Randomized informed consent

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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.