Medical research procedures
A medical research practitioner who is required to complete a section 81 certificate under the Act can click here for the section 81 certificate.
Note: If the patient is likely to recover decision-making capacity within a reasonable time to make a medical treatment decision in relation to a medical research procedure, a medical research procedure must not be administered without obtaining the patient’s consent.
In determining what is a ‘reasonable time’ given the nature of the relevant research project, regard must be had to the following:
- the medical or physical condition of the person
- the stage of medical treatment or care
- other circumstances specific to the person.
If the medical research practitioner administers a medical research procedure in accordance with the process set out in the Act, they must record on the patient’s clinical records that:
- the person did not have decision-making capacity
- the person was not likely to recover decision-making capacity within a reasonable time and
- the reasons for being so satisfied.