Evaluating the Effectiveness of an Illustrated Permission/Assent Form.

Issues of language and literacy represent a significant barrier to participation in clinical research. This study was designed to explore whether illustrating the permission/assent (P/A) document offers an alternative strategy for communicating study related information to underserved populations. Participants were verbally introduced to a mock study and asked to review the corresponding P/A form with companion pictorials. Questionnaires were used to examine whether the form addressed essential elements of a P/A (as defined under the Code of Federal Regulations) and evaluate the effectiveness of the companion pictures. Over 93% of participants agreed that the form addressed the required basic elements of a P/A. Pictures depicting study procedures were highly effective while images depicting nebulous concepts such as research and voluntariness were deemed less effective. The medical research community can expand enrollment opportunities to underserved populations by using visual aids to complement the informed consent process.