STC3141 – An Open Label, Multi-Centre Study to Determine the Safety and Efficacy of STC3141 Administered as an Infusion for up to 5 Days in Subjects with COVID-19 Respiratory Distress Syndrome Requiring Intensive Care  NSWCATGD 16 (available on Caselaw) required the Tribunal to consider whether to allow a trial to use human subjects who are unable to give their own consent to participation in a trial, and whether a person responsible can provide consent on the subject person’s behalf if the subject person is unable to give their own consent.
STC3141 is a new medication designed by researchers at the Australian National University developed to be a potential treatment for patients with ARDS.
The Tribunal approached the matter by reference to the following questions:
- Is STC3141 intended to cure or alleviate a particular condition from which the patients suffer?
- Will the Trial involve any known substantial risk to the patients (or, if there are existing treatments for the condition concerned, will not involve material risks greater than the risks associated with those treatments)?
- Has the development of SCT3141 reached a stage at which safety and ethical considerations make it appropriate that STC3141 be available to patients who suffer from COVID-19 even if those patients are not able to consent to taking part in the Trial?
- Having regard to the potential benefits (as well as the potential risks) of participation in the Trial, is it in the best interests of patients who suffer from COVID-19 that they take part in the Trial?
- Has the Trial been approved by a relevant ethics committee and does it comply with any relevant guidelines issued by the National Health and Medical Research Council?
The Tribunal approved the clinical trial under s 45AA of the Guardianship Act 1987 (NSW) .