Dissertation Research: Research Ethics and Public Values Decision-Making: Implications for Human Subject Review

该SDEST论文研究改进补助金旨在解释美国六所研究型大学机构研究委员会（IRB）的决策过程，并将IRB结构和流程与其效率和有效性联系起来。在许多科学和技术领域，人类受试者问题提出了平衡研究参与者和社会的风险和利益的基本问题。IRB的建立是为了确保在涉及人类参与者的研究实施中的道德标准，它由来自研究机构和社区的科学家和非科学家组成。他们可以批准、修改或禁止研究方案。在美国有超过1,800个IRB，有各种各样的结构、过程和制度背景。虽然最近的研究已经检查IRB的工作量和效率，系统的理论驱动的实证研究是缺乏对成员的不同组成的影响，以及IRB的决策如何从机构到机构的变化。本研究将主要通过对来自研究型大学样本的IRB成员的个人访谈，研究IRB组成与人类受试者决策过程的关系。透过政策研究的跨学科透镜，本研究将有助于基于决策理论、科学技术研究、风险理论和参与分析的IRB决策模型的发展。

This SDEST dissertation research improvement grant intends to explain the decision-making process of Institutional Research Boards (IRBs) at six U.S. research universities and to relate IRB structures and processes to their efficiency and effectiveness. In many areas of science and technology, human subjects issues raise fundamental questions about balancing risks and benefits to research participants and to society. Established to ensure ethical standards in the implementation of research that involves human participants, IRBs consist of groups of scientists and nonscientists, from the research institution and the community. They can approve, alter, or prohibit research protocols. Over 1,800 IRBs exist in the U.S., with a variety of structures, processes, and institutional contexts. While recent studies have examined IRB workloads and efficiency, systematic theory-driven empirical research is lacking on the effects of varying compositions of membership and on how IRB decision-making varies from institute to institute. This research will examine the relationship of IRB composition with human subjects decision processes, primarily via personal interviews with IRB members from a sample of research universities. Through the interdisciplinary lens of policy studies, this research will contribute to the development of an IRB decision-making model based on decision theory, science and technology studies, risk theory, and participatory analysis.