Ethics, Bioethics, and Biomedical Research

Two stories in the past two weeks, one on the therapeutic cloning of human stem cells,1 and the other on the successful replication of DNA containing two new, non-naturally occurring synthetic DNA bases in a cell2 have prompted me to turn to the subject of bioethics.  I have been studying and writing about biotechnology since 1984 and for quite a while people would conflate biotechnology with bioethics. When I would tell people that my area of law was focused on biotechnology, I would frequently get the response, “like designer babies?”   I would respond, “No, that’s a bioethics issue, and I rarely do anything ethical.”  My joking response was intended to emphasize the distinction between biotechnology, which is simply the use of modern molecular biology as a tool in a variety of areas, from bioethics, which is the effort to analyze issues concerning human life and health in ethical terms. In the 1980′s and much of the ’90′s,  my response was true. The biotechnology industry was focused on healthcare innovation and faced numerous issues concerning intellectual property rights and federal regulation. Very few, if any, of the issues faced by the developing biotechnology industry raised new or difficult ethical issues.   Continue reading