IRBs: Ethics, Context and Interpretations

描述（由申请人提供）： 我计划写一本书，探讨有关机构审查委员会（IRB）的几个关键和相关问题，这些问题越来越多地面临着关键的挑战，问题和困境。在塔斯基吉丑闻之后，为了保护人类受试者，IRB成立于1974年，已被证明是不一致和不一致的，采用不同的标准，并面临越来越多的挑战（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，促进社区和公众的信任。但批评者认为，IRB会延迟或阻碍招募&某些类型的研究，阻碍重要知识的获得，从而对抗可能试图“弯曲规则”的首席研究员（PI）。不道德的做法可能会造成伤害（例如，受试者死亡）和不信任，特别是在弱势群体中。这些问题对于艾滋病毒和其他快速发展的领域（例如，在发展中国家，美国资助的研究正在增加。最近，IRB受到了更多的学术关注，但大多数工作都是理论上的。我进行的采访表明，IRB深深植根于复杂的社会，监管，政治，制度，历史和科学背景。一些定量研究考察了IRB的后勤问题（例如，然而，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过IRB本身如何应对他们所面临的复杂需求、冲突以及社会和制度压力。本书的具体目的是提供一个框架，以审查几个问题，例如，1)IRB与PI的冲突，2）IRB之间的差异，3）改革的建议。要理解这些现象，就必须掌握IRB今天的功能：决策的内容和背景。我将探讨几个关键问题：1）IRB认为自己在决策内容方面面临哪些问题？(e.g.,他们如何衡量个人和社会的风险和利益，相互竞争的道德原则，以及对原则和法规的不同解释和应用）？2)IRB在决策背景方面面临哪些挑战（即，不断变化的社会、经济、体制和科学研究背景，例如，更多的多点研究，行业资助的试验，大学-行业合作，管理式医疗，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PI成本，以及不一致性），以及可能的变更（例如，集中的IRB或上诉程序）？4)上述对改善教育有何影响（例如，IRB，PI和政策制定者），IRB的做法和政策，以及在这一领域的未来研究？我采访了来自60多个IRB的深入主席和成员，以及其他关键利益相关者（例如，主要是在美国，以及在较小程度上在发展中国家。这本书，我在牛津大学出版社的编辑对出版非常感兴趣，将重点关注美国的IRB，尽管在发展中国家也探讨了这些问题，尽管程度较低。

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.