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，同意书也变得越来越长、越来越技术性、越来越复杂。这个项目的目的是在各种研究项目中测试更简单、更简洁的同意书和标准同意书。两份同意书都包含联邦法规要求的所有元素，并由IRB批准。这些试验的参与者随机接受标准同意书或简明同意书，然后要求他们完成一份调查问卷，以测试他们对研究信息的理解程度和对过程的满意度。我们的假设是，两组人的理解程度相似，接受简明形式的那组人的满意度更高。两项针对健康志愿者的研究和一项针对来自世界各地的4000名患者志愿者的研究已经完成并发表。接受标准形式和简明形式的人的理解没有区别。鉴于我们的数据，可以鼓励调查人员和机构编写更易于阅读和更简短的表格。目前正在对同意表格的变化进行进一步分析，并对在同意过程中披露信息的新形式进行研究。

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.