Franco Furger and I have just released the final report of our Human Biotechnologies Governance Project. The report calls for the creation of a new federal regulatory agency to oversee human reproductive medicine in the United States. It argues that the current regulatory structure, spread between the FDA, NIH, and state regulatory bodies, is inadequate to deal with the ethical challenges posed by new biotechnologies.
We are both supporters of embryonic stem cell research, and think that the Bush administration’s policy, in place since 2001, is too restrictive. But we also believe that future research should be carried out only under a much stronger regulatory framework than currently exists.
Apart from issues specifically related to reproductive medicine, the report deals with a problem typical of all federal regulation. The debate over stem cell research has been highly polarized between the scientific community and various patient advocacy groups who want research with no restrictions, on the one hand, and pro-life groups opposed to any research that harms embryos. Poll data shows, however, that a strong majority of Americans are in favor of a much more centrist position that would permit, for example, stem cell research but only using excess IVF embryos. The problem is that the public debate is completely dominated by the more polarized and better organized interest groups, leading to the deadlock we have seen over the past five years in this area. One of the objects in designing a new regulatory institution is finding a way to tap into the more centrist views of ordinary Americans. This situation recurs in areas like environment, nuclear power, and other policy domains where existing mechanisms for public participation, defined under the 1946 Administrative Procedures Act, are inadequate to generate real public consensus.
The report contains the most comprehensive account we know of concerning current American and international regulation of human reproductive medicine. It can be downloaded at https://www.biotechgov.org. We also have a limited number of print copies available which can be purchased on the web site for $14.