28SClinical trial licences and clinical practice licences—requirement for ongoing monitoring protocols and to notify adverse events

28S Clinical trial licences and clinical practice licences—requirement for ongoing monitoring protocols and to notify adverse events

(1) A person who is or was the holder of a clinical trial licence must have in place, and comply with, protocols for: (a) monitoring the pregnancy of trial participants who achieve pregnancy using a mitochondrial donation technique under the licence and any childbirths resulting from such pregnancies; and (b) monitoring the ongoing health and development of children born as a result of such pregnancies; and (c) seeking the ongoing engagement of trial participants referred to in paragraph (a), and children referred to in paragraph (b), in relation to such monitoring; and (d) notifying in accordance with subsection (3) adverse events, for those participants or children, that the person becomes aware of as a result of monitoring referred to in paragraph (a) or (b) of this subsection. (2) A person who is or was the holder of a clinical practice licence must have in place, and comply with, protocols for: (a) monitoring the pregnancy of patients who achieve pregnancy using a mitochondrial donation technique under the licence and any childbirths resulting from such pregnancies; and (b) notifying in accordance with subsection (3) adverse events, for those patients, that the person becomes aware of as a result of monitoring referred to in paragraph (a) of this subsection. (3) If a person who is or was the holder of a clinical trial licence or a clinical practice licence becomes aware of an adverse event for a trial participant referred to in paragraph (1)(a), a child referred to in paragraph (1)(b) or a patient referred to in paragraph (2)(a), the person must notify the adverse event to: (a) the NHMRC Licensing Committee; and (b) the Secretary; and (c) such other persons as are prescribed by the regulations for the purposes of this paragraph; within the period, in a form and manner, and in accordance with any other requirements, specified in the regulations. (4) Without limiting subsection (3), the regulations may require a notification to be in the form approved by the CEO of the NHMRC and to contain any information required by the form. (5) A person who is or was the holder of a clinical trial licence or a clinical practice licence must not include in a notification for the purposes of subsection (3) the name, or any other information that could be used to discover the identity, of: (a) a trial participant or patient; or (b) a child of a trial participant or patient. (6) Despite subsections (1), (3) and (5), in the case of a clinical trial licence a person is not subject to a requirement under any of those subsections unless the person is a constitutional corporation. (7) A person commits an offence if the person intentionally engages in conduct knowing that, or reckless as to whether, the conduct breaches a requirement under subsection (1), (2), (3) or (5) to which the person is subject.