Risk Screening, Testing, And Diagnosis Research Paper

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The Human Genome Organization project has increased enormously the possibilities to predict disability or disease either for an individual or for his or her offspring. Information obtained from genetic testing raises ethical and legal issues that have been debated for several decades. New issues are emerging due to rapid advances in molecular genetics.

From an ethical point of view, risk screening, genetic testing, and diagnosis belong to the most controversial and contested areas in contemporary medicine. The new genetics will have a profound impact on our self-images and on our understanding of the relations between environment and heritage. Conceptual, normative, and empirical issues are here intertwined in a complex way. To begin with, a preliminary clarification of the key concepts will be necessary.

The expression ‘risk’ will here be taken to refer to an adverse or negative future event that is probable but not certain. Any risk can then be analyzed in two components: the probability of occurrence of an event and the magnitude of its negativity according to certain explicitly stated norms and values (including kind, degree, duration, and timing). Risk assessment accordingly analyzes these two components, while risk management proposes strategies for handling the risk in ways that minimize the negativity and probability.

 However, risks involving probabilities are not the only sort of risks that are relevant in this context. The expression ‘epistemic risk’ has been coined to refer to risks due to ignorance, and in particular due to ignorance of what we are ignorant about (e.g., Sahlin and Persson1994). This notion is particularly relevant to many clinical applications of molecular genetics, involving unknown factors. The ways in which these risks are communicated will then be important from an ethical point of view.

Testing should be distinguished from screening. Harper has proposed the following definition: ‘Genetic testing is the analysis of a specific gene, its product of function, or other DNA and chromosome analysis, to detect or exclude an alteration likely to be associated with a genetic disorder’ (Harper and Clarke 1997). Testing refers to procedures performed at the request of individuals or families, and should always be voluntary. This holds also for genetic testing of members of families known to be at high risk, such as the siblings of persons with cystic fibrosis (Wertz and Fletcher 1989).

‘Screening,’ however, implies application to large population groups, to entire populations or subsets of populations (e.g., pregnant women, newborns, or job applicants). Screening is not performed at the request of individuals or families but rather based on policy or public health decisions. It may be mandatory or voluntary.

Both the expressions ‘genetic information’ and ‘genetic disorder’ are vague and ambiguous concepts (Zimmern 1999). The same holds for the key concepts of health, disease, and illness. The advances in molecular and clinical genetics may profoundly change our understanding of the latter concepts. They may have an impact on health care policy, on the patient– physician relationship as well as the way in which access to care is allocated (Murray et al. 1996).

Genetic information differs from other private information in that it reveals information not only about a particular individual but also about that individual’s blood relatives. Genetic test results may also provide information about population groups. Moreover, genetic information can be obtained from any cell in a person’s body, not just by examining, for example, particular malfunctioning organs or tissues.

The concept of genetic information is difficult to define and delimit in a clear and uncontroversial way. Just by asking for the age of a person’s parents and grandparents, genetic information in a certain sense can be obtained. The necessary and sufficient conditions for a disease or disorder to be ‘genetic’ are far from clear. If these expressions ‘genetic information’ and ‘genetic disorder’ are to appear in legislative texts, they have to be made precise.

There are many kinds of genetic disorders, including (1) chromosome changes, like trisomy 21 or Down’s syndrome, (2) monogenetic disorders which depend on a mutation in one gene, like Huntington’s chorea, and (3) polygenetic disorders like diabetes which are due to mutations in several genes in combination with environmental factors.

These distinctions are important for several reasons. What holds for monogenetic diseases concerning genetic determinism cannot be generalized to genetic disorders of other kinds. Thus, presymptomatic testing can be done for disorders in group (2) but rarely and with much less certainty, if at all, for those in group (3).

1. Public Concerns

Genetic testing may be beneficial in those cases where early detection makes a difference, for example, makes it possible to prevent or cure the disease. The validity and the reliability of the test methods will then be of crucial importance. The background of many national screening programs, like the one launched in Ontario, Canada, in 1999, to detect risk of hereditary breast, ovarian, and colon cancers is that early detection can lead to medical interventions and surveillance. This can significantly reduce the risk of developing the disease and hence be cost-effective.

The concern expressed over genetic testing and screening, however, is that it may threaten privacy and civil rights and be the basis of genetic discrimination or stigmatization of individuals as well as of groups. Moreover, it has been feared that widespread use of genetic testing will help to foster intolerance of people with genetic variations. It may be difficult, too, if not impossible, for people with certain inherited disorders to obtain a life insurance. Finally, people may feel a pressure to be tested, as a result of cost–benefit analysis. In general, of course, the negative consequences of testing people and disclosing information about their test results to blood relatives will have to be weighed against the benefits of this, if any, for those concerned. However, this weighing operation is far from simple.

Guidelines for genetic testing and screening have been proposed in the attempt to maximize the beneficial consequences and minimize the adverse ones (by e.g., UNESCO 1997, Council of Europe 1992, 1996, Nuffield Council on Bioethics 1993, Danish Council of Ethics 1993). These guidelines include discussions of genetic counseling, informed consent, disclosure to individuals and family members, confidentiality, employment, insurance, as well as public policy. The commercial availability of genetic test kits raises both operational and ethical issues, dealt with in the principles and recommendations suggested by National Institutes of Health (1997). This report discusses the validity of genetic testing, deals with genetic counseling and the informed consent process, as well as recommendations on quality assurance measures for laboratories performing genetic tests and the need for a national body with the authority to review genetic testing procedures.

2. Ethical Issues

It has often been recommended that genetic information in health care should be acquired and used ‘in a manner that respects the autonomy of individuals’ (Institute of Medicine 1994), but it has proved hard to explain the precise meaning of this in a noncontroversial way. The autonomy of what individuals should be respected? Sometimes respecting the autonomy of one individual may conflict with respecting the autonomy of another.

A general problem raised by all forms of genetic testing and screening is, first, how to give nondirective information, that is, information that makes autonomous decisions possible by individuals and couples, and then to obtain consent in a way that avoids exercise of pressure.

Why is nondirectiveness an important goal? In brief, the reasons are the value of autonomy and the importance for geneticists to dissociate themselves from the dark history of genetics, from abuse of genetics for eugenic purposes. But nondirectiveness in practice is not uncomplicated, and the goal is also controversial. There is now a debate on the process of genetic counseling beyond nondirectiveness (Clarke 1994, Harper and Clarke 1997).

Particular problems are raised by the testing of individuals or groups with reduced autonomy, like children, demented people, or immigrants who do not understand the language. The testing of a healthy child could arise in at least three different contexts (Chadwick 1998): predictive testing, to see if the child will develop a specific disease that runs in the family; carrier testing, to see if the child may be at risk of having an affected child; and a screening test unrelated to family history to identify children with increased susceptibility to some common disease such as diabetes or ischaemic heart disease. Children are vulnerable and their parents therefore have to be involved in the decision procedure. But how? The nature of parental consent and the degree to which children are to be involved according to their maturity need close examination. If relatives are to be informed, who should do this? The geneticist, the hospital, or those already tested? And in what way? How many relatives should be informed? How closely related to the person asking to be tested (the index person) should the relatives be for the clinical geneticist to be responsible for informing them?

Different consent models are available, each with their own pros and cons. One main alternative is called ‘opt in,’ which means that if you have not said yes, you have said no; another is called ‘opt out,’ which means that if you have not said no, you have said yes. The conditions under which any of these models may or must be used is an important ethical issue.

The challenge to genetic privacy concerns the control of personal genetic information. Privacy has two dimensions, according to the Canadian Human Rights Commission (1992): protection from the intrusion of others and protection from one’s own secrets. Does this entail a right to genetic ignorance, a right not to know about one’s own or one’s relatives’ genetic risk profile? Is there a duty for geneticists or tested persons to disclose such information to those who might benefit from it? What is the basis of such rights and duties, and what are the consequences for the various people concerned of accepting or rejecting them? Opposite positions have been argued for by Rhodes (1998) and Takala and Hayry (2000). Several compromise positions have been put forward. Tested persons should be encouraged to share what they know about their genetic risk profile with their blood relatives, when this information would be of vital health interest to their relatives (Chadwick et al. 1997, Hermeren 2000).

The privacy and confidentiality of the information needs to be protected against third party interests, including other family members, employers, and insurers. It has been suggested that genetic information should not be given to unrelated third parties, without the explicit and informed consent of the tested persons. In many countries, access to genetic information is regulated by law. The conditions or criteria under which medical confidentiality may or must be breached are bound to be controversial (Harper and Clarke 1997).

The practical problems raised by genetic testing also have to do with how to estimate and evaluate risks, communicate them in an understandable way, and decide which risks are acceptable and which are not. This includes the risk that a person will have an increased risk for a genetic disorder and the risk that the test result is not accurate. Communicating risks is obviously an important part of the genetic counseling process.

The accuracy of the tests—their validity and reliability—and the predictive value of the test or the screening method is another important issue in this context. To estimate the predictive value, one has to be able to compute the number of false positives and false negatives as well as to know about the prevalence of the genetic disorder.

Finally, there are issues of justice and fair access. If testing and screening is to be done on an equitable basis, it should not be available on the basis of such accidents as in which geographical region a person happens to be born.

These ethical problems arise in somewhat different ways, according to the type and purpose of testing or screening. The difficulties are not the same in all cases. In particular, certain forms of screening and pre-symptomatic testing for late onset genetic disorders present problems from an ethical point of view. Some of the most common types of genetic testing and screening will therefore be described below along with a brief indication of the particular ethical problems they raise.

3. Types Of Testing And Screening

3.1 Presymptomatic Testing

Individuals may be tested for monogenetic disorders (of which there are many though each is fairly rare) by DNA analysis before any symptoms are shown. If an early diagnosis is of value, because the disease can be prevented, presymptomatic testing is fairly uncontroversial. If the disorder cannot be prevented, the value of presymptomatic testing is more difficult to judge. This holds also in cases where there is a method of prevention but it is nevertheless impossible to guarantee that the person tested positively will not get the disease (for example, breast cancer).

In addition to the obvious difficulty of informing people in such a way that they can make autonomous decisions, presymptomatic testing raises problems about how the information obtained from the tests should be handled, and who should have access to it. Likewise, it is controversial whether blood relatives should be contacted and who should contact them in that case (the person tested, the hospital, the clinic, the geneticist, etc.). Moreover, in many countries there is great concern about how to prevent certain external third parties, like employers or insurers, from getting access to information about the test result.

3.2 Prenatal Diagnosis

Prenatal diagnosis can be regarded as a special case of presymptomatic testing. By prenatal diagnosis it is possible to discern whether a fetus is at risk for various disabilities or diseases.

There are several methods for prenatal diagnosis. Some are visual—either noninvasive, like ultra-sonography, or invasive, like embryoscopy or fetoscopy, which uses a camera on a needle inserted in the uterus to view the fetus. Other methods are based on analysis of fetal tissues (like amniocentesis or chorionic villus sampling). By ultrasound tomography it is possible to create fetal images on a screen.

The indications of when prenatal diagnosis should be offered include advanced maternal age, a genetic history of abnormalities in the family, repeated miscarriages, or previous infants with birth defects. Then a prenatal diagnosis may be offered to provide information to couples about what they can expect. A normal result is found in most cases. If not, prenatal diagnosis may make it possible for them to adjust and may also influence the way in which the baby is delivered.

There has been great concern about the risk of spontaneous abortion induced by the use of amniocentesis or chorionic villus sampling. This is a problem one does not have with ultrasonography. On the other hand, ultrasonography may give information that is unexpected or not wanted, for example, that some organs or limbs are malformed. With other methods, too, one may make unexpected or unwanted discoveries, for example, that the social father is not the biological father.

All this serves to underline the necessity of careful counseling before the diagnosis, so that the woman or the couple knows what the test may show and how certain the result is. Informed consent is crucial, and the difficulties of nondirective counseling should not be underestimated.

Other ethical issues raised by this type of diagnosis are concerned with how to preserve the confidentiality of the information obtained. Since prenatal diagnostics sometimes leads to abortion, it may be controversial in the eyes of some people for the same reasons that abortion is controversial. The impact of prenatal diagnosis on our views of people with handicap has also been a matter of concern.

3.3 Preimplantation Diagnosis

Preimplantation diagnosis means that the diagnosis is carried out before (in connection with in vitro fertilization) the pre-embryo is implanted in the woman’s uterus. If there were a history of sex-linked diseases in a family, it would then be possible to prevent a child with such a disease being born. Thus the resulting pregnancy could be normal and the woman would not have to abort the fetus at a later stage or give birth to a child with a very serious or lethal disease. Preimplantation diagnosis is becoming an established medical practice in many countries.

The first serious ethical problem that arises is to whom these tests should be offered. Usually, they are limited to severe illnesses and to persons in specific ‘high risk’ groups. But both these criteria are value laden, and the indications may be narrowed down or widened. There are also considerable variations not only between lay people but also between geneticists over the severity of different genetic conditions (Chadwick 1998).

Preimplantation diagnosis at the beginning of the twenty-first century is thus limited to sorting out fertilized eggs carrying genes associated with severe diseases for which there is no cure at present, like Huntington’s chorea and certain X-linked diseases. Concern has been expressed that the practice may be extended to diseases that are less serious (Shenfield 1997). Obviously, there is a risk of a slippery slope in this area.

Preimplantation diagnosis also, at least theoretically, opens up possibilities for a shift of power from the woman to the geneticist, as well as for cloning and manipulation of human pre-embryos that many people find too risky or simply ethically unacceptable. In some countries, like the UK, manipulation of human pre-embryos is illegal.

3.4 Prenatal And Neonatal Screening

Newborn screening involves the analysis of blood or tissue samples taken in early infancy in order to detect inherited diseases where early intervention can minimize or eliminate the risk of later serious health problems or premature death.

In screening, a group of individuals is examined directly with DNA, RNA or biochemical analysis to find those who will later in life have an increased risk of developing a particular genetic disorder. A good screening method is reliable and valid, with a minimum of false positives (who are worried unnecessarily) and false negatives (who are lulled into false security).

The best-known example of uncontroversial neonatal screening is screening for phenylketonuria (PKU), a genetic disease. The reason is that PKU, if undetected, can lead to serious mental retardation. Moreover, it can be discovered easily and prevented through early intervention. For many other conditions, such as cystic fibrosis and galactosemia, the benefits of early detection are more controversial. Screening programs for newborns also raise the issues of freedom of choice and informed consent by parents (Hermeren 1999).

Newborn screening raises several ethical issues, among them the nature of informed parental consent and how it is obtained, confidentiality and privacy, and the interests of third parties, as well as issues of justice such as equal access to testing and treatment. Moreover, it is clear that more research needs to be carried out on the psychological responses to newborn screening, particularly when the health benefits are disputed (Harper and Clarke 1997).

People with certain genetic disorders have had difficulties in getting a life insurance. In some countries the right of insurance companies to ask for genetic information has been regulated by law. In Norway, it is forbidden. In other countries—The Netherlands and Sweden, for instance—there has been a temporary voluntary moratorium during which the insurance companies will not ask for genetic information, provided that the life insurance asked for will not exceed a certain amount. This is still a very controversial area (Sandberg 1996).

3.5 Carrier Screening

Carrier screening identifies individuals with a gene or chromosome abnormality that may cause problems either for offspring or for the person screened. The testing of blood or tissue samples can indicate the existence of particular genetic trait changes in chromosomes or changes in DNA that are associated with inherited diseases in asymptomatic individuals. Carrier screening exists for sickle cell anemia, for Tay Sachs disease, as well as for cystic fibrosis, Duchenne muscular dystrophy, hemophilia, and Huntington’s chorea.

Carriers have one normal copy of a gene and one copy that varies from the normal gene. Since one gene is normal, the carriers ordinarily do not exhibit symptoms of a genetic disorder. A woman who is a carrier of an X-linked disease such as Duchenne muscular dystrophy or fragile X syndrome, has a variant gene on one of their two X (sex-determining) chromosomes. Her risk of transmitting the variant gene to each child can be estimated accurately.

The purpose of carrier testing is to inform potential parents of their genetic risk profile so that they can make informed reproductive decisions. National screening programs are usually justified by cost–benefit analysis. The question is then which costs and whose costs are taken into account, and how the benefits are defined and evaluated. The importance of cultural differences as to what constitutes benefits, and how benefits are ranked, should not be underestimated.

The right to autonomous choices is an important issue also in this area. Whether the choices open to people found to carry a disease gene are acceptable or not, may depend on their life plans, their ethical views, the laws of their country, as well as their culture and social customs. Before a carrier screening program is decided on and implemented, these questions need to be considered. In practice there may be subtle coercion, even if a carrier screening program is formally voluntary.

Screening the subset of a population at risk rather than the entire population makes sense from a medical and economic point of view, but selecting target groups for such screening programs also creates ethical problems. For example, there have been in the past controversies over whether these screening programs in effect had a eugenic purpose, particularly when the diseases screened for are over-represented in certain ethnic groups.

3.6 Testing In The Work Place

Susceptibility screening can be used as a form of presymptomatic testing, but is also used to identify workers who may be susceptible to toxic or carcinogenic substances such as benzene in their workplace (Van Damme et al. 1997, Surralles et al. 1997, Jarvholm et al. 1999). This susceptibility may lead to occupational health problems and future severe disabilities.

Van Damme et al. (1995) have proposed a conceptual model of the complex interactions between exposure, acquired and inherited susceptibility, and risk for disease. The validity of tests for determining genotype and phenotype and their relevance for the disease must be evaluated critically to provide an objective basis for ethical discussions. The acceptability of such tests is related to a number of issues which Van Damme et al. identify and discuss.

Genetic testing of employees and job applicants is controversial. The first basic question concerning testing in the work place is simple—for whose sake is the test performed? Is the test performed in order to protect persons with increased (inherited) susceptibility to hazards at the workplace? Or is the test in the interest of the employer, so that the employer can avoid improving the working conditions and avoid hiring people who would be damaged by the work they do? Here it is essential to separate the situation of the job applicant from the situation of the person already with a job. The latter could be monitored for exposures and early effects of, for example, toxic substances on the genes.

There are methods of detecting inherited predisposition to cardiovascular diseases as well as to adverse effects from otherwise well-tolerated exposures related to the job. Clearly, with widespread use of genetic testing in the workplace there is the obvious danger of discrimination and stigmatization of individuals or groups. It may be tempting for employers to use tests to select only workers who will be able to work in the present working conditions, instead of improving the working conditions. The result could be that large groups of people would be barred from the job market.

3.7 Forensic Testing

A comparatively new use of genetic testing is to examine a possible genetic linkage between, for example, alleged fathers and their children, or between suspects and evidence discovered in criminal investigations, like hair, blood, sperm, saliva, or skin. The idea is to use genetic methods of analysis to clear the innocent and identify the guilty. However, concern has been expressed that mistakes can be made. Critics argue that it is necessary to improve the quality control of the test laboratories. Another problem is the confidentiality of the DNA profiles obtained from criminal investigations and stored in national police databanks. For how long time will they be stored? Who will have access to them and for what purpose?

4. Concluding Remarks

Genetic testing and screening should be done for ‘health purposes.’ This is sometimes stated as a necessary condition for genetic testing (Council of Europe 1992, 1996). Health purposes could include diagnostic and therapeutic purposes as well as medical research and health care planning. Moreover, ‘health’ can be defined in several ways. It is important to state more precisely what this means.

Careful counseling remains crucial. One of the present concerns is that do-it-yourself test kits for genetic disorders may be bought via the Internet or over the counter without any professional counseling to explain what the findings mean, how certain the test is, etc. There is an urgent need to find ways of regulating the economic interest of commercial bio- technological companies in order to minimize the harm of premature use and overuse of genetic testing.


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