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是否招募?:一位研究人员在决定让研究参与者参与一项可能挽救他们生命的临床试验时陷入挣扎。

To Enroll or Not to Enroll?: A Researcher Struggles with the Decision to Involve Study Participants in a Clinical Trial That Could Save Their Lives.

作者信息

Abadie Roberto

出版信息

Narrat Inq Bioeth. 2017;7(1):71-77. doi: 10.1353/nib.2017.0019.

DOI:10.1353/nib.2017.0019
PMID:28713147
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5568791/
Abstract

Hundreds of thousands of clinical trials are conducted annually around the world, working to further scientific knowledge and expand medical treatment. At the same time, clinical trials also present novel challenges to researchers who have access to large pools of research participants and are routinely approached by pharmaceutical companies seeking to recruit subjects for clinical trials. This case study discusses the ethical dilemmas faced by a community health investigator who received an invitation to enroll people who inject drugs (PWID) into a clinical trial of a drug that promised a new treatment option for Hepatitis C. The author elaborates on the ethical tensions that he confronted between "doing good" and "avoiding harm. The paper suggests that issues of distributive justice should also be considered, particularly when the drugs being tested might eventually command prices that place them out of reach of the population enrolled in the trial. This case does not attempt to provide an ethical road map to assist researchers in similar circumstances, but rather to illustrate some of the considerations involved in making a decision about whether or not to participate in clinical trials research.

摘要

全球每年都会开展数十万项临床试验,致力于增进科学知识并拓展医学治疗方法。与此同时,临床试验也给研究人员带来了新的挑战,他们能够接触到大量研究参与者,制药公司也经常找上门来,希望他们为临床试验招募受试者。本案例研究探讨了一位社区健康调查员所面临的伦理困境,该调查员收到邀请,要将注射毒品者纳入一种有望为丙型肝炎提供新治疗方案的药物的临床试验。作者详细阐述了他在“做好事”和“避免伤害”之间所面临的伦理冲突。本文认为,还应考虑分配正义问题,尤其是当所测试的药物最终定价可能使参与试验的人群无力承担时。本案例并非试图提供一份伦理路线图来帮助处于类似情况的研究人员,而是为了说明在决定是否参与临床试验研究时所涉及的一些考量因素。

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Social Determinants of HIV/HCV Co-Infection: A case Study from People Who Inject Drugs in Rural Puerto Rico.艾滋病毒/丙型肝炎病毒合并感染的社会决定因素:来自波多黎各农村地区注射吸毒者的案例研究。
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World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects.世界医学协会《赫尔辛基宣言》。涉及人类受试者的医学研究伦理原则。
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Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research.区分研究与治疗:一种分析临床研究伦理的系统方法。
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