Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form (Report‪)‬

Although informed consent is a fundamental ethical requirement for research with humans, many studies indicate that research volunteers often do not understand critical aspects of the research in which they are participating, suggesting that the "informed" part of consent to participate is imperfectly realized. (1) For instance, a study of 287 adult cancer patients participating in clinical trials revealed that 70% of patient-subjects did not recognize the unproven nature of the study drug. (2) At the same time, concerns have arisen that the increasing length and complexity of consent forms are inhibiting information disclosure and impeding understanding. (3) Consequently, critics worry that the informed consent process does not accomplish the goal of adequately informing prospective participants about the nature of a study and its potential risks and benefits. Several attempts at improving informed consent have been evaluated. (4) Some preliminary and small studies suggest that decreasing the length and complexity of consent forms may improve understanding, satisfaction with the informed consent process, or both. (5) However, not all studies found improvement. (6) Moreover, these studies have important limitations. Many used consent documents in hypothetical situations rather than in actual research studies. (7) Also, most of the consent studies involved participants who were receiving a study intervention for a disease or disorder (8) and thus may not apply to healthy volunteers who participate in phase I drug development research.