Assessing Genetic Risks Implications for Health and Social Policy (1994) / Chapter Skim
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8 Social, Legal, and Ethical Implications of Genetic Testing
8 Social, Legal, and Ethical Implications of Genetic Testing
Pages 247-289
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From page 247... ...
Should people be able to control access to the results of their tests? If test results are released to third parties such as employers or insurers, what protections should be in place to ensure that people are not treated unfairly because of their genotype?
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From page 248... ...
Legal Issues The legal concept of autonomy serves as the basis for numerous decisions protecting a person's bodily integrity. In particular, cases have held that competent adults have the right to choose whether or not to undergo medical interventions.2 Before people make such a choice, they have a right to be informed of facts that might be material to their decision,3 such as the nature of their condition and its prognosis,4 the potential risks and benefits of a proposed test or treatment,s and the alternatives to the proposed intervention.6 In the genetics context, health care providers have been held liable for not providing the information that a genetic test is available.7 People also have a right to be informed about and to control the subsequent use of tissue that has been removed from their bodies.8 There is some leeway under the federal regulations governing research involving human subjects for researchers to undertake subsequent research on blood samples provided for genetic tests (as in the newborn screening context)
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From page 249... ...
Once persons undergo genetic tests, privacy includes the right to make an informed, independent decision about whether and which-others may know details of their genome (e.g., insurers, employers, educational institutions, spouses and other family members, researchers, and social agencies)
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Their presence is not surprising, because such rules are often justified on the basis of their instrumental value: if prospective patients cannot count on health care professionals to maintain confidentiality, they will be
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Second, health care professionals may also have a moral or legal right (and sometimes even an obligation) to infringe rules of confidentiality, for example, to prevent a serious harm from occurring.
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For instance, a society has to determine whether to distribute a scarce resource such as health care according to persons' differences in need, social worth, or ability to pay. One crucial question is whether genetic disorders or predispositions provide a basis for blocking access to certain social goods, such as employment or health insurance.
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From page 253... ...
If, however, the needs are viewed as unfair as well as unfortunate, society may have a duty of justice to try to meet those needs. One prominent argument for the societal provision of a decent minimum of health care is that, generally, health needs are randomly distributed and unpredictable, as well as overwhelming when health crises occur.25 Because of these features of health needs, many argue that it is inappropriate to distribute health care according to merit, societal contribution, or even ability to pay.
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From page 254... ...
. CURRENT PRACTICE OF PROTECTION IN GENETICS The development of genetic testing has raised numerous concerns about autonomy, confidentiality, privacy, and equity that are exacerbated by the range of contexts in which such tests are undertaken, the sheer volume of tests that could be offered, the many uses that can be made of test results, and the variety of institutions that store genetic information.
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From page 255... ...
In a survey by Dorothy Wertz and John Fletcher,30 numerous geneticists suggested that there were at least four situations in which they would breach confidentiality and disclose genetic information without the patient's permission, even over the patient's refusal: (1) 54 percent said they would disclose to a relative the risk of Huntington disease; (2)
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From page 256... ...
In contrast to infectious disease, the transmission of genetic diseases does not present an immediate threat to society. Whereas infectious disease can cause rapid devastation to a community, the transmission of genetic disorders to offspring does not necessarily have an immediate detrimental effect, but rather creates a potential risk for a future generation in society.37 U.S.
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From page 257... ...
Additionally, policy concerns raised by attempts to stop the transmission of genetic diseases differ from those addressed to infectious diseases because genetic diseases may differentially affect people of different races or ethnic backgrounds. For that reason, some commentators contest the applicability of the infectious disease model to government actions regarding genetic disorders.
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From page 258... ...
David Brock similarly noted that most disorders lie between the extremes of Tay-Sachs disease and alkaptonuria; what a physician advises "depends as much on the physician's ethical preconceptions as his medical experience."44 Despite the fact that the public health model does not fit the situation of genetics, the individual rights model should not be seen as absolute. There are certain situations in which the values of autonomy, privacy, confidentiality, and equity should give way to prevent serious harm to others.
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From page 259... ...
The proposed informed consent guidelines for research involving genetic testing suggested by the Alliance of Genetic Support Groups provide an excellent starting point for the development of informed consent policies in the genetics area (see Chapter 41. The potential development of multiplex testing adds another wrinkle to the issue of informed consent for genetic testing.
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From page 260... ...
Two states (Missouri and South CarolinaJ have criminal penalties for parents who refuse newborn screening of their children.52 The idea behind mandatory newborn screening is a benevolent one to try to ensure that all children get the benefits of screening for PKU and hypothyroidism,
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From page 261... ...
Recent studies show that the few states with voluntary newborn screening programs screen a higher percentage of newborns than some states with mandatory newborn screening programs; for 1990, voluntary programs reported reaching 100 percent of newborns in their states, while some states with mandatory programs report reaching 98 percent, and some even less than 96 percent.53 Relevant research has suggested that even when a newborn screening program is completely voluntary and parents may refuse for any reason, the actual refusal rate is quite low, about 0.05 percent (27 of 50,000 mothers)
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From page 262... ...
In the postgenome era, people will be facing the possibility of undergoing many more genetic tests in their lifetimes, and will need to master a wealth of genetic information that is relevant to their health, their reproductive plans, and the choices they make about what to eat, where to live, and what jobs to take. The more settings in which they can be informed about genetics, the more able they will be to make these decisions.
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From page 263... ...
Treatment of children identified through screening for maple syrup urine disease may have only limited effectiveness at best, and parents may face a quandary about whether or not to treat. Even if hypothetical benefits exist, newborn screening programs need close scrutiny to determine if the necessary treatments are actually provided to the children.
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From page 264... ...
Genetic information is unlike other medical information. It reveals not only potential disease or other risks to the patient, but also information about potential risks to the person's children and blood relatives.
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. Since most people at risk for Huntington disease have not chosen testing to see if they have the`genetic marker for the disorder,67 geneticists may be overestimating the relative's desire for genetic information and infringing upon the relative's right not to know.
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From page 266... ...
Since genetic disorders are not communicable to the spouse, a counter argument could be made that there is no legitimate reason for disclosing them. However, the spouse might have a great interest in the genetic information because he or she would like to protect any potential children from risk.
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From page 267... ...
the disclosure is limited to the information necessary for diagnosis or treatment of the relative. Even in the more compelling situation of disclosure to relatives, the health care provider is not in a professional relationship with the relative, and previous legal cases regarding a duty to provide genetic information have all involved a health care provider in a professional relationship with the person to be informed.
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From page 268... ...
Such discrimination has occurred both when the information has been obtained through genetic testing and when the information has been obtained in other ways (e.g., inadvertent release of a relative's medical record or disclosure from payment for medical service for a child) .83 In the future, third parties may want access to genetic information or may wish to mandate genetic testing.
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From page 269... ...
of the U.S. Congress found that insurers see a role for genetic information in medical underwriting.
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From page 270... ...
These incidents include cases in which a person with a positive test for a genetic disorder had his or her insurance canceled or "rated up" as a result;98 where genetic disorders such as alpha~-antitrypsin were defined as preexisting conditions, thus excluding payment for therapy; where a particular genetic condition resulted in exclusion from maternity coverage;99 and where the birth of a child affected with a serious recessive disorder led to the inability of the parents and unaffected siblings to obtain insurance.~°° Genetic information provides serious challenges to the traditional operation of insurance. Health insurance in this country is premised on the notion that risks can be predicted on a population-wide basis, but not well on an individual basis; thus insurance becomes a mechanism for spreading risks.
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From page 271... ...
However, insurance discrimination based on genetic information not obtained through DNA testing is not forbidden by the law. There is also much concern about the use of genetic information in the employment context.
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From page 272... ...
A more effective approach to protecting the public's safety would be routine testing of a worker's actual capacity to function in a job that is safety-sensitive. 1 15 The opinion points out that capacity testing is more appropriate because it would not cause discrimination against someone who has the gene for a disorder but who is totally asymptomatic, yet it would "detect those whose incapacity would not be detected by genetic tests, either because of a false-negative test result or because the incapacity is caused by something other than the disease being tested for."t i6 In the employment context, a New Jersey law prohibits employment discrimination based on an "atypical hereditary cellular or blood trait." 17 In New York, a statute prohibits genetic discrimination based on sickle cell trait, Tay-Sachs trait, or Cooley anemia (beta-thalassemia)
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From page 273... ...
The possibility that someone, later in life, might become incapable of doing a job does not provide a suff~cient rationale for not letting him or her undertake the job at the current time. Consequently, in most situations, periodic medical screening for symptoms rather than genetic screening will be a more appropriate means of determining whether an employee presents a serious risk of harm to third parties.~23 FINDINGS AND RECOMMENDATIONS Overall Principles The committee recommends that vigorous protection be given to autonomy, privacy, confidentiality, and equity.
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From page 274... ...
IRB approval should be obtained before new tests are added to newborn screening. Autonomy Informed Consent The committee recommends that for a proper informed consent to be obtained from a person who is considering whether to undergo genetic testing, the person should be given information about the risks, benefits, efficacy, and alternatives to the testing; information about the severity, potential variability, and treatability of the disorder being tested for; and information about the subsequent decisions that will be likely if the test is positive (e.g., whether the person will have to make a decision about abortion)
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Multiplex Testing Performing multiple genetic tests on a single sample of genetic materialoften using techniques of automation has been called multiplex testing. The committee recommends that informed consent be gained in advance of such multiplex testing.
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Screening and Testing of Children The committee recommends that newborn screening programs be voluntary. The decision to make screening mandatory should require evidence that without mandatory screening-newborns will not be screened for treatable illnesses in time to institute effective treatment (e.g., in PKU or congenital hypothyroidism)
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The individuals should have a right to consent or to object to particular uses of the sample or information. Subsequent anonymous use of samples for research is permissible, including in state newborn screening programs.
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On balance, the committee recommends that health care providers not reveal genetic information about a patient's carrier status to the patient's spouse without the patient's permission. Furthermore, information about misattributed paternity should be revealed to the mother but should not be volunteered to the woman's partner.
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From page 279... ...
, including genetic information that is obtained through specific genetic testing of a person as well as genetic information about a person that is obtained in other ways (e.g., physical examination, knowledge of past treatment, or knowledge of a relative's genetic status) ; · confidentiality of genetic information should be protected no matter who obtains or maintains that information, including genetic information collected or maintained by health care professionals, health care institutions, researchers, employers, insurance companies, laboratory personnel, and law enforcement officials; and .
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From page 280... ...
population (approximately 156 million people) is covered by some kind of life insurance, the use of genetic information in medical underwriting decisions about life insurance appears to raise different and somewhat lesser concerns than the use of genetic information in health insurance underwriting.
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From page 281... ...
A means of access to health care should be available to every American without regard to the individual's present health status or condition, including genetic makeup. Any health insurance reform proposals need to be evaluated to determine their effect on genetic testing and the use of genetic information in health insurance (see Chapter 74.
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From page 282... ...
The committee recommends that if an individual consents to the release of genetic information to an employer or potential employer, the releasing entity should not release specific information, but instead answer only yes or no regarding whether the individual was fit to perform the job at issue. The committee recommends that the EEOC recognize that the language of the Americans with Disabilities Act provides protection for presymptomatic people with a genetic profile for late-onset disorders, unaffected carriers of disorders that might affect their children, and people with genetic profiles indicating the possibility of increased risk of a multifactorial disorder.
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From page 283... ...
Rothstein, "The Use of Genetic Information in Health and Life Insurance." In Friedman, T
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37. Moreover, it should be noted that this risk (transmission of genetic disease to offspring)
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56. Currently, Colorado and Wyoming include cystic fibrosis testing as a part of their mandatory newborn screening program; Wisconsin includes cystic fibrosis in newborn screening as part of an experimental research protocol.
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From page 286... ...
. Under the New York law, human research is defined to exclude "studies exclusively utilizing tissue or fluids after removal or withdrawal from a human subject in the course of medical practice." Some researchers argue that blood and urine left over after a patient's tests are done should be available without requiring the patient's informed consent.
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89. Mark Rothstein, "The Use of Genetic Information in Health and Life Insurance," in Molecular Genetic Medicine, ea., Ted Friedman (New York: Academic Press, 1993)
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126. American Council on Life Insurance, 1992 Life Insurance Fact Book 19 (1992)
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From page 289... ...
Standards for medical underwriting vary substantially by insurance company, and underwriting decisions are considered crucial business decisions by insurers and are thus considered "trade secrets." 128. Paul Billings, "Testimony`Before Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations," U.S.
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