IRBs: Ethics, Context and Interpretations

描述(由申请人提供)： 我计划写一本书，探讨与机构审查委员会(IRBs)相关的几个关键问题，这些委员会越来越面临严峻的挑战、问题和困境。IRBs成立于1974年，在塔斯基吉丑闻之后成立，旨在保护人类受试者，已被证明是不一致和不一致的，应用不同的标准，面临着越来越多的挑战(例如，关于临床试验)。理想情况下，IRB审查可以促进研究，保护受试者，避免不必要的伤害，培养社区和公众的信任。然而，批评人士认为，IRBs可能会推迟或阻碍招募人员&某些类型的研究，阻碍重要知识的获得，从而激怒首席调查员(PI)，他们可能会试图“变通规则”。不道德的做法可能造成伤害(例如，受试者死亡)和不信任，特别是在脆弱的社区。这些问题对于艾滋病毒和其他快速发展的领域(例如遗传学)尤其重要，在发展中国家，美国资助的研究正在增加。最近，IRBs受到了更多的学术关注，但这些工作大多是理论上的。我进行的采访表明，IRBs深深植根于错综复杂的社会、监管、政治、体制、历史和科学背景中。一些定量研究研究了关于IRBs的后勤问题(例如，组成)，但几乎没有定性数据探讨这些复杂的问题。没有一本书系统地研究了IRBs本身是如何应对它们面临的复杂需求、冲突以及社会和制度压力的。这本书的具体目的是为审查几个问题提供一个框架，例如，1)IRBs面临的与PI的冲突，2)IRb之间的差异，以及3)改革的建议。要理解这些现象，必须掌握IRBs在当今的运作方式：决策的内容和背景。我将探讨几个关键问题：1)IRBs认为自己在决策内容方面面临哪些问题？(例如，他们如何权衡个人和社会的风险和利益，相互竞争的伦理原则，以及对原则和法规的不同解释和应用)？2)IRBs在决策的背景下面临什么挑战(即，改变研究的社会、经济、机构和科学背景，例如，更多的多站点研究、行业资助的试验、大学与行业合作、管理性医疗和研究“丑闻”)？3)IRB如何看待和解决这些问题和批评(例如，IRB审查的PIs的成本，以及不一致)，可能的变化(例如，集中化的IRBs或上诉程序)？4)上述内容对改进教育(例如，IRB、PI和政策制定者)、IRB实践和政策以及该领域未来的研究有何影响？我深入采访了来自60多个IRBs的主席和成员，以及其他关键的利益相关者(例如，PI和研究人员，以及研究对象)，主要在美国，其次是发展中国家。我在牛津大学出版社的编辑对出版这本书非常感兴趣，该书将聚焦于美国的IRBs，尽管在较小程度上也探讨了发展中国家的IRBs问题。

DESCRIPTION (provided by applicant): I plan to write a book exploring several crucial & related issues concerning Institutional Review Boards (IRBs), which have increasingly been facing critical challenges, problems & dilemmas. Established in 1974, following the Tuskegee scandal, to protect human subjects, IRBs have been shown to be inconsistent & discrepant, applying standards differently, & are facing mounting challenges (e.g., concerning clinical trials). Ideally, IRB review can abet research, protecting subjects, & avoiding unnecessary harms, fostering trust of communities & the public. Yet critics argue that IRBs can delay or impede recruitment & some kinds of research, hampering attainment of important knowledge, thus antagonizing Principal Investigators (PIs) who may then try to "bend the rules". Unethical practices can cause harms (e.g., death of subjects), & distrust, especially in vulnerable communities. These issues are particularly important with HIV, & other rapidly evolving areas (e.g., genetics), & in the developing world, where US-funded research is increasing. Recently, IRBs have been receiving more scholarly attention, but most of this work has been theoretical. Interviews I have conducted suggest that IRBs are deeply embedded in intricate social, regulatory, political, institutional, historical & scientific contexts. A few quantitative studies have examined logistical issues about IRBs (e.g., composition), but almost no qualitative data have explored these complex issues. No book has systematically examined how IRBs themselves grapple with the complex demands, conflicts, & social & institutional pressures they confront. The specific aims of this book are to provide a framework for examining several issues, e.g., 1) conflicts IRBs face with PIs, 2) variations between IRBs, & 3) suggestions for reform. To understand these phenomena, it is essential to grasp how IRBs function today: the contents & contexts of decisions. I will explore several key questions: 1) What problems do IRBs see themselves as facing regarding the contents of decisions? (e.g., what & how they weigh individual & social risks & benefits, competing ethical principles, & varying interpretations & applications of principles & regulations)? 2) What challenges do IRBs face regarding the contexts of decisions (i.e., shifting social, economic, institutional & scientific contexts of research, e.g., more multi-site studies, industry-funded trials, university-industry collaborations, managed care, & research "scandals")? 3) How do IRBs view & address these problems & criticisms (e.g., costs to PIs of IRB review, & inconsistencies), & possible changes (e.g., centralized IRBs, or appeals processes)? 4) What are the implications of the above for improving education (e.g., of IRBs, PIs, & policy-makers), IRB practices & policies, & future research in this area? I have interviewed in-depth chairs & members from over 60 IRBs, & other key stakeholders (e.g., PIs & research staff, & study subjects), mostly in the US, & to a lesser extent in the developing world. The book, which my editor at Oxford University Press is extremely interesting in publishing, will focus on IRBs in the US, though exploring these issues, though to a lesser degree, in the developing world as well.