Hostname: page-component-76fb5796d-9pm4c Total loading time: 0 Render date: 2024-04-27T03:41:27.224Z Has data issue: false hasContentIssue false

Introduction: The Crucial Role of Law in Supporting Successful Translation of Genomics into Clinical Care

Published online by Cambridge University Press:  01 January 2021

Abstract

Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application, available at <https://consortium.umn.edu/research/lawseqsm-building-sound-legal-foundation-translating-genomics-clinical-application> (last visited October 25, 2019).+(last+visited+October+25,+2019).>Google Scholar
See Evans, B. J., Javitt, G., Hall, R., Robertson, M., Ossorio, P. N., Wolf, S. M., Morgan, T., and Clayton, E. W., “How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 4468.CrossRefGoogle Scholar
See Marchant, G., Barnes, M., Evans, J. P., LeRoy, B., and Wolf, S. M., “From Genetics to Genomics: Facing the Liability Implications in Clinical Care,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 1143.Google Scholar
See Encyclopedia Britannica, “Scylla and Charybdis,” available at <https://www.britannica.com/topic/Scylla-and-Charybdis> (last visited October 26, 2019).+(last+visited+October+26,+2019).>Google Scholar
See Clayton, E. W., Evans, B. J., Hazel, J. W., and Rothstein, M. A., “The Law of Genetic Privacy: Applications, Implications, and Limitations,” Journal of Law and the Biosciences 6, no. 1 (2019): 136.Google Scholar
See Evans, B. J., “Commentary: HIPAA's Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights,” American Journal of Human Genetics 102, no. 1 (2018): 510; Wolf, S. M. and Evans, B. J., “Return of Results and Data to Study Participants,” Science 362, no. 6411 (2018): 159–160.CrossRefGoogle Scholar
See Cheung, F. Y., Clatch, L., Wolf, S. M., Clayton, E. W., and Lawrenz, F., “Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems & Potential Solutions,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 87104.CrossRefGoogle Scholar
See Wolf, S. M., Ossorio, P. N., Berry, S. A., Greely, H. T., Penny, A. L. McGuire, , , M. A., and Terry, S. F., “Integrating Rules for Genomic Research, Clinical Care, Public Health Screening & DTC Testing: Creating Translational Law for Translational Genomics,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 6986.CrossRefGoogle Scholar
Marchant et al., supra note 4.Google Scholar
Evans et al., supra note 3.Google Scholar
Wolf et al., supra note 9.Google Scholar
Clayton et al., supra note 6.Google Scholar
See Evans, B. J., “The Streetlight Effect: Regulating Genomics Where the Light Is,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 105118; Johnson, K. B., Clayton, E. W., Starren, J., and Peterson, J., “The Implementation Chasm Hindering Genome-informed Health Care,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 119–125; Wolf, L.E., Hammack, C. M., Brown, E. F., Brelsford, K. M., and Beskow, L. M., “Protecting Participants in Genomic Research: Understanding the ‘Web of Protections’ Afforded by Federal and State Law,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 126–141; McGeveran, W. and Schmitz, C., “General-Purpose Privacy Regulation and Translational Genomics,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 142–150; Greely, H. T., “The Future of DTC Genomics and the Law,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 151–160.Google Scholar
See, e.g., Burke, W., Clayton, E. W., Wolf, S. M., Berry, S. A., Evans, B. J., Evans, J. P., Hall, R., Korngiebel, D., Laberge, A. M., LeRoy, B. S., and McGuire, A. L., “Improving Recommendations for Genomic Medicine: Building an Evolutionary Process from Clinical Practice Advisory Documents to Guidelines,” Genetics in Medicine 21, no. 7 (2019): 18; Clayton, E. W., Halverson, C. M., Sathe, N. A., and Malin, B. A., “A Systematic Literature Review of Individuals' Perspectives on Privacy and Genetic Information in the United States,” PLoS ONE 13, no. 10 (2018): e0204417; Morgan, T. M., “Genomic Screening: The Mutation and the Mustard Seed,” Journal of Law, Medicine & Ethics 46, no. 2 (2018): 541–546; Wolf, S. M., “The Continuing Evolution of Ethical Standards for Genomic Sequencing in Clinical Care: Restoring Patient Choice,” Journal of Law, Medicine & Ethics 45, no. 3 (2017): 333–340; Wolf, S. M., Amen-dola, L. M., Berg, J. S., Chung, W. K., Clayton, E. W., Green, R. C., Harris-Wai, J., Henderson, G. E., Jarvik, G. P., Koenig, B. A., Lehmann, L. S., McGuire, A. L., O'Rourke, P., Somkin, C., Wilfond, B. S., and Burke, W., “Navigating the Research-Clinical Interface in Genomic Medicine: Analysis from the CSER Consortium,” Genetics in Medicine 20, no. 5 (2017): 545–553.CrossRefGoogle Scholar
LawSeq Database, available at <https://lawseq.umn.edu/> (last visited October 25, 2019).+(last+visited+October+25,+2019).>Google Scholar
Wolf, S. M., Clayton, E. W., and Lawrenz, F., eds., “The Future of Informed Consent in Research and Translational Medicine: A Century of Law, Ethics & Innovation,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 7129.CrossRefGoogle Scholar
Consortium on Law and Values in Health, Environment & the Life Sciences, National Conference: The Future of Informed Consent in Research and Translational Medicine: A Century of Law, Ethics & Innovation, available at <https://consortium.umn.edu/conference/national-conference-future-informed-consent-research-and-translational-medicine-century-law-ethics-innovation> (last visited October 26, 2019).+(last+visited+October+26,+2019).>Google Scholar
Bruce, M., Bonham, V. L., and Wolf, S. M., eds., “Law, Genomic Medicine & Health Equity: How Can Law Support Genomics and Precision Medicine to Advance the Health of Under-served Populations,” Ethnicity & Disease 29, Suppl. 3 (2019): 623674.Google Scholar
Consortium on Law and Values in Health, Environment & the Life Sciences, Conference, “Law, Genomic Medicine & Health Equity: How Can Law Support Genomics and Precision Medicine to Advance the Health of Underserved Populations?” available at <https://consortium.umn.edu/conference/lawgenomic-medicine-health-equity-how-can-law-support-genomics-and-precision-medicine-advance-health-underserved-populations> (last visited October 25, 2019).+(last+visited+October+25,+2019).>Google Scholar
Consortium on Law and Values in Health, Environment & the Life Sciences, Conference, “LawSeq: Building a Legal Foundation for Translating Genomics into Clinical Application,” April 25, 2019, available at <https://consortium.umn.edu/conference/lawseq-building-legal-foundation-translating-genomics-clinical-application> (last visited October 25, 2019).+(last+visited+October+25,+2019).>Google Scholar