Problem Definition and Funding

A research agenda is a manifestation of human values. Major ethical questions generated during this stage in genetic research concern who sets the agenda and the form it takes.

In the early days indivdual scientists pursuing their own curiosity generally selected the research topics to be studied. As the amount of resources required to conduct both field and laboratory genetics research has increased, however, governments, private foundations, and more recently private business enterprises have played a more central role. In the United States, programs managed by the National Institutes of Health (NIH), the Department of Energy (DOE), and the Department of Defense (DOD) have become the primary sources of funds, and hence they are highly influential in setting the agenda. In one enlightened set of events, an examination of ethical issues has been a part of the United States' Human Genome Project, funded by the NIH and DOE, since its inception. Under the influence of its first director, James Watson, about 3 % of its annual budget is devoted to the study of ethical, legal, and social implications under a program whose acronym is ''ELSI.'' (ELSI currently receives about 5% of the budget.) This is one of the first instances in history of a program dedicated to studying the ethical implications and consequences of basic research prospectively and, hopefully, preemptively.

For some specific kinds of genetic diseases, private foundations, such as the American Heart Association, Muscular Dystrophy Association, and Susan G. Koman Foundation for Breast Cancer, constitute alternative sources of research funding. Each of these foundations fund research aimed at decreasing the mortality and morbidity of given diseases. Both governments and foundations, with input from scientists, however, generally set the overarching agenda and then evaluate individual scientist's project proposals according to the guidelines they establish. The guidelines are usually based on political considerations and personal preferences. Thus, during the process of program guideline development, important stakeholders' needs, such as patients with or without a given disease, could be overridden. Moreover, by responding to these programs and their guidelines in order to get support for their research, scientists often must give up research ideas in other areas which they think are more valuable.

For example, a group of concerned families whose members have a history of a disease called dysautono-

mia found that the affliction was of little scientific interest to researchers. Dysautonomia is a degenerative neurological disease which occurs predominantly among Ashkenazi Jews and is currently incurable. It results from inheriting a recessive gene found in about 1 in 30 Ashkenazis. Thus, the chances both members of an Ashkenazi couple will carry the mutated allele are about 1 in 900 [(1/30) X (1/30)]. Based on Mendel's formula, there is a 1 in 4 chance that each child born to the couple will inherit copies of the gene from both parents and, therefore, have the disease. This yields an incidence of about 1 in 3600 within the Ashkenazi population. People of Ashkenazi descent, however, make up a very small percentage of the U.S. population; so, what is a significant incidence of disease for them within their subgroup does not figure so prominently in the concerns for the nation as a whole. This may be one reason why very little research effort was devoted to the disorder. Nevertheless, these peoples' loved ones had been suffering from it, and, this led members of the concerned families to set up the Dysautonomia Foundation to support research into the disease. As of 1996 the markers for the gene have been identified and, if the necessary pedigree information is also available, a prenatal diagnostic test may reveal whether or not the fetus has dys-autonomia. Some observers believe that these grassroots efforts make for the most effective and just overall allocation of research resources; others believe that they tend to dissipate valuable resources best used elsewhere.

The dysautonomia case is also an example of the problem of opportunity costs associated with the allocation of research funds and of finding the most effective organizational mechanisms for using them. These questions have been raised in genetics research since the early 1980s when national budget deficits placed political pressure on government allocations. The National Institutes of Health and the Department of Energy currently spends about $200 million annually on genetic research. Continual efforts to cut this budget have resulted, among other things, in an arrangement known as the cooperative research and development agreement (CRADA) between federal agencies and private enterprises. This is a joint agreement in which scientists, often university based, can participate without a legal conflict of interest. Some observes believe, however, that these arrangements divert research efforts away from basic research and redirect them toward producing more com-mercializable knowledge.

Genetic knowledge bestows power on its possessors. Because of their central role in all life, the results of research in genetics are a source of social and economic power raising all of the attendant concerns people have about the moral and ethical use of power, and, it is doing this at all societal levels. Nationally, concerns about ''Big Brother'' have reemerged. As early as 1971 Joseph Fletcher observed of genetic research, ''Even though its medical aims were only to gain control over the basic 'stuff' of our human constitution it could no doubt also be turned into an instrument of power.'' (1971. Ethical Aspects of Genetic Controls: Designed Genetic Changes in Man, New England Journal of Medicine, Vol. 285, pp. 776-783). Insurance companies and employers potentially have the power to select or deselect their customers or employees based on their genetic makeup. Individuals potentially have the power to select the genetically ''best'' mate for themselves or for their relatives and to decide whether or not to carry a pregnancy to term.

Any research project that might serve to redistribute the social balance of power should be examined very carefully. Increased private sector involvement is bringing this concern to public attention. As the profit-making potential of genetic tests and therapies has become more evident, commercial diagnostic labs, pharmaceutical companies, and other business firms, both established and newly created, have become a major source of research funding and a major user of research results. By 1994 the pace of research in the biotechnology industry was generating about one new gene or so a day, one new company per week, and one new drug a year for potential use in therapy. In 1996 the biotechnology industry consisted of over 1300 companies, employed about 100,000 people, had sales of over $7 billion, and had reached a market capitalization of over $45 billion. Their total contribution to R&D was about $15 billion and exceeded $50 billion in 2000. This rapid pace of innovation has increased the output of research—but, it has also created puzzling conflicts of interest among researchers, universities, the scientific community, the public, and business.

In a harbinger event, the Biogen Company was set up in the early 1980s by Harvard professor Walter Gilbert, a Novel Laureate and developer of DNA sequencing technology, under the assumption that the commercialization of his research was an appropriate extension of his work as a scientist. This and many other similar events since have raised several important questions of ethics, including conflict of interest. Should the scientific agenda be shifted from seeking basic knowledge (the university's traditional role) to seeking commercializa-ble, profitable knowledge (the private sector's role)? Should the public agenda for producing basic knowledge be augmented to include the development and production of usable genetic products which benefit the public? Since most basic research is funded by public tax dollars, the scientific establishment may have an ethical obligation to facilitate the return of the ''fruits'' of their re search to the public directly. Ultimately, this raises questions about the ethics of cooperative capitalism. Does competition among scientists working under grants from different companies jeopardize the open and free flow of scientific communication among the scientific community? What are the implications of the commercialization of scientists' research for their obligations and allegiance to their universities or other employing research organizations? Since universities may also profit from controlling the publication of research, what obligations do they have to ensure the timely dissemination of research results produced by their faculty and staff? And, given that a university's faculty works on industry-sponsored research grants, does this tend to compromise the education of their students and research fellows?

By late 1999 several private sector firms were in a race with the NIH-sponsored Human Genome Project to complete the sequencing. Celera Genomics, headed by J. Craig Venter, intended to complete the entire sequence by spring 2000. Incyte Pharmaceuticals planned to map only the most active 10% of the human genome by that time. There were discussions about the research rivals collaborating in order to complete the sequencing more quickly. Under an accord known as the Bermuda Agreement, the rivals submitted new DNA data every 24 hours to a public data bank. This was controversial. Most scientists believed that the human genome should be in the public domain; Celera, however, planned to file patent applications on any commercially valuable DNA sequences and favored a disclosure period longer than 24 hours and closer to 3 months. Celera, Incyte, and Hyseq charge substantial subscription fees for widespread access to their genetic library. Executives at these firms contend that the real value of genomic data lies in the analysis of it and that only under a for-profit business model will the information be effectively mined. Hyseq is marrying its genetic research with electronic commerce and selling and licensing genetic information-gene sequences, homology, and expression data—over the Web through a site called By using a fee-per-item plan, Hyseq hopes to reach a larger customer base for its proprietary gene sequences and related non-published data.

Genetics research is raising many concerns about the appropriate roles of the public sector and the private sector in an information society. Those who favor com-mericalization of genetic research stress benefits such as providing sequence data more quickly, making biologically important work a research priority, freeing scientists to work on projects that apply newfound sequence data without restraints, creating a useful public-private partnership, and providing valuable competition to stimulate both private and public sector development. Others see significant disadvantages such as companies claiming ownership to parts of the genome by means of patents, profits flowing to the commercial companies while the costs remain in publicly funded centers, an emphasis on ''quantity'' of data produced rather than its ''quality,'' a slowing of the distribution of new results from daily updates—as public centers currently do—to quarterly or periods advantageous to the company, and an erosion of international agreements on DNA patent rights. The patenting of DNA sequences raises deep questions about intellectual property rights. Which portions of human DNA have moral significance? DNA is produced originally by nature. Who owns it? Even if a scientist develops a DNA sequence in the laboratory that is other than a natural form, does it become the scientist's property and thus become patentable? Will restrictions on patents impede genetic research?

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