Exploring the Consent Process: Perspectives of IRB Members and Rural Research Participants

探索同意程序：IRB 成员和农村研究参与者的观点

• 批准号: 0821751
• 负责人: Ann Cook
• 金额: $ 35.06万
• 依托单位: University of Montana
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0821751&HistoricalAwards=false
• 关键词: Exploring; Consent; Process; Perspectives; IRB

This research, co-funded by the Science, Technology & Society program and the EPSCoR program at NSF, examines the impacts of Institutional Review Board rulings on human subjects research. Research that advances scientific, engineering, biomedical, and technological knowledge often requires the participation of human subjects. In order to be enrolled in such research, subjects must give their voluntary and informed consent. Institutional Review Boards (IRBs) serve as the oversight bodies charged with ensuring that: risks to human subjects are minimized and reasonable, subject selection is equitable, and the informed consent documents are adequate. Yet little is known about how IRBs actually deliberate and perform these oversight functions, or about the extent to which the experiences, preferences and values of potential research subjects are incorporated into the IRB-approved informed consent process. Thus, it is not clear if the IRB oversight process for monitoring informed consent achieves its stated goal of ensuring protection and voluntarism of human subjects. This research examines the relationship between science and society as evidenced in the process of monitoring and obtaining informed consent from human subjects. The examination will focus on two distinct populations: IRB members and research participants. Using qualitative and exploratory methods, the first study examines the norms and processes that IRBs use when assessing and monitoring the adequacy of the informed consent process. The study will include representatives from a variety of current types of IRBs: academic, for-profit, hospital, and community boards. The second study examines the experiences, preferences and levels of understanding that research subjects bring to the informed consent process, focusing on human subjects from rural locations. The findings from these two efforts will bring together and compare the perspectives and levels of understanding of two key stakeholder groups. These findings will be widely disseminated in order to inform the development of a consent process that takes into account not only regulatory requirements, but also the information that prospective research participants need and want to know in order to offer true and voluntary consent.

这项研究由NSF的科学、技术与社会计划和EPSCoR计划共同资助，考察了机构审查委员会的裁决对人类受试者研究的影响。推进科学、工程、生物医学和技术知识的研究往往需要人类受试者的参与。为了参加这类研究，受试者必须自愿并知情同意。机构审查委员会(IRBs)是监督机构，负责确保：对人类受试者的风险最小化和合理，受试者的选择是公平的，知情同意文件是充分的。然而，对于研究所实际如何考虑和履行这些监督职能，或者潜在研究对象的经验、偏好和价值观在多大程度上被纳入IRB批准的知情同意程序，人们知之甚少。因此，目前还不清楚IRB监测知情同意的监督程序是否实现了确保保护和自愿保护人类受试者的既定目标。这项研究考察了科学和社会之间的关系，在监测和获得人类受试者知情同意的过程中得到了证明。考试将集中在两个不同的人群：IRB成员和研究参与者。第一项研究采用定性和探索性的方法，审查了IRBs在评估和监测知情同意程序的充分性时所使用的规范和程序。这项研究将包括来自当前各种类型的IRBs的代表：学术委员会、营利性委员会、医院委员会和社区委员会。第二项研究考察了研究对象为知情同意过程带来的经验、偏好和理解水平，重点是来自农村地区的人类受试者。这两项工作的结果将汇集并比较两个关键利益攸关方群体的视角和了解程度。这些调查结果将被广泛传播，以便为同意程序的发展提供信息，该程序不仅考虑到监管要求，而且考虑到预期研究参与者为了提供真正和自愿的同意而需要和希望知道的信息。