Description of the Research
The need to rapidly plan and implement a vaccine clinical research response to the emerging threat of Ebola virus disease 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 of the clinical research process in general, and of the PREVAIL study specifically, to ensure that potential subjects provided valid informed consent. Brainstorming alternatives to the long, text-heavy consent documents that serve as the standard for most clinical trials led our team to consider graphic presentation of relevant material. Cards produced by the Centers for Disease Control and Prevention (CDC) depicting Ebola control and prevention recommendations (e.g., safe burial practices, what to do when in contact with a sick person) were proposed as an example. The team initiated discussions with CDC National Center for Immunization and Respiratory Diseases staff to request guidance and initial assistance, based on CDC experience in Sierra Leone. CDC collaborators shared existing illustrations of study-specific draft pictorials. The team created an outline of main concepts to be captured in the guide, searched picture banks, 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 Liberian collaborators, CDC staff, and the study team members. Liberian collaborators provided invaluable guidance on verbiage and illustrations, which reflected Liberian cultural norms. For example, Liberian men do not wear white T-shirts that can be seen under their shirts, as they had been represented in an initial version of the illustrations.
The illustrations were submitted for IRB approvals and posted in the ‘consent room.’ Potential subjects reviewed flip book binders as part of the consent process. The consenting team member reviewed study information and requirements with the potential subject and obtained a signature or fingerprint on an abbreviated informed consent document. Liberian research staff and subjects responded well to the graphic aids, and they served as a useful tool in guiding the consent discussion.