determine whether the patient is likely to be capable to consent to the procedure within a reasonable time. The period that constitutes a reasonable time will vary depending upon each patient's circumstances.
To guide practitioners, the GAA provides that the 'reasonable time' is the time by which, given the nature of the relevant research project, the procedure would need to be performed on the patient, having regard to:
- the medical or physical condition of the patient
- the stage of treatment or care
- other circumstances specific to the patient
If the patient is likely to be capable of giving consent within a reasonable time, then a practitioner must not proceed to step 3 or step 4 (as the case may be).
If the patient is not likely to recover within a reasonable time, then a practitioner may proceed to step 3 and step 4 (as the case may be).
Before, or soon after, the medical research procedure is carried out on the patient, the practitioner must write in the patient's clinical records:
- his or her belief that the patient is or was not likely to be capable of giving consent within a reasonable time;
- the reason for that belief.
Step 3 - Consent of person responsible
The third step is to seek the consent of the person responsible for the patient to the carrying out of the medical research procedure on the patient.
The person responsible may consent to the carrying out of a medical research procedure on the patient.
'Person responsible' is the first person listed below who is responsible for the patient and who, in the circumstances, is reasonably available and willing and able to make a decision:
- A person appointed by the patient under the Medical Treatment Act 1988
- A person appointed by VCAT to make decisions in relation to the proposed treatment
- A person appointed under a guardianship order with power to make decisions in relation to the proposed treatment
- A patients' enduring guardian with power to make decisions in relation to the proposed treatment
- A person appointed in writing by the patient (before the patient became incapable of giving consent) to make decisions in relation to medical or dental treatment which includes the proposed treatment
- The patient's spouse or domestic partner
- The patient's primary carer
- The patient's 'nearest relative'
The person responsible may only consent to the carrying out of the procedure if he or she believes that the carrying out of the procedure would not be contrary to the best interests of the patient.
The consent given must be consistent with the usual requirements for consent and any conditions of approval specified by the HREC.
Step 4 - Procedural authorisation
The fourth step involves the concept of 'procedural authorisation'. A practitioner may proceed to this fourth step only if the person responsible for the patient cannot be ascertained or contacted. Therefore, a practitioner cannot use procedural authorisation if a patient's person responsible is ascertained or contacted and the person responsible makes a decision that the patient is not to be enrolled in the research project.
Researchers who intend to utilise procedural authorisation must ensure they comply with all of its numerous, detailed requirements.
The practitioner may carry out, or supervise the carrying out of, a medical research procedure on a patient without the consent of the person responsible for the patient provided all of the following apply:
- The patient's person responsible cannot be ascertained or contacted after reasonable steps have been taken to do so
- The patient is not likely to be capable within a reasonable time of giving consent
- The practitioner believes on reasonable grounds that the medical research procedure is not contrary to the best interests of the patient
- The practitioner does not have any reason to believe the carrying out of the procedure would be against the patient's wishes
- The practitioner believes on reasonable grounds that the HREC has approved the study
- The practitioner believes on reasonable grounds that:
- the medical research procedure is to assess the effectiveness of the therapy being researched
- the medical research procedure poses no more of a risk than is inherent in patient's condition and alternative treatment.
The practitioner believes on reasonable grounds that the medical research procedure is based on a valid scientific hypothesis (or hypotheses) that support a reasonable possibility of benefit for the patient compared with standard treatment.
Under procedural authorisation, practitioners must also ensure they do all the following:
- Before, or soon after, the medical research procedure is carried out, the practitioner supervising or carrying out the procedure must sign a Section 42T Certificate that certifies all of the matters set out above and that states that the person responsible (if any) or the patient (if the patient gains/regains capacity) will be informed of the matters set out in paragraph 3 below.
- The registered practitioner supervising or carrying out the procedure must:
- forward a copy of the Section 42T Certificate described in paragraph 1 above to the Office of the Public Advocate and the HREC that has approved the study as soon as practicable but no later than 2 working days after supervising or carrying out the procedure; and
- ensure that the original Section 42T Certificate is kept in the patient's clinical records.
- The Section 42T Certificate and the relevant contact details are available from the Office of the Public Advocate. A separate certificate must be completed and submitted for each patient recruited into a research project under procedural authorisation.
The Public Advocate does not authorise the conduct of a medical research procedure on a patient; the Public Advocate must simply be provided with the relevant certificate/s.
A registered practitioner involved in the research project must inform the person responsible (if any) or the patient (if the patient gains/regains capacity) as soon as reasonably practicable of:
- the patient's inclusion in the research project
- the option to refuse consent to continue to be involved in the research and to withdraw from the project without prejudice to the patient's ability to receive any alternative treatment
If the medical research procedure lasts for more than one month after the original certificate is sent to the Public Advocate and the HREC, the registered practitioner supervising or carrying out the procedure must sign a new certificate and forward a copy to the Public Advocate and the HREC at least every month while the procedure continues. The certificate must certify that each of the requirements for procedural authorisation continue to apply. The practitioner must ensure that the original certificate is kept in the patient's clinical records.
For a medical research procedure that lasts for more than one month, the registered practitioner supervising or carrying out the medical research procedure must ensure that:
- the relevant requirements for the conduct of the research continue to be met but the person responsible has not been able to be ascertained or contacted
- the patient has not gained or regained the capacity to consent
Notwithstanding that a medical research procedure is carried out on a patient under procedural authorisation, the registered medical practitioner must continue to take reasonable steps to ascertain whether there is a person responsible and if so, to seek his or her consent to the proposed procedure.
Furthermore, if at any time the person gains or regains capacity to consent, his or her consent must be sought because he or she will no longer be a person to whom the requirements of procedural authorisation apply.
The Guardianship and Administration Act 1986 (Vic) prescribes a 4-step process for obtaining consent for patients who cannot consent to medical research procedures for themselves. These steps are:
- Step 1 > Section 42Q - Approval of the research project by the relevant HREC.
- Step 2 > Section 42R - Is the patient likely to recover within a reasonable time?
- Step 3 > Section 42S - Consent of person responsible.
- Step 4 > Section 42T - Procedural authorisation
It is the principal researcher's responsibility to ensure that he/she and all members of the research team are fully conversant with the requirements of the Guardianship and Administration Act 1986 (Vic) and the Guardianship and Administration (Further Amendment) Act 2006 (Vic) and, in particular, Part 2 of the latter Act which describes these steps in detail.