Evidence-Based Improvement in the Consenting Process

这项拟议研究的目标是通过以下方式加强对人类主体的保护 以证据为基础改进知情同意程序。研究小组提出了一种 实现这一目标的三步走模式。首先，研究小组将设计和应用一份问卷，以评估参与者与临床研究相关的知识水平。受试者将从正在进行的研究中挑选出来，并在审查和签署同意书后立即被要求填写一份电脑辅助问卷。第二，获得的信息将提交给调查人员及其工作人员。该项目的具体目的是提高知情同意声明的清晰度，并改进相关的知情同意程序。这一点将通过显示标准程序中的弱点和建议加强同意程序的潜在改进来实现。最后，根据前两步的研究结果，研究小组将为调查人员和研究人员以及患者开发教育材料的内容。教育将包括举办研讨会，传播和讨论评估研究的结果，为研究人员和研究行政人员进行有针对性的演讲，并制作一份患者通讯和一段研究志愿者短片。预计大部分患者教育将包括关于潜在风险和好处的信息传播，以及患者在临床研究中的权利和责任。这个拟议的项目是建立在这样一个假设之上的，即收集这些信息和教育研究团队将改善对人类受试者的保护和道德待遇。我们致力于在本申请资金的项目期后继续开展教育活动。

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.