In 1978, the birth of the world’s first “test-tube baby” led to debates over the use of embryos in research for in vitro fertilization. These questions were reviewed by the U.S. Department of Health, Education and Welfare’s now-defunct Ethics Advisory Board. Two decades later, scientific discussion related to cloning and the use of human embryonic stem cells led to additional questions about what research is permissible and what should considered be unethical, which were addressed by President Bill Clinton’s National Bioethics Advisory Commission and President George W. Bush’s President’s Council on Bioethics.
The Biden administration should also form a national bioethics commission to study and make recommendations related to issues raised by biomedical research. One area of concern that should be addressed is lab-developed models of embryos.
In March, three research groups reported breakthroughs in constructing lab models of embryos. These models, known as stem cell-based embryo models or embryoids, were created from living cells and designed to behave similarly to embryos. The research was conducted to better understand fundamental questions of human development, which we have been unable to answer previously, as well as help understand and prevent infertility, pregnancy loss, birth defects and early developmental disorders and diseases.
While in its infancy today, these technologies could one day allow scientists to use human cells to make viable embryos in the lab. While the work is remarkable, it raises new questions about what human embryo research should and should not be permitted. However, there is no national bioethics commission to review and make recommendations.
Current laws and ethical guidelines also do not offer answers. Are they just cells, are they embryos, or something else? How sophisticated would they need to be to be considered embryos? Furthermore, human embryo research is banned by the Dickey-Wicker Amendment, which defines an embryo broadly as any organism “that is derived by fertilization, parthenogenesis, cloning or any other means from one or more human gametes or human diploid cells.” Based on this definition, should lab models of embryos be considered embryos and banned from funding? Or do models, which lack the capacity to fully develop, be viewed differently?
The National Institutes of Health, which funds biomedical research, offers little guidance to scientists. Instead, NIH officials suggest that each grant will be reviewed on a case-by-case basis to determine if it can be funded. This situation leaves scientists in a precarious position where they have to spend hours writing and submitting a grant before knowing if it is fundable, perhaps wasting valuable time.
A national bioethics commission should be designed to include a diverse group of experts that reflect a wide range of perspectives to review this and other bioethics issues, conduct public hearings and make recommendations to the president. It should be tasked with conducting transparent, inclusive, open and robust dialogues with the public, scientists and policymakers to help understand the limits of the research and its benefits, as well as ethical concerns it creates.
Only with thoughtful dialogue will we see policies developed that will provide guidelines for scientists and acknowledge the knowledge to be gained through these models while respecting public concerns.
Kirstin R.W. Matthews, Ph.D, is a fellow in science and technology at the Rice University’s Baker Institute for Public Policy and a lecturer in the Department of Bioscience at Rice University. krwm@rice.edu Ana S. Iltis, Ph.D, is the Carlson professor of University Studies, professor of Philosophy, and director of the Center for Bioethics, Health and Society at Wake Forest University. iltisas@wfu.edu