48NArrangements for consent to continuing participation in research by person responsible

### 48N Arrangements for consent to continuing participation in research by person responsible > > (1)  If a person to whom this Part applies does not regain decision-making ability in relation to decisions related to the conduct of health and medical research in relation to that person and a person responsible is identified, the lead health and medical researcher for the relevant research project is to, as soon as is reasonably practicable, ensure that the person responsible is – > > > > > > (a) informed of the inclusion of the person with impaired decision-making ability in the relevant research project; and > > > > > > > (b) requested to provide consent to the person’s continued participation in the research project where the relevant research project is ongoing; and > > > > > > > (c) provided with a clear and candid explanation of the relevant research project, including information about the associated risk or any common or expected side effects of any activities undertaken for the purposes of the research; and > > > > > > > (d) provided with a clear and candid explanation of any treatment or health care that may be available, including information about the advantages and disadvantages of any treatment given as part of a health or medical research trial as an alternative to, or in addition to, that treatment or health care; and > > > > > > > (e) provided with any other information that is considered by the lead health and medical researcher to be of relevant importance and likely to influence the person responsible's decision-making with regard to the person's continuing participation in the relevant research project; and > > > > > > > (f) provided with an opportunity to ask questions regarding the research project and to receive clear and candid answers to those questions; and > > > > > > > (g) given a reasonable opportunity to – > > > > > > > > > > (i) obtain independent medical or other advice; and > > > > > > > > > > > (ii) consider the advantages and disadvantages of giving consent. > > > (2)  If the person responsible for a person with impaired decision-making ability does not provide consent to the person's continued participation in the relevant research project following a request under [subsection (1)(b)](#GS48N@Gs1@Hpb@EN) , the lead health and medical researcher for the relevant research project is to ensure that the necessary arrangements are made to withdraw the person from future participation in the research project without compromising the person’s ability to receive any available standard medical treatment or health care. > > > (3)  In circumstances where, after reasonable efforts by the lead health and medical researcher for the relevant research project, a person responsible is unable to be identified, the lead health and medical researcher may seek advice and direction from the Tribunal under [section 48O](#GS48O@EN) .