48IConsent of person responsible

### 48I Consent of person responsible > > (1)  The person responsible for a person to whom this Part applies may consent to the conduct of health and medical research in relation to that person if the person responsible reasonably believes that the person would have consented to the conduct of that health and medical research if the person had decision-making ability. > > > (2)  For the purposes of [subsection (1)](#GS48I@Gs1@EN) , in determining whether a person would have consented to the conduct of the health and medical research, the person responsible is to have regard to – > > > > > > (a) any relevant directions, values or preferences outlined in an advance care directive given by the person in relation to whom the proposed health and medical research is to be conducted; and > > > > > > > (b) if the person has not given any relevant directions, values or preferences in an advance care directive, the views, wishes and preferences expressed by the person other than by way of an advance care directive; and > > > > > > > (c) if the person has not expressed any views, wishes or preferences, what the person responsible reasonably believes the views, wishes and preferences of the person are likely to be, based on all the information available including the values of the person inferred from the person's life; and > > > > > > > (d) whether consent to the conduct of the health and medical research will promote the person's personal and social well-being; and > > > > > > > (e) the likely effects and consequences of the health and medical research, including the likely effectiveness of the health and medical research, and whether these are consistent with the person's preferences and values; and > > > > > > > (f) the likely effects and consequences of the conduct of the health and medical research in relation to that person including – > > > > > > > > > > (i) the known risks of the conduct of the health and medical research; and > > > > > > > > > > > (ii) any risks to the person that are greater than the risk that is inherent in the person's condition and in standard medical treatment or health care; and > > > > > > > (g) whether there are any alternatives, including refusing the conduct of the health and medical research. > > > (3)  For the purposes of [subsection (2)](#GS48I@Gs2@EN) , the lead health and medical researcher for a relevant research project is to provide, or cause to be provided, to the person responsible for a person under this Part – > > > > > > (a) the following information: > > > > > > > > > > (i) 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 proposed to be undertaken for the purposes of the research; > > > > > > > > > > > (ii) a clear and candid explanation of any treatment or health care that may be available, including information about the associated 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; > > > > > > > > > > > (iii) 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 the relevant research project; and > > > > > > > (b) an opportunity to ask questions regarding the research project and to receive clear and candid answers to those questions; and > > > > > > > (c) a reasonable opportunity to – > > > > > > > > > > (i) obtain independent medical or other advice; and > > > > > > > > > > > (ii) consider the advantages and disadvantages of giving consent. > > > (4)  Consent given under this section must be consistent with any requirements for consent specified in the relevant human research ethics committee approval for the relevant research project or the conditions of that approval. > > > (5)  Consent given by a responsible person under this section may be withdrawn by that responsible person at any time. > > > (6)  Where consent under this section is withdrawn, the lead health and medical researcher for the relevant research project is to ensure that the necessary arrangements are made to withdraw the person in respect of whom the consent is withdrawn from future participation in the relevant research project without compromising the person’s ability to receive any available standard medical treatment or health care. > > > (7)  If a person in respect of whom consent has been given under this section 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 is to, as soon as is reasonably practicable, ensure – > > > > > > (a) that the person is informed of the person’s inclusion in the relevant research project; and > > > > > > > (b) that the consent of the person to the person’s continued participation in the research project is sought; and > > > > > > > (c) where consent is refused, 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.