Rethinking Human Challenge Trials in the Age of COVID-19

Ian Freckelton1

1Law and Psychiatry, University of Melbourne, Australia

COVID-19 has generated a new and distinctive focus on the debates about the legitimacy of human challenge studies. Although vaccines are now available for COVID-19, there remain multiple deficits in knowledge in respect of treatment and prevention of the infection and a powerful impetus for solutions given the level of its global morbidity and mortality. Thus, there are potent incentives for unorthodox acceleration of medical knowledge but against these must be balanced ethical and pragmatic considerations. Such trials have an inglorious history and have led to Professor Joerg Hasford, the President of the Association of Medical Ethics Committees in Germany, to proclaim that ‘one can only hope that human challenge trials with SARS-CoV-2 will not be performed as human beings should not become just a means to an end.’ However, a heavily funded program of human challenge trials was announced in early 2021 in the United Kingdom to facilitate research into the treatment and prevention of COVID-19. This paper reviews the literature on such issues by reflecting on the ethical principles that are applicable and identifying the arguments that have been mustered for and against human challenge studies in relation to COVID-19. It argues that, given the limited state of knowledge about the diverse and longer term risks from contraction of COVID-19, considerable care needs to be devoted to any assessment of the appropriateness of human challenge trials – either in relation to treatment for the virus or measures to prevent it.


Biography:

Ian Freckelton is a Queen’s Counsel in full-time practice throughout Australia. He is a Professorial Fellow in Law and Psychiatry at the University of Melbourne, an Adjunct Professor of Forensic Medicine at Monash University, a judge of the Supreme Court of Nauru, and a member of Victoria’s Coronial Council and the Bar Council of Victoria. He is a past bi-national and Victorian President of ANZAPPL. Ian is the Editor of the Journal of Law and Medicine and the Founding Editor and Editor-at-Large of Psychiatry, Psychology and Law. In 2021 he was made an Officer of the Order of Australia for distinguished service to law and the legal profession, including to health, medicine, and technology.

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