Consent process for research involving people without decision-making capacity

Medical Treatment Planning and Decisions Act 2016

The Act allows Victorians to:

• Create an Advance Care Directive (Instructional Directive and/or Values Directive)
• Appoint a Medical Treatment Decision Maker to make decisions on their behalf when they lack decision-making capacity
• Appoint a Support Person to help them gather and interpret information required to make a medical decision and help them to communicate that decision if required

The provisions of the Medical Treatment Planning and Decisions Act 2016 for research involving people without decision-making capacity replace in full the provisions for people without decision-making capacity prescribed within the Guardianship and Administration Act 1986 (Vic).

Under the Medical Treatment Planning and Decisions Act 2016, the medical treatment decision-maker may consent to the carrying out of a medical research procedure on an adult who does not have decision-making capacity regarding the procedure.

If there is not an instructional directive or a medical treatment decision-maker, a health practitioner must obtain consent from the Public Advocate if the proposed medical treatment is significant. 

Process for obtaining consent

The Medical Treatment Planning and Decisions Act 2016 sets out a four-step process regarding how researchers may obtain consent for the recruitment of adults who do not have decision-making capacity into research studies (Part 5 – Medical Research).

Step 1: Approval of research by a Human Research Ethics Committee (HREC)

The first step is to ensure that the relevant research project has been approved by HREC. A medical research procedure must be carried out in accordance with any conditions of the HREC's approval.

A medical research procedure cannot be administered to a person who does not have decision-making capacity relating to the procedure unless the research project has been approved by the relevant human research ethics committee.

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 on each patient's circumstances.

To guide practitioners, the Act states 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 administer the medical research procedure to the patient under this section of the Act (Part 5)

If the patient is not likely to recover within a reasonable time, then a practitioner may proceed to the next steps.

Before, or soon after, the medical research procedure is carried out on the patient, the practitioner must write in the patient's clinical records:

• That the practitioner was satisfied that the person did not have decision-making capacity
• The person was not likely to recover decision-making capacity within a reasonable time frame
• The reason or reasons for being so satisfied

Step 3: Find out existence of advance care directives and medical treatment decision-makers

The next step is to make reasonable efforts in the circumstances to find out if the person has either or both of the following:

• Advance care directive
• A medical treatment decision-maker

Advance care directive

A health practitioner will be required to make reasonable efforts in the circumstances to locate an advance care directive and medical treatment decision maker. What this requires will depend on the circumstances. It may be reasonable for a health practitioner to:

• Check a patient’s clinical record
• Ask any family or friends present
• Contact a medical treatment decision-maker
• Contact a next of kin or emergency contact on the patient’s medical record
• Contact the person’s GP, or
• Contact any residential care facility or other health facility the person may have attended

It would never be reasonable to delay medical treatment to locate an advance care directive if this would cause the person’s health to significantly deteriorate.

Medical treatment decision-maker

Medical treatment decision-maker is the first person listed below who is willing and able to make a decision (note: there can only be one medical treatment decision-maker at a time):

• An appointed medical treatment decision maker
• A guardian appointed by the Victorian Civil and Administrative Tribunal (VCAT)
• The first of the following with a close and continuing relationship with the person:
  • Spouse or domestic partner
  • Primary carer of the person
  • Oldest adult child of the person
  • Oldest parent of the person
  • Oldest adult sibling of the person

If a child does not have decision-making capacity, their medical treatment decision-maker will be a parent, guardian or other person with parental responsibility. 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: Process if there is no advance care directive and no medical treatment decision maker

If a health practitioner makes reasonable efforts in the circumstances to locate an advance care directive and/or a medical treatment decision-maker, but is unable to locate either, the Act provides a process for proceeding.

A practitioner may not proceed if a patient's medical treatment decision maker is ascertained or contacted and makes a decision that the patient is not to be enrolled in the research project.

A medical research practitioner may administer a medical research procedure under this Division without consent to a person who does not have a medical treatment decision-maker if:

1. The medical research practitioner believes on reasonable grounds that inclusion of the person in the relevant research project, and being the subject of the proposed procedure, would not be contrary to the following:
   • The person's values, whether expressed by way of a values directive or otherwise; or inferred from the person's life
   • Any other relevant preferences that the person has expressed, having regard to the circumstances in which those preferences were expressed
   • The personal and social wellbeing of the person, having regard to the need to respect the person's individuality, and
2. The medical research practitioner believes on reasonable grounds that the relevant human research ethics committee has approved the relevant research project in the knowledge that a person may participate in the project without the prior consent of:
   • The person, or
   • A medical treatment decision-maker, and
3. The medical research practitioner believes on reasonable grounds that:
   • One of the purposes of the relevant research project is to assess the effectiveness of the procedure being researched
   • The medical research procedure poses no more of a risk to the person than the risk that is inherent in the person's condition and alternative medical treatment, and
4. The medical research practitioner believes on reasonable grounds that the relevant research project is based on valid scientific hypotheses that support a reasonable possibility of benefit for the person as compared with standard medical treatment

A medical research practitioner must continue to take reasonable steps to identify and contact the person's medical treatment decision-maker to seek consent to the continuation of the procedure on the person.

Medical research practitioner’s certificate

Before, or as soon as practicable after, administering a medical research procedure under Division 3 (Part 5 of the Act) (and in the case of a procedure lasting longer than 30 days, at intervals of no longer than 30 days), a medical research practitioner a must sign a certificate certifying that:

1. The person to whom the medical research procedure is being administered does not have decision-making capacity to make a medical treatment decision in respect of that procedure, and
2. The person's medical treatment decision-maker cannot be identified or contacted (as the case may be)

And stating that:

3. The person's medical treatment decision maker (if one is subsequently identified) will be informed of the procedure, or
4. If the person recovers decision-making capacity, the person will be informed of the procedure

The medical research practitioner must inform the person's medical treatment decision maker (if one is subsequently identified) or, if the person recovers decision-making capacity, the person, as soon as reasonably practicable of—

• The person's inclusion in the relevant research project, and
• The option to refuse the continuation of the procedure and withdraw the person from future participation in the project without compromising the person's ability to receive any available alternative medical treatment or care

The medical research practitioner must:

• Forward a copy of each certificate to the Public Advocate and the relevant human research ethics committee:
  • In the case of the first certificate, as soon as practicable (and in any event within 2 business days) after administering the procedure, or
  • In any other case, at intervals of no more than 30 days, and
  • Ensure that each certificate is kept in the person's clinical records

If the medical research procedure lasts for more than 30 days 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 30 days while the procedure continues.

Medical research procedures in an emergency

In the case of an emergency, a medical research procedure may be administered to a person who does not have decision-making capacity without that person’s consent. The medical research practitioner must believe, on reasonable grounds, that the medical research procedure is necessary, as a matter of urgency, to:

1. Save the person’s life
2. Prevent serious damage to the person’s health, or
3. Prevent the person from suffering or continuing to suffer significant pain or distress.

A medical research practitioner cannot provide a medical research procedure just because it is an emergency if they are aware that the person has refused the particular medical research procedure in an instructional directive or through another legally valid and informed refusal of treatment.

The relevant research project under which the medical research practitioner is providing the emergency medical research procedure must have received prior approval from the relevant human research ethics committee.

It is not intended that the emergency medical research procedure provisions will be widely used. Instead, they are aimed at medical research into the efficacy of emergency treatments, when it would not ordinarily be possible to obtain consent to the necessary treatments.

For example, research may be conducted to compare two emergency medical treatments when there is believed to be clinical equipoise. Once the procedures are randomised, they will become medical research procedures but will still be necessary, as a matter of urgency, to save the person’s life.

In this case, the medical research procedure could be provided without consent, as long as the person had not previously refused the particular procedure (see also Part 4 of the Act 2016, Division 1).