EPISTEMOLOGY AND ETHICS OF QUALITY IMPROVEMENT

这次研究会议将于2001年12月8日至9日举行，将研究和开发一个框架，以阐明质量改进工作所产生的认识论和伦理困境，以建议目前保护人类研究对象的过程和程序是否适当地应用于质量改进工作。具体目标是： 1.阐明关于可从质量改进工作中获得的知识的性质以及评估其有效性的标准的主要论点。 2.检查QI的潜在风险、益处和危害，并确定QI工作的执行需要哪些级别的好处，以及哪些级别的风险是可以接受的。 3.确定QI工作中出现的隐私问题和知情同意考虑事项。 4.确定质量改进的概念、伦理和经验层面的优先研究领域，特别是在与保护人类受试者有关的QI监管方面具有特殊重要性的领域。 这次邀请性会议的大约30名参与者将包括：临床研究人员；卫生服务研究人员；人类学、定性社会学和教育创新方面的研究人员；从事QI工作的医疗、护理和专职卫生专业人员；在QI项目中担任监督角色的医务管理人员；风险管理者；IRB成员；伦理学家；患者权益倡导者；以及政府代表(例如AHRQ)。为了制定会议议程，最后确定发言者名单，并概述将在受邀文件中讨论的概念性问题，规划委员会将于2000年7月15日在弗吉尼亚州阿灵顿的兰德办公室举行会议。将委托讨论四篇论文和文献综述，作为会议议程的一部分。会议结束后，乔安妮·林恩医学博士、马萨诸塞州布鲁斯·詹宁斯博士、梅丽莎·M·博特雷尔博士、公共卫生硕士、博士和规划委员会的其他成员将准备一份综合会议对具体问题和方法的见解的手稿。这份手稿将提交给专业期刊，并在万维网上提供。在与生物伦理和研究监管有关的专业会议上，将至少做一次陈述。

This research conference, to be held December 8-9, 2001, will examine and develop a framework for articulating the epistemology of and ethical dilemmas produced by quality improvement (QI) efforts so as to suggest if current processes and procedures for protecting human research subjects are appropriately applied to QI work. The specific aims are to: 1. Articulate the major arguments about the nature of the knowledge that can be gained from quality improvement efforts and standards for assessing its validity. 2. Examine the potential risks, benefits and harms of QI and determine what levels of benefit are necessary, as well as what levels of risk are acceptable, for the performance of QI work. 3. Identify privacy concerns and informed consent considerations that arise from QI work. 4. Identify priority areas for research on the conceptual, ethical and empirical dimensions of quality improvement especially in areas that have specific importance in the regulation of QI with respect to protection of human subjects. The approximately 30 participants at the invitational conference will include: clinical researchers; health services researchers; researchers in anthropology, qualitative sociology and educational innovation; medical, nursing and allied health professionals engaged in QI; medical administrators with oversight roles in QI projects; risk managers; IRB members; ethicists; patient advocates; and government representatives (e.g. AHRQ). To develop the conference agenda, finalize the list of speakers and outline the conceptual issues to be discussed in the invited papers, a meeting of the planning committee will be held on July 15, 2000 at RAND offices in Arlington, VA. Four papers and a review of the literature will be commissioned for discussion as part of the conference agenda. After the conference, a manuscript synthesizing the conference insights on specific questions and methodological approaches will be prepared by Joanne Lynn, MD, Bruce Jennings, MA, Melissa M. Bottrell, MPH, PhDc, and other members of the planning committee. The manuscript will be submitted to professional journal and be made available on the World Wide Web. At least one presentation will be made at a professional meeting concerned with bioethics and research regulation.