Sometimes the opportunity to participate in medical research is offered to patients.
This may involve:
- being part of a clinical trial
- the administration of medication
- the use of equipment or a device.
It may also involve nonintrusive procedures such as observation.
The Approval Process for Medical Research flowchart (right menu) provides guidance on the process of offering the opportunity to participate in medical research to a person who is unable to consent.
If a patient is not able to consent to taking part in medical research, the person responsible may consent on the patient’s behalf.
The medical research procedure may be:
- part of a clinical trial
- the administration of medication
- the use of equipment or device.
Not all medical research involves medical research procedures. Some medical research may involve observations of the patient, or non-intrusive examinations, or surveys collecting information. These types of medical research may be carried out without the consent of the person responsible.
If a patient cannot consent to medical research and there is no person responsible available to provide consent, the procedures can be carried out if the legislative requirements under Section 42T of the Guardianship and Administration Act 1986 are met.
A medical research procedure can go ahead without the consent of the person responsible when:
- it is an emergency, or
- the medical practitioner (doctor) is unable to find the person responsible or if there is no person responsible, and
- the medical practitioner believes the procedure is not contrary to the best interests of the patient and follows the procedure set down in the Guardianship and Administration Act 1986.
If a medical research procedure begins without consent, the person responsible may consent to the patient’s continued involvement with the research, or withhold their consent. When making this decision, the person responsible considers whether the continuation of the treatment is not contrary to the best interests of the patient.
If the medical practitioner believes the treatment is in the best interests of the patient, they must submit a Section 42T Certificate (right menu) to OPA’s Advice Service. A Section 42T Continuing Certificate (right menu) must be completed for each month the procedure continues.
The medical research has to be approved by a human research ethics committee based at the hospital where the patient is being treated, or at another hospital, university or other institution. If consent is to be provided by the person responsible, the medical practitioner should tell the person responsible where the committee is and how they can be contacted.
The human research ethics committee may set special requirements relating to the consent of the person responsible when they approve the research project. The person responsible can speak to the medical practitioner or the ethics committee about any special requirements. Consent by the person responsible must be consistent with the requirements specified by the ethics committee.
Not all medical procedures or medical research procedures are safe.
When approving research for people who cannot provide consent or who are highly dependent on medical care, a human research ethics committee will consider if the:
- research is therapeutic and the research procedure poses no more risk than the risks inherent in the patient’s condition and in alternative methods of treatment
- research is based on valid scientific principles and reasonably offers a possible benefit over standard care
- patient or the person responsible will be informed about the research and have the option to withdraw from the research without any reduction in the quality of care.
The patient’s best interests
The patient should not be worse off for being involved in the medical research procedure when compared to other medical procedures. If the patient is likely to be worse off, then it is contrary to their best interests to participate in the medical research procedure.
When making a decision, the person responsible can be guided by the:
- wishes of the patient (if known)
- wishes of nearest relative of any other family members of the patient
- nature and degree of any benefits, discomforts and risks for the patient in having or not having the procedure (including comparing the medical research procedure to alternative procedures)
- consequences to the patient if the procedure is or is not carried out
The person responsible can:
- discuss any questions about the research or the patient’s involvement with the medical practitioners involved
- discuss the matter with a doctor who treats the patient
- contact the person nominated on the information sheet provided by the researchers
- contact OPA’s Advice Service for help.
VCAT can provide further advice and assistance by:
- making an order that the proposed medical research procedure is not contrary to the best interests of the patient
- giving directions to help resolve conflicts between people who have different views about what to do
- appointing a guardian if required.