Randomized informed consent

随机知情同意书

• 批准号: 8952846
• 负责人: Christine P Grady
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8952846
• 关键词: Complex; Comprehension; Consent; Consent Forms; Data; Elements; Enrollment; Ethics; Goals; Informed Consent; Institution; Institutional Review Boards; Participant; Patients; Process; Publishing; Questionnaires; Randomized; Reading; Regulation; Research; Research Personnel; Research Project Grants; Series; Testing; Time; Writing; healthy volunteer; randomized trial; satisfaction; volunteer

Informed consent is an important component of ethical research. Unfortunately, data show that research participants do not always understand key features of the research they participate in. At the same time, consent documents are increasingly becoming longer, more technical, and complex. This project aims to test a simpler, more concise consent form against the standard consent form in a variety of research projects. Both consent forms contain all the elements required by federal regulations, and are approved by an IRB. Participants in these trials are randomized to receive either the standard or the concise consent form and then asked to complete a questionnaire that tests their comprehension of study information and their satisfaction with the process. Our hypothesis is that comprehensionn will be similar in both groups and satisfaction higher in the group that receives the concise form. If the data support our hypothesis, investigators and institutions may be encouraged to write forms that are easier to read and shorter. Two studies with healthy volunteers are complete and published. The data from a third enrolling patient volunteers from around the world is being analyzed.

知情同意是道德研究的重要组成部分。 不幸的是，数据表明，研究参与者并不总是了解他们参与的研究的关键特征。与此同时，同意文件越来越长得更长，更具技术性和复杂性。 该项目旨在根据各种研究项目中的标准同意书来测试更简单，更简洁的同意书。两种同意书都包含联邦法规要求的所有要素，并由IRB批准。这些试验的参与者被随机分配以接收标准或简洁的同意书，然后要求完成一份问卷，以测试他们对研究信息的理解及其对过程的满意度。我们的假设是，在两组中，Consecensionn将相似，并且在接受简洁形式的组中的满意度更高。 如果数据支持我们的假设，则可能鼓励调查人员和机构编写更容易阅读和缩短的表格。 对健康志愿者的两项研究已完成和发表。 正在分析来自世界各地的第三名患者志愿者的数据。