25 Ethical Issues in Human Gene Transfer Research

Abstract

The autumn of 1995 celebrated a number of important anniversaries for the ethics of human gene-transfer research. October 1995 marked 30 years since R.D. Hotchkiss introduced the label “genetic engineering” in an essay entitiled “Portents for a Genetic Engineering” that appeared in the Journal of Heredity (Hotchkiss 1965). December 1995 marked 20 years since the federal Guidelines for Recombinant DNA Research were developed to regulate genetic engineering, after scientists went public with their concerns in the early 1970s upon actually developing the tools to do what Hotchkiss anticipated (Krimsky 1985). November of 1995 was the tenth anniversary of the submission of the first formal protocol to conduct a clinical trial of gene therapy on a human being, and that trial began 5 years later, in September 1990 (Thomson 1994). Today, that first human gene therapy trial has been declared a success, more than 200 other trials are under way, and squadrons of molecular geneticists and biotechnologists now blithely call themselves “genetic engineers,” oblivious to the ironic origins of the label.

One of the striking features of this 30-year history is the extent to which the discussion of human genetic engineering has been open to and influenced by concerns over social values and the public’s voice. From the beginning, human gene transfer research seems to have been recognized to involve social value commitments that require the approval of the democratic process. Hotchkiss set the tone by concluding his prescient prediction of genetic interventions we are now capable of performing by prescribing...