Evaluating the Effectiveness of an Illustrated Permission/Assent Form
- 182 Downloads
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.
KeywordsPictures Illustrations Consent Families Research
Sincere appreciation is extended to Mike Venneman, Linda Taloney, and Gabriela Flores who assisted with the coordination of this study; Rebecca Ballard for her thoughtful review of the project; and Dee Jo Miller for thoughtful discussions about the concept.
- 1.Bourgeois FT, Murthy S, Ioannidis JPA, et al. Clinical drug trials: a paucity of pediatric representation mismatched to global disease burden [abs]. Boston, MA: PAS meeting; 2012.Google Scholar
- 8.Travaline JM, Ruchinskas R, D’Alonzo GE. Patient–physician communication: why and how. J Am Osteopat Assoc Clin Practice. 2000;105:13–7.Google Scholar
- 17.Ryan C. Language use in the United States: 2011. U.S. Census Bureau. August 2013. https://www.census.gov/prod/2013pubs/acs-22.pdf. Accessed 5 Aug 2014.
- 18.Kirsch IS, Jungeblut A, Jenkins L, et al. Adult literacy in America. National Center for Education Statistics, U.S. Department of Education. April 2002. https://nces.ed.gov/pubs93/93275.pdf. Accessed 5 Aug 2014.
- 19.National Research Council. Responsible research: a systems approach to protecting research participants. Washington, DC: The National Academies Press; 2002. p. 123–7.Google Scholar
- 20.Protection of Human Subjects—Elements of Informed Consent, 21 C.F.R. pt. 50.25 (2011).Google Scholar
- 25.Ryan RE, Prictor MJ, McLaughlin KJ, et al. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2008; 1:CD00371.Google Scholar