Controlled human infection with SARS-CoV-2 to study COVID-19 vaccines and treatments: bioethics in Utopia

Abstract

<jats:p>A number of papers have appeared recently arguing for the conclusion that it is ethically acceptable to infect healthy volunteers with severe acute respiratory syndrome coronavirus 2 as part of research projects aimed at developing COVID-19 vaccines or treatments. This position has also been endorsed in a statement by a working group for the WHO. The papers generally argue that controlled human infection (CHI) is ethically acceptable if (1) the risks to participants are low and therefore acceptable, (2) the scientific quality of the research is high, (3) the research has high social value, (4) participants give full informed consent, and (5) there is fair selection of participants. All five conditions are necessary premises in the overall argument that such research is ethically acceptable. The arguments concerning risk and informed consent have already been critically discussed in the literature. This paper therefore looks specifically at the arguments relating to condition 3 ‘high social value’ and condition 5 ‘fair selection of participants’ and shows that whereas they may be valid, they are not sound. It is highly unlikely that the conditions that are necessary for ethical CHI trials to take place will be fulfilled. Most, if not all, CHI trials will thus be well intentioned but unethical.</jats:p>

Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials

“…Together, these findings are inconsistent with expressed concerns that human challenge trials with the novel coronavirus would be “ prima facie unethical” because they would be expected to follow a “pattern of exploitative recruitment” 11 . Whereas human challenge trial recruitment could be viewed as inherently exploitative if it attracted volunteers who find participation “very attractive as a result of being in a socioeconomically disadvantaged position as a result of social injustice” 11 or whose volunteerism reflects “financial desperation, or a distorted understanding of the risks” 38 , our results indicate that such trials tend to attract volunteers who are primarily motivated by altruism and do not on the whole exhibit any indicators of socioeconomic or psychological vulnerability to exploitation.…”

“…By contrast, the risks and burdens of challenge trials—including infection-related risks, prolonged period of biocontainment and possible trial vaccine or treatment side effects—fall largely on volunteers 9 . These risks and burdens (which are heightened by uncertainty about COVID-19 disease outcomes) coupled with the absence of obvious direct benefits for volunteers have led some bioethicists to suggest that challenge trials using the novel coronavirus may be unethical 10,11,12 . Some commentators worry that challenge trials might attract volunteers who are vulnerable to undue inducement or problems understanding relevant risks, which might invalidate volunteers’ consent or result in their exploitation 13,14 .…”

“…We hypothesized that COVID-19 challenge trial volunteerism reflects heightened altruistic values and preferences. In light of concerns that challenge trials may attract participants who are unusually insensitive to risk or who are in dire economic need 10,11,17 , we also tested the alternate hypotheses that challenge trials attract participants who engage in elevated risk behaviors (including specifically health and safety related risk behaviors) or those who are economically or otherwise vulnerable to exploitation. Either of these issues could raise concerns about the ethical permissibility of trials, although trialists could still try to select for those intended volunteers who have accurate risk perceptions and no socioeconomic motivations.…”

For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development

“…Very little has been said so far in the literature about payment or other incentives to potential HCS volunteers (25,26). A misconception about immunological protection is only one of several such incentives, which could include monetary payments, a common inducement in HCS for other diseases.…”

Race, Power, and COVID-19: A Call for Advocacy within Bioethics

“…In one discussion on the ethics of challenge studies for COVID-19, Søren Holm largely agrees with the World Health Organization's (WHO) working group that "those whose background [health] risk is high as a result of social injustice should be excluded from participation because their inclusion could be considered unethical exploitation (i.e, taking advantage of those who have already been wrongly disadvantaged)." However, Holm also points out that WHO's definition is incomplete because social injustice does not only manifest in health-related background risks, but also in economic risks (Holm 2020). The more dire a participant's economic situation is, the more likely they will risk their health for monetary gain-which may then fall under the definition of exploitation.…”