The Center for Synthetic Regulatory Genomics (SyRGe)

www.thedarkmatterproject.org

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Institute for Systems Genetics

NYU Langone Health

2026 GENOME WRITING WORKSHOP

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Ethical Considerations

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Carolyn Riley Chapman, PhD MS

Genome Writing and Engineering: Some Key Ethical Frameworks

• Ethical Frameworks

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• Principlism (Beauchamp & Childress/ Belmont Report)
• Beneficence / Non-maleficence (Benefits & Risks)
• Autonomy
• Justice

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• Other important principles/ethical requirements:
• Scientific validity, Community Engagement

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• Responsible Research & Innovation
• AREA Framework (UKRI)
• Anticipate, Reflect, Engage, Act

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• Ethics of engineering🡪 “Whole engineer”
• NSPE Code of Ethics for Engineers

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Beneficence (Doing Good) and Non-maleficence (Avoiding Harm)

• BENEFITS
• What are the potential benefits of a particular genome engineering application?
• Human (individual/groups/society)
• Animals
• Environment

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• RISKS
• What will the potential risks of a particular genome engineering application?
• Human (individual/groups/society)
• Animals
• Environment

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• TRADEOFFS are often involved

Autonomy …. and Beyond

• Autonomy is usually focused on individual’s (or appropriate surrogate) right to consent

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• However, SynBio benefits and risks have impacts on groups as well
• Organizations/ For-profit entities
• Communities
• Stakeholders
• Broader public---across town, state, national boarders
• Areas of “common good”--- e.g., oceans, outer space

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• Therefore, public consultation is important for SynBio applications impacting communities or the environment
• What are the aims of a specific consultation?
• Who should be involved?
• What happens if consensus is not reached? How should disagreements be resolved?

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• Inherent Power imbalances

“public concerns cannot be reduced to questions of risk, but rather encompass a range of concerns relating to the purposes and motivations of research…”

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--Stilgoe, Owen, Macnaghten 2013

Justice

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• Access to the Technology itself
• Democratizing access --> Genome Writing Workshop 2026
• Yet wider access to genome engineering technology may also contribute to risk, e.g., dual use nature as well as unintended consequences

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• Access to Benefits of the technology
• To which humans will the benefits accrue?
• Will everyone have access?

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• Burdens of Risks of the technology
• To which humans will the risks accrue?
• Are some disproportionately burdened?

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• Fair distribution of benefits and risks 🡪 challenging

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• Inherent power imbalances and potential conflicts of interest

AREA Approach for Responsible Research and Innovation

• Innovation can raise questions and dilemmas, is often ambiguous in terms of purposes and motivations, and unpredictable in terms of impacts, beneficial or otherwise.

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• RR&I creates spaces and processes to explore these aspects of innovation in an open, inclusive, and timely way.

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• RR&I is a collective responsibility: funders, researchers, stakeholders and the public all have an important role to play.

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• RR&I includes, but goes beyond, considerations of risk and regulation.

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• The AREA approach can support RR&I.

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--UK Research and Innovation (UKRI) Engineering and Physical Sciences Research Council (EPSRC)

NSPE Code of Ethics for Engineers

Preamble

Engineering is an important and learned profession. As members of this profession, engineers are expected to exhibit the highest standards of honesty and integrity. Engineering has a direct and vital impact on the quality of life for all people. Accordingly, the services provided by engineers require honesty, impartiality, fairness, and equity, and must be dedicated to the protection of the public health, safety, and welfare. Engineers must perform under a standard of professional behavior that requires adherence to the highest principles of ethical conduct.

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Fundamental Canons

Engineers, in the fulfillment of their professional duties, shall:

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1. Hold paramount the safety, health, and welfare of the public.
2. Perform services only in areas of their competence.
3. Issue public statements only in an objective and truthful manner.
4. Act for each employer or client as faithful agents or trustees.
5. Avoid deceptive acts.
6. Conduct themselves honorably, responsibly, ethically, and lawfully so as to enhance the honor, reputation, and usefulness of the profession.

Note: Everyone may not define “honorably, responsibly, ethically” (virtues/character traits) in the same way

Genome Writing and Engineering: Governance and Oversight

• International

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• Convention on Biological Diversity (CBD) (U.S. not a party but observes and advocates positions)
• Legally binding international treaty focused on the conservation of biodiversity, sustainable use, and fair/equitable sharing of benefits from genetic resources.
• Cartagena protocol on biosafety
• Safety regarding Living Modified Organisms (LMOs)
• Kunming-Montreal Global Biodiversity Framework 
• Target 17: strengthening biosafety and benefits of use of biotechnology
• Nagoya protocol on access and benefit sharing

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• Biological Weapons Convention (BWC) (U.S. a party)
• Legally binding international treaty effectively prohibiting the development, production, acquisition, transfer, stockpiling and use of biological and toxin weapons

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• Organisation for Economic Co-operation and Development (OECD) (U.S. a member)
• Consensus documents on biotechnology

NB: This list is not comprehensive

Genome Writing and Engineering: Governance and Oversight

• United States

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• Federal regulations
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• U.S. Department of Agriculture (USDA)

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• State regulations
• Some states have relevant laws

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• Institutional level policies, in alignment with laws
• Institutional Review Boards (IRBs) (human research)
• Institutional Animal Care and Use Committee (IACUCs)(animal research)
• Institutional Biosafety Committees (IBCs)
• NIH Guidelines for Research Involving Recombinant or Synthetic Acid Molecules (NIH Guidelines)
• Embryonic Stem Cell Research Oversight Committee (ESCRO)

NB: This list is not comprehensive

Current attention on biotechnology regulation in the U.S.

Biosafety and Biosecurity

are related to benefits and risks and therefore are part of—but not the only— social and ethical considerations for genome writing/engineering

Key References (I)

Office of the Secretary, Department of Health, and The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979. https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf.

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Beauchamp, Tom L., and James F. Childress. Principles of biomedical ethics. Edicoes Loyola, 1994.

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Emanuel, Ezekiel J., David Wendler, and Christine Grady. “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 2701–11. https://doi.org/10.1001/jama.283.20.2701.

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Emanuel, Ezekiel J., David Wendler, Jack Killen, and Christine Grady. “What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research.” The Journal of Infectious Diseases 189, no. 5 (2004): 930–37. https://doi.org/10.1086/381709.

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Owen, Richard, Phil Macnaghten, and Jack Stilgoe. “Responsible Research and Innovation: From Science in Society to Science for Society, with Society.” Science and Public Policy 39, no. 6 (2012): 751–60. https://doi.org/10.1093/scipol/scs093.

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Stilgoe, Jack, Richard Owen, and Phil Macnaghten. “Developing a Framework for Responsible Innovation.” Research Policy 42, no. 9 (2013): 1568–80. https://doi.org/10.1016/j.respol.2013.05.008.

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United Kingdom Research and Innovation (UKRI). Framework for responsible research and innovation. (2026) Available at https://www.ukri.org/who-we-are/epsrc/our-policies-and-standards/framework-for-responsible-innovation/

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National Society of Professional Engineers (NSPE). (2026) NSPE Code of Ethics for Engineers (Rev July 2019). Available at https://www.nspe.org/career-growth/ethics/nspe-code-ethics-engineers

Key References (II)

Organisation for Economic Co-operation and Development (OECD).Consensus documents: harmonization of regulatory oversight in biotechnology. Available at https://www.oecd.org/en/topics/sub-issues/biosafety-novel-food-and-feed-safety/consensus-documents-work-on-harmonisation-of-regulatory-oversight-in-biotechnology.html

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United Nations Office for Disarmament Affairs. Biological Weapons Convention (entered into force in 1975). Available at https://disarmament.unoda.org/en/our-work/weapons-mass-destruction/biological-weapons/biological-weapons-convention

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United States Department of Health and Human Services, National Institutes of Health. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). (2024) Available at https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm

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The White House, United States. Improving the Safety and Security of Biological Research (Executive Order). (May 2025) Available at https://www.whitehouse.gov/presidential-actions/2025/05/improving-the-safety-and-security-of-biological-research/

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Tom Cotton Press Release. Cotton, Klobuchar introduce bill to establish federal biotech security framework. (February 2026) Available at https://www.cotton.senate.gov/news/press-releases/cotton-klobuchar-introduce-bill-to-establish-federal-biotech-security-framework

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Patrick, Stewart and Josie Barton. Carnegie Endowment for International Peace. Mitigating Risks from Gene Editing and Synthetic Biology: Global Governance Priorities. (October 2024). Available at https://carnegieendowment.org/research/2024/10/mitigating-risks-from-gene-editing-and-synthetic-biology-global-governance-priorities

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Ethical and regulatory considerations of genome writing need ongoing attention

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THANK YOU!

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Carolyn Riley Chapman, PhD MS

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www.linkedin.com/in/carolynrileychapman

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carolynchapman1@mac.com