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.
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.
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要注册还是不注册？
DOI：
10.1353/nib.2017.0019
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发表时间：
2017
影响因子：
--
通讯作者：
Abadie R
中科院分区：
文献类型：
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作者：
Abadie R
世界各地每年进行数十万项临床试验，致力于进一步加深科学知识并扩大医疗治疗。与此同时，临床试验也给研究人员带来了新的挑战，因为他们可以接触到大量的研究参与者，并且制药公司通常会与他们联系以招募临床试验受试者。本案例研究讨论了一名社区健康调查员所面临的道德困境，该调查员收到了邀请注射吸毒者（PWID）参加一项药物临床试验的邀请，该药物承诺为丙型肝炎提供新的治疗选择。作者详细阐述了他在“行善”和“避免伤害”之间面临的道德紧张关系。本文建议还应该考虑分配正义问题，特别是当正在测试的药物最终可能会收取超出参与试验的人群的价格时。该案例并不试图提供道德路线图来帮助处于类似情况的研究人员，而是说明在决定是否参与临床试验研究时涉及的一些考虑因素。
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.