Randomized informed consent

随机知情同意书

• 批准号: 10019967
• 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/10019967
• 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; 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 simpler, more concise consent forms against standard consent forms 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. Two studies with healthy volunteers and a study of 4000 patient volunteers from around the world are complete and published. Understanding did not differ between those who received the standard form and those who received a concise form. Given our data, investigators and institutions may be encouraged to write forms that are easier to read and shorter. Further analysis related to changes in consent forms is ongoing, as is research into new forms of disclosing information in the consent process.

知情同意是伦理研究的重要组成部分。 不幸的是，数据显示，研究参与者并不总是了解他们所参与研究的关键特征。与此同时，同意文件变得越来越长、技术性更强、也越来越复杂。 该项目旨在根据各种研究项目中的标准同意书测试更简单、更简洁的同意书。两份同意书均包含联邦法规要求的所有要素，并经 IRB 批准。这些试验的参与者被随机分配接受标准同意书或简明同意书，然后被要求填写一份调查问卷，以测试他们对研究信息的理解以及对过程的满意度。我们的假设是，两个组的理解力相似，并且接受简洁形式的组的满意度更高。 两项针对健康志愿者的研究和一项针对来自世界各地 4000 名患者志愿者的研究已经完成并发表。收到标准表格的人和收到简明表格的人之间的理解没有差异。 鉴于我们的数据，可能会鼓励研究人员和机构编写更易于阅读和更简短的表格。 与同意书变化相关的进一步分析正在进行中，对同意过程中信息披露新形式的研究也在进行中。