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Evaluating the Effectiveness of an Illustrated Permission/Assent Form

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Journal of Immigrant and Minority Health Aims and scope Submit manuscript

Abstract

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.

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Acknowledgments

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.

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Authors and Affiliations

  1. Division of Clinical Pharmacology and Therapeutic Innovation, Children’s Mercy Hospital, 2401 Gillham Rd., Kansas City, MO, 64108, USA

    Susan M. Abdel-Rahman

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  1. Susan M. Abdel-Rahman
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Correspondence to Susan M. Abdel-Rahman.

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Abdel-Rahman, S.M. Evaluating the Effectiveness of an Illustrated Permission/Assent Form. J Immigrant Minority Health 17, 1504–1508 (2015). https://doi.org/10.1007/s10903-014-0116-6

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  • DOI: https://doi.org/10.1007/s10903-014-0116-6

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