Abstract
Human infection challenge studies (HCS) have been proposed as a means to accelerate SARS-CoV2 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 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: Background risk; COVID-19; Controlled human infection model; Coronavirus; Human challenge studies; Infectious disease; Modelling; Research Ethics; Risk.
【저자키워드】 COVID-19, coronavirus, risk, modelling, Infectious disease, Background risk, Controlled human infection model, Human challenge studies, Research Ethics, 【초록키워드】 public health, SARS-CoV-2, Vaccine, Vaccine development, SARS-CoV2, Trial, Vaccines, Human, Infection, Health policy, risk, Local, Infectious disease, Health crisis, Research Ethics, Probability, comparison, Research, Community, epidemiological, assessment, acceleration, Interaction, balance, not limited, assessments, global public health, help, human infection, participant, criterion, potential benefits, second, mitigate, benefit, highlight, identify, condition, potential benefit, Controlled, competing, accelerate, 【제목키워드】 coronavirus, Human, challenge, Potential, Assessing,