Evidence-Based Improvement in the Consenting Process

知情同意过程中的循证改进

• 批准号: 6591608
• 负责人: Barton W. Palmer
• 金额: $ 10万
• 依托单位: VETERANS MEDICAL RESEARCH FDN/SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591608
• 关键词: computer data analysis; computer program /software; data management; education evaluation /planning; educational resource design /development; ethics; health science research support; human rights; information systems; informed consent; questionnaires; statistics /biometry

The goal of this proposed research is to enhance the protection of human subjects through evidence-based improvement of the informed consent process. The research team proposes a three-step model to achieve this goal. First, the research team will design and apply a questionnaire to assess participants' level of knowledge pertinent to clinical research studies. Subjects will be selected from ongoing studies and will be asked to complete a computer-aided questionnaire immediately following the review and signing of their consent form. Second, the information obtained will be presented to the investigators and their staff. It is the specific aim of this project to enhance the clarity of informed consent statements and to improve associated informed consent processes. This will be achieved by showing weaknesses in the standard process and by suggesting potential improvements for an enhanced consent process. Finally, based on the findings of the previous two steps, the research team will develop the content of educational materials for investigators and research staff, as well as patients. Education will include seminars to disseminate and discuss the results of the assessment study, targeted talks for research staff and research administrators, and the development of a patient newsletter and a short research volunteer video. It is anticipated that much of the patient education will include information dissemination on the potential risks and benefits; and patients' rights and responsibilities in clinical studies. This proposed project is build upon the hypothesis that gathering this information and educating research teams will improve the protection and ethical treatment of human subjects. We are committed to continue educational activities beyond the project period of this request for funding.

这项拟议研究的目标是通过以下方式加强对人类受试者的保护： 基于证据的知情同意过程的改进。研究小组提出了一个 三步走模型来实现这一目标。首先，研究团队将设计并应用问卷来评估参与者对临床研究的知识水平。受试者将从正在进行的研究中选出，并在审查和签署同意书后立即要求填写计算机辅助调查问卷。其次，获得的信息将提交给调查人员及其工作人员。该项目的具体目标是提高知情同意声明的清晰度并改进相关的知情同意流程。这将通过显示标准流程中的弱点并提出增强同意流程的潜在改进建议来实现。最后，根据前两步的研究结果，研究团队将为研究者、研究人员以及患者开发教育材料的内容。教育将包括传播和讨论评估研究结果的研讨会、针对研究人员和研究管理人员的有针对性的演讲，以及制作患者通讯和研究志愿者短片。预计大部分患者教育将包括有关潜在风险和益处的信息传播；以及患者在临床研究中的权利和责任。该拟议项目建立在这样的假设之上：收集这些信息并教育研究团队将改善对人类受试者的保护和道德待遇。我们致力于在本次资金申请的项目期限结束后继续开展教育活动。