Clinical Research without Consent: Challenges for COVID-19 Research.

Freckelton, Ian

The imperatives generated by the need for research into efficacious forms of treatment for COVID-19 have shone a fresh light upon the criteria for inclusion in clinical trials of persons unable to provide informed consent by reason of a number of factors including the seriousness of their illness symptomatology. This column identifies diversity in European, United States and Australian legislative and other guidance on the ethical issues that arise in respect of clinical research to which participants are not able to consent. It reviews the decision-making by the New South Wales Civil and Administrative Tribunal in a 2020 case in which permission was sought to conduct a clinical trial into a drug, STC 3141, designed by researchers as a potential treatment for patients with Adult Respiratory Distress Syndrome arising from COVID-19. It outlines the reasoning of the Tribunal in the context of debates about the balance to be struck between clinically useful medication trials and the need to avoid exploitation of vulnerable persons not able to provide their own consent, be that by virtue of disabilities such as acuteness of illness or dementia symptomatology. It contends that the decision illustrates the potential for research to be undertaken safely and ethically, utilising subjects in an intensive care unit who are unable to provide consent.