Author:
Wolf Susan M.,Scholtes Emily,Koenig Barbara A.,Petersen Gloria M.,Berry Susan A.,Beskow Laura M.,Daly Mary B.,Fernandez Conrad V.,Green Robert C.,LeRoy Bonnie S.,Lindor Noralane M.,O'Rourke P. Pearl,Breitkopf Carmen Radecki,Rothstein Mark A.,Van Ness Brian,Wilfond Benjamin S.
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.
Publisher
Cambridge University Press (CUP)
Subject
Health Policy,General Medicine,Issues, ethics and legal aspects
Reference36 articles.
1. 29. U.S. Department of Health and Human Services (DHHS), Protection of Human Subjects, Requirements for Permission by Parents or Guardians and for Assent by Children, supra note 28.
2. “Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine,”;Green;American Journal of Human Genetics,2016
3. 26. Id., at 450.
4. 21. Jarvik et al., supra note 15.
5. 23. Wolf et al., supra note 1. See also note 8, supra.
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