The world's scientific community must engage with a broad range of stakeholders to develop guidelines on embryo and embryoid research, according to a new paper from Rice University's Baker Institute for Public Policy.
Human embryo and embryoid research has expanded in recent years due to technological advances. But inconsistent or ambiguous restrictions among the 22 leading research and development nations causes confusion about what is allowed, the authors argue.
"The views of the human embryo and embryoids as a research tool vary internationally from permissive to completely prohibitive," wrote Kirstin Matthews, fellow in science and technology policy at the Baker Institute, and Daniel Morali, a research associate at the institute.
Among the top R&D-investing nations, Matthews and Morali found 12 countries have a 14-day limit on embryo research after fertilization, one has a seven-day limit, five have less restrictive prohibitions and four have no laws or guidelines at all.
The 14-day limit is a "boundary that prohibits scientists from culturing or conducting research on an in vitro human embryo beyond 14 days after fertilization or after the development of the primitive streak (a faint streak on the embryo that establishes bilateral symmetry and potential further development)," according to the paper.
When the 14-day limit was established for the United States in 1979 by its Department of Health, Education and Welfare, it was "technologically infeasible to culture human embryos beyond 14 days; thus, it imposed no limits on research," according to the paper. Now the U.S. is one of four countries without a 14-day limit or other restrictions on human embryo research.
Two developments have encouraged global scholars to revisit embryo research polices.
First, two independent research groups in the U.S. and U.K. were able to culture human embryos in vitro "to understand early human development, including how embryo cells organize, differentiate and generate tissues to allow proper implantation," according to the paper. The two groups did not expand their research beyond the 14-day limit out of respect to international norms (in the U.S.'s case) and laws (U.K.).
Second, scientists are now using organized pluripotent stem cell models - embryoids or artificial embryos - to study early human development. However, most national laws and guidelines are ambiguous about embryoid research, leaving what is and is not permitted unclear, according to the authors.
"Several countries limit research on cells with the potential to become a human embryo," they wrote. "This affects researchers' ability to conduct embryoid research when potential is not defined."
Matthews and Morali argue that embryoid research will need its own set of guidelines, separate from human embryo research policies, since it addresses a different set of ethical and scientific issues.
To encourage research in these areas, "scientists will need to engage with invested and interested stakeholders, such as funders, religious leaders (concerned about the use of embryos in research), donors, patients and others who might gain from knowledge obtained from human embryo and embryoid research," they wrote.
"Working with stakeholders to develop thoughtful and appropriate guidelines would acknowledge the sensitive nature of the work, provide an opportunity for public engagement and promote high-quality science," they added. "Otherwise, scientists run the risk of losing public trust and seeing more restrictive regulations being instituted."