{"title":"Risky first-in-human clinical trials on medically fragile persons: owning the moral cost","authors":"Christopher Bobier","doi":"10.1007/s11017-024-09682-2","DOIUrl":null,"url":null,"abstract":"<p>The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry <i>significant</i> foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would be a bad deal for participants, and the research is considered justifiable because of the promise of significant potential social benefit. I argue that there is an ethical tension inherent in risky FIH research and that researchers should fairly compensate risky FIH trial participants. This does not make the risk–benefit outcome more favorable for participants; rather, it amounts to a collective reckoning with the ethical tension inherent in the research.</p>","PeriodicalId":46703,"journal":{"name":"Theoretical Medicine and Bioethics","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Theoretical Medicine and Bioethics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11017-024-09682-2","RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0
Abstract
The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry significant foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would be a bad deal for participants, and the research is considered justifiable because of the promise of significant potential social benefit. I argue that there is an ethical tension inherent in risky FIH research and that researchers should fairly compensate risky FIH trial participants. This does not make the risk–benefit outcome more favorable for participants; rather, it amounts to a collective reckoning with the ethical tension inherent in the research.
首次人体(FIH)临床试验的目的是收集有关药物或器械如何影响人体并与人体相互作用的信息:其安全性、副作用和(潜在)剂量。因此,FIH 试验的主要目的不是让参与者受益,而是了解药物或器械的疗效,即人体安全性基线知识。有些 FIH 临床试验会给参与者带来巨大的可预见风险,而几乎没有可预见的参与者获益。参与此类试验对参与者来说是一笔不划算的交易,而研究被认为是合理的,因为有望带来巨大的潜在社会效益。我认为,有风险的 FIH 研究本身就存在伦理矛盾,研究人员应该公平地补偿有风险的 FIH 试验参与者。这并不会使风险-收益结果对参与者更有利;相反,这相当于对研究中固有的伦理紧张关系进行集体清算。
期刊介绍:
AIMS & SCOPE
Theoretical Medicine and Bioethics examines clinical judgment and reasoning, medical concepts such as health and disease, the philosophical basis of medical science, and the philosophical ethics of health care and biomedical research
Theoretical Medicine and Bioethics is an international forum for interdisciplinary studies in the ethics of health care and in the philosophy and methodology of medical practice and biomedical research. Coverage in the philosophy of medicine includes the theoretical examination of clinical judgment and decision making; theories of health promotion and preventive care; the problems of medical language and knowledge acquisition; theory formation in medicine; analysis of the structure and dynamics of medical hypotheses and theories; discussion and clarification of basic medical concepts and issues; medical application of advanced methods in the philosophy of science, and the interplay between medicine and other scientific or social institutions. Coverage of ethics includes both clinical and research ethics, with an emphasis on underlying ethical theory rather than institutional or governmental policy analysis. All philosophical methods and orientations receive equal consideration. The journal pays particular attention to developing new methods and tools for analysis and understanding of the conceptual and ethical presuppositions of the medical sciences and health care processes.
Theoretical Medicine and Bioethics publishes original scholarly articles, occasional special issues on important topics, and book reviews.
Related subjects » Applied Ethics & Social Responsibility – Bioethics – Ethics – Epistemology & Philosophy of Science – Medical Ethics – Medicine – Philosophy – Philosophy of Medicine – Surgery