Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics

for the LawSeq Framework Task Force

doi:10.1177/1073110520916996

Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics

for the LawSeq Framework Task Force

Research output: Contribution to journal › Article › peer-review

12 Scopus citations

Abstract

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

Original language	English (US)
Pages (from-to)	69-86
Number of pages	18
Journal	Journal of Law, Medicine and Ethics
Volume	48
Issue number	1
DOIs	https://doi.org/10.1177/1073110520916996
State	Published - Mar 1 2020

Bibliographical note

Funding Information:
Prof. Wolf, Dr. Berry, and Prof. Greely report grants from NIH during the conduct of the study. Dr. Ossorio reports personal fees from Roche-Genentech and from Eli Lilly and grants from NIH outside of the submitted work. Dr. McGuire reports grants from the NIH during the conduct of this study, personal fees from Geisinger Research, Morgridge Institute of Research, Danaher Life Sciences, and the Greenwall Foundation outside the submitted work. Dr. Penny reports other support from Biogen outside of the submitted work. Ms. Terry reports other support from Genome Medical, other support from LunaDNA, and grants from Illumina outside of the submitted work. Acknowledgments

Funding Information:
Preparation of this article was supported by National Human Genome Research Institute and National Cancer Institute of the National Institutes of Health (NIH) under award number R01HG008605 for “LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application.” The content is solely the responsibility of the authors and does not necessarily represent the views of the funders. Thanks to Ellen Wright Clayton, Barbara Evans, and Leslie Wolf for helpful review and to Kate Hanson, Travis Panneck, and Noah Sattler for research assistance.

Publisher Copyright:
© 2020 American Society of Law, Medicine & Ethics.

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title = "Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics",

abstract = "Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.",

author = "{for the LawSeq Framework Task Force} and Wolf, {Susan M.} and Ossorio, {Pilar N.} and Berry, {Susan A.} and Greely, {Henry T.} and McGuire, {Amy L.} and Penny, {Michelle A.} and Terry, {Sharon F.}",

note = "Funding Information: Prof. Wolf, Dr. Berry, and Prof. Greely report grants from NIH during the conduct of the study. Dr. Ossorio reports personal fees from Roche-Genentech and from Eli Lilly and grants from NIH outside of the submitted work. Dr. McGuire reports grants from the NIH during the conduct of this study, personal fees from Geisinger Research, Morgridge Institute of Research, Danaher Life Sciences, and the Greenwall Foundation outside the submitted work. Dr. Penny reports other support from Biogen outside of the submitted work. Ms. Terry reports other support from Genome Medical, other support from LunaDNA, and grants from Illumina outside of the submitted work. Acknowledgments Funding Information: Preparation of this article was supported by National Human Genome Research Institute and National Cancer Institute of the National Institutes of Health (NIH) under award number R01HG008605 for “LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application.” The content is solely the responsibility of the authors and does not necessarily represent the views of the funders. Thanks to Ellen Wright Clayton, Barbara Evans, and Leslie Wolf for helpful review and to Kate Hanson, Travis Panneck, and Noah Sattler for research assistance. Publisher Copyright: {\textcopyright} 2020 American Society of Law, Medicine & Ethics.",

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Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics

Abstract

Bibliographical note

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