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Scott Schweikart, "Human Genome Editing: An Ethical Analysis and Arguments for Regulatory Guidance..."

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Scott Schweikart, "Human Genome Editing: An Ethical Analysis and Arguments for Regulatory Guidance..."

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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: Scott Schweikart, Senior Research Associate, Council on Ethical and Judicial Affairs, American Medical Association and Legal Editor, AMA Journal of Ethics - Human Gene Editing: An Ethical Analysis and Arguments for Regulatory Guidance at Both the National and Global Levels

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: Scott Schweikart, Senior Research Associate, Council on Ethical and Judicial Affairs, American Medical Association and Legal Editor, AMA Journal of Ethics - Human Gene Editing: An Ethical Analysis and Arguments for Regulatory Guidance at Both the National and Global Levels

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

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Scott Schweikart, "Human Genome Editing: An Ethical Analysis and Arguments for Regulatory Guidance..."

  1. 1. Human Genome Editing: An Ethical Analysis and Arguments for Regulatory Guidance at Both the National and Global Levels Scott J. Schweikart, JD, MBE
  2. 2. Introduction: Genome Editing is Raising Profound Ethical Concerns Image: VOA/Iris Tong Image: TotallyMJ/Shutterstock
  3. 3. Genome Editing Technologies Meganucleases, ZFNs and TALENs Predominantly used methods of gene editing technology before the advent of CRISPR. Disadvantages is that they are more expensive and technically challenging. Require protein engineering to target specific DNA sequences, hence the expense and technical challenges. CRISPR-Cas9 Advantage of being less expensive and more precise other nucleases Use of guide RNA strand to guides Cas9 nuclease enzyme to desired part of genome Edits can be then performed by Homology Directed Repair or Non-Homologous End Joining Image: molekuul_be/Shutterstock
  4. 4. Ethical Considerations: Somatic vs. Germline Genome Editing Somatic  Targets some of an individual’s cells, but NOT the germline; any edits will not be transmitted to the next generation.  Potential therapeutic uses include cancer, treatments for sickle cell. Germline  Also known as “heritable genome editing”; involves cells of the germline, i.e., gametes, zygotes, and embryos.  Edits may pass sexually and thus generationally; potential to shape human evolution.
  5. 5. Principles of Biomedical Ethics • Autonomy • Non-maleficence • Beneficence • Justice Image: Beauchamp and Childress/Oxford University Press
  6. 6. Autonomy Individual liberty, privacy, choice, and freedom of will.  Relevant for both somatic and germline editing: With both somatic and germline editing, at issue is an individual’s desire to modify their own body, or more specifically, their genome.  Autonomy of future generations: With germline editing, how can the consent of future generations be obtained? Can the autonomy of future generations be violated if they have not yet come into existence?
  7. 7. Non-maleficence and Beneficence “Do no harm” (non-maleficence) and “act for the benefit of others” (beneficence).  Weighing of the potential harms and benefits  Therapeutic treatment or enhancement  Safety concerns: off-target effects and significant unknowns of genome editing  Genetic Essentialism: view of how essential or determinative genetics are in the human identity; nature vs. nurture debate
  8. 8. Social Justice  Fair and Equitable: Justice is derived from what is fair and equitable.  Widen Gaps: Potential to further widen gaps between advantaged and disadvantaged members of society.  Access: Wealthy may have greater access to genome editing, including “enhancements” of desirable social and physical traits, furthering social divide. Human rights: Potential exists for new forms discrimination based on genetic status.
  9. 9. Example of Different Weighing of Values: Treatment vs. Enhancement  National Academies recommend that regulatory agencies not allow genome editing for enhancement purposes.  Nuffield Council recommendation is open to allowing enhancement editing, provided that concerns about welfare of the individual and society are considered and met. Different weighing of “genetic essentialism” (subject to different priorities and values) may account for difference in regulatory recommendation. [Credit: Eli Adashi and Glenn Cohen note this observation. Adashi EY, Cohen IG, The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area, 320(24) JAMA 2531 (2018).]
  10. 10. National Regulations Scope: Scope of national regulations should encompass both somatic and germline editing.  Administrative Safety and Efficacy Regulations: FDA evaluating safety and efficacy of research and therapies.  Research Funding: NIH will not fund research involving germline genome modification. Dickey-Wicker Amendment prohibits any funding to create a human embryo or modify a human embryo, including heritable modification.  Tort Law: How tort law develops has potential to act as a regulatory driver.  Patent Law: Moral or beneficial utility doctrine and license restrictions have potential to influence ethical usage of new technologies. Image: dikobraziy/Shutterstock
  11. 11. Global Regulations Scope: Germline editing must be encompassed by global regulations, as the consequences are international and global in nature.  International Collaboratives: International treaties or collaboratives with binding force between nation states are one, although perhaps unlikely, route.  International Decree: Another alternative is to create an international decree, that would give guidance to nations about how to approach regulation of germline editing. Image: IndianSummer/Shutterstock
  12. 12. German Ethics Council Recommendation on Germline Editing  Council does not consider germline editing to be “inviolable”, meaning that editing is not impermissible absolutely; in certain conditions it can be ethically performed.  Currently there should be a moratorium on germline editing because of the “incalculable risks” associated.  Governments work together to create a binding international agreement.  https://www.ethikrat.org/en/press-releases/2019/ethics-council-germline-interventions-currently-too-risky-but-not- ethically-out-of-the-question/  https://www.ethikrat.org/fileadmin/Publikationen/Stellungnahmen/englisch/opinion-intervening-in-the-human- germline-summary.pdf
  13. 13. Concluding Remarks • Heritable genome editing requires special regulatory attention at a global scale • Prudence is necessary in the face of unknown risks coupled with potentially large consequences • German Council recommendation may provide a balanced and prudent approach Image: Lonely/Shutterstock
  14. 14. Thank you! Scott J. Schweikart, JD, MBE American Medical Association Chicago, Illinois scott.schweikart@ama-assn.org @ScottSchweikart

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