[This information is in addition to the fact sheet Medical/Dental Treatment for Patients Who Cannot Consent - The person responsible]

The person responsible may consent to the carrying out of a medical research procedure on a patient.

What is a medical research procedure?

A medical research procedure is a medical procedure that is carried out for the purposes of medical research. The medical research procedure may be:

• part of a clinical trial
• the administration of medication
• the use of equipment or a device.

Not all medical research involves medical research procedures. Some medical research may involve observations of the patient, or non-intrusive examinations, or surveys or collecting information. These types of medical research may be carried out without the consent of the person responsible.

How do I know if the medical research procedure is legal?

To be legitimate, the medical research procedure must be part of medical research approved by a human research ethics committee. The human research ethics committee may be based at the hospital where the patient is being treated or it may be at another hospital, a university or other institution. The medical practitioner should tell you where the committee is and how they can be contacted.

If you would like to know more about medical research, see our information sheet Medical Research in Victoria on our website.

How will I know if the medical research procedure is safe for the patient?

Not all medical procedures are safe and not all medical research procedures are safe. Safety cannot be guaranteed. However, there are protections.

When approving research for people who cannot provide consent or who are highly dependent on medical care, a human research ethics committee will consider factors such as:

• that the research is therapeutic and the research procedure poses no more of a risk than the risks already part of the patient's condition and in alternative methods of treatment
• the research is based on valid scientific principles which support a reasonable possible benefit over standard care
• the 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.

How do I decide what is not contrary to the patient's best interests?

The patient should not be worse off for being involved in the medical research procedure when compared with other medical procedures. If you think the patient will be worse off, then it would be contrary to their best interests to participate in the medical research procedure.

The person responsible needs to take into account the following when making your decision:

1. the wishes of the patient (if known)
2. the wishes of any nearest relative or any other family members of the patient
3. the 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)
4. any other consequences to the patient if the procedure is or is not carried out.

What else should I know?

The human research ethics committee may have set out requirements for obtaining your consent when they approved the research project. You may wish to speak to the doctor or dentist or the ethics committee about any special requirements.

Other issues

If the patient is an involuntary patient under the Mental Health Act, am I still able to provide consent?
Yes. If the procedure is a medical research procedure then you can provide consent to the procedure.

The only exception to this is that a patient can object under the Act to certain relatives being involved in any decisions to do with them regarding medical research procedures.

Can a medical research procedure go ahead without my consent?
Yes:

• if it is an emergency, or
• if the medical practitioner were unable to find you - as the person responsible to provide consent - and believed the procedure was not contrary to the best interests of the patient and followed the procedure set down in the Guardianship and Administration Act 1986.

If the medical research procedure began without my consent, can I do anything?
Now that you are aware of the medical procedure you may consent to its continuing or withhold your consent. When making a decision you must have regard to whether the continuation of the treatment is not contrary to the best interests of the patient.

Is there anywhere I can go for help?
Yes. There are a number of things you can do:

• discuss any questions you may have about the project or the patient's involvement with the medical practitioners involved
• if you would like to discuss the matter with a doctor that you know, consider talking to your family doctor, or any doctor who treats the patient
• contact the person nominated on the information sheet that you have been provided by the researchers. This document will have been assessed by the human research ethics committee which has approved the research, and will include the name of a person to contact. (This might be a person who works at the committee, or a hospital patient advocate).

You can also phone the Office of the Public Advocate for help. If you are still unsure about what decision to make and need further advice and would like assistance you can approach VCAT to:

• give you advice
• make an order that the proposed medical research procedure is not contrary to the best interests of the patient
• give directions to help resolve conflicts between people who have different views about what to do.

VCAT can also appoint a guardian if required.