Developing a Reflexive, Anticipatory, and Deliberative Approach to Unanticipated Discoveries: Ethical Lessons from iBlastoids

REFERENCES

• Aguilera-Castrejon, A., B. Oldak, T. Shani, N. Ghanem, C. Itzkovich, S. Slomovich, S. Tarazi, J. Bayerl, V. Chugaeva, M. Ayyash, et al. 2021. Ex utero mouse embryogenesis from pre-gastrulation to late organogenesis. Nature 593 (7857):119–24. doi:10.1038/s41586-021-03416-3.
   PubMed Web of Science ®Google Scholar
• Ankeny, R. A., and S. Dodds. 2008. Hearing community voices: Public engagement in Australian human embryo research policy 2005-7. New Genetics and Society 27 (3):217–32. doi:10.1080/14636770802326901.
   Web of Science ®Google Scholar
• Australian Commonwealth. 2002. Research Involving Human Embryos Act 2002. https://www.legislation.gov.au/Details/C2016C00968
   Google Scholar
• Australian Commonwealth. 2006. Prohibition of Human Cloning for Reproduction and Regulation of Human Embryo Research Amendment Act 2006. https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd0607/07bd059
   Google Scholar
• Australian National Health and Medical Research Council (NHMRC). 2006. ‘Human embryo’–A biological definition: A discussion paper. https://www.nhmrc.gov.au/about-us/publications/embryo-research-licensing-key-terms
   Google Scholar
• Australian National Health and Medical Research Council (NHMRC). 2021. NHMRC Statement: Nature paper: Modelling human blastocysts by reprogramming fibroblasts into iBlastoids. https://www.nhmrc.gov.au/about-us/news-centre/nhmrc-statement
   Google Scholar
• Barben, D., E. Fisher, C. Selin, and D. Guston. 2008. Anticipatory governance of nano-technology: Foresight, engagement, and integration. In The handbook of science and technology studies, ed. E. Hackett, M. Lynch, and J. Wajcman, 979–1000, 3rd ed. Cambridge: MIT Press.
   Google Scholar
• Copeland, S. 2019. On serendipity in science: Discovery at the intersection of chance and wisdom. Synthese 196 (6):2385–406. doi:10.1007/s11229-017-1544-3.
   Web of Science ®Google Scholar
• Dodds, S. M., and R. A. Ankeny, eds. 2016. Big picture bioethics: Developing democratic policy in contested domains. Dordrecht: Springer.
   Google Scholar
• Dodds, S. M., and R. A. Ankeny. 2006. Regulation and hESC research in Australia: Promises and pitfalls for deliberative democratic approaches. Journal of Bioethical Inquiry 3 (1–2):95–107. doi:10.1007/s11673-006-9007-4.
   Google Scholar
• Fan, Y., Z.-Y. Min, S. Alsolami, Z.-L. Ma, K. Zhong, W.-D. Pei, P.-Y. Zhang, X.-J. Kang, Y.-Y. Zhang, H.-Y. Zhu, et al. 2021. Generation of human blastocyst-like structures from pluripotent stem cells. bioRxiv. doi:10.1101/2021.03.09.43431.3
   Google Scholar
• Findlay, J. K., M. L. Gear, P. J. Illingworth, S. M. Junk, G. Kay, A. H. Mackerras, A. Pope, H. S. Rothenfluh, and L. Wilton. 2007. Human embryo: A biological definition. Human Reproduction 22 (4):905–11. doi:10.1093/humrep/del467.
   PubMed Web of Science ®Google Scholar
• Fu, J., A. Warmflash, and M. P. Lutolf. 2021. Stem-cell-based embryo models for fundamental research and translation. Nature Materials 20 (2):132–44. doi:10.1038/s41563-020-00829-9.
   PubMed Web of Science ®Google Scholar
• Guston, D. H. 2014. Understanding 'anticipatory governance'. Social Studies of Science 44 (2):218–42. doi:10.1177/0306312713508669.
   PubMed Web of Science ®Google Scholar
• Hajer, M. 2003. Policy without polity? Policy analysis and the institutional void. Policy Sciences 36 (2):175–95. doi:10.1023/A:1024834510939.
   Web of Science ®Google Scholar
• Harvey, A., and B. Salter. 2012. Anticipatory governance: Bioethical expertise for human/animal chimeras. Science as Culture 21 (3):291–313. doi:10.1080/09505431.2011.630069.
   PubMed Web of Science ®Google Scholar
• Harvey, O. 2008. Regulating stem cell research and human cloning in an Australian context: The Lockhart Review. New Genetics and Society 27 (1):33–42. doi:10.1080/14636770701843600.
   Web of Science ®Google Scholar
• Hyun, I., M. Munsie, M. F. Pera, N. C. Rivron, and J. Rossant. 2020. Toward guidelines for research on human embryo models formed from stem cells. Stem Cell Reports 14 (2):169–74. doi:10.1016/j.stemcr.2019.12.008.
   PubMed Web of Science ®Google Scholar
• International Society for Stem Cell Research (ISSCR). 2016. ISSCR guidelines for stem cell research and clinical translation. https://www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinical-translation/guidelines-archive
   Google Scholar
• International Society for Stem Cell Research (ISSCR). 2021. ISSCR guidelines for stem cell research and clinical translation (2021 update). https://www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinical-translation
   Google Scholar
• Jarvis, G. E. 2016. Early embryo mortality in natural human reproduction: What the data say. F1000Research 5:2765. doi:10.12688/f1000research.8937.2.
   PubMedGoogle Scholar
• Kuhlmann, S., P. Stegmaier, and K. Konrad. 2019. The tentative governance of emerging science and technology: A conceptual introduction. Research Policy 48 (5):1091–7. doi:10.1016/j.respol.2019.01.006.
   Web of Science ®Google Scholar
• Lancaster, M. A., and J. A. Knoblich. 2014. Organogenesis in a dish: Modeling development and disease using organoid technologies. Science 345 (6194):1247125. doi:10.1126/science.1247125.
   PubMed Web of Science ®Google Scholar
• Liu, X., J. F. Ouyang, F. J. Rossello, J. P. Tan, K. C. Davidson, D. S. Valdes, J. Schröder, Y. B. Y. Sun, J. Chen, A. S. Knaupp, et al. 2020. Reprogramming roadmap reveals route to human induced trophoblast stem cells. Nature 586 (7827):101–7. doi:10.1038/s41586-020-2734-6.
   PubMed Web of Science ®Google Scholar
• Liu, X., J. P. Tan, J. Schröder, A. Aberkane, J. F. Ouyang, M. Mohenska, S. M. Lim, Y. B. Y. Sun, J. Chen, G. Sun, et al. 2021. Modelling human blastocysts by reprogramming fibroblasts into iBlastoids. Nature 591 (7851):627–32. doi:10.1038/s41586-021-03372-y.
   PubMed Web of Science ®Google Scholar
• Maienschein, J., M. Sunderland, R. A. Ankeny, and J. S. Robert. 2008. The ethos and ethics of translational research. The American Journal of Bioethics 8 (3):43–51. doi:10.1080/15265160802109314.
   PubMed Web of Science ®Google Scholar
• Matthews, K. R. W., and D. Moralí. 2020. National human embryo and embryoid research policies: A survey of 22 top research-intensive countries. Regenerative Medicine 15 (7):1905–17. doi:10.2217/rme-2019-0138.
   PubMed Web of Science ®Google Scholar
• Mazzucato, M. 2021. Mission Economy. London: Penguin.
   Google Scholar
• Michener, W. K., K. L. Bildstein, A. Mckee, R. R. Parmenter, W. W. Hargrove, D. Mcclearn, and M. Stromberg. 2009. Biological field stations: Research legacies and sites for serendipity. BioScience 59 (4):300–10. doi:10.1525/bio.2009.59.4.8.
   Web of Science ®Google Scholar
• Moris, N., K. Anlas, S. C. van den Brink, A. Alemany, J. Schröder, S. Ghimire, T. Balayo, A. van Oudenaarden, and A. M. Arias. 2020. An in vitro model of early anteroposterior organization during human development. Nature 582 (7812):410–5. doi:10.1038/s41586-020-2383-9.
   PubMed Web of Science ®Google Scholar
• Nordmann, A. 2014. Responsible innovation, the art and craft of anticipation. Journal of Responsible Innovation 1 (1):87–98. doi:10.1080/23299460.2014.882064.
   Google Scholar
• Pasteur, L. [1854]1948. Inaugural address, opening of the Faculté des Sciences, Lille (7 December 1854). In R. Vallery-Radot, The Life of Pasteur, trans. R. L. Devonshire, 76. London: Constable & Company.
   Google Scholar
• Ravetz, J. 1997. The science of ‘what-if? Futures 29 (6):533–9. doi:10.1016/S0016-3287(97)00026-8.
   Web of Science ®Google Scholar
• Rivron, N. C., J. Frias-Aldeguer, E. J. Vrij, J.-C. Boisset, J. Korving, J. Vivié, R. K. Truckenmüller, A. van Oudenaarden, C. A. van Blitterswijk, and N. Geijsen. 2018. Blastocyst-like structures generated solely from stem cells. Nature 557 (7703):106–11. doi:10.1038/s41586-018-0051-0.
   PubMed Web of Science ®Google Scholar
• Rossant, J., and P. P. L. Tam. 2017. New insights into early human development: Lessons for stem cell derivation and differentiation. Cell Stem Cell 20 (1):18–28. doi:10.1016/j.stem.2016.12.004.
   PubMed Web of Science ®Google Scholar
• Salmon, R. A., R. K. Priestley, and J. Goven. 2017. The reflexive scientist: An approach to transforming public engagement. Journal of Environmental Studies and Sciences 7 (1):53–68. doi:10.1007/s13412-015-0274-4.
   Google Scholar
• Sample, M., M. Boulicault, C. Allen, R. Bashir, I. Hyun, M. Levis, C. Lowenthal, D. Mertz, N. Montserrat, M. J. Palmer, et al. 2019. Multi-cellular engineered living systems: Building a community around responsible research on emergence. Biofabrication 11 (4):043001. doi:10.1088/1758-5090/ab268c.
   PubMed Web of Science ®Google Scholar
• Savulescu, J. 2021. Ethics, iBlastoids, and brain organoids: Time to revise antiquated laws and processes. Journal of Medical Ethics Blog https://blogs.bmj.com/medical-ethics/2021/03/18/ethics-iblastoids-and-brain-organoids-time-to-revise-antiquated-laws-and-processes/.
   Google Scholar
• Schick, A. 2016. Where to speculative bioethics? Technological visions and future simulations in a science fictional culture. Medical Humanities 42 (4):225–31. doi:10.1136/medhum-2016-010951.
   PubMed Web of Science ®Google Scholar
• Schuurbiers, D. 2011. What happens in the lab does not stay in the lab [corrected]: Applying midstream modulation to enhance critical reflection in the laboratory. Science and Engineering Ethics 17 (4):769–88. doi:10.1007/s11948-011-9317-8.
   PubMed Web of Science ®Google Scholar
• Scott, C. 2015. Treading the line between sensational and groundbreaking science. The American Journal of Bioethics 15 (12):1–2. doi:10.1080/15265161.2015.1119012.
   PubMed Web of Science ®Google Scholar
• Shapin, S. 1992. Why the public ought to understand science in the making. Public Understanding of Science 1 (1):27–30. doi:10.1088/0963-6625/1/1/006.
   Google Scholar
• Sinclair, A. H., and P. R. Schofield. 2007. Human embryonic stem cell research: An Australian perspective. Cell 128 (2):221–3. doi:10.1016/j.cell.2007.01.008.
   PubMed Web of Science ®Google Scholar
• Skene, L. 2012. Legal regulation of human stem cell technology. In Stem cells: New frontiers in science and ethics, ed. M. Quigley, S. Chan, and J. Harris, 85–105. Singapore: World Scientific.
   Google Scholar
• Sozen, B., V. Jorgensen, M. Zhu, T. Cui, and M. Zernicka-Goetz. 2021. Reconstructing human early embryogenesis in vitro with pluripotent stem cells. bioRxiv doi:10.1101/2021.03.12.435175.
   Google Scholar
• Stilgoe, J., R. Owen, and P. Macnaghten. 2013. Developing a framework for responsible innovation. Research Policy 42 (9):1568–89. doi:10.1016/j.respol.2013.05.008.
   Web of Science ®Google Scholar
• Tomlinson, T. 2013. Respecting donors to biobank research. The Hastings Center Report 43 (1):41–7. doi:10.1002/hast.115.
   PubMed Web of Science ®Google Scholar
• Woolgar, S. W. 1976. Writing an intellectual history of scientific development: The use of discovery accounts. Social Studies of Science 6 (3–4):395–422. doi:10.1177/030631277600600306.
   Web of Science ®Google Scholar
• Zheng, Y., X. Xue, Y. Shao, S. Wang, S. N. Esfahani, Z. Li, J. M. Muncie, J. N. Lakins, V. M. Weaver, D. L. Gumucio, et al. 2019. Controlled modelling of human epiblast and amnion development using stem cells. Nature 573 (7774):421–5. doi:10.1038/s41586-019-1535-2.
   PubMed Web of Science ®Google Scholar