{"title":"公共卫生突发事件期间的研究伦理义务:COVID-19 大流行的启示。","authors":"Mariana Barosa, Euzebiusz Jamrozik, Vinay Prasad","doi":"10.1007/s11019-023-10184-6","DOIUrl":null,"url":null,"abstract":"<p><p>In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise-i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention-has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions.</p>","PeriodicalId":47449,"journal":{"name":"Medicine Health Care and Philosophy","volume":" ","pages":"49-70"},"PeriodicalIF":2.3000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10904511/pdf/","citationCount":"0","resultStr":"{\"title\":\"The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic.\",\"authors\":\"Mariana Barosa, Euzebiusz Jamrozik, Vinay Prasad\",\"doi\":\"10.1007/s11019-023-10184-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise-i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention-has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions.</p>\",\"PeriodicalId\":47449,\"journal\":{\"name\":\"Medicine Health Care and Philosophy\",\"volume\":\" \",\"pages\":\"49-70\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10904511/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medicine Health Care and Philosophy\",\"FirstCategoryId\":\"98\",\"ListUrlMain\":\"https://doi.org/10.1007/s11019-023-10184-6\",\"RegionNum\":2,\"RegionCategory\":\"哲学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/12/28 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Medicine Health Care and Philosophy","FirstCategoryId":"98","ListUrlMain":"https://doi.org/10.1007/s11019-023-10184-6","RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/12/28 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ETHICS","Score":null,"Total":0}
The Ethical Obligation for Research During Public Health Emergencies: Insights From the COVID-19 Pandemic.
In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise-i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention-has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions.
期刊介绍:
Medicine, Health Care and Philosophy: A European Journal is the official journal of the European Society for Philosophy of Medicine and Health Care. It provides a forum for international exchange of research data, theories, reports and opinions in bioethics and philosophy of medicine. The journal promotes interdisciplinary studies, and stimulates philosophical analysis centered on a common object of reflection: health care, the human effort to deal with disease, illness, death as well as health, well-being and life. Particular attention is paid to developing contributions from all European countries, and to making accessible scientific work and reports on the practice of health care ethics, from all nations, cultures and language areas in Europe.