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Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants

Published online by Cambridge University Press:  01 January 2021

Abstract

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research (CSER) Consortium. The authors then negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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Footnotes

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Note: Authors are listed alphabetically after the three Principal Investigators and Research Assistant.

References

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As we stated in our prior paper, “In different contexts, the representative may vary. A Legally Authorized Representative (LAR), Executor, Next-of-Kin, Spouse or Partner, or Parent/Guardian may qualify, depending on applicable federal and state law. HIPAA uses the term ‘personal representative’ to refer to the authorized representative, including after the participant's death.” Wolf et al., supra note 1, at 460. For further discussion, see id., at 441, 443-44, 449, 460, 461 n. 15.Google Scholar
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This project participated in the CSER1 Consortium, whose website was at <https://cser-consortium.org/>. This is now the website for the follow-on CSER2 Consortium, but includes CSER1-generated resources. For a description of the work of the CSER1 Consortium, see Green, R. C. et al., “Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine,” American Journal of Human Genetics 98, no. 6 (2016): 10511066. For a description of CSER2, see National Human Genome Research Institute (NHGRI), Clinical Sequencing Evidence-Generating Research (CSER2), at <https://www.genome.gov/27546194/clinical-sequencing-exploratory-research-cser/> (last visited October 27, 2017).Google Scholar
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