ELSI-Dedicated Genome Engineering Working Group

The Dark Matter Project is proud to launch EDGE: ELSI-Dedicated Genome Engineering Working Group

 EDGE’s mission is to make sure the broad ethical, legal, and social implications (ELSI) of scientific innovation in Big DNA technology are considered as it happens. For example, EDGE plans to delineate ELSI related to genomically-rewritten and tailored genetically engineered mouse models (GREAT GEMMS). 

We plan to host webinars featuring experts in the science, ethics and regulatory oversight of projects involving transgenic humanized mice and/or Big DNA technology, and to publish on these issues in academic journals as well in mainstream and alternative/independent media and specialized press.

Ran Brosh and Carolyn Chapman are co-chairing EDGE. We are currently putting together a core working group, to formulate priorities and brainstorm specific plans together. Over time, we will grow the group by recruiting more members from inside and outside the Center. The goal is to create a diverse, interdisciplinary, productive committee that is able to leverage and facilitate networks and connections. If you are interested in learning more about EDGE and its work, please contact us!

Below is a list of publications related to ELSI of synthetic biology and genetically-humanized mice. We will continue to add to this reference list. Please send us suggestions for any additions to this resource.

Synthetic Biology Literature

Anderson J, Strelkowa N, Stan GB, Douglas T, Savulescu J, Barahona M, Papachristodoulou A. Engineering and ethical perspectives in synthetic biology: Rigorous, robust and predictable designs, public engagement and a modern ethical framework are vital to the continued success of synthetic biology. EMBO reports. 2012;13(7):584-90. https://pubmed.ncbi.nlm.nih.gov/22699939/

Arnason G. Synthetic Biology between Self-Regulation and Public Discourse: Ethical Issues and the Many Roles of the Ethicist. Cambridge Quarterly of Healthcare Ethics. 2017;26(2):246-56. Epub 2017/03/31. https://pubmed.ncbi.nlm.nih.gov/28361722/

Bensaude Vincent B. Ethical perspectives on synthetic biology. Biological Theory. 2013;8(4):368-75. https://link.springer.com/article/10.1007/s13752-013-0137-8

Buchanan A, Powell R. The ethics of synthetic biology: Suggestions for a comprehensive approach. 2011. https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/The-Ethics-of-Synthetic-Biology-Suggestions-for-a-Comprehensive-Approach.pdf

Carter S, DiEuliis D. Mapping the Synthetic Biology Industry: Implications for Biosecurity. Health Secur. 2019;17(5):403-6. doi: 10.1089/hs.2019.0078. https://pubmed.ncbi.nlm.nih.gov/31593512/

Carter SR, Rodemeyer M, Garfinkel MS, Friedman RM. Synthetic biology and the US biotechnology regulatory system: Challenges and options. J. Craig Venter Institute, Rockville, MD (United States), 2014. https://www.osti.gov/biblio/1169537

Coradini ALV, Hull CB, Ehrenreich IM. Building genomes to understand biology. Nature Communications. 2020;11(1):6177. doi: 10.1038/s41467-020-19753-2. https://pubmed.ncbi.nlm.nih.gov/33268788/

Coyne L. The ethics and ontology of synthetic biology: A neo-Aristotelian perspective. NanoEthics. 2020;14(1):43-55. https://link.springer.com/article/10.1007/s11569-019-00347-2

Dablain D, Huang L, Sepulvado B. Developing an NLP-based Recommender System for the Ethical, Legal, and Social Implications of Synthetic Biology. arXiv preprint arXiv:220706360. 2022. https://arxiv.org/abs/2207.06360

Douglas T, Savulescu J. Synthetic biology and the ethics of knowledge. Journal of medical ethics. 2010;36(11):687-93. https://pubmed.ncbi.nlm.nih.gov/20935316/

Georgiadis MM, Ryznar M. Regulating What Has Yet To Be Created: An Introduction. Tex L Rev Online. 2019;98:71. https://texaslawreview.org/regulating-what-has-yet-to-be-created-an-introduction/

***Gutmann A. The ethics of synthetic biology: guiding principles for emerging technologies. Hastings Center Report. 2011;41(4):17-22. https://pubmed.ncbi.nlm.nih.gov/21845917/

***Häyry M. Synthetic biology and ethics: past, present, and future. Cambridge Quarterly of Healthcare Ethics. 2017;26(2):186-205. https://pubmed.ncbi.nlm.nih.gov/28361718/

Jin A, Linkov I. Synthetic Biology Brings New Challenges to Managing Biosecurity and Biosafety. 2021 Sep 8. In: Trump BD, Florin MV, Perkins E, et al., editors. Emerging Threats of Synthetic Biology and Biotechnology: Addressing Security and Resilience Issues. Dordrecht (DE): Springer; 2021. Chapter 8. Available from: https://www.ncbi.nlm.nih.gov/books/NBK584263/ doi: 10.1007/978-94-024-2086-9_8

Kaebnick GE, Gusmano MK, Murray TH. The ethics of synthetic biology: next steps and prior questions. Hastings Center Report. 2014;44(S5):S4-S26. https://pubmed.ncbi.nlm.nih.gov/25418704/

Kaiser J. Oversight but no strict rules for synthetic biology. Science. 2010;330(6008):1166. https://pubmed.ncbi.nlm.nih.gov/21109641/

Keiper F, Atanassova A. Regulation of synthetic biology: developments under the convention on biological diversity and its protocols. Frontiers in bioengineering and biotechnology. 2020;8:310. https://pubmed.ncbi.nlm.nih.gov/32328486/

Kumar S, Rai A. Synthetic biology: The intellectual property puzzle. Tex L Rev. 2006;85:1745. https://scholarship.law.duke.edu/faculty_scholarship/1628/

***Mackelprang R, Aurand ER, Bovenberg RAL, Brink KR, Charo RA, Delborne JA, Diggans J, Ellington AD, Fortman JLC, Isaacs FJ. Guiding ethical principles in engineering biology research. ACS Synthetic Biology. 2021;10(5):907-10. https://pubs.acs.org/doi/10.1021/acssynbio.1c00129

McLennan A. Patent law and the emerging science of synthetic biology: an examination of principle and practice. Biotechnology Law Report. 2017;36(2):59-74. https://www.liebertpub.com/doi/10.1089/blr.2017.29009.am

Parens E, Johnston J, Moses J. Ethical issues in synthetic biology: An overview of the debates. Woodrow Wilson International Center for Scholars, New York, Garrison, The Hastings Center. 2009. https://www.wilsoncenter.org/sites/default/files/media/documents/publication/synbio3.pdf

***Presidential Commission for the Study of Bioethical I. New directions: The ethics of synthetic biology and emerging technologies. DC: Presidential Commission for the Study of Bioethical Issues. 2010. https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/PCSBI-Synthetic-Biology-Report-12.16.10_0.pdf

Rai A, Boyle J. Synthetic biology: caught between property rights, the public domain, and the commons. PLoS biology. 2007;5(3):e58. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1821064/

Rogers W. Ethical issues in synthetic biology: A commentary. Macquarie Law Journal. 2015;15:39-44. https://www.mq.edu.au/__data/assets/pdf_file/0020/213761/mlj_2015_rogers.pdf

Schindler D, Dai J, Cai Y. Synthetic genomics: a new venture to dissect genome fundamentals and engineer new functions. Current opinion in chemical biology. 2018;46:56-62. https://pubmed.ncbi.nlm.nih.gov/29751161/

Schmidt M, Ganguli-Mitra A, Torgersen H, Kelle A, Deplazes A, Biller-Andorno N. A priority paper for the societal and ethical aspects of synthetic biology. Systems and synthetic biology. 2009;3:3-7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2759426/

Torrance AW. Synthesizing law for synthetic biology. Minn JL Sci & Tech. 2010;11:629. https://scholarship.law.umn.edu/mjlst/vol11/iss2/8/

Trump BD. Synthetic biology regulation and governance: Lessons from TAPIC for the United States, European Union, and Singapore. Health Policy. 2017;121(11):1139-46. https://pubmed.ncbi.nlm.nih.gov/28807332/

Trump BD, Galaitsi SE, Appleton E, Bleijs DA, Florin MV, Gollihar JD, Hamilton RA, Kuiken T, Lentzos F, Mampuys R. Building biosecurity for synthetic biology. Molecular systems biology. 2020;16(7):e9723. https://pubmed.ncbi.nlm.nih.gov/32692486/

Wang G, Kong Q, Wang D, Asmi F. Ethical and Social insights into Synthetic Biology: Predicting Research Fronts in the Post-COVID-19 Era. Frontiers in Bioengineering and Biotechnology.11:706. https://pubmed.ncbi.nlm.nih.gov/37274167/

Wang F, Zhang W. Synthetic biology: recent progress, biosafety and biosecurity concerns, and possible solutions. Journal of Biosafety and Biosecurity. 2019;1(1):22-30. https://www.sciencedirect.com/science/article/pii/S2588933818300104

Zhang W, Mitchell LA, Bader JS, Boeke JD. Synthetic Genomes. Annual Review of Biochemistry. 2020;89(1):77-101. https://www.annualreviews.org/doi/abs/10.1146/annurev-biochem-013118-110704

Genetically-Humanized Mice

Abbott A. Regulations proposed for animal-human chimaeras. Nature. 2011;475(7357):438. https://pubmed.ncbi.nlm.nih.gov/21796179/

The Academy of Medical Sciences. Animals containing human material. 2011 Available at https://acmedsci.ac.uk/policy/policy-projects/animals-containing-human-material.

Devoy A, Bunton-Stasyshyn RK, Tybulewicz VL, Smith AJ, Fisher E. Genomically humanized mice: technologies and promises. Nature Reviews Genetics. 2012;13(1):14-20. https://pubmed.ncbi.nlm.nih.gov/22179716/

Hinterberger A. Composite Animals: Then and Now. Hastings Center Report. 2022;52:S24-S8. https://pubmed.ncbi.nlm.nih.gov/36484511/

Kwisda K, White L, Hübner D. Ethical arguments concerning human-animal chimera research: a systematic review. BMC medical ethics. 2020;21(1):1-14. https://pubmed.ncbi.nlm.nih.gov/32293411/

Robert JS, Baylis F. Crossing species boundaries. American Journal of Bioethics. 2003;3(3):1-13. https://pubmed.ncbi.nlm.nih.gov/14594461/

Shultz LD, Ishikawa F, Greiner DL. Humanized mice in translational biomedical research. Nature Reviews Immunology 2007;7(2):118-130. https://pubmed.ncbi.nlm.nih.gov/17259968/

UK Home Office. Guidance on the use of Human Material in Animals, ed. Version 1.1. ed 2016. Available at https://www.gov.uk/government/publications/guidance-on-the-use-of-human-material-in-animals.

Weichseldorfer M, Heredia A, Reitz M, Bryant JL, Latinovic OS. Use of humanized mouse models for studying HIV-1 infection, pathogenesis and persistence. Journal of AIDS and HIV treatment. 2020;2(1):23.

Zhu F, Nair RR, Fisher EMC, Cunningham TJ. Humanising the mouse genome piece by piece. Nature Communications 2019;10(1):1845

General Interest

Torres-Padilla M-E, Bredenoord AL, Jongsma KR, et al. Thinking “ethical” when designing an international, cross-disciplinary biomedical research consortium. The EMBO Journal 2020;39(19):e105725.

Zoloth, Laurie. "The ethical scientist in a time of uncertainty." Cell 184, no. 6 (2021): 1430-1439. https://doi.org/10.1016/j.cell.2021.02.051