Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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.
Penalty: Imprisonment for 2 years.
(8) In this section:
"adverse event" , for a trial participant or patient, or a child of a trial participant, has the meaning given by the regulations.