48LBasis for conducting health and medical research without prior consent to be included in clinical records

### 48L Basis for conducting health and medical research without prior consent to be included in clinical records > If health and medical research is conducted under this Division, the lead health and medical researcher responsible for that research must include, or cause to be included, in the person's clinical records relating to the conduct of the health and medical research, a written statement – > > > > (a) that the lead health and medical researcher is satisfied that – > > > > > > > > (i) the person has impaired decision-making ability in respect of decisions relating to the conduct of the health and medical research; and > > > > > > > > > (ii) the person was not likely to recover decision-making ability within a reasonable time; and > > > > > > > > > (iii) the reason or reasons for being so satisfied; and > > > > > (b) providing details of – > > > > > > > > (i) the nature of the risk presented in the person's condition; and > > > > > > > > > (ii) the grounds on which the lead health and medical researcher formed the view that the conduct of the research would be likely to benefit the person as compared to the standard medical treatment; and > > > > > > > > > (iii) the relevant human research ethics committee's approval for the person to participate in the health and medical research without prior consent; and > > > > > (c) confirming that – > > > > > > > > (i) no advance care directive has been located for the person; and > > > > > > > > > (ii) no person responsible for that person is available or able to give or refuse consent to the conduct of the research in relation to that person.