IRBs: Ethics, Context and Interpretations

IRB：道德、背景和解释

基本信息

批准号：
8144256
负责人：
ROBERT L KLITZMAN
金额：
$ 7.99万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2012-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8144256
关键词：
AIDS/HIV problem Address Adverse event Applications Grants Area Attention Behavior Behavioral Belmont Report Benefits and Risks Bible Books Boxing Cavia Cessation of life Clinical Trials Communities Complex Conflict (Psychology)Conflict of Interest Congresses Data Data Collection Data Set Decision Making Disease Economics Education Ensure Ethics Face Fostering Funding Future Genetic Genetic Research Grant HIV Health Individual Industry Industry Collaboration Informed Consent Institution Institutional Review Boards International Interview Knowledge Letters Light Literature Managed Care Manuals Medical Methods Participant Patients Pharmacologic Substance Police Policies Policy Maker Principal Investigator Process Protocols documentation Public Health Publishing Recommendation Recording of previous events Regulation Research Research Ethics Research Personnel Rights Role Scholarship Series Shapes Site Source Structure Study Subject Suggestion Syphilis System Testing Time Trust Typology Universities Variant Work Writing common rule comparative cost grasp human subject improved interest meetings member pressure prevent response social user-friendly

项目摘要

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.

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，这些委员会日益面临严峻的挑战、问题和困境。塔斯基吉丑闻发生后，IRB 于 1974 年成立，为了保护人类受试者，IRB 已被证明不一致且不一致，应用标准不同，并且面临着越来越多的挑战（例如，在临床试验方面）。理想情况下，IRB 审查可以促进研究、保护受试者并避免不必要的伤害，从而培养社区和公众的信任。然而批评者认为，IRB 可能会延迟或阻碍招募和某些类型的研究，阻碍重要知识的获取，从而激怒首席研究员 (PI)，后者可能会试图“违反规则”。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）以及美国资助的研究不断增加的发展中国家尤其重要。最近，IRB 受到了更多学术界的关注，但大部分工作都是理论上的。我进行的采访表明，IRB 深深植根于错综复杂的社会、监管、政治、制度、历史和科学背景中。一些定量研究探讨了 IRB 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 IRB 本身如何应对他们所面临的复杂要求、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来研究几个问题，例如，1）IRB 与 PI 面临的冲突，2）IRB 之间的差异，以及 3）改革建议。要理解这些现象，必须了解IRB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）IRB 认为自己在决策内容方面面临哪些问题？（例如，他们权衡个人和社会风险和利益的内容和方式、相互竞争的道德原则以及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（即改变研究的社会、经济、机构和科学背景，例如更多的多地点研究、行业资助的试验、大学与行业合作、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 成本和不一致）以及可能的变化（例如，集中式 IRB 或上诉流程）？ 4) 上述内容对于改善教育（例如 IRB、PI 和政策制定者的教育）、IRB 实践和政策以及该领域的未来研究有何影响？我深入采访了来自 60 多个 IRB 的主席和成员，以及其他主要利益相关者（例如 PI 和研究人员以及研究对象），这些利益相关者大部分来自美国，少数来自发展中国家。我在牛津大学出版社的编辑对出版这本书非常感兴趣，该书将重点关注美国的IRB，同时也会探讨发展中国家的这些问题，尽管程度较小。