Hostname: page-component-586b7cd67f-l7hp2 Total loading time: 0 Render date: 2024-12-03T19:22:59.266Z Has data issue: false hasContentIssue false

Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems and Potential Solutions

Published online by Cambridge University Press:  01 January 2021

Abstract

The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to successfully integrate genomics into clinical care. The respondents in this study identified a wide range of interconnected issues, focusing specifically on the need for clear guidelines about how to use these data, fear of liability for those who use these data, and the need to protect patients from use of this information particularly by insurers, while endorsing data sharing. Developing legal strategies to support appropriate use of genomics now and in the future clearly will require making trade-offs, taking into account the full complexity of this legal ecosystem.

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

Food and Drug Administration (FDA), Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germ-line Diseases: Guidance for Stakeholders and Food and Drug Administration Staff (April 13, 2018): at 1319, available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-development-and-analytical-validation-next-generation-sequencing-ngs-based> (last visited January 29, 2020); FDA, Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics, Guidance for Stakeholders and Food and Drug Administration Staff(April 13, 2018), available at <https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm509837.pdf> (last visited January 29, 2020); see also Press Release, FDA, “FDA Finalizes Guidances to Accelerate the Development of Reliable, Beneficial Next Generation Sequencing-Based Tests,” April 12, 2018, available at <https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604462.htm> (last visited January 29, 2020).+(last+visited+January+29,+2020);+FDA,+Use+of+Public+Human+Genetic+Variant+Databases+to+Support+Clinical+Validity+for+Genetic+and+Genomic-Based+In+Vitro+Diagnostics,+Guidance+for+Stakeholders+and+Food+and+Drug+Administration+Staff(April+13,+2018),+available+at++(last+visited+January+29,+2020);+see+also+Press+Release,+FDA,+“FDA+Finalizes+Guidances+to+Accelerate+the+Development+of+Reliable,+Beneficial+Next+Generation+Sequencing-Based+Tests,”+April+12,+2018,+available+at++(last+visited+January+29,+2020).>Google Scholar
Javitt, G. H. and Carner, K. S., “Regulation of Next Generation Sequencing,” Journal of Law, Medicine & Ethics 42, no. 3 suppl. (2014): 921.CrossRefGoogle Scholar
Curnutte, M. A. et al., “Development of the Clinical Next-Generation Sequencing Industry in a Shifting Policy Climate,” Nature Biotechnology 32, no. 10 (2014): 980982.Google Scholar
Beskow, L. M. and Smolek, S. J., “Prospective Biorepository Participants’ Perspectives on Access to Research Results,” Journal of Empirical Research on Human Research Ethics 4, no. 3 (2009): 99111; Kaufman, D. J. et al., “Public Opinion About the Importance of Privacy in Biobank Research,” American Journal of Human Genetics 85, no. 5 (2009): 642–654; Murphy, J. et al., “Public Expectations for Return of Results from Large-Cohort Genetic Research,” American Journal of Bioethics 8, no. 11 (2008): 36–43; Trinidad, S. B. et al., “Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?” AJOB Primary Research 3, no. 3 (2012): 3–11.CrossRefGoogle Scholar
Curnutte et al., supra note 5; Downing, N. R. et al., “Genetics Specialists' Perspectives on Disclosure of Genomic Incidental Findings in the Clinical Setting,” Patient Education and Counseling 90, no. 1 (2013): 133138; Miller, J. et al., “Professionals' Attitudes Regarding Large-Scale Genetic Information Generated Through Next Generation Sequencing in Research a Pilot Study,” Journal of Empirical Research on Human Research Ethics 9, no. 3 (2014): 56–58; Ramoni, R. B. et al., “Experiences and Attitudes of Genome Investigators Regarding Return of Individual Genetic Test Results,” Genetics in Medicine 15, no. 11 (2013): 882–887.Google Scholar
Jones, L. K. et al., “Developing Pharmacogenomic Reports: Insights from Patients and Clinicians,” Clinical and Translational Science 11, no. 3 (2018): 289295; Patel, H. N. et al., “Stakeholder Views on Pharmacogenomic Testing,” Pharmacotherapy 34, no. 2 (2014): 151–165.CrossRefGoogle Scholar
See, e.g., Berkman, B. E. and Rothenberg, K. H., “Teaching Health Law,” Journal of Law, Medicine & Ethics 40, no. 1 (2012): 147153; Clayton, E. W. and McGuire, A. L., “The Legal Risks of Returning Results of Genomics Research,” Genetics in Medicine 14, no. 4 (2012): 473–477; Evans, B. J., “Minimizing Liability Risks Under the ACMG Recommendations for Reporting Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 12 (2013): 915–920; Evans, B. J., “The First Amendment Right to Speak About the Human Genome,” University of Pennsylvania Journal of Constitutional Law 16, no. 3 (2014): 549–636; Gordon, M. P., “A Legal Duty to Disclose Individual Research Findings to Research Subjects?,” Food and Drug Law Journal 64, no. 1 (2009): 225–260; Marchant, G. E. et al., “Personalized Medicine and Whole Genome Sequencing in the Era of Big Data: Challenges and Opportunities,” ISPOR Connections 20, no. 4 (2014): 4–6; Marchant, G. E., Lindor, R. A., and Campos-Outcalt, D. E., “Physician Liability: The Next Big Thing for Personalized Medicine?” Personalized Medicine 8, no. 4 (2012): 457–467; McGuire, A. L., Knoppers, B. M., Zawati, M. H., and Clayton, E. W., “Can I be Sued for That? Liability Risk and the Disclosure of Clinically Significant Genetic Research Findings,” Genome Research 24, no. 5 (2014): 719–723; Milstein, A. C., “Research Malpractice and the Issue of Incidental Findings,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 356–360; Wolf, S. M., “The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science,” Minnesota Journal of Law, Science & Technology 13, no. 2 (2012): 435–448.CrossRefGoogle Scholar
Marchant, G. E. and Lindor, R. A., “Genomic Malpractice: An Emerging Tide or Gentle Ripple?” Food and Drug Law Journal 73, no. 1 (2018): 137.Google Scholar
Creswell, J. and Clark, V. Plano, Designing and Conducting Mixed Methods Research (Los Angeles: Sage Publications, 2018); Fowler, F. J., Survey Research Methods (Thousand Oaks: Sage Publications, 2014); Josselson, R., Interviewing for Qualitative Inquiry (New York: The Guilford Press, 2013); Seidman, I., Interviewing as Qualitative Research (New York: Teachers College Press, 2006); Tashakkori, A. and Teddlie, C., Handbook of Mixed Methods in Social and Behavioral Research (Thousand Oaks: Sage Publications, 2010).Google Scholar
Salkind, N. J., Encyclopedia of Research Design (Los Angeles: Sage, 2010), 344346.Google Scholar
Creswell and Clark, supra note 11; Saldana, J., The Coding Manual for Qualitative Researchers (Thousand Oaks: Sage Publications, 2016).Google Scholar
Anfara, V., Brown, K., and Mangione, T., “Qualitative Analysis on Stage: Making the Research Process More Public,” Educational Researcher 31, no. 7 (2002): 2838; Saldana, supra note 13.CrossRefGoogle Scholar
See Josselson, R., Interviewing for Qualitative Inquiry (New York: The Guilford Press, 2013); Rubin, H. and Rubin, I., Qualitative Interviewing the Art of Hearing Data (Thousand Oaks: Sage Publications, 2012); Seidman, I., Interviewing as Qualitative Research (New York: Teachers College Press, 2006).Google Scholar
See Anfara, et al., supra note 14; Creswell and Clark, supra note 11; Saldana, supra note 13.Google Scholar