{"title":"新冠肺炎人类挑战研究中的风险、收益和社会价值:历史背景下的大流行决策","authors":"Mabel Rosenheck","doi":"10.1007/s40592-022-00156-6","DOIUrl":null,"url":null,"abstract":"<p><p>During the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom's consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9200217/pdf/","citationCount":"0","resultStr":"{\"title\":\"Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.\",\"authors\":\"Mabel Rosenheck\",\"doi\":\"10.1007/s40592-022-00156-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>During the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom's consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts.</p>\",\"PeriodicalId\":43628,\"journal\":{\"name\":\"Monash Bioethics Review\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2022-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9200217/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Monash Bioethics Review\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s40592-022-00156-6\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/6/15 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Monash Bioethics Review","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40592-022-00156-6","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/6/15 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
Risk, benefit, and social value in Covid-19 human challenge studies: pandemic decision making in historical context.
During the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom's consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts.
期刊介绍:
Monash Bioethics Review provides comprehensive coverage of traditional topics and emerging issues in bioethics. The Journal is especially concerned with empirically-informed philosophical bioethical analysis with policy relevance. Monash Bioethics Review also regularly publishes empirical studies providing explicit ethical analysis and/or with significant ethical or policy implications. Produced by the Monash University Centre for Human Bioethics since 1981 (originally as Bioethics News), Monash Bioethics Review is the oldest peer reviewed bioethics journal based in Australia–and one of the oldest bioethics journals in the world.
An international forum for empirically-informed philosophical bioethical analysis with policy relevance.
Includes empirical studies providing explicit ethical analysis and/or with significant ethical or policy implications.
One of the oldest bioethics journals, produced by a world-leading bioethics centre.
Publishes papers up to 13,000 words in length.
Unique New Feature: All Articles Open for Commentary