Advancing Informed Consent for Vulnerable Populations

Informed consent is essential for the conduct of ethical biomedical research.1 Despite its importance, obtaining informed consent is often a complex process, which raises concerns about the extent to which participants are truly informed. Effective implementation is especially difficult among research participants who have limited health literacy. Often, these potential participants are from traditionally high-risk groups, including underrepresented minorities and children. With this in mind, we suggest an innovative approach that uses low health-literacy communication strategies and visual aids to augment and potentially replace the traditional approach to informed consent. The tension is clear. To provide a comprehensive review of the proposed research, the informed consent document and process are often lengthy, complex, and burdensome.2 Consequently, research participants who sign or verbalize consent often do so without truly understanding the form that they are being asked to sign. In a recent systematic review, participants in one-third of trials assessed did not have adequate understanding in the areas of risks, benefits, randomization, study aims, withdrawal, and voluntarism.3 There are no clear standards for “how much” understanding is adequate. Furthermore, we know that lower education levels, lower literacy, and a participant’s primary language are all associated with poor comprehension of the informed consent process.4 These issues are particularly important when studies are being done in children, adding an additional dimension to vulnerable populations. Our approach was developed as a part of an ongoing randomized controlled trial (RCT) designed to prevent … Address correspondence to William Heerman, MD, MPH, Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Fl, Nashville, TN 37212. E-mail: bill.heerman{at}vanderbilt.edu