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Emily Qian, "Physician-Mediated Elective Whole Genome Sequencing Tests"

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Emily Qian, "Physician-Mediated Elective Whole Genome Sequencing Tests"

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May 17, 2019

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

As these questions become more pressing, now is the time to re-consider what ethical and regulatory safeguards should be implemented and discuss the many questions raised by advancements in consumer genetics.

Presentation: Emily Qian, Genetic Counselor, Veritas Genetics (with Magalie Leduc, Rebecca Hodges, Bryan Cosca, Ryan Durigan, Laurie McCright, Doug Flood, and Birgit Funke) - Physician-Mediated Elective Whole Genome Sequencing Tests: Impacts on Informed Consent

Learn more: https://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

May 17, 2019

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

As these questions become more pressing, now is the time to re-consider what ethical and regulatory safeguards should be implemented and discuss the many questions raised by advancements in consumer genetics.

Presentation: Emily Qian, Genetic Counselor, Veritas Genetics (with Magalie Leduc, Rebecca Hodges, Bryan Cosca, Ryan Durigan, Laurie McCright, Doug Flood, and Birgit Funke) - Physician-Mediated Elective Whole Genome Sequencing Tests: Impacts on Informed Consent

Learn more: https://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

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Emily Qian, "Physician-Mediated Elective Whole Genome Sequencing Tests"

  1. 1. Physician-Mediated Elective Whole Genome Sequencing Tests: Impacts on Informed Consent Emily Qian, MS, CGC Petrie-Flom Center Annual Conference Consuming Genetics: Ethical and Legal Considerations of New Technologies May 17, 2019
  2. 2. Disclaimer/COI I am a full-time employee at Veritas Genetics.
  3. 3. Genetic Testing Process ResultsSample Collected Laboratory Analysis & Interpretation Symptoms
  4. 4. Genetic Testing Process ResultsSample Collected Laboratory Analysis & Interpretation Symptoms
  5. 5. Genetic Testing Process ResultsSample Collected Laboratory Analysis & Interpretation Symptoms Test Authorization & Informed Consent
  6. 6. Service Delivery Models
  7. 7. Direct-to-consumer (DTC) 5/22/2019 7 No healthcare provider (HCP) involvement
  8. 8. Physician-initiated 5/22/2019 8 HCP initiates discussion and guides selection
  9. 9. Physician-Mediated Direct-to-Consumer (PM-DTC) 5/22/2019 9 HCP involved, usually test order is initiated by the consumer
  10. 10. Key Stakeholders For PM-DTC genetic testing: 1. The Consumer 2. The Healthcare Professional (HCP) providing test authorization 3. The Clinical Laboratory performing the test 5/22/2019 10
  11. 11. What is “Informed Consent”?
  12. 12. Informed Consent is a Process American Medical Association: Code of Medical Ethics Opinion 2.1.1 “The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention…” a) Assess the patient’s ability to understand relevant medical information… b) Present relevant information accurately and sensitively… I. …the burdens, risks, and expected benefits of all options… 5/22/2019 12 https://www.ama-assn.org/delivering-care/ethics/informed-consent Accessed May 9, 2019
  13. 13. Topics Covered During Informed Consent • Test purpose • Possible results & consequences • Testing limitations • Confidentiality and privacy • Risks of testing & familial implications • Voluntary participation 5/22/2019 13
  14. 14. Veritas myGenome Lifestyle Traits Disease Risk Ancestry Pharmaco- genomics
  15. 15. 5/22/2019 15 PAGE 1 OF 6
  16. 16. What types of healthcare providers authorize consumer- initiated genetic testing?
  17. 17. Study Design • First 500 samples 5/22/2019 ***CONFIDENTIAL*** 17
  18. 18. Study Design • First 500 samples • NPI number data 5/22/2019 ***CONFIDENTIAL*** 18 NPI 1234567890 Taxonomy Practice Location
  19. 19. Analysis: HCP Demographics 5/22/2019 19 69% 2% 3% 26% Primary Care-Like Genetics Complementary & Alternative Medicine Specialists Primary Care-Like: MD, DO, NP, PA Internal Medicine Family Medicine Etc.
  20. 20. Analysis: HCP Demographics 5/22/2019 20 69% 2% 3% 26% Primary Care-Like Genetics Complementary & Alternative Medicine Specialists Genetics: MD, MS Medical Genetics Genetic Counselors
  21. 21. Analysis: HCP Demographics 5/22/2019 21 69% 2% 3% 26% Primary Care-Like Genetics Complementary & Alternative Medicine Specialists Complementary & Alternative Medicine: DC, ND, NMD Chiropractors Naturopaths
  22. 22. Analysis: HCP Demographics 5/22/2019 22 69% 2% 3% 26% Primary Care-Like Genetics Complementary & Alternative Medicine Specialists Specialists: MD DO PharmD DPM (Podiatrists) Powered by WordArt.com
  23. 23. Study Design • First 500 samples • Family name “match” 5/22/2019 ***CONFIDENTIAL*** 23 Qian Dr. Qian Match&
  24. 24. Analysis: Family Name • N=22 (4.4%) matches 5/22/2019 ***CONFIDENTIAL*** 24
  25. 25. Informed Consent: Whose responsibility? Consumers Provided with reasonable notice & opportunity ??? HCPs Results raise suspicion that a portion may have difficulties with aspects of informed consent process • Genetic literacy • Familial relation bias 5/22/2019 25 Laboratory Provide informed consent documents available on website Availability of clinical staff to answer questions • Low uptake of internal clinical services • Clickwrap may not be adequate
  26. 26. Questions Raised • Why are consumers choosing to pursue test authorization from friends and family? • Ease of access? • Privacy concerns? • Coercion? • How do we ensure informed consent is responsibly executed? 5/22/2019 26
  27. 27. Acknowledgments Birgit Funke, PhD, FACMG Magalie Leduc, PhD, FACMG Genetic Counseling • Sharon Namaroff, MS, CGC • Rebecca Hodges, MS, CGC • Lisa Paglierani, MS, CGC • Laurie McCright (GC Assistant) Operations • Ryan Durigan Bioinformatics • Bryan Cosca Design • Monika Chas And the rest of the Veritas team! 5/22/2019 27

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