Coronavirus Human Infection Challenge Studies: Assessing Potential Benefits and Risks
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SYMPOSIUM: COVID-19
Coronavirus Human Infection Challenge Studies: Assessing Potential Benefits and Risks Euzebiusz Jamrozik
&
George S. Heriot & Michael J. Selgelid
Received: 18 May 2020 / Accepted: 11 August 2020 # Journal of Bioethical Inquiry Pty Ltd. 2020
Abstract Human infection challenge studies (HCS) have been proposed as a means to accelerate SARSCoV2 vaccine development and thereby help to mitigate a prolonged global public health crisis. A key criterion for the ethical acceptability of SARS-CoV2 HCS is that potential benefits outweigh risks. Although the assessment of risks and benefits is meant to be a standard part of research ethics review, systematic comparisons are particularly important in the context of SARS-CoV2 HCS in light of the significant potential benefits and harms at stake as well as the need to preserve public trust in research and vaccines. In this paper we explore several considerations that should inform systematic assessment of SARS-CoV-2 HCS. First, we detail key potential benefits of SARS-CoV-2 HCS including, but not limited to, those related to the acceleration of vaccine development. Second, we identify where modelling is needed to inform risk-benefit (and thus ethical) assessments. Modelling will be particularly useful in (i) comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological E. Jamrozik (*) : M. J. Selgelid Monash Bioethics Centre, Monash University, Melbourne, Australia e-mail: [email protected] E. Jamrozik Royal Melbourne Hospital Department of Medicine, University of Melbourne, Melbourne, Australia G. S. Heriot School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
conditions and (ii) estimating marginal risks to HCS participants in light of the background probabilities of infection in their local community. We highlight interactions between public health policy and research priorities, including situations in which research ethics assessments may need to strike a balance between competing considerations. Keywords Infectious disease . Human challenge studies . Controlled human infection model . Research Ethics . Risk . Background risk . Modelling . Coronavirus . COVID-19
Introduction Human infection challenge studies (HCS)—i.e., experiments involving the intentional infection of research participants—have improved scientific understanding and public health responses to multiple infectious diseases. In particular, HCS are a key method of accelerating or improving vaccine development, and HCS results have contributed to the recent licensure or approval of vaccines for cholera and typhoid (Jamrozik and Selgelid 2020a; Tacket et al. 1999; Jin et al. 2017). In response to the COVID-19 pandemic, challenge studies have been proposed as a means of accelerating the development of SARS-CoV-2 vaccines (Eyal et al. 2020; Plotkin and Caplan 2020; Schaefer et al. 2020). Novel research designs, particularly where such studies might be controversial as in the case of SARS-CoV-2 HCS,
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