Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p36
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 36/40)
Character Range: 127538–130195

that is freely given on the basis of information concerning the potential risks and benefits of the treatment that is sufficient to allow the person, or the person's guardian, to make an informed decision about whether to consent to the treatment.

Division 7.2—Exemptions for experimental uses

7.3  Conditions of approval—use of device by person to whom approval is given (Act s 41HB)
 (1) For subsection 41HB(3) of the Act, the conditions mentioned in this regulation apply to an approval granted to a person to use a kind of medical device solely for experimental purposes in humans.
 (2) Before the commencement of any clinical trial proposed to be undertaken in relation to the device, the person to whom the approval is granted and the principal investigator of the clinical trial must give to the Secretary:
 (a) a written assurance that each clinical trial will be conducted in accordance with the 'National Statement on Ethical Conduct in Research Involving Humans', published by the National Health and Medical Research Council, as in force from time to time; and
 (b) a written undertaking:
 (i) that the person will comply with any request by an authorised person, whether made before or after the commencement of a clinical trial, to give to the authorised person information about the conduct of the trial; and
 (ii) that the person will allow an authorised person to do any of the things mentioned in regulation 7.4 in relation to a clinical trial.

7.4  Powers of authorised persons in relation to medical devices being used in clinical trials
 (1) Subject to subregulation (2), an authorised person may do any of the following things in relation to a clinical trial mentioned in regulation 7.3 or in item 2.3 of the table in Part 2 of Schedule 4:
 (a) enter a site of the trial;
 (b) search the site and any thing on the site;
 (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial;
 (d) take photographs, make video recordings or make sketches of the site or any thing on the site;
 (f) request the principal investigator of the trial to:
 (i) answer any question asked by the authorised person; or
 (ii) produce any book, record or other document requested by the authorised person.
Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.
 (2) An authorised person is not entitled to do a thing mentioned in subregulation (1) if:
 (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised person to