Department of Psychiatry, Columbia University, 1051 Riverside Dr, Unit 15, New York, NY 10032, USA.
J Med Ethics. 2013 Apr;39(4):224-9. doi: 10.1136/medethics-2011-100439. Epub 2012 Sep 14.
Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored.
I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members.
IRBs wrestled with defining of 'coercion' and 'undue inducement', most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on 'gut feelings', and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should 'get paid' versus 'volunteer' (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research.
These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research.
学者们一直在争论如何定义强制和不当影响，但机构审查委员会（IRB）在实际案例中如何看待和做出这些问题的决定尚未得到探讨。
我联系了 60 家美国 IRB 的领导层（按美国国立卫生研究院资助排名前 240 家机构名单中的每四家），并采访了其中 34 家机构的 39 名 IRB 领导或管理人员（回应率=55%）和 7 名成员。
IRB 就“强制”和“不当诱导”的定义进行了激烈的争论，尤其是在决定参与者补偿问题上。IRB 通常将这些术语同义使用，并以不同的方式定义不当诱导，经常在这些问题上纠结，依靠“直觉”，并寻求妥协。出现了模糊性，部分反映了潜在的紧张关系：受试者是否应该“获得报酬”还是“自愿”（即，受试者是否应该因补偿还是利他主义而受到激励），以及是否应该根据收入对受试者进行不同的报酬，考虑到可能导致的选择偏见。在不同的 IRB 之间甚至在单个 IRB 内部都出现了缺乏一致标准的情况。一些研究出现了问题，例如如何看待和权衡在研究中提供免费护理，招聘传单是否应该提及补偿，以及如何在儿科、发展中国家或学生研究中避免强制。
这些数据是首次深入探讨 IRB 如何看待和处理关于强制、不当影响和参与者补偿的问题，并检查 IRB 如何审查实际案例的，揭示了几个关键的模糊性和困境，对未来的实践、教育、政策和研究具有重要意义。
