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genetic screening

genetic screening The process by which the genome of a human or other organism is analysed for genetic markers (see marker gene) that indicate the presence of particular genes, especially ones that cause or predispose to certain diseases. Increased knowledge of the human genome (see Human Genome Project) and technological advances have simplified genetic screening in persons with a family history of certain inherited diseases, e.g. certain forms of breast cancer. Clinical gene testing is now used routinely to screen for many different genes, either to assess the risk of disease in susceptible individuals or their offspring or to confirm a diagnosis of inherited disease. Commercial gene test kits are also available to the general population, although claims that these can determine the risk of healthy individuals developing, say, heart disease or cancer should be treated with caution. Such tests have major implications for the insurance industry as well as for medicine. For example, some healthy individuals may be expected to pay a higher premium for life insurance because genetic screening reveals the presence of such genes. See also preimplantation genetic diagnosis.

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genetic screening

genetic screening n. screening tests to discover individuals whose genotypes are associated with specific diseases. Such individuals may later develop the disease itself or pass it on to their children (see carrier).
www.parliament.uk/documents/upload/POSTpn227.pdf Overview of the principles of genetic testing from the Houses of Parliament website

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genetic screening

genetic screening: see genetic testing.

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Genetic Screening

GENETIC SCREENING

The scientific procedure of examining genetic makeup to determine if an individual possesses genetic traits that indicate a tendency toward acquiring or carrying certain diseases or conditions. In 2001, scientists first published the complete human genome map (a human's genetic blueprint), greatly advancing the capability and use of genetic screening, manipulation, and replication.

Genetic testing of humans facilitates the discovery and treatment of genetic defects, both before and after birth. civil rights proponents, employers, and those who suffer from genetic diseases have debated genetic screening because the procedure poses practical and theoretical legal, economic, and ethical problems. Some theorists, for example, have suggested that genetic screening could improve society if it were made mandatory before hiring or marriage. Others say that this practice would be unconstitutional. Genetic screening is a dynamic rather than static field of medical and scientific experimentation and application that clearly involves scientific, legal, and ethical interests which may differ or compete. Accordingly, each new milestone or discovery warrants commensurate review of these interests for both beneficial and potentially detrimental consequences.

Federal and State Legislation

The earliest national and state legislation concerning genetic screening was enacted in the 1970s. The legislation focused on voluntary genetic testing. The laws generally protect the interests of those who suffer from genetic disease, offer federal and state subsidies for counseling, and support research in genetic diseases.

Congress enacted in 1976 the National Sickle Cell Anemia, Cooley's Anemia, Tay-Sachs, and Genetic Diseases Act (42 U.S.C.A. § 300b-1 et seq.), which permitted the use of public funds for voluntary genetic screening and counseling programs. State legislatures passed measures, with certain exceptions, requiring genetic screening of school-age children for sickle cell anemia. New York enacted a law that provides for premarital testing to identify carriers of the defective sickle cell gene (N.Y. Dom. Rel. Law §13aa [McKinney 1977]). Other states provided for voluntary premarital testing for the sickle cell disease (e.g., Cal. Health & Safety Code § 325-331 [West 1978]); Ga. Code Ann. § 19-3-40 [1974]). Such legislation often included provisions for voluntary, funded counseling (see Va. Code Ann. § 32.1-68 [Michie]).

With the advent of new technology in genetics came increasing concern about its application. In 1996, Congress passed the all-encompassing Health Insurance Portability and Accountability Act (P.L.104-191). One key provision barred group insurance plan administrators from using individual employees' genetic information as a factor when writing group policies (unless such information already resulted in the diagnosis of a illness). However, the bill addressed neither individual policies and premiums nor the use of genetic information in the workplace.

Consequently, in 2000, President bill clinton signed executive order 13145, prohibiting discrimination in federal employment based on genetic information. As of early 2003, no similar federal law covered the private sector workplace. However, according to the National Human Genome Research Institute (a division of the National Institutes of Health), 39 states had enacted bills addressing genetic discrimination in health insurance (see, e.g. Alabama Code §27–53–2,4; Alaska Statutes Annotated §21.54.100; Louisiana Revised Statutes Annotated §22.213.6,7, and so on). Another 27 states had passed bills addressing genetic discrimination in the workplace.

The Constitution, Civil Rights, and Scientific Theory

In 1981 and again in 2002, Congress held hearings to identify potential problems of widespread genetic screening. Subsequent legal and medical discussion has focused on the ethics of certain practices such as eugenics, a form of genetic engineering that involves the systematic programming of genes to create a specific life form or the use of living animals for experimentation. Both House and Senate committees had pending bills before Congress (S 318, S 382) hoping to create national legislation addressing prohibited uses of genetic screening.

One potential problem with genetic screening arises in its use by employers. Although an employer considering hiring an individual with a genetic disease often relies primarily on economic issues, the practice of screening prospective employees and eliminating those with defective genes may be discriminatory because some genetic diseases afflict certain ethnic and racial groups more often than others. G-6-PD deficiency, for example, occurs most frequently in blacks and persons of Mediterranean descent. If screening excludes persons with G-6-PD deficiency, it will have a stronger effect on those groups. This practice could violate Title VII of the civil rights act of 1964 (42 U.S.C.A. §§ 2000e et seq.).

In early 2001, the first federal court lawsuit of its kind was filed against a private company alleging violations under the Americans with Disabilities Act (ADA), P.L. 101-336 and several state laws. According to the suit, employer Burlington Sante Fe Railroad began furtively testing the blood of workers with carpal tunnel syndrome. At least 18 employees claimed to have been subjected to nonconsensual genetic testing. Still, other courts have permitted limited use of genetic screening as an adjudicatory aid in disputes. In a South Carolina child custody case, a judge ordered a woman to undergo genetic testing for Huntington's Disease, because the result could impact her ability to care for the children. While some experts would argue that these factors are important to proper legal and personal decision making, others question where the line will be drawn.

Nevertheless, some legal scholars maintain that compulsory genetic screening programs violate the Constitution. They assert, for example, that taking a child's blood sample constitutes a physical invasion of the body in violation of the fourth amendment. Compulsory counseling programs for parents, they say, interfere with the fundamental rights to marry and procreate. The critics of screening propose that less intrusive voluntary programs together with education could accomplish the same objectives.

Even though genetic screening involves at least a minor intrusion into an individual's body and may involve a search within the meaning of the Fourth Amendment, proponents of genetic science maintain that such searches are not unreasonable if executed in a proper manner and justified by a legitimate state interest (see Schmerber v. California, 384 U.S. 757, 86 S. Ct. 1826, 16 L. Ed. 2d 908 [1966] [holding that a compulsory blood test to determine intoxication of an automobile driver is not an unreasonable search]). Proponents of mandatory screening and counseling agree that these practices could interfere with the right to procreate. However, they suggest that the state's interests in improving the quality of a population's genetic pool in order to minimize physical suffering and reduce the number of economically dependent persons justifies the infringement on the civil liberties of individuals.

Amniocentesis and the Abortion Debate

A specific form of genetic screening known as amniocentesis raised fundamental constitutional issues when first introduced; in the twenty-first century, however, it is considered standard operating procedure for older women to undergo amniocentesis when they have conceived for the first time. Amniocentesis consists of inserting a needle through the abdominal wall of a pregnant woman into the amniotic sac containing the fetus, withdrawing a sample of the sac fluid, analyzing it for genetic characteristics, and determining whether the fetus has certain genetic defects. If amniocentesis reveals a genetically defective fetus, the parents may choose to abort it or carry it to term. Children born with genetic defects have brought legal claims against their parents for the tort of wrongful life, or wrongful birth.

Before the advent of amniocentesis, wrongful life actions generally failed (Pinkney v. Pinkney, 198 So. 2d 52, [Fla. App. 1967] [refusing to recognize tort of wrongful life for extramarital child plaintiff against father]; and Zepeda v. Zepeda, 41 Ill. App. 2d 240, 190 N.E.2d 849 [1963], cert. denied, 379 U.S. 945, 85 S. Ct. 444, 13 L. Ed. 2d 545 [1964]). The development of procedures such as amniocentesis, coupled with a shift in societal attitudes toward abortion, has led to successful claims for wrongful life. For example, in Haymon v. Wilkerson, 535 A.2d 880 (D.C. App. 1987), a mother brought a

wrongful birth action against a physician after her child was born with Down's syndrome. The court of appeals held that the mother was entitled to recover extraordinary medical and health care expenses incurred as a result of the child's mental and physical abnormalities. As a result of cases such as Haymon, doctors have increased their use of genetic counseling and prenatal testing.

The Future of Genetic Screening

In 1993, the Nobel Prize for chemistry was awarded to Kary Mullis for his development of a technique known as polymerase chain reaction, a method for rapidly isolating and copying any DNA sequence out of a sample that may contain thousands of other genes. This technology is rapidly developing for application not only in eugenics but also for gene manipulation to correct defective gene sequences in many diseases or conditions (nanotechnology). Researchers at Oxford University's Wellcome Trust Centre for Human Genetics announced in 2003 the development of a methodology for concurrently evaluating the functional significance of millions of noncoding polymorphisms that exist in the human genome. This development is expected to contribute greatly to the determination of genetic susceptibility to disease and assessing future health risk through genetic screening.

further readings

Beauchamp, Tom L., and James F. Childress. 1983. Principles of Biomedical Ethics. New York: Oxford Univ. Press.

Bettelheim, Adriel. 2001. "Cures May Arise from Genome Mapping, but Congress Anticipates Headaches." CG Weekly 59.

"A Comparison of Enacted State Genetic Discrimination Legislation." 2001. Council for Responsible Genetics (summer). Available online at <www.gene-watch.org> (accessed July 26, 2003).

Darvall, Leanna. 1993. Medicine, Law, and Social Change. Aldershot, England; Brookfield, Wis.: Dartmouth.

Hawkins, Dana. 2001. "The Dark Side of Genetic Testing." U.S. News & World Report 130.

Higgins, Michael. 1998. "Tempest in a Tube." ABA Journal 84.

Mason, John Kenyon, and R. A. McCall-Smith. 1994. Law and Medical Ethics. London: Butterworths.

——. 1987. Butterworths Medico-Legal Encyclopedia. London: Butterworths.

Reilly, Philip R. 1993. "Public Policy and Legal Issues Raised by Advances in Genetic Screening and Testing." Suffolk University Law Review (winter).

"Researchers Describe Advances in Determining Genetic Susceptibility to Disease." 2003. Genomics and Genetics Weekly. Available online at <NewsRx.com> (accessed July 26, 2003).

Smith, George P., II. 1993. Bioethics and the Law. Lanham, Md.: Univ. Press of America.

——. 1981. Genetics, Ethics, and the Law. Gaithersburg, Md.: Associated Faculty Press.

Stever, Pamela S. 1989. "Haymon v. Wilkerson: The Wrongful

Birth Cause of Action Emerges in the District of Columbia." Contemporary Health Law and Policy 51.

cross-references

American Medical Association; Disability Discrimination; Employment Law; Fetal Rights; Privacy; Search and Seizure.

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