Returning individual research results in international direct-to-participant genomic research: results from a 31-country study

Abstract

This paper summarizes the results of a 31-country qualitative study of expert perspectives on the regulation of international “direct-to-participant” (DTP) genomic research. We outline how the practice of directly recruiting participants for genomic studies online complicates ethics and regulatory considerations for the return of individual research results. As part of a larger project supported by the National Human Genome Research Institute, National Institutes of Health, we prepared and distributed to 31 global legal experts a questionnaire intended to ascertain opinions and perspectives on the way international DTP genomic research is likely to be regulated. We found significant disagreement across jurisdictions on the most favorable approach to managing such results, with some countries favoring return by default and others preferring to return only with the express consent of research participants. We conclude by outlining policy considerations that should guide researcher practices in this context. As international DTP genomic research evolves, jurists and ethicists should be attentive to the ways novel approaches to subject recruitment align with existing ethical and regulatory norms in research with human participants. This paper is a preliminary step toward documenting such alignment in the context of the return of individual research results.

Views of providers and clients on feedback and benefit sharing in studies using biological materials in Eldoret Kenya

“…It should also be clarified what role is played by specific people (researchers, sponsors) in implementing efficient feedback of results [8,30]. Furthermore, as we reflect on guidelines to support the release of individual results in any research, we must be cognizant of blurred aspects noted in the process of returning results [36][37][38]. For every new research project, each research team needs to make informed ethical and societal considerations for the return of individual results.…”

“…The results that are returned also require thorough analytic and clinical validity, and an effective communication plan to ensure all individual participants are reached and informed well. For many nations, there is a need to restructure the legal and regulatory landscape to support these efforts to return individual research results [8,[36][37][38].…”

Happy 30th birthday to the European Journal of Human Genetics!

“…Returning results from large scale genomic studies to participants is controversial. Lang et al discuss genetic issues around "direct to participant" genomic studies [11].…”