Page 3772 - Week 11 - Thursday, 24 November 2022
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This bill also amends the Guardianship and Management of Property Act and the Powers of Attorney Act to remove an impediment to clinical trials being considered low-risk research. Under the legislation, a health attorney, who is usually a family member, can be appointed for a protected person to consent to that person participating in low-risk research. The current definition of low-risk research does not include activities that are part of a clinical trial. “Clinical trial” refers to a research method and is not an indicator of the level of risk associated with the research.
Excluding clinical trials from being considered by a health attorney has meant that ACT Health has not been able to participate in a range of low-risk research, particularly in an emergency care setting, such as the ICU. This has significant implications for the ICU, which has been unable to re-establish its research portfolio, and has resulted in patients, clinicians and researchers in the ACT missing out on valuable research opportunities.
While these provisions engage the right to not to be subject to medical experimentation without free consent, the right is not limited by these provisions as they provide for substituted consent with the following safeguards.
Firstly, the clinical trial must be only for: (a) a therapeutic good, such as a drug or device, that is included on the Australian Register of Therapeutic Goods; and (b) a healthcare procedure, process or technique supported by a substantial number of practitioners in the relevant field of health care.
Secondly, the research must pose no foreseeable risk of harm to the person, other than any harm usually associated with the person’s condition and does not change the treatment appropriate for the person’s condition.
Thirdly, a health professional may only ask a health attorney to consent to a person participating in low-risk research if they believe on reasonable grounds that the person is likely to benefit from participating. This research must be approved by an ethics committee.
And, finally, the health professional must provide the health attorney with access to an independent doctor where the research involves a clinical trial. The independent doctor is to be made available to the decision-maker to answer any questions and provide unbiased information about the risks of participating in the trial.
These amendments aim to reinstate the original intent of the legislation and allow for low-risk research to be undertaken, including in critical care settings, with appropriate safeguards to ensure that the amendment is consistent with the rights of people with impaired decision-making capacity.
This bill also amends the Security Industry Act to extend the period of time for which a security licence can be suspended and to confirm that the ACT Civil and Administrative Tribunal, or ACAT, is empowered to further suspend a licence. Under the act, if the Commissioner for Fair Trading intends to apply, or has applied, to the ACAT for an occupational disciplinary order for a security industry licensee, the
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