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Genomics and Ethics

PILAR N. OSSORIO

University of Wisconsin Law School Madison, Wisconsin

The U.S. Human Genome Project (HGP) is the first federally funded science program in which a portion of the budget is set aside for studying the ethical, legal, and social implications (ELSI) of the science. Ten years of ELSI research have produced numerous empirical and theoretical studies. Here I briefly address only two ELSI topics: 1) medical information privacy as applied to human genetics, and 2) ethical problems arising from the use of genetic interventions to change who will live in the future.

GENETICS RESEARCH AND INFORMATION PRIVACY PROTECTION

Numerous parties—scientists, biotechnology companies, pharmaceutical companies, and patient advocacy groups, for instance—have begun to value DNA not only for its biochemical properties but also for the many layers of information it contains. This information can be used to identify health-related traits and to predict the probabilities that individuals will develop certain diseases. In the future, genetic information may provide one means of predicting behavioral tendencies, personality traits, or abilities that are related to the acquisition of resources and social positions (i.e., wealth, desirable jobs, or political office). Because people's DNA contains much sensitive information about them, and because DNA itself can be used as a means of identifying persons, new research raises many problems concerning who should have access to genetic information, under what circumstances, and for what purposes.

Genetic information privacy is a subset of broader questions about the privacy of medical and other personal information. People value privacy for instru-



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Page 75 Genomics and Ethics PILAR N. OSSORIO University of Wisconsin Law School Madison, Wisconsin The U.S. Human Genome Project (HGP) is the first federally funded science program in which a portion of the budget is set aside for studying the ethical, legal, and social implications (ELSI) of the science. Ten years of ELSI research have produced numerous empirical and theoretical studies. Here I briefly address only two ELSI topics: 1) medical information privacy as applied to human genetics, and 2) ethical problems arising from the use of genetic interventions to change who will live in the future. GENETICS RESEARCH AND INFORMATION PRIVACY PROTECTION Numerous parties—scientists, biotechnology companies, pharmaceutical companies, and patient advocacy groups, for instance—have begun to value DNA not only for its biochemical properties but also for the many layers of information it contains. This information can be used to identify health-related traits and to predict the probabilities that individuals will develop certain diseases. In the future, genetic information may provide one means of predicting behavioral tendencies, personality traits, or abilities that are related to the acquisition of resources and social positions (i.e., wealth, desirable jobs, or political office). Because people's DNA contains much sensitive information about them, and because DNA itself can be used as a means of identifying persons, new research raises many problems concerning who should have access to genetic information, under what circumstances, and for what purposes. Genetic information privacy is a subset of broader questions about the privacy of medical and other personal information. People value privacy for instru-

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Page 76 mental reasons and, perhaps, for some noninstrumental ones. Instrumental reasons for valuing genetic information privacy are to avoid unfair denial of goods and services, unfair denial of opportunities, or stigmatization. Genetic information might be used as a basis for limiting an individual's access to insurance, denying or limiting employment opportunities, or limiting one's educational opportunities. By creating privacy protections, we can prevent insurers, employers, educational institutions, and others from using or misusing genetic information to harm us. We may also value information privacy for noninstrumental reasons. Part of developing a personal identity consists of determining who should know what about us. Scholars have argued that information privacy is essential in allowing people to develop as autonomous individuals who have some control over what “face” they present in particular circumstances. Part of showing respect for a person consists of not exposing their private aspects or information. This argument applies to genetic information, because knowledge of your genetic predispositions may affect how people treat you or conceive of you—it may affect their attribution of an identity to you. There are numerous ways in which genetic information generated during research can become known to “third parties.” For instance, if the research involves genetic testing or sequencing and the reporting back of test results, these results may become part of a subject's medical records and/or school records and, therefore, may become accessible to hundreds of people; if the research involves DNA sequencing and the sequence information is linkable to a subject's identity and not stored securely, it may become accessible; and if the research involves banking of bodily materials and those materials can be both linked to the subject and used for DNA sequencing or testing by other researchers or at a later date, genetic information may become “public.” Sequence information raises particularly difficult privacy concerns, because when we obtain sequence data, we do not necessarily understand or recognize all of the information the data contain. The sequence of a gene and its surrounding regions may contain mutations that predispose to a disease, but we may not yet recognize this. Another possibility is that the sequence may contain elements that regulate how and when a gene is turned on and off, but we again might not yet recognize this. Sequence data can be “mined” repeatedly for new information and knowledge: data that at first seem innocuous and unprejudicial might turn out to be far more problematic as our knowledge expands. Both ethical and legal theorists acknowledge that individual privacy interests or rights must always be weighed against other social goods. In the case of biomedical research, the primary good at stake is great medical advances. However, scientists also recognize that these advances will not take place, or will be delayed, if people refrain from participating in research because they fear losing their insurance or jeopardizing their jobs. Medical quality control and perhaps

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Page 77 some other social goods, such as increasing equality of opportunity, could also be served by some disclosures of genetic information. Society balances these privacy interests against other interests through several different sets of rules and ethical norms; these include federal and state statutes, common law such as privacy torts, institutional rules, and institutional and professional ethics norms. Federal human subjects research regulations currently are considered inadequate with respect to protecting genetic privacy, but they are under review by the National Bioethics Advisory Commission, and recommendations for their revision are forthcoming. Many states have genetic information privacy laws; however, because these laws differ from each other in fundamental ways (such as in their definitions of “genetic information”), they may undermine researcher's ability to undertake the large-scale, multistate projects that will be necessary for the next phase of genetics discoveries. The U.S. Congress has been attempting for several years now to pass comprehensive legislation concerning medical information privacy (which would cover genetic information generated during research), but the complexity of the issues, in addition to a lack of political consensus, has prevented the passage of legislation. Most scholars believe that we need antidiscrimination rules in addition to privacy rules. Antidiscrimination rules limit what people or institutions can do with genetic information if they obtain it. We need antidiscrimination rules because we cannot and should not have absolute information privacy; the absolutist approach would undermine other important social goals. Currently, some state laws on genetics include antidiscrimination provisions. In addition, some existing federal laws, such as the Americans with Disabilities Act of 1990 (ADA), may provide a degree of protection against discrimination based on genetic information. NEW ETHICAL CHALLENGES: FUTURE GENERATIONS' PROBLEMS Thus far, the legal and ethical questions I have discussed are difficult, but they do not substantially challenge our models of ethical analysis; we have the intellectual tools to address problems associated with genetic and other medical information privacy. Advances in genetics, however, have also highlighted some areas in which our current ethical and legal theories are inadequate. One such area is the problem of determining what parents, physicians, and the society as a whole are permitted or obligated to do on behalf of future generations. The notion that people have obligations to those who will live in the future, particularly their descendants, is deeply ingrained in many societies. The degree to which present choices and actions reflect concern for impacts on future generations is one measure of an individual or society's moral character. With respect to genetics research and the application of genetic technologies, the issue of obligations to future generations arises because genetic technologies can be used

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Page 78 in conjunction with reproductive technologies to influence the traits of people who will be born. One early use of genetics has been to attempt the birth of children who are free of diseases with a known genetic cause (e.g., Tay Sachs disease, cystic fibrosis, Huntington's disease). In the future, we may employ germ-line genetic interventions (germ-line gene therapy) to change the genomes of our offspring. This could be done for therapeutic reasons—to prevent the person who will be born from having a disease—or to enhance or change some trait, such as height, weight, skin color, or psychological predisposition. By changing the germ-line, one could change the genome of an entire lineage. Note, however, that it is not necessarily the case that an entire lineage would be affected. A person with a germ-line modification would have the same reproductive freedom as anybody else, and could choose whether to become a genetic parent, and whether to use assisted reproduction to prevent his or her genetic modification from being transmitted to future generations. What ethical principles or approaches should guide us as individuals or as a society in determining which genetic interventions are permissible/impermissible or obligatory? One important part of that equation is the child who will be born, and that child's lineage. We want to ask what is best for the future child: What should we do on behalf of the person who will be born? But this leads us to a particular paradox: many of the genetic interventions we might do on behalf of a future person would actually change whowill be born. If we employ a technology that uses genetic testing to select which embryos should and should not be implanted or aborted, then we are clearly choosing that some people will be born in place of others. Even if we alter the genome of an existing embryo, we might change who is born. This might be the case because more than one numerical person can arise from the same fertilized egg (conceptus). Identical twins arise from the same conceptus, and they are not the same person, demonstrating that one genome can lead to more than one person. If this is the case with twins, it should also be the case with a conceptus that does not become twins. That conceptus might become one of several different people, depending on events that occur during its development. One event that could occur is that one or some of its genes might be changed. If these changes substantially affect embryonic and perinatal development, they might result in the birth of a person different from the one who would have been born in the absence of genetic intervention. Why does it matter that our genetic interventions might change who is born? Because our standard ethical theories make it difficult to argue that you can do something on somebody's behalf if your actions mean that they will not be born and instead a different person will come into existence. You cannot say that the life of the person who would have been born with Tay Sachs disease or cystic fibrosis is made better if what you have done is substituted a different person who will not have the disease. And the new person has not been made better off,

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Page 79 because he or she would not have been born with a disease in the absence of intervention; he or she would not have been born at all! This problem, called the “nonidentity problem,” throws into doubt the application of traditional ethical notions of harm and benefit, at least with respect to many decisions that one would like to make on behalf of future generations. This is because our standard notions of harm and benefit are “person affecting”; they rely on the possibility that some particular person's interests will be advanced or thwarted by our actions. For instance, our standard notion of preventing disease means preventing people from developing or acquiring the disease, which is different from preventing the disease by preventing the birth of people with the disease. To address the nonidentity problem, philosophers have proposed that future generations' choices in which we change who is born should be characterized by an “impersonal” ethic. An impersonal principle of beneficence would look something like the following: if in two possible futures the same number of people would be born, it would be worse if those who lived were worse off than others who could have lived. This is a principle that judges the rightness of a choice by weighing two possible future worlds against each other: If we make the better choice, there will be people who are better off, but the reason that choice was better is not because any particular people have been made better off! If we are to use impersonal principles to guide and evaluate choices about genetic interventions that affect future generations, then there are still many issues to be addressed. Are impersonal harms just as bad as person-affecting harms? What methodology should we use to evaluate the two hypothetical future worlds? Should impersonal principles only apply when the nonidentity problem arises?

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