This document discusses governing non-traditional biology. It outlines how gene editing equipment and capabilities have advanced and become more accessible outside of traditional academic and research settings. This raises issues around oversight of emerging community labs and amateur experimentation. The document considers different stakeholders' interests and potential regulatory options, including maintaining the status quo, greater self-governance through non-traditional biology organizations and review boards, or prohibiting certain activities.

1. Governing Non-Traditional
Biology
Max Mehlman
June 17, 2019
NIH Human Genome Research Institute
1R03HG010256-01A1

2. TRADITIONAL SCIENCE

3. NON-TRADITIONAL SCIENCE

4. NON-TRADITIONAL BIOLOGY

5. COMMUNITY LABS

6. GENE EDITING EQUIPMENT

7. TRADITIONAL GENE EDITING

9. NON-TRADITIONAL GENE EDITING

10. IGEM

11. ON-LINE GENE EDITING EQUIPMENT

12. FBI RAIDS

14. GENE DRIVES

15. “Adopt safe practices.”
“Biotechnology should only
be used for peaceful
purposes.”

16. “It remains to be seen how the ease
of CRISPR will impact …use. Garage
applications are not realistic ….”

17. “Most DIYers are still learning
basic biotechnology.”

18. “SPACE TRAVEL IS BUNK” – SIR
HAROLD SPENCER JONES,
BRITISH ROYAL ASTRONOMER,
TWO WEEKS BEFORE LAUNCH
OF SPUTNIK, 1957

19. CURRENT NTB GENE EDITING CAPABILITIES
• Gene drives in non-animal organisms.
• Gene drives in some vertebrates (fish, frogs)
• Humans?

20. NON-TRADITIONAL BIOLOGY: HUMAN GENE EDITING

21. ON THE GENE-EDITING HORIZON

22. ON THE GENE-EDITING HORIZON

23. HAM RADIO

24. SPORT ROCKETRY

25. HOME BREWING

26. DRONES

27. COMPUTER HACKING

28. INTERESTS AT STAKE
(VARY BY STAKEHOLDER)
• Freedom to experiment.
• Advancement of science.
• Spread of scientific knowledge.
• Counterculture ethos.
• Financial gain.
• Non-interference with traditional biological interests (careers, status,
wealth).
• Avoidance of harm to subjects.
• Public health, safety, and well-being.

29. REGULATORY OPTIONS
• Status quo.
• Greater self-governance.
• Industry restrictions on access to commercial materials and
equipment.
• Legal requirements (licensure, training requirements, prior approval).
• Liability for harm to subjects or the environment.
• Prohibition (Germany).

30. GREATER SELF-GOVERNANCE
• More active and effective self-governing bodies, perhaps led by
community labs.
• Self-monitoring.
• NTB IRBs.
• Sanctions on unethical experimenters (exclusion from labs, iGEM, and
gatherings; being reported to government regulators).