All of us in research are aware of the challenges with length and understandability of informed consent documents. In a new article found in the December issue of Anesthesiology News entitled “Uninformed Consent: Average Study Participant Likely Unaware of Risks,” the author shares a report of a study conducted by Dr. Swaminathan, associate professor of anesthesiology and director of perioperative echocardiography in the Division of Cardiothoracic Anesthesiology and Critical Care Medicine at Duke University School of Medicine, in Durham, N.C. The study analyzed a random sample of IRB approved consent forms. Five validated and standardized readability tests were used to analyze the consent forms that represented 15 studies.
A key quote from the article: “Everyone knows research consent forms are too long and complicated,” Dr. Tremaine (director of the Office of Human Research Protection at Mayo Clinic) told Anesthesiology News. “These results underscore the importance of using consent forms as only one part of the informed consent process for research.”
To read the full article and learn more, click here.