48MArrangements for continuing participation in research of person who regains decision-making ability

### 48M Arrangements for continuing participation in research of person who regains decision-making ability > > (1)  If a person to whom this Part applies regains decision-making ability in relation to decisions related to the conduct of health and medical research in relation to that person, the lead health and medical researcher for the relevant research project is to, as soon as is reasonably practicable, ensure that – > > > > > > (a) the person is informed of their participation in the relevant research project; and > > > > > > > (b) the consent of the person is obtained to their continued participation in the research project where the relevant research project is ongoing; and > > > > > > > (c) the person is provided with a clear and candid explanation of – > > > > > > > > > > (i) 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 > > > > > > > > > > > (ii) 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 > > > > > > > (d) the person is 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’s decision-making with regard to continuing participation in the relevant research project; and > > > > > > > (e) the person is provided with an opportunity to ask questions regarding the research project and to receive clear and candid answers to those questions; and > > > > > > > (f) the person is given a reasonable opportunity to – > > > > > > > > > > (i) obtain independent medical or other advice; and > > > > > > > > > > > (ii) consider the advantages and disadvantages of giving consent. > > > (2)  If a person who has regained decision-making ability does not consent to their continued participation under [subsection (1)(b)](#GS48M@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.