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Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia

Wednesday, September 16, 2015 — Poster Session I

3:30 p.m. – 5:00 p.m.
FAES Terrace
NIAID
RSCHSUPP-26

Authors

  • JF Pierson
  • SL Kopka
  • SM Albert
  • JP Meyer
  • TJ Miller

Abstract

The need to rapidly plan and implement a vaccine clinical research response to the emerging Ebola virus disease threat in West Africa provided the opportunity to develop a graphic aid to augment the informed consent process for the study “Partnership for Research on Ebola VAccines In Liberia – PREVAIL.” As an economically challenged country with limited existing clinical research infrastructure and an illiteracy rate of 57.1%, Liberia presented substantial obstacles to the informed consent process. Of primary concern was the ability to meaningfully convey the most important points to ensure that potential subjects provided valid informed consent. Brainstorming alternatives to the long, text-heavy consent documents that are the standard for most clinical trials led the NIAID team to consider graphic presentation of relevant material. The team outlined main concepts to be captured and engaged an illustrator to develop country-appropriate illustrations of each idea to be conveyed. Simple, concise text was drafted to provide relevant study details related to each illustration. Drafts were refined through reviews by domestic and international study team members. Liberian collaborators provided invaluable guidance on verbiage and illustrations, which reflected Liberian cultural norms. Potential subjects reviewed IRB-approved flip book binders as part of the consent process. The consenting team member reviewed study information and requirements with potential subjects and obtained a signature or fingerprint on an abbreviated informed consent document. Liberian research staff and subjects responded well to the graphic aids, which provided a useful tool in guiding the consent discussion.

Category: Research Support Services