Section 65

Form 25

Clinical trial or experimental treatment informed consent

Full name of patient: Also known as: Date of Birth: / /	Sex: ☐ Male ☐ Female ☐ Non-binary ☐ Not specified HRN: Name of Approved Treatment Facility or Agency or patient’s residential address:
Informed consent of patient I have had the details of the proposed clinical trial and/or experimental treatment clearly explained to me and I consent to being involved with the trial and treatment process.
I was given a period of to consider my response for consent and confirm that I have been provided with the following: ☐ A clear explanation of the assessment and possible diagnosis, the nature of the proposed treatment, including sufficient information about the type of treatment, its purpose and likely duration to permit the person to make a balanced judgment regarding undertaking it; and ☐ An adequate description, without concealment, exaggeration or distortion, of the benefits, discomforts and risks associated with the treatment; and ☐ An adequate description of any appropriate alternative form of treatment that is reasonably available; and ☐ A clear answer to all relevant questions asked by the person (and the answer has been understood by the person); and ☐ Advice that the treatment may be refused or consent may be withdrawn at any time while the treatment is being undertaken; and ☐ Advice that independent legal or medical advice may be obtained in relation to the treatment before giving consent (and reasonable assistance is provided to obtain that advice, if requested); and ☐ Advice of all rights of review and appeal under this Act; Please provide a link/reference to the list of Consumers and Carers rights to ensure Clinicians, Consumers and Carers are able to access; and ☐ Advice of any relevant financial advantage that may be gained by a medical practitioner proposing the treatment and by the approved treatment facility or approved treatment agency where the treatment is to be undertaken; and ☐ Advice of any relevant research relationship between a medical practitioner proposing the treatment and the approved treatment facility or approved treatment agency where the treatment is to be undertaken; and ☐ Explanations, descriptions and advice in a manner or form that the person is used to communicating in (and due regard is to be given to age, culture, disability, impairment and any other factors that may influence the person understanding the explanation).
Signature of patient: Date: / /	Signature of witness: Date: / /
Human Research Ethics Committee approval The clinical trial and/or experimental treatment has been reviewed by the following Ethics Committee/s as nominated by the Chief Health Officer: The clinical trial and/or experimental treatment was subsequently: ☐ Approved ☐ Not Approved The details of approval/denial of approval include:
Full name of person providing ethics committee approval details: Signature: Date: / /	Position of person providing ethics committee approval details: ☐ Medical Practitioner ☐ Authorised Psychiatric Practitioner (APP) ☐ Designated Mental Health Practitioner (DMHP)
Name of Approved Treatment Facility, Agency or medical practice:

Form Requirements

☐ Placed on clinical file