ance between NIH and DOE was also a first (see Cook-Deegan, 1991; NRC, 1988; OTA, 1988), as was the allocation of 3 percent of the research budget for the study of ethical, legal, and social implications of the application of knowledge gained from the mapping and sequencing research enterprise. Never before had the federal government rushed headlong into such an ambitious research program while at the same time supporting efforts that would raise questions about the wisdom, pace, and potential social consequences of its actions.
The knowledge gained from the Human Genome Project is expected to have major impacts on the understanding of disease, both genetic and acquired, for society in general, and for us, as individuals. It is the ability to characterize and profile the genetic information of individuals that has led to speculation and concern about the use and potential abuse of such information in terms of discrimination, stigmatization, and potential medical harm.
Although these concerns are not new-they were previously raised in concert with early genetic diagnostic capabilities such as sickle cell carrier screening and the use of prenatal diagnosis for selective abortion-the debate about the human genome initiative brought many of these issues to the surface once again because of the scale and magnitude of the mapping effort. Whereas ethical, legal, and social concerns were previously addressed on a case-by-case basis, the accelerated pace of new discoveries from the Human Genome Project could render such an approach dangerously obsolete. The genome project will inevitably lead to genetic tests that are faster, cheaper, more accurate, and more applicable to a multitude of diseases. The effects on the conduct of biomedical research and approaches to disease treatment could be revolutionary.
James D. Watson, codiscoverer of the molecular structure of DNA and a early proponent of a federal effort to map the human genome, recognized the need to confront these policy issues early in the project. He reiterated his commitment at a press conference in October 1988 announcing his appointment as the first head of the NIH Office of Human Genome Research:
Some very real dilemmas exist already about the privacy of DNA. The problems are with us now, independent of the genome program, but they will be associated with it. We should devote real money to discussing these issues. People are afraid of genetic knowledge instead of seeing it as an opportunity [quoted in Roberts, 1989].
Watson felt that the NIH program should spend some of its genome money on pursuing the social, legal, and ethical issues raised by rapid advances in genetic knowledge. This belief led to the creation of the Ethical, Legal, and Social Implications (ELSI) Program, a grant-making and policymaking body within the National Institutes of Health.