COMMUNICATING ELSI ISSUES IN NEUROBIOBANKING AND STROKE GENOMIC RESEARCH IN AFRICA: PROJECT INTERVENTION TOOLS DEVELOPMENT AND EVALUATION PROCEDURES

Activities about appropriate community engagement and communication of research outcomes with stakeholders have received the attention of scholars in different sub-fields of clinical research. However, given its novel nature, especially in Sub-Saharan Africa, community engagement addressing the ethical, legal, and social implications (ELSI) of neurobiobanking and stroke genomic research has not received much scholarly attention. Therefore, this study was designed to report the procedures for developing and evaluating intervention tools for the community engagement component of the African Neurobiobank for Precision Stroke Medicine ELSI Project. A community-based participatory research design was adopted to develop three intervention tools. An adapted Doak and Doak's Suitability Assessment Measure (SAM), the Agency for Healthcare Research and Quality (AHRQ) Patient Education Materials Assessment Tool (PEMAT), and semi-structured interview questions based on Willis’ Cognitive Interviewing Techniques were used to evaluate the suitability, actionability, understandability and cultural appropriateness of the tools. PEMAT mean percentage scores of 71.4% for actionability and 82.4% for understandability, and a SAM suitability score of 67.9% were reported for the videos. Identified weaknesses captured in seven thematic areas after analysis of assessment by experts and community members guided the final refinement of the tools. The overall reviewers’ reports and evaluation scores indicate that, generally, the intervention tools are suitable for community deployment in the sub-Saharan African setting. Clinical researchers must clearly define their policy objectives, partner with key stakeholders, define desired behaviour change, and develop appropriate strategies, tools of engagement and communication channels.