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

Abstract

In this paper, we explore the recent creation of “iBlastoids,” which are 3-D structures that resemble early human embryos prior to implantation which formed via self-organization of reprogrammed adult skin cells. We explore some of the ethical, philosophical, social, and regulatory issues related to this research, with focus particularly on what it means to “anticipate” research outcomes when using novel methods or when serendipitous discoveries are made. We defend the need for reflexive, anticipatory, and deliberative ethical and conceptual work by researchers working in emerging and contentious research domains, in collaboration with interdisciplinary scholars, as well as regulators, funders, and publics.

Keywords:

• Stem cell research
• cloning
• research ethics
• regulatory issues

This article is referred to by:

Response to Open Peer Commentaries on “Developing a Reflexive, Anticipatory, and Deliberative Approach to Unanticipated Discoveries: Ethical Lessons from iBlastoids”

Amplifying the Call for Anticipatory Governance

Governance of Emerging Biotechnologies: Lessons from Two Chinese Cases

Anticipatory Governance and Foresight in Regulating for Uncertainty

How Ethics Can Better Anticipate the Consequences of Emerging Biotechnologies

A RAD Approach to iBlastoids with a Moral Principle of Complexity

Why iBlastoids (Embryo-like Structures) Do Not Rise Significant Ethical Issues

ACKNOWLEDGMENTS

We are particularly grateful to José M. Polo (Monash University), whose lab led the iBlastoid research discussed in this article, for feedback and permission to use the figure reproduced above.

DISCLOSURE STATEMENT

RAA, MM, and JL have received funding from the Australian Government Medical Research Futures Fund including the Stem Cell Mission and the Australian Research Council for research relating to topics discussed in this article. MM also has received funding from the Special Research Initiative in Stem Cell Science, Stem Cells Australia, and is a member of the expert panel that authored the International Society for Stem Cell Research Guidelines on Stem Cell Research and Clinical Translation and was a former Ethics Committee Chair (received no monetary payment for her contribution).

Notes

1 Coinciding with these publications in Nature, two other groups reported 3-D models of human blastocyst development on a preprint server (Fan et al. 2021; Sozen et al. 2021); we do not explore these in any detail as they have not yet undergone peer review.

2 On the day that the Liu et al. iBlastoid paper was published, the NHMRC issued a statement that they considered iBlastoids to meet the definition of a human embryo in the Research Involving Human Embryos Act 2002, and that future work on iBlastoids would require an appropriate licence (NHMRC 2021).

3 In May 2021, the International Society for Stem Cell Research released updated Guidelines (ISSCR 2021). While research involving the creation of human stem cell-based embryo models that “represent integrated development of the entire embryo” such as that seen in iBlastoids remain permissible following comprehensive scientific and ethical review, the requirement to limit culture to 14 days has been removed. The revised recommendation is to culture the models for “the minimum time necessary” to achieve the study’s scientific objectives. 

4 Legislation to allow mitochondrial donation, Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021, has recently been introduced to Parliament with a vote anticipated in the coming year.