Developing procedural guidance for the return of individual pharmacogenomic research results in Uganda: “A Modified ADAPTE Approach”

<ns3:p>Background The ongoing debate on whether, how and to what extent results from genomic and genetic analyses should be returned to participants, raises an urgent need for contextualized guidance. This study sought to develop procedural guidance and a logical process for the return of individual pharmacogenomic to research participants. Methods We employed the ADAPTE (guideline development) process methodology, which was developed by a group of researchers, guideline developers, and guideline implementers for adaptation of existing guidelines to fit local cultural circumstances using an active, systematic and participatory approach. The guidance development involved three phases that included the set-up phase, adaptation phase and finalization phase. Following a search for guidance and other relevant literature related to the subject, the Human Heredity and Health in Africa guideline for feedback of individual genetic research findings for genomics research in Africa was selected and evaluated by a panel of multidisciplinary professionals. The panel suggested adaptation of the guideline by modifying specific recommendations to reflect the needs and preferences of people living with HIV involved in pharmacogenomic research in Uganda. Lastly, we sought feedback from thirty-two potential end-users of the guidance in the finalization phase of the guidance development. Results Throughout the three stages of the modified ADAPTE process, we developed a procedural guidance for the return of individual pharmacogenomic research results comprising three main phases; (i) the pre-study phase (protocol development phase), (ii) the feedback of individual results phase, and (iii) the post-feedback of individual results phase. Conclusion The developed procedural guidance contributes to the ongoing debates on how individual pharmacogenomics research results can be safely returned to research participants in a low-resource setting. We recommend further research to explore culturally appropriate strategies to enhance participants’ understanding of pharmacogenomic research information and the implications of these results.</ns3:p>