The return of individual findings in genetic research can raise tricky ethical questions. Do participants want to receive their results (given their potential impact upon insurance cover if an individual is genetically deemed to be at risk of a disease). How should results be returned (to protect the privacy of individuals and to mitigate risk). Balanced against personal choice and risk minimisation factors (e.g. could an individual reduce their risk if they made changes to their lives). Different jurisdictions can have different policy settings: default return or not to return – perhaps with guidance on the ethical considerations. For multi-jurisdiction projects, researchers must be aware of and adhere to those requirements. This variation can create additional complexity for single ethical review and reciprocity in reviews between sites. We have included links to four related items.
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.
Lang, M., Zawati, M.H. (2022) Returning individual research results in international direct-to-participant genomic research: results from a 31-country study. European Journal of Human Genetics.
Publisher (Open Access): https://www.nature.com/articles/s41431-022-01103-z