A medical research procedure is a procedure carried out for the purposes of medical research, including as part of a clinical trial, the administration of prescription pharmaceuticals, the use of equipment or a device, or a prescribed medical research procedure.
Process and requirements
For the process under the Medical Treatment Planning and Decisions Act 2016, see OPA's medical research procedures flowchart.
If the patient is likely to recover decision-making capacity within a reasonable time
If the patient is likely to recover decision-making capacity within a reasonable time to make the decision in relation to a medical research procedure, the 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, consider:
- 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.