코비드19 백신 개발을 위한 인간 도전 시험의 윤리 : Nir Eyal의 논변을 중심으로
Ethics of Human Challenge trial for COVID-19 Vaccine Development: how can it be justified?
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현재 신종 코로나 바이러스의 전파를 대항할 수 있는 방안으로 그에 효과적인 백신 개발이 검토 되고 있다. 그러나 통상적으로 백신 개발은 그 절차가 복잡하며 시간이 길게 소요되어 현재 직면한 위 기를 빠르게 대항하기 힘들다는 지적을 받아왔다. 이에 대해 Nir Eyal 등은 병원체를 직접 연구 참여 자에게 노출시켜 그 병원체 노출에 대한 백신의 보호 효과를 더욱 효율적으로 탐구할 수 있게 하는 “인간 도전 시험(Human Challenge Trial)”을 백신 개발의 기간과 절차를 획기적으로 줄일 수 있는 대 안으로 제시했다. 그러나 인간 도전 시험은 신종 코로나 바이러스에 대한 효과적인 치료제가 없는 상 황에서 병원체 노출이 줄 수 있는 위험의 수준이 그 연구를 정당화하기에는 지나치게 크다는 지적을 받아왔다. 그러나 이에 대해 Nir Eyal 등은 다음과 같은 주장을 통해 이를 정당화했다. 첫째, 이 연구 를 통해 얻게 될 막대한 사회적 혜택은 분명히 이 연구의 윤리성을 판단하는 데에 적절히 고려되어야 한다. 둘째, 연구 참여자가 받을 직접적인 혜택(예. 백신의 효과)은 다소 미미할 수 있겠지만, 그들이 받게 될 부차적인 혜택(예. 최선의 의료 서비스 제공)까지 고려한다면 이들이 받을 혜택의 정도는 그 들이 받을 위험을 일부 정당화할 수 있는 정도이다. 셋째, 연구 참여자들에게 지워질 위험은 무시할 수 없는 수준이지만, 그들의 연령층을 20대로 제한한다면 그 치명률은 0.2%로 매우 낮을 것이며 이 는 기존 연구 윤리에서 거칠게 계산한 위험의 한계 수준인 1%를 다소 하회한다. 넷째, 연구에 참여하 지 않거나, 이 시험을 대체할 기존 유효성 검증 시험에 참여하는 경우 노출될 위험 수준과 비교했을 경우, 특히 그 연구 참여자들을 대유행의 위협에 크게 직면한 인구 집단에서 모집할 때, 인간 도전 시 험으로 인해 발생되는 추가적인 위험은 비교적 높은 수준이 아니다. 마지막으로, 연구 참여자들의 구 체적이고 자발적인 동의가 있다면, 그러한 위험을 감수하겠다는 결정을 사회가 금지할 이유가 부족하 며 이들의 이타적이고 숭고한 가치 추구는 윤리적으로 용납된다. 이에 대해 착취의 문제와 개인의 동 의 요건에 대한 여러 반론이 존재하나, 대부분 이를 고려하더라도 인간 도전 시험에 참여할 인구를 일부 제한함으로써 많은 부분이 해소되며, 특히 이러한 문제들에 대한 적절한 규제가 함께 이루어진다 면 인간 도전 시험이 윤리적으로 이루어질 가능성은 충분하다고 판단된다. 끝으로 이 논의는 백신 개 발 이후 분배정의 문제와 직, 간접적으로 연관되어 있으며 관련 논의를 통해 기존 연구윤리에서도 보 다 광범위한 인구 수준(population-level)의 관점이 필요하다는 주장을 덧붙인다.
Abstract
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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