Background articles that may be useful for this conference include:
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Amendola, L.M., Robinson, J.O., Hart, R., Biswas, S., Lee, K., Bernhardt, B.A., East, K., Gilmore, M.J., Kauffman, T.L., Lewis, K.L., Roche, M., Scollon, S., Wynn, J. and Blout, C. Why Patients Decline Genomic Sequencing Studies: Experiences from the CSER Consortium. J Genet Counsel 2018;27: 1220-1227.
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Bélisle-Pipon, J., Vayena, E., Green, R.C. et al. Genetic testing, insurance discrimination and medical research: what the United States can learn from peer countries. Nature Medicine 2019;25:1198–1204.
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Bombard Y, Brothers KB, Fitzgerald-Butt S, et al. The Responsibility to Recontact Research Participants after Reinterpretation of Genetic and Genomic Research Results. American Journal of Human Genetics 2019;104(4)578-595.
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Bruce MA, Bonham VL, Wolf SM, eds., Law, Genomic Medicine & Health Equity: How Can Law Support Genomics and Precision Medicine to Advance the Health of Underserved Populations? Ethnicity & Disease 2019;29 Suppl 3:623-674.
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Burke W, Clayton EW, Wolf SM, Berry SA, Evans BJ, Evans JP, Hall R, Korngiebel D, Laberge AM, LeRoy BS, McGuire AL. Improving Recommendations for Genomic Medicine: Building an Evolutionary Process from Clinical Practice Advisory Documents to Guidelines. Genetics in Medicine 2019;21(7):1-8.
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Clayton EW, Evans BJ, Hazel JW, Rothstein MA. The Law of Genetic Privacy: Applications, Implications, and Limitations. Journal of Law and the Biosciences 2019;6(1)1–36.
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Couzin-Frankel J. Genomics Breeds New Legal Questions. Science 2019;364(6440)521.
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David KL, Best RG, Brenman LM, et al. Patient Re-contact After Revision of Genomic Test Results: Points to Consider — A Statement of the American College of Medical Genetics and Genomics (ACMG). Genetics in Medicine 2019;21(4)768-771.
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Evans BJ. Commentary: HIPAA’s Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights. American Journal of Human Genetics 2018;102:05-10.
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Evans BJ, Clayton EW. Deadly Delay: The FDA’s Role in America’s COVID Testing Debacle. The Yale Law Journal Forum 2020;130:78-100.
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Evans BJ, Javitt GH, Hall R, Robertson M, Ossorio PN, Wolf SM, Morgan TM, Clayton EW. How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care? Journal of Law, Medicine & Ethics Spring 2020; 48-1 in press.
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Evans BJ, Ossorio P. The Challenge of Regulating Clinical Decision Support Software after 21st Century Cures. American Journal of Law and Medicine 2018;44:237-251.
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Evans BJ, Wolf SM. A Faustian Bargain That Imperils People’s Rights to See Their Own Personal Information. Florida Law Review 2019;71(5). Note: online version forthcoming
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Guerrini CJ, Wagner JK, Nelson SC, Javitt GH, McGuire AL. Who’s on Third? Regulation of Third-Party Genetic Interpretation Services. Genetics in Medicine 2019;22:4-11.
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Klonoff DC, Gutierrez A, Fleming A. Real-World Evidence Should be Used in Regulatory Decisions About New Pharmaceutical and Medical Device Products for Diabetes. Journal of Diabetes Science and Technology 2019;13(6)995-1000.
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Lynch HF, Wolf LE, Barnes M. Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence. Journal of Law, Medicine & Ethics 2019;47(2):213-231.
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Hazel JW, Slobogin C. Who Knows What, and When?: A Survey of the Privacy Policies Proffered by US Direct-to-Consumer Genetic Testing Companies. Cornell Journal of Law and Public Policy 2018;28(35):35-66.
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Majumder MA, Guerrini CJ, Bollinger JM, Cook-Deegan R, McGuire AL. Sharing Data Under the 21st Century Cures Act. Genetics in Medicine 2017;19:1289-1294.
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Mansfield E, Donigan K, Tjoe S, Berger AC. Chapter 21-Regulation of Genomic Technologies. Genomic and Precision Medicine (Third Edition) 2017;313-326.
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Marchant GW, Barnes M, Clayton EW, Evans JP, LeRoy BS, Wolf SM. From Genetics to Genomics: Facing the Liability Implications in Clinical Care. Journal of Law, Medicine & Ethics Spring 2020;48-1 in press.
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Marchant GW, Lindor RA. Genomic Malpractice: An Emerging Tide or Gentle Ripple? Food and Drug Law Journal 2018;73:1-37.
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Milko, L.V., Chen, F., Chan, K. et al. FDA oversight of NSIGHT genomic research: the need for an integrated systems approach to regulation. npj Genomic Medicine 2019;4(32).
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Rothstein MA. GINA at Ten and the Future of Nondiscrimination Law. Hastings Center Report 2018;48(3):5-7.
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Rothstein MA. Reconsidering the Duty to Warn Genetically At-Risk Relatives. Genetics in Medicine 2018;20:285-290.
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Stevens YA, Senner GD, Marchant GE. Physicians’ Duty to Recontact and Update Genetic Advice. Personalized Medicine 2017;14(4):367-374.
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Wolf LE, Brown EF, Kerr R, Razick G, Tanner G, Duvall B, Jones S, Brackney J, Posada T. The Web of Legal Protections for Participants in Genomic Research. Health Matrix Cleveland 2019;29(1):3.
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Wolf SM, Evans BJ. Defending the Return of Results and Data. Science 2018;362(6 420):1255-1256.
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Wolf SM, Evans BJ. Return of Results and Data to Study Participants. Science 2018;362(6 411):159-160.
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Wolf SM, Ossorio PN, Berry SA, Greely HT, McGuire AL, Penny MA, Terry SF. Integrating Rules for Genomic Research, Clinical Care, Public Health Screening & DTC Testing: Creating Translational Law for Translational Genomics. Journal of Law, Medicine & Ethics Spring 2020;48-1 in press.