Randomized informed consent

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参与的研究的关键特征。 与此同时，同意文件越来越长，越来越技术化和复杂化。 该项目旨在测试更简单，更简洁的同意书对各种研究项目的标准同意书。两份知情同意书均包含联邦法规要求的所有要素，并经IRB批准。这些试验的参与者随机接受标准或简明同意书，然后要求他们完成一份问卷，以测试他们对研究信息的理解和对过程的满意度。我们的假设是，理解将是类似的两组和满意度更高的一组，收到简洁的形式。 两项针对健康志愿者的研究和一项针对来自世界各地的4000名患者志愿者的研究已经完成并发表。接受标准表格的人和接受简明表格的人之间的理解没有差异。 鉴于我们的数据，研究人员和机构可能会被鼓励编写更容易阅读和更短的表格。 目前正在对同意书的变化进行进一步分析，并正在研究在同意过程中披露信息的新形式。

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.