Ethical Issues In The ‘New’ Genetics Research Paper

Concern about implications of the new genetics for human societies grew with scientists’ ability to decipher and manipulate DNA. The late 1960s saw discussions of human cloning, followed in the 1970s and early 1980s by safety concerns about recombinant DNA and social concerns about genetic discrimination. When the Human Genome Project was proposed for substantial funding in the United States in the late 1980s, the Project’s first director, Dr. James Watson, suggested that 5 percent of the funding be set aside to study the ‘ethical, social, and legal implications’ of human genetics (Cook-Deegan 1994). The subsequent financial commitment led to the rapid expansion of ‘ELSI’ studies across many disciplines and the publication of a vast number of articles and books on these topics.

Three general caveats are useful in surveying the resulting discussions. First, although new genetic technologies will sometimes provide great predictive power, oftentimes their predictions will be weak. The percentage of people with a particular set of genetic variations (or ‘genotype’) who develop a particular ‘phenotype’ (trait or condition), a percentage known as ‘penetrance,’ often will be low. Second, although the technologies are quite novel, their implications almost always have parallels in the social effects of other modern technologies. Third, although much of the discussion of the consequences of new genetic technologies has focused on individuals or families, these technologies usually also have implications for broader human groupings. With those caveats in mind, this research paper will discuss the ethical, social, and legal effects of the new genetics in seven areas: health care, establishing identity, predicting the future, revealing the past, genetic manipulation, ownership and control of genetic material and information, and cultural understandings.

1. Issues Arising From Medical Successes

Writing on social issues of genetics focuses on the dangers of human genetics. It rarely looks at the implications of the hoped-for uses of genetics to prevent and treat disease. The vast sums, private and public, spent on research into genetics are not being committed purely in a search for knowledge, but in the expectation that the research will bring immense medical benefits. The diseases in question may not be limited to ‘genetic diseases’; the tools of the new genetics are allowing unprecedented understanding, at the molecular level, of how human cells and human pathogens function. The most powerful lesson of the first 25 years of the biotechnology industry has been that the human body and its functions are more complicated than expected, but those complications are steadily being tackled by the new genetics. A steady stream of new treatments, derived from increased knowledge of genes and their associated proteins, is flowing towards approval.

The results might include a significant extension of average human lifespan; an increase in pharmaceutical costs; and changes, up and down, in the demand for various medical services. The social implications could be substantial on pension plans, voting blocks, and health care systems. Some more focused medical consequences of genetic research such as individualizing patient therapies as a result of genetic tests (called ‘pharmacogenomics’) or some kinds of proposed gene therapy or tissue replacement will require that treatments be created just for one patient, straining the existing mechanisms for drug development, manufacturing, approval, and financing. Any new treatment will raise questions of availability, both within a country and between countries. The new genetics has created a uniquely high expectation of medical progress; its successes therefore may raise all these issues in dramatic form.

2. Establishing Identity

The new genetics raises three issues centering around identity: forensic identification, personal identity, and ethnic identity.

2.1 Forensic Identification

The new genetics has already led to major changes in forensic identification. Any tissue from a person that contains DNA can be tested for a pattern of identifying markers, sections of the genome that vary from one person to another. Those markers can be compared with markers analyzed from tissue found in connection with a crime (National Research Council 1992). Powerful techniques for analyzing DNA mean only tiny amounts of genetic material are needed, derived from flesh, blood, semen, or even cells found in saliva. A negative test is very powerful. If the markers are significantly different, the tissues cannot be from the same person. Initially, there was concern that a positive match might not be compelling because ethnic groups might share common patterns of markers. These fears have been assuaged through more information on the distribution of the markers. (National Research Council 1996).

Forensic use of DNA is not essentially different from the use of fingerprints, blood groups, or dental records. Like those techniques, it has had to prove itself in judicial cases. Like the earlier techniques, it can never be conclusive. Good defense counsel will always investigate the possibilities of an innocent explanation for the presence of the DNA or for mistakes, contamination, or fraud in the process of collection and analysis.

The real issues about the forensic use of DNA now concern not individual cases, but the collection and retention of DNA or DNA records for identification purposes. Many countries or states are creating DNA repositories with DNA samples from convicted, or even merely accused, criminals. These samples can be used to seek matches in criminal cases or for the identification of human remains. If markers from the samples are analyzed in advance, the results can be put into a database and used to seek ‘cold matches’ to samples or tissue of unknown origin. These repositories raise two different issues. The first involves their creation. Should people be forced to give samples? If so, who should be required to provide samples—convicted sex offenders, convicted felons, those arrested, or the whole population? A more subtle, but equally important, issue concerns what the repository should contain—a DNA sample or only the marker analysis. The markers used for forensic identification are not associated with any traits. If the markers are kept, no information about a person other than identity can be discussed. If samples of whole DNA are kept, however, they could be analyzed for DNA associated with a wide variety of characteristics, raising serious privacy concerns.

2.2 Personal Identity

The furor about the possible use of somatic cell nuclear transfer technology to clone humans involves many issues (National Bioethics Advisory Commission 1997), most of which have already been raised by in vitro fertilization. The issue unique to cloning is a concern about human identity. Would a person with the same genome as another living individual be a copy of the first person?

Monozygotic twins have always shared the same genome. Although their physical similarity is strong, no one doubts that they have individual identities and separate personalities. Cloning by somatic cell nuclear transfer could not produce individuals more alike than monozygotic twins. The clone and the source of the clone’s DNA would most likely be much less alike. They would develop in the wombs of different women, subject to different environmental influences in utero. Once born, they would be subject to different environments, often in different decades. The degree to which identical human genotypes born from different wombs produce similar phenotypes would be an interesting research question, if it could ethically be studied. The popular perception of identity would likely prove grossly exaggerated.

2.3 Ethnic Identity

Ethnic groups often share both a common culture and a substantial degree of common ancestry. This genealogical connection implies a genetic connection; particular variations in DNA sequences, or patterns of those variations, will be more common in some populations than in others. For example, each of the four ABO blood groups, which are genetically determined, are found in all (or almost all) of the world’s populations, but in different proportions in different groups. Other variations in DNA sequence may be found at high levels in some groups but rarely in most others (Cavalli-Sforza et al. 1994).

This kind of variation can be used for anthropological research; it could also be used to try to define a person’s ethnic identity. Of course, no known DNA variations are found in every member of an ethnic group and never found in nonmembers. Given the human history of frequent intermixing, adoption, and conversion, no such variations are likely. The ethical implications of the naıve use of such inherently inaccurate methods for defining ethnicity will depend on the circumstances, including whether they were adopted by the group itself or imposed on it.

3. Predicting The Future

The most discussed issues arising from the new genetics come from its ability to predict individuals’ futures as a result of associations between genetic variations and physical and behavioral traits. The strength of the predictions will vary dramatically. Some conditions, such as Huntington’s disease, follow inevitably from possession of a particular genetic variation. For other conditions or traits, a person with a particular genetic variation will have a somewhat increased but still small likelihood of having that condition or trait. The ethical significance of such predictions will vary largely based on who uses what predictions for which ends.

3.1 Prenatal Selection To Avoid Disease

The new genetics brings the ability to test the DNA of the parents and of the embryos and fetuses they create. Where the genotypes are strongly or completely associated with particular phenotypes, whether the children might (when the parents are tested) or would (when the embryos or fetuses were tested) show those traits can be confidently predicted. This kind of prenatal testing has been used for several decades to avoid serious genetic diseases such as sickle cell anemia and Tay–Sachs disease. In some cases prospective parents have been tested to alert to them to whether such a disease is a possibility for their children. This carrier testing is simple and relatively uncontroversial.

Testing of fetuses is possible only with genetic material from the fetus, currently retrieved from the amniotic fluid or from the chorionic villi well into a pregnancy. Both procedures are expensive and somewhat risky. After a direct genetic test of the fetus, the parents could choose to abort or could prepare themselves better for the birth of a child with the particular genetic condition. Testing of fetuses for genetic conditions has been more controversial. Some oppose it because it often leads to abortion, which they condemn as murder. Advocates for the disabled argue that this testing implies that the lives of people with those genetic conditions are not worth living. In the United States, abortion, at least through the second trimester, is legal for any reason, so there has been little discussion of outlawing abortion based on genetic tests; many countries do regulate the reasons for abortion and must face this issue. Even in the United States, a question remains as to whether prenatal genetic testing for such conditions should be encouraged or discouraged.

A recent technical advance may change discussions about prenatal genetic testing. ‘Pre-implantation genetic diagnosis’ makes it possible to test an embryo before it is implanted. This procedure can only be done with in vitro fertilization. One cell is detached from an embryo and the DNA in that cell tested. Based on the results, the parents can decide whether to implant that embryo or not. No fetus would be aborted; instead, some embryos would just not be implanted.

3.2 Prenatal Selection For Genetic ‘Enhancement’

Pre-implantation genetic diagnosis increases the possibility of parents selecting children based on genetic traits that would ‘enhance’ their children. The idea of using genetic testing to select ‘enhanced’ genetic traits for offspring has raised many concerns (Parens 1998). Some fear that allowing parents to choose traits for their children would deny those children their right to ‘an open future’ not of their parents’ choosing. Others worry that the rich will be able to buy unfair genetic advantages for their offspring. Still others worry that parental selection will lead to a homogenization of the human gene pool, as parents opt for children with similar traits. Finally, some fear that these parental choices could lead to a self-perpetuating genetic caste system. These results can only follow if genetic variations are identified that strongly predict ‘success’ and if many parents are willing to undergo preimplantation genetic diagnosis. Neither is certain.

One might also question whether parents choosing to enhance their children’s lives through genetics is fundamentally different from efforts to do the same through environment. Rich parents send their children to ‘good’ schools. Parents may push their children from an early age to excel in certain activities— Wolfgang Mozart and Tiger Woods are both successful examples. Arguably, a major goal of parenting is to ‘deny’ one’s children certain unhappy or illegal futures. The argument that enhancement through genotype selection is inherently more threatening than other kinds of enhancement is not obvious. (Sex selection is a special case of ‘genetic enhancement,’ though one that is also done without genetics, by sonography.)

3.3 State-Sponsored Prenatal Genetic Selection

The discussion thus far has focused on parental choices about their children’s genetic make-up, but those decisions need not be made by parents. Governments have intervened to prevent people with ‘inferior’ genes from having children; such eugenics laws could come again in more precise forms. ‘Eugenics’ is discussed in detail in other articles and will not be reviewed here except to note two things. First, state actions to encourage prenatal genetic selection without compulsion can also be ‘eugenics.’ Second, the ethics of government-sponsored eugenics depends on striking a balance between government public health powers and individual procreative liberty that remains in debate.

3.4 Postnatal Genetic Testing

The possibilities of genetic testing do not end at birth. Genetic tests can help diagnose diseases or predict future disease risks. Like all medical interventions, their value depends on their appropriate use (President’s Commission 1983, Institute of Medicine 1993). Postnatal genetic tests provide information that can lead to a medically useful interventions, that can help the patient make life plans, and that might just satisfy a patient’s desire to know her future. Genetic testing also has costs. Test results may pose psychological problems for those tested or affect the patient’s relationships with family members. They may also have implications for the patient’s dealings with the broader society, through employment or insurance discrimination. In the absence of useful interventions, the benefits from genetic testing depend greatly on the circumstances and personality of each individual. Where tests, genetic or otherwise, do not have powerful implications for medical intervention, the strong influence of the individual’s personality and circumstances on the value of testing argues for a particularly good process of informed consent, especially when the patient’s understanding of the links between genetic variations and disease may be weak. Such testing is particularly suspect for children, if the benefits of such testing could be put off until they reach adulthood and make their own informed decision.

Of course, many nongenetic medical tests predict higher or lower disease risks. The diagnosis of a disease, whether through genetic or nongenetic methods, can trigger many of the same costs as prediction. Genetic diseases do implicate family members to an unusual extent, but shared environments or diets also put family members at shared risk.

3.5 Genetic Discrimination

Great concern has been expressed about the possible uses of genetic tests to discriminate against people based on genetically predicted susceptibilities. Employment, life insurance, and, in the United States, health insurance are the fields where genetic discrimination is most feared. The likelihood of genetic discrimination depends on two different sets of factors: the strength of the prediction possible from genetic information and the social structure governing the relevant fields.

For someone with the allele that leads inevitably to the fatal condition Huntington’s disease, genetic prediction is quite powerful. Fortunately, such powerful genetic predictions are rare; it is not clear that employers or insurers would find significant an increased risk of diabetes from 5 percent to 8 percent. Similarly, discrimination in health insurance is mainly a concern in the United States; all other rich countries guarantee all, or almost all, their residents health coverage. Even in the United States, the great majority of Americans with health insurance obtain it through methods that are not susceptible to genetic discrimination. Medicare, Medicaid, and employer-provided health insurance are not medically underwritten—they must accept everyone eligible without using any medical exclusions. There is little good evidence that genetic discrimination in employment or insurance exists in the United States, although there is clear evidence of public fear of such discrimination.

Whether such discrimination turns out to be common or rare, the question remains what to do about it. Thus far, no general federal law bans genetic discrimination in insurance or in employment (although the opaque Americans with Disabilities Act may prohibit some employment discrimination based on genetic characteristics). Most US states have limited the use of genetic information in health insurance, many have limited their use in employment decisions. No states have forbidden their use in life insurance (Bobinski 2000). The United Kingdom, where the National Health Service makes private health insurance of limited importance, has set up a regulatory authority to pass on whether or not life insurers may require tests for particular genetic conditions, recently allowing the use of Huntington’s disease testing. How well statutes limiting genetic discrimination will work remains unclear. If statutes banning genetic discrimination can function with low costs, one might justify them on the ground that they increase the research on and clinical use of human genetics by reducing public fears, whether or not those fears are justified (Greely 2001).

3.6 Prediction Of Behavioral Traits

The successes of the new genetics have largely been with physical traits or conditions. Public interest in genetics, though, seems to lie disproportionately in behavioral traits. Some human behavioral traits have been linked to genetic variations, including some forms of mental retardation. For the most part, though, efforts to link genetic variations with human behavioral variations have, thus far, had little success. If such predictions were possible, the ethical implications could be substantial (Carson and Rothstein 1999).

Strong links between genetic variations and behavior would undercut notions of personal responsibility for the involved behaviors. At the broadest level, they could affect society’s view of the extent of individual free will. More narrowly, they could affect society’s view of, for example, ‘genetically determined’ criminal behavior or sexual orientation, although whether the result would be more or less tolerance for the behavior is not clear. These kinds of genetic predictions could also lead to interventions in individual’s lives—people predicted to act violently might be put into custody before they committed any offense. The successful association of behaviors with genetic variations would boost the interest of both parents and governments in prenatal genetic selection.

Societies make predictions about future individual behavior in many ways. Except prenatally, it is not clear that doing a genetic test to determine, for example, musical ability, would offer any advantages over a direct test of such ability. Genetic tests would have an advantage only when the prediction is strong and the behavior is not easily observed directly. At this point, it is not clear to what extent genetic variations will prove able to lead to strong behavioral predictions.

4. Uncovering The Past

DNA can reveal aspects of the past as well as the present and future. Sometimes it raises in new contexts issues of the privacy of historical figures in matters such as Thomas Jefferson’s relationship with his slave, Sally Hemmings. Other historical uses of DNA raise broader questions.

4.1 Individual Ancestry

Genetic variations can be used in a straightforward way to establish close biological relationships. Blood groups or isoforms of particular proteins have long been able to provide such information; direct DNA testing can increase accuracy. The ethical implications of such paternity or maternity testing varies according to its use. If done with consent, it seems unproblematic. If done without consent, it might be justified, as in establishing child support obligations, but would require consideration. One problem occurs where genetic testing, done for some other reason, such as attempting a diagnosis of a child’s disease, reveals unsought information about ‘false paternity’ that be unwelcome or even dangerous.

4.2 Group Histories

Analysis of patterns of genetic variation among different human populations can reveal how closely related two populations are. This information then becomes evidence about human history and migrations. It is not conclusive evidence, but joins with linguistic, archaeological, anthropological, historical, and other sources to improve understanding of the human past (Cavalli-Sforza et al. 1994). The evidence may not always be welcome. It may contradict a population’s own beliefs about its history and origins. In some situations, that information alone might destabilize or disrupt the entire culture. It could also have modern political implications where ancestral origins, and the length of time in possession of particular territories, could affect land disputes. Whether a historical researcher has ethical obligations to avoid doing research that could provoke such consequences is unclear. Similarly unclear is whether there is an ethical obligation to seek the informed consent of the entire group to such genetic research that might have consequences for the group (Greely 1997). Such consent has not generally been thought necessary for other historical investigations affecting contemporary peoples; some might argue that ‘genetic history’ is different, either because of the nature of the materials being used—DNA samples from living and sometimes dead members of the population—or the different degree of certainty perceived for such ‘scientific’ evidence.

5. Manipulating Genes

The new genetics may make it possible not just to read person’s genes but to change them. That ability would create additional concerns.

5.1 Somatic Cell Gene Therapy

Somatic cell gene therapy involves the placement of a human gene into a living person’s somatic cells—cells that do not produce the eggs and sperm that in turn produce the next generation. Somatic cell gene therapy would aim to cure a disease only in the patient, not in the patient’s descendants. It was initially conceived as introducing a properly functioning copy of a gene into a person who had a genetic disease as a result of inheriting only improperly functioning copies. Different types of somatic cell gene therapy have since been investigated for the treatment of diseases that are not primarily caused by inherited genes, such as AIDS and cancer. Over 100 clinical trials of somatic cell gene therapy have taken place; very few have, thus far, shown any success.

The genetic aspects of somatic cell gene therapy have been largely uncontroversial. In essence, the gene therapy is merely another drug delivery system, a different way to get a normal human protein to the right place in the body. Somatic cell gene therapy therefore stands in the same position as most experimental therapies. Like such therapies, it has prompted concerns that desperate patients are not truly giving informed consent and that the possible benefits of the treatment are exaggerated. Gene therapy may face the latter problem to a greater extent than most experimental treatments because of the exaggerated public view of the power of anything genetic.

5.2 Germ Line Gene Therapy

Germ line gene therapy is much more controversial (Nelson 2000). It would introduce ‘normal’ human genes into the eggs or sperm of parents, or into the fertilized egg or early embryo of the offspring. The goal would be to change the eventual child’s genetic inheritance. This could be done in order to avoid a genetic disease or in order to introduce an ‘enhancing’ genetic variation. There have been no trials of human germ line gene therapy; indeed, there is an informal moratorium in the scientific community on trying such experiments in humans. Both its feasibility and its value are unclear.

New genes have been successfully introduced into the germ lines of other mammals, but with very low efficiency. At the same time, pre-implantation genetic diagnosis allows parents to choose embryos based on their genetic variations, as long as the parents themselves produced the desired variations. If not, donated eggs or sperm would be a much safer and easier way to introduce the desired genes than somatic cell gene therapy. Germ line gene therapy may turn out to be most important as a barrier to somatic cell gene therapy. If germ line gene therapy were banned, researchers using somatic gene therapy might need to make the difficult showing that the transplanted genes could not ‘infect’ the patient’s germ cells and thus constitute inadvertent germ line gene therapy.

5.3 Chimeras

The manipulation of genes permits the creation of ‘chimeras,’ creatures that are genetically a mix of two species, including organisms that could not possibly mate. In agriculture, this mixing of genes from very different organisms has been perceived by many as unethical and potentially dangerous. Unless one takes a strong view of the sanctity of sharp lines between species, it is hard to make a strong ethical argument against such mixes. On the other hand, one might argue that a gene in the setting of new species might develop different, possibly harmful, functions than in its home species.

Chimeras involving human genes provoke other worries. Intentionally moving nonhuman genes into humans could be seen as lessening the recipient’s humanity; moving human genes into nonhumans could be seen as investing nonhumans with some aspects of humanity. The former has not been at- tempted; the latter is routine. Most of the products of the biotechnology industry are made by creatures that are genetically partially human and partially nonhuman. Human genes are transferred into useful host cells such as yeast that then produce large amounts of the corresponding human protein. Of course, an organism with 6,000 yeast genes and one human gene does not seem very human; concerns about this kind of chimera require a strong belief in the essentially human, or sacred, nature of any human DNA sequence. Moving more human genes or moving human genes into more closely related organisms such as chimpanzees could provoke more serious concern about blurring the definition of humanity.

5.4 Artificial Genes Or Genomes

It is possible to create ‘new’ genes, not found in any existing species, that would create new or modified proteins. One branch of the biotechnology industry specializes in this effort, through what is called ‘directed evolution.’ The technology takes related genes from different species, recombines them or makes mutations in them, and then examines how well the resulting protein functions. Similarly, scientists could construct, piece by piece, a novel genome. Placed inside a cell, it might be able to generate a new living organism. This issue has been discussed to some extent in the context of the now-abandoned ‘minimal genome’ project (Cho et al 1999). The safety of making new genes, proteins, or is an obvious concern. A deeper concern would be whether humanity should ‘play God’ by intentionally creating such new entities. Humans have long created new organisms by crossbreeding between species and by selective breeding within species. New genes are created whenever a gene is mutated. The speculative possibilities outlined here are more significant, and less accidental, interventions. It is not clear whether that makes them ethically different.

6. Ownership And Control

6.1 Research

Rules governing the conduct of human genetics research control the research subject’s genetic materials and information. Those rules generally require the informed consent of the subject to the research. Research subjects, however, rarely have any control over the subsequent uses of materials or information derived from them. The California Supreme Court decision in Moore . Regents of the Uni ersity of California (1990) ruled that the plaintiff could not assert a property interest in a cell line derived from cells taken from his body, although it allowed him to try to prove that the physician-researcher had not gotten his informed consent. Although the Moore case is the only decision on this point, current practice generally follows it and gives research subjects no control over who can use their genetic materials and information, for what purposes, or for how long. Current practices also discourage any sharing of financial benefits of the research with the subjects on the theory that the hope of such benefits could be an ‘undue inducement’ to them to take part in the research.

A new kind of human genetics research raises other issues about the control of research subject information and materials. Associational research seeks to find weaker connections between genetic variations and disease by searching for correlations between the genotypic and phenotypic data of large groups of people. This kind of research requires the creation of a resource made up of health records and DNA samples of hundreds of thousands of people. These resources would be too expensive to create to study just one illness. Instead, the resources would be available to test a wide range of hypotheses. This kind of ‘genotype phenotype resource’ is most advanced in Iceland, where the government has given a private firm, deCODE Genetics, the license to create a health records database with clinical medical information on all 275,000 residents of the country.

In the case of Iceland, the legislation also provides that consent is presumed; unless an Icelander opts out of the database, his medical records will be included. The Icelandic plan has raised numerous ethical concerns, including the use of presumed consent, the absence of discussion of the risks and benefits of specific research done on the resource, the degree that privacy would be protected, the access (if any) of other researchers to the company’s data, the propriety of having a for profit company control this information, and the financial fairness of the agreements between Iceland and deCODE (Greely 2000). It is not clear on what terms this kind of research will ultimately proceed, in Iceland or elsewhere.

6.2 Patents

When the US Supreme Court, in Diamond . Chakrabarty, approved a patent on a genetically altered bacterium, it started a continuing debate over the patenting and genetics (Diamond . Chakrabarty 1980). To many patent lawyers, DNA is just another organic molecule and patenting of forms or portions of it falls within long-established principles concerning the composition of matter patents on molecules not found in pure or refined form in nature (Eisenberg 1990). Others object to some, or all, genetic patents on a variety of grounds. Those objections can be put into two categories: fundamental and technical.

Some people have fundamental objections to patents on genes, on human genes, or on genetically modified life forms. One set of objections, focusing on genes, contends that they are ‘discoveries,’ not ‘inventions’ and so should not be patented. Others point out that genes were made by God, nature, or evolution—in any event, something other than the ‘inventors’ filing the patent claims—and should not be claimable as someone’s intellectual property. Another objection is that human genes are the common heritage of mankind and should be held in common. Still others oppose gene patents as part of broader opposition to biotechnology. Proponents of patents put forward answers to each of these objections; throughout the industrialized world, the proponents have won. Patents on genes, human genes, and to a somewhat lesser extent genetically modified life forms have been commonly allowed in the United States, Europe, and Japan. It is worth noting, though, that patents usually expire 20 years from the date of application. The first wave of gene patents will soon expire; presumably all patents on human genes will have expired by 2021, 20 years from the publication of ‘the human genome.’

Technical arguments continue to rage within the field. The biggest fight has largely been over the patent requirement of ‘utility’: how much, or little, knowledge about the uses of a genetic sequence is sufficient to convey what kind of patent rights? This controversy became open in the early 1990s when the National Institutes of Health filed patent applications on expressed sequence tags (‘ESTs’), small sections of DNA from inside genes of unknown sequence and function. The fight has continued over patent applications on single nucleotide polymorphisms, one base pair differences in the genome. It has also included how much information about a gene and its function is necessary in order to grant a patent.

6.3 Privacy

Protecting the privacy of genetic information is one way to control its use (Annas et al. 1995, Rothstein 1997). But such ‘genetic privacy’ legislation raises its own set of problems.

The first problem is definitional—what is the ‘genetic information’? Information about a person’s genetic variations can come from DNA tests, from other biochemical tests, from a naked eye examination, or from family history. A narrow definition, focusing on the results of ‘DNA tests,’ would miss such powerful information as the 50 percent chance that the child of a Huntington’s disease patient carries the Huntington’s allele. A broad definition, covering everything from which an inference can be drawn about a person’s genotype, would cover almost all medical information. A very high cholesterol level is strong evidence that a person carries two alleles for familial hypercholesteremia. An average or low level is strong evidence that he or she does not.

If almost all medical information leads to inferences about genotypes, it may not make sense to try to protect ‘genetic information’ separately from medical information. And it may not be possible to ‘protect’ a person’s medical information from the many institutions that have legitimate uses for it, including physicians; hospitals; and those employers, insurers, and governments who pay health care bills. At the same time, the passage of legislation expressly to protect ‘genetic’ information sends the public the inaccurate message that genetic information is much more powerful and important than other medical information. Legislation to protect genetic privacy has been introduced in the United States Congress but has not yet been passed. Several states have passed such legislation, but it is too early to tell how effective that legislation will prove.

7. Cultural Consequences

The most far-reaching, but hardest to predict, ethical implications of the new genetics may lie in its effects on society’s beliefs. Three areas stand out.

First, the new genetics demonstrates graphically that all life is related. Over a third of the genes found in the single-celled brewer’s yeast have recognizable relatives in the human genome. Some stretches of DNA appear in close to identical form in humans, mice, and fruit flies. Indeed, there appear to be few, if any, ‘human genes’—just human variants of genes shared by all mammals, vertebrates, multicellular creatures, or life forms generally. Darwin’s thesis that all earthly life is related by descent from a common ancestor can be seen in these similarities in DNA. It is unclear what cultural significance this will have. It should not promote vegetarianism, because the new genetics shows that carrots and corn, like sheep and cattle, are our relatives. It might, however, promote greater respect for nonhuman life.

Second, the new genetics shows that all humans are closely related. Our DNA differs, on average, at one spot in 1,000. In the regions of the genome that code for protein, the differences are one base pair in 10,000. Humans from opposite ends of the earth are far more similar to each other genetically than chimpanzees from the same band. Genetic theories were used to provide support for a ‘scientific’ racism in the first part of the twentieth century. The new genetics should provide evidence against such racism.

Third, genetics may shift the balance in the cultural debate between nature and nurture as the source of human characteristics (Degler 1991). Dr. James Watson, co-discoverer of the structure of DNA, was famously quoted as saying ‘We used to think that our fate was in the stars. Now we know, in large measure, our fate is in our genes.’ DNA may appear to be proof that individuals are powerfully shaped by inherited forces. In fact, the new genetics paints a more complicated picture. Genes play a role in the development of many traits or diseases, but the environment or luck may also be essential. The general population seems to hold a much stronger belief in the power of genes. For that reason, the new genetics could end up promoting a more closed and fatalistic view of human life and abilities than either current society holds or than science would support (Nelkin and Lindee 1995). That reaction may prove to be the most significant ethical challenge of the new genetics.

Bibliography:

1. Annas G J, Glantz L H, Roche P A 1995 The Genetic Privacy Act and Commentary. Boston University School of Health, Boston, MA
2. Bobinski J A 2000 Genetic Information, Legal, ERISA Preemption, and HIPAA Protection. In: Murray T H, Mehlman
3. M J (eds.) Encyclopedia of Ethical, Legal, and Policy Issues in Biotechnology. John Wiley & Sons, New York
4. Carson R A, Rothstein M A (eds.) 1999 Behavioral Genetics: The Clash of Culture and Biology. Johns Hopkins University Press, Baltimore, MD
5. Cavalli-Sforza L L, Menozzi P, Piazza A 1994 The History and Geography of Human Genes. Princeton University Press, Princeton, NJ
6. Cho M K, Magnus D, Caplan A L, McGee D 1999 Ethical considerations in synthesizing a minimal genome. Science 286: 2087–90
7. Cook-Deegan R M 1994 The Gene Wars: Science, Politics, and the Human Genome. Norton, New York
8. Degler C N 1991 In Search of Human Nature: The Decline and Revival of Darwinism in American Social Thought. Oxford University Press, New York
9. Diamond . Chakrabarty 1 1980 444 US 397
10. Eisenberg R S 1990 Patenting the human genome. Emory Law Journal 39: 721–45
11. Greely H T 1997 The control of genetic research involving the ‘groups between.’ Houston Law Review 1397–1430
12. Greely H T 2000 Iceland’s plan for genomics research: Facts and implications. Jurimetrics Journal 40: 153–91
13. Greely H T 2001 Genotype discrimination. Pennsylvania Law Review 149: 1483–1505
14. Institute of Medicine, US National Academy of Sciences 1993 Assessing Genetic Risks: Implications for Health and Social Policy. National Academy Press, Washington, DC
15. Moore . Regents of the University of California 1990 51 Cal.3d 120
16. National Bioethics Advisory Commission 1997 Cloning Human Beings. NBAC, Rockville, MD
17. National Research Council 1992 DNA Technology in Forensic Science. National Academy Press, Washington, DC
18. National Research Council 1996 DNA Technology in Forensic Science: An Update. National Academy Press, Washington, DC
19. Nelkin D, Lindee M S 1995 The DNA Mystique: The Gene as a Cultural Icon. WH Freeman, New York
20. Nelson R 2000 Gene therapy, ethics, germ cell gene transfer. In: Murray T H, Mehlman M J (eds.) Encyclopedia of Ethical,
21. Legal, and Policy Issues in Biotechnology. John Wiley & Sons, New York
22. Parens E 1998 Enhancing Human Traits: Ethical and Social Implications. Georgetown University Press, Washington, DC President’s Commission for the Study of Ethical Problems in Medicine and Biomedical Research 1983 Screening and Counseling for Genetic Conditions: A Report on the Ethical, Social, and Legal Implications of Genetic Screening, Counseling and Education Programs. The Commission, Washington, DC
23. Rothstein M A (ed.) 1997 Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era. Yale University Press, New Haven, CT