Abstract
Advances in genomic technology make possible the large-scale collection of genomic data for research purposes. Many international initiatives seek to collect genomic data on large populations, often relying on existing collections to populate their databases. As these efforts progress, the debate over whether or not to return individual genetic research results to study participants remains an area of much contention. Some recommend returning results to participants only if the issue was addressed in the original study consent form. Much of the data being used in current studies, however, may have been derived from biospecimens collected years ago with consent documents that did not anticipate the possibility of returning individual level genomic results. We conducted an analysis of informed consent documents from published genome-wide association studies (GWAS) (n=40) to explore whether future research use of biospecimens or data is anticipated, and if return of results is addressed and how it is described to better understand participants’ expectations for future disclosure. The majority (70%) of the GWAS consent documents we analyzed either stated explicitly that individual genomic results would not be returned or were silent on the issue. This has implications for how researchers and members of Research Ethics Committees manage the return of results from sequencing studies using legacy samples and data.
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Acknowledgements
This work was funded by support from the Baylor College of Medicine Clinical and Translational Research Program and the Baylor Annual Fund. ALM was supported by National Institutes of Health grant R21HG006612. We would like to thank Drs Steven Joffe, Rachel Ramoni, and Sharon Plon for their valuable contributions to this project. In addition, we thank Hayley Peoples for her research assistance on this paper.
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Pereira, S., Oliver Robinson, J. & McGuire, A. Return of individual genomic research results: what do consent forms tell participants?. Eur J Hum Genet 24, 1524–1529 (2016). https://doi.org/10.1038/ejhg.2016.76
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DOI: https://doi.org/10.1038/ejhg.2016.76
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