The "Hinxton Group" Considers Transnational Stem Cell Research

Science today is a transnational activity: scientists work across borders. The regulation of science is a national activity, however. Laws and ethical standards frequently differ across countries, of course, and this impedes science.

Nowhere is the problem of variable national regulation more apparent than in human embryonic stem cell research, entangled as it is with controversies over the destruction of human embryos and their production through the process of nuclear transfer, or cloning. While there is a global consensus to ban human reproductive cloning, the regulation of therapeutic cloning and embryonic stem cell research varies among nations. The notorious scientific misconduct of Woo-Suk Hwang, which involved fraudulent claims that embryonic stem cell lines had been derived from cloned human embryos, prominently featured collaboration between U.S. and Korean researchers who had to deal with differing legislative and ethical regulations.

Transnational variation in law and ethical regulation has several important implications. Legal differences can leave scientists uncertain about their legal standing when working internationally. Ambiguous use of technical language may discourage scientists from developing legal avenues of research. Alternatively, scientists working within the law may be the target of legal proceedings initiated by people who wish to challenge those ambiguities.

Transnational collaboration also poses complex jurisdictional problems. Italy bans the use of human embryos for research: would an Italian scientist be legally exposed when collaborating on stem cell research in the United Kingdom? Would he be able to support grant/job applications with publications from such collaboration?

This February, over fifty scientists, clinicians, ethicists, journal editors, lawyers, and policy-makers from fourteen countries convened in Hinxton, Cambridge, to address such problems. The "Hinxton Group," as it came to be called, articulated a series of normative principles to govern international collaboration in stem cell research.

The Hinxton Group made specific recommendations for scientists and journal editors. Scientists should submit stem cell lines to national or international depositories that subscribe to internationally accepted standards of quality and that make cell lines and relevant information publicly available. Journal editors should require authors to provide specific information about the source of the cells used in research, submit data verifying the authenticity of new human embryonic stem cell lines, and explain how they have complied with accepted standards of good cell culture practice. In general, journal editors should encourage authors to include explicit descriptions of their role in international collaboration. They should also require a statement from scientists that their research conforms to local laws and policies and has been approved by all applicable oversight committees. Scientists should be ready and willing to provide information that may bear on the ethics of their research.

Other recommendations were aimed more broadly. The group encouraged policy-makers to consult with scientists and with the public when designing policy, which should be clear yet flexible enough to take account of rapid scientific progress. Scientists should be able to conduct any research that is ethically defensible, has real scientific value, and is legal in the country where it occurs, without fear of sanction of any kind elsewhere. The group also called for a publicly accessible database of policies, information provided to potential human participants, and other documents that bear on the ethics of human embryonic stem cell research.

The Hinxton process had limitations. Most notably, nearly everyone in it broadly supported embryonic stem cell research. Still, it generated a set of principles publicly articulated by a group of authoritative figures and could form a basis for further public and political dialogue. It is also a very significant step toward scientific self-regulation. Most credible scientists, after all, do not want unrestricted rights to pursue research. Where science is unregulated, there are often vast differences in scientific and ethical standards, and the quality of the research itself is called into question.