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KMID : 1011120200130030027
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Bioethics Policy Studies
2020 Volume.13 No. 3 p.27 ~ p.60
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Ethics of Human Challenge trial for COVID-19 Vaccine Development: how can it be justified?
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Lee Kyung-Do
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Abstract
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Amid ongoing threats from COVID-19, developing an effective vaccine against COVID-19 is deemed to be, hopefully, the only means of dealing with those threats. To accelerate Coronavirus vaccine licensure, Human Challenge trial, in which researchers would deliberately expose Coronavirus to research participants with the purpose of assessing the effectiveness of vaccine candidates, has been proposed by Nir Eyal, Marc Lipsitch, and Peter Smith, as an alternative research design to conventional 3rd phase efficacy trial which usually takes a long period of time and needs to recruit, by and large, over thousands of participants. Despite common worries around Human Challenge trial for Coronavirus mostly grounded on traditional research ethics, such as those pointing out excessive harm to participants, no significantly effective treatment option, and exploitation, Nir Eyal et al. have claimed this research design is ethically justifiable. The main supporting points are the following: (1) vast social benefits, i.e. preventing millions of deaths by expediting vaccine development, should be taken into consideration properly; (2) secondary gains provided to each participant, e.g. access to health services of best quality and being prioritized in getting scarce medical resources, such as ventilators, should fall into the category of relevant “benefits” to participants, as primary gains, i.e. protective effects of vaccine candidates, obviously do, in order to prudentially and reasonably balance risks and benefits given to each research participant; (3) the risk of dying or acquiring severe adverse outcomes from Coronavirus infection, if research participants are recruited among those in 20s, seems not significant, about 0.2%, which is lower than 1% which major research ethicists have agreed to be one crude threshold of permissible risk; (4) compared to the level of risks which, if participants opt out from participating Human Challenge trials, status quo, research participants would be exposed to and the risks which, if research participants are recruited in conventional 3rd phase efficacy trials, research participants would be exposed to, the level of incremental risks imposed to participants in Human Challenge trials is not seriously higher, in some cases, may be even lower; (5) if research participants grant their consent of fairly good quality, it seems wrong for a state to forbid them, particularly those with purely altruistic goals, from participating in Human Challenge trials. Even though there can be several counterarguments finding Human Challenge trials as problematic, grounded on potential exploitation and the required level of informed consent, there are many practical ways to minimize their worries, such as, setting age limits of participants as 20s, excluding volunteers under extreme deprivation, and selecting geographical regions under severe pandemical threats of COVID-19 but without deeply entrenched injustice. Lastly, addressing distributive concerns and more population-wide approach in research ethics will be vastly needed to ensure fairness in later rollout of vaccines and articulate ethical research protocols of Human Challenge trials.
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KEYWORD
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Human Challenge Trial, COVID-19, vaccine development, research ethics, bioethics, Population-level Bioethics, risk appraisal, distributive justice
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