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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

Susan M. Wolf ,
Emily Scholtes ,
Barbara A. Koenig ,
Gloria M. Petersen ,
Susan A. Berry ,
Laura M. Beskow ,
Mary B. Daly ,
Conrad V. Fernandez ,
Robert C. Green  and
Bonnie S. LeRoy
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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
Information
Journal of Law, Medicine & Ethics , Volume 46 , Issue 1: The Future of Informed Consent in Research & Translational Medicine: A Century of Law, Ethics & Innovation , Spring 2018 , pp. 87 - 109
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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