Modeling policy development: examining national governance of stem cell-based embryo models

Researchers can now coax human pluripotent stem cells to imitate the structure and spontaneous self-organization of the developing human embryo. Although these stem cell-based embryo models present an advantageous alternative to embryo research, they also raise ethical and policy challenges. In 2021, the International Society for Stem Cell Research revised its Guidelines for Stem Cell Research and Clinical Translation, providing contemporaneous best practices for ethical conduct in the field. The Guidelines complement national governance frameworks; however, they also contain contentious and aspirational norms that might catalyze change in research practice and in the enactment of national policies. Using a sample of 11 research-intensive countries, the authors compare research policy frameworks against the International Society for Stem Cell Research Guidelines to showcase how developments in global and national policies might affect stem cell-based embryo model research governance and illustrate fertile areas for ethical reflection and policy development. Plain language summaryFollowing scientific advances, researchers can induce stem cells to model the development of the human embryo with increasing accuracy. The International Society for Stem Cell Research Guidelines for Stem Cell Research and Clinical Translation provide contemporary standards for research on so-called stem cell-based embryo models (SCB-EMs). However, because SCB-EMs are not mentioned in national policies and do not fit neatly into existing regulatory categories, it is unclear how countries intend to regulate them. In this article, the authors compare policy frameworks in 11 research-intensive countries to analyze how the influential Guidelines both complement and catalyze change in national policies. The Guidelines provide specific instructions for assessing and monitoring different kinds of SCB-EM research proposals, serving as a useful reference to bolster open-ended national policy requirements. However, in some areas the Guidelines appear to conflict with national policies governing stem cell and embryo research, reflecting divergent priorities and ethical assessments. Without policy review to address regulatory and ethical uncertainty, researchers may default to adherence to the Guidelines, a global standard that does not necessarily reflect local historic, legal and cultural influences. Evidence from France and Israel indicates that comprehensive legislative review is both useful and can proceed without eroding compromises designed to uphold plural beliefs regarding the moral status of the human embryo. As exemplified in countries such France and Israel, mandated legislative review processes are useful tools that can be deployed in manner that upholds pluralistic beliefs regarding the human embryo's moral status. They can serve as a pathway to re-engage the public and ensure diverse viewpoints are reflected in governance of SCB-EM research, ultimately facilitating public trust in science. Tweetable abstractThe International Society for Stem Cell Research Guidelines are the eminent global standard for ethical conduct in stem cell research. Although they complement national governance frameworks, they also contain contentious and aspirational norms that should catalyze policy review.

Automated summary

Researchers have developed stem cell-based embryo models that imitate the structure and organization of the human embryo, raising both ethical and policy challenges. The International Society for Stem Cell Research has revised its guidelines to address these challenges, but conflicts and divergences still exist between these guidelines and national policies. Policy review and legislative processes, such as those seen in France and Israel, can help address these issues and ensure ethical governance of stem cell-based embryo model research.