Informed consent without words

May 8, 2003  |  Steven Byers
6 Comment(s)

Investigators must obtain informed consent from human subjects before enrolling them in a clinical trial. This is usually done with a document and a conversation. The information conveyed has to do with risks and benefits, the concept that this is research and not treatment, compensation, and other elements required by regulation. The quality of the informed consent form varies tremendously – readability, reading level, clarity, and so on, and is the object of much review and discussion before the research is approved. My question is inspired by Dr. Tufte’s Bose product manual: Would it be possible to convey graphically the information, much of which is abstract, needed by a subject to give informed consent to participate in research? That is, with no or few words?