The Hinxton consensus: a guiding light for scientists in international stem cell research

Since its origins eight years ago, the field of human embryonic stem cell (ES cell) research has stirred perhaps more ethical debate than any other scientific advance of recent years. Between the age-old arguments regarding embryo research, debates about egg donation, false claims regarding human cloning and recent furore over scientific fraud, it is likely to remain a controversial and much-discussed topic into the future. One issue that has received insufficient attention to this point, however, is the question of how ES cell research can and should operate in the international scientific environment.

The common response to ethical concerns over ES cell research has been for countries to introduce laws that regulate such research, operating to control or prohibit research activities that may raise ethical questions. However, the nature, scope and effects of such regulations varies drastically between different jurisdictions: from fairly permissive to highly restrictive. The issue faced by today's scientists is how to conduct their research in the face of such pluralistic regulation at the global level: science is an international field and research often crosses political and regulatory boundaries, through both collaborations and the general dissemination of newly acquired knowledge. When research is lawful in one country and banned in another, how should scientists of either country proceed with trans-national research?

It was in this context that the 'Hinxton group' was formed to address questions and concerns about the operation of embryo and stem cell research in the international scientific community. Representing a broad spectrum of those concerned and involved with stem cell research, including scientists, bioethicists, policy advisors and regulators, and with members from countries with diverse regulatory backgrounds including the UK and Europe, the United States, Asia and Australia, the consortium was able to approach these issues from a variety of pertinent perspectives. Members of the group met at an intensive think-tank workshop for two days in February to discuss and consider the challenges involved in taking embryo research to a global level.

Among the questions considered especially relevant were those relating to regulation of trans-national research, particularly relating to international collaborations and the traffic of resources, knowledge and scientists themselves across countries with differing laws regarding embryo research. The group also considered provisions for in-country regulation in terms of maximising the effectiveness of regulation, drawing on the experience represented amongst the members of different models of regulation. Further aims were to facilitate and ensure scientific and ethical integrity within the research community, and to identify in advance new issues that might arise over the next few years with respect to embryo and stem cell research. The primary outcome of the Hinxton meeting was the release of a consensus statement on trans-national cooperation in stem cell research, based on the output and group discussions during the meeting.

A key recommendation with respect to regulation was that laws should incorporate sufficient flexibility to accommodate the rapid development of science in this area. This was backed by the experience of many countries, notably Australia, where the legislation was recently reviewed after just three years in operation, and the United States, where legislation over cloning and embryo research is still in an uncertain state; and by policy advisors, particularly from the UK, whose regulatory system is often regarded as providing an exemplary combination of flexibility and careful control.

Other recommendations included a call for legal certainty, to protect scientists carrying out research within their own jurisdiction and in collaboration with researchers from other countries, and to establish a framework whereby trans-national collaboration across regulatory boundaries might operate. There was overwhelming agreement that the global nature of science should not be compromised. Scientists should be free to carry out research in any country in which it is lawful, so long as it is done in accord with recognised standards of ethical and scientific integrity. The consideration of such standards is in itself another important role for the group: where regulation is limited to national scope, the international scientific and ethical community must act responsibly and set guidelines for its own regulation. In forming a working group representing this community, the Hinxton project has laid important foundations for international cooperation in science and ethics.

World governments, as some commentators on the Hinxton consensus statement have pointed out, are unlikely to reach any official political consensus on embryo research and its regulation, at least in the near future. Far from being a criticism of the group's aims and work, however, this highlights perfectly one of the strengths of the group and a crucial part of the rationale for its existence. In the absence of an international political consensus, the Hinxton statement provides some much-needed guidance by which members of the international research community might steer a course through the labyrinth of ethical, legal and scientific conundrums that ES cell research presents today.