After section 22 of the Principal Act , the following Division is inserted in Part II:

Division 7 - Donations for approved research

22A.     Interpretation

In this Division –

approved research means research approved by a human research ethics committee in accordance with the Australian Code and the National Statement;

Australian Code means the Australian Code for the Responsible Conduct of Research, issued by the NHMRC in 2018, as amended and in force from time to time;

human research ethics committee means a committee formed in accordance with the requirements stated in the National Statement;

National Statement means the National Statement on Ethical Conduct in Human Research, issued by the NHMRC in 2007, as amended and in force from time to time;

NHMRC means the National Health and Medical Research Council established under the National Health and Medical Research Council Act 1992 of the Commonwealth.

22B.     Authorised donation by child

(1)  The removal of tissue from a child’s body is authorised if –

(a) it is done –

(i) for the purpose of approved research; and

(ii) in accordance with the approval given in respect of that research, including any conditions of the approval; and

(b) consent is given in accordance with the National Statement; and

(c) one or more of the following applies:

(i) the approved research is for the benefit of the child;

(ii) the removal of the tissue occurs during a procedure that is for the benefit of the child and a medical practitioner is satisfied that the removal of the tissue for approved research is not likely to prejudice the health of the child;

(iii) a medical practitioner is satisfied that the removal of the tissue will involve a negligible or low risk of harm and minimal discomfort to the child.

(2)  For the purposes of subsection (1)(c)(ii) and (iii) , the medical practitioner must make a record of the practitioner’s satisfaction.

(3)  For the purposes of subsection (1)(c)(iii) , the medical practitioner’s satisfaction, and the record of that satisfaction, may relate to –

(a) a particular child or children; or

(b) a group of children that is or may be participating in stated approved research.