Feeding back of individual genomic results in Botswana: mapping opportunities and challenges

Purpose: We aimed to explore the views of stakeholders in Botswana involved in developing, implementing and applying ethical standards for return of individual study results from genomic research on feeding back individual genomic research results, thus mapping opportunities for and challenges regarding actionability requirements that could determine whether individual genomic research results should be fed back to participants. Methods: : Using in-depth interviews, we explored the views of sixteen (16) stakeholders involved in the conduct or regulation of genomic research in Botswana regarding what they thought were the opportunities for and challenges in feeding back individual genomic research results. We also deliberated on questions regarding whether the feedback of findings was necessary or not, whether only genomic results that have been verified in accredited diagnostic laboratories should be fedback and how important it is that participants who receive results have access to the interventions that would mediate the effects of the genomic findings. Coded data was analyzed through an iterative process of analytic induction to document and interpret themes. Results: Overall, respondents were of the view that feedback of actionable individual genomic results was an important outcome that could benefit participants. However, a number of themes surfaced that pointed to opportunities for and challenges that exist in Botswana regarding requirements for feedback of actionable results that were mapped. Some of the opportunities cited by the respondents included the existence of good governance; democracy and humanitarianism; universal healthcare system; national commitment to science; research and innovation to transform Botswana into a knowledge-based economy; and applicable standard of care which could promote actionability. On the other hand, contextual issues like the prerequisite for return of only genomic research results that have been validated in accredited laboratories, the high cost of validation of genomic results, and linkage to care, as well as lack of experts like genomic scientists and counselors were considered as challenges for return of individual results. Conclusion: We propose that decisions whether and which genomic results to return take into consideration contextual opportunities and challenges for actionability for return of results in a research setting. This is likely to avoid or minimize ethical issues of justice, equity and harm regarding actionability decisions.