Key messages

  • There is a four-step process for including those not able to give consent in research procedures.
  • It is important to ensure research is in the best interests of the patient.
  • The person responsible for a patient unable to give consent or the parent or guardian of a person under eighteen years must be consulted.

People who are incapable of consenting to medical research procedures can only participate in these procedures according to a strict regime governed by the Guardianship and Administration Act 1986.

There is a four-step process for authorising these medical research procedures for ‘patients’ within the meaning of that Act.

A ‘patient’ is a person with a disability (intellectual impairment, mental disorder, brain injury, physical disability or dementia) who is 18 years of age or over and is incapable of giving consent to the carrying out of a medical research procedure.

Definition of medical research procedure

A medical research procedure is any procedure carried out for the purposes of medical research, including clinical trials that involve the administration of medication or the use of equipment or devices.

These are not medical research procedures and are not regulated by the Guardianship and Administration Act:

  • 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 or undertaking a survey (because these are not physically invasive)
  • collecting or using information, including personal or health information (because such activities are already separately regulated by privacy and confidentiality laws including the Health Records Act 2001, the Information Privacy Act 2000, s. 141 of the Health Services Act 1988 and the Mental Health Act 2014)
  • any other procedure that is prescribed by regulations not to be a medical research procedure – there are no such regulations at this stage.

Researchers may contact the relevant human research ethics committee or the Office of the Public Advocate for further guidance about the definition of medical research procedures.

Consent to research for a patient 18 years and over

A person must give informed consent for a medical research procedure to be performed.

If an adult patient is incapable of giving consent to any research that is a medical research procedure, the research may be performed in accordance with the four-step process outlined in the Guardianship and Administration Act.

The authorised psychiatrist cannot consent to the research on behalf of the patient, even where the research procedure or clinical trial might be thought of as being treatment of a mental disorder.

Four-step process

Step 1: Determine whether an ethics committee has approved the project (s. 42Q Guardianship and Administration Act).

and

Step 2: Determine whether the patient is likely to recover capacity within a reasonable time to give consent to the procedure. If the patient is likely to recover capacity within a reasonable time, the researchers must wait and seek the patient’s own consent (s. 42R Guardianship and Administration Act).

or

Step 3: If the patient is not likely to recover capacity within a reasonable time, seek the consent of the ‘person responsible’ (s. 42S Guardianship and Administration Act).

or

Step 4: If the ‘person responsible’ cannot be identified or contacted, consider procedural authorisation.

Section 42T of the Guardianship and Administration Act provides a scheme to enable procedural authorisation for carrying out medical research procedures on patients in certain circumstances.

The ‘four-step process’ is explained in detail in the guideline Guardianship and Administration Act 1986 – Medical research procedures involving patients under a legal incapacity, with additional information available from the Public Advocate.

Best interests and confidentiality

Steps 3 and 4 of the four-step process require a judgment about whether the proposed medical research procedure is contrary to the best interests of the patient.

Section 42U of the Guardianship and Administration Act lists the matters that must be taken into account when making this judgment.

This includes a patient’s right to confidentiality, even where the wishes of family members need to be taken into account in a judgment about the person’s best interests.

Consent to research for a patient under 18 years

If medical or psychiatric research involves a child or young person under 18 years, a decision must be made about who will provide consent .

The National Statement on Ethical Conduct in Human Research provides guidance for this issue.

Young people with capacity to give informed consent

A young person may give informed consent to research, depending on their level of maturity and capacity to understand the nature and expected outcomes of the research.

If a young person can give valid consent to research, the consent of the parents or guardian is not strictly necessary. However, parents and guardians should be involved in the decision wherever possible.

If a patient under the age of 18 years has capacity to make a decision about research and refuses consent, the research cannot be performed.

Young people without capacity to give informed consent

If a patient under the age of 18 years does not have capacity to consent to research, in general the parent or guardian may give consent on their behalf.

The authorised psychiatrist should seek advice from the Office of the Public Advocate if there is any doubt about whether a parent or guardian has the power to give consent to research on behalf of a child or there is disagreement between the parents and the child.

If a young person is incapable of consenting to research and there is no parent or guardian who is reasonably available, willing and able to make a decision, the research cannot be performed.

If the research is considered necessary, the authorised psychiatrist might consider making an application for a guardian to be appointed under the Children, Youth and Families Act 2005. Seek advice from the Office of the Public Advocate.

The authorised psychiatrist cannot consent to research, even when the research may be considered to be a psychiatric treatment, for example, a drug trial intended to treat the young person’s mental illness.

Refusal of treatment certificate

A medical practitioner must not carry out any medical research procedure, including any emergency treatment (see below), if the practitioner knows that a ‘Refusal of treatment certificate’ has been completed and is in force in accordance with the Medical Treatment Act 1998.

Emergency treatment

A medical research procedure (which is part of a research project that has been approved by a human research ethics committee) may be carried out without consent if a registered medical practitioner believes, on reasonable grounds, that the procedure is necessary, as a matter of urgency, to:

  • save a patient’s life
  • prevent serious damage to a patient’s health
  • prevent a patient from suffering or continuing to suffer significant pain or distress.

However, this source of authority would be rarely exercised in the context of research.

The practitioner would need to have reasonable grounds for believing that the medical research procedure is necessary on the basis that available conventional treatment would not meet the patient’s urgent clinical needs.