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Human Genome News, January-June 1997; 8:(3-4)
by Philip R. Reilly, Shriver Center
Legislative interest in regulating the uses of genetic information is at an all-time high, after decades in which not one legislator at either the congressional or state level introduced a bill to control the use of genetic information. Since 1989, however, the number of such proposals, as well as the territory they seek to cover, has expanded steadily as genetic data has proliferated.
In the early 1990s, legislation focused almost exclusively on attempting to forbid insurers from using genetic information in health-insurance underwriting decisions. Currently, the social concern driving legislative interest is fear of genetic discrimination, defined here as discrimination against otherwise-healthy individuals on the basis of a genotypic variation. As of April 1997, at least 15 states had enacted genetic privacy laws. More than 75 similar bills are pending in more than 30 states, according to a survey by the Biotechnology Industrial Organization, and several federal bills have been introduced into the 105th Congress.
Protection Under HIPPA
Significant legislation at the state level has been more than eclipsed by a new federal law, "The Health Insurance Portability and Accountability Act of 1996" (PL-104-191), which takes effect this year. HIPAA provides an important new protection for people who want to undergo genetic testing but fear discrimination by health insurers if their test results indicate an increased risk for developing a serious disease. Section 101 of HIPAA sharply curtails the right of group health insurers to limit coverage of new employees because of "preexisting conditions." As of August 1997, group health insurance plans may impose a preexisting-condition exclusion only when medical advice, diagnosis, care, or treatment was recommended or received within the 6-month period before enrollment.
The new law also forbids group health insurance plans to apply the preexisting-condition rule to genetic information unless the person has been diagnosed with the illness predicted by the genetic test. For example, a woman who does not have cancer may not be denied coverage even if her test results indicate a predisposing mutation for breast or ovarian cancer.
Given the scope of HIPAA, rapid proliferation of similar state laws, steady growth of managed care, and public mood, individuals who decide to undergo DNA-based predispositional testing may face relatively little risk of discrimination in health insurance. Nevertheless, a widespread concern stimulated in part by the emergence of tests to identify persons at increased risk for cancer is that test results can and will be used against people. Some are so concerned that even protective legislation is unlikely to reassure them.
The vast number of genetic privacy bills circulating in state legislatures has generated many questions. Four of the most important are (1) What is meant by a genetic test? (2) Is genetic information distinct from or merely one form of medical information? (3) Should a tissue sample and data derived from it be the property of the person from whom it was taken? (4) Do we need more stringent oversight of human genetic research?
Defining "Genetic Test"
Deciding what constitutes a genetic test is not so easy, and definitions vary widely. A current Texas bill (TX75RSB98) defines it as a test of an "individual's DNA, RNA, or chromosomes...associated with a predisposition for a clinically recognized disease or disorder." Note that this definition does not include proteins, so it excludes some newborn screening, prenatal tests for neural tube defects, and many tests currently used by geneticists to make diagnoses. A more-inclusive Vermont bill (H.89), on the other hand, defines genetic testing as analysis of a chromosome, a gene, DNA, RNA, or protein encoded by a gene...." Both bills also exclude certain standard medical tests from their reach. If eachstate bill has its own particular definition and many become law, these variations may someday haunt insurers, employers, and testing laboratories that seek to comply with laws in the individual states.
Protection for Other Clinical Data
Is genetic information so different from other clinical data that it deserves special protection? There is, admittedly, precedent for this. Our society traditionally accords a special level of protection to psychiatric records, and, to some extent, we have condoned a higher degree of protection to HIV test results. In essence, the argument that genetic data is different from regular medical information and deserves special protection is two pronged:
True enough but the ability to treat genetic information with special care depends on how well it can be separated from other clinical information. If genetic testing permeates medical care, as it almost certainly will within the next 20 years, it will be very difficult to implement a law that requires separate treatment of portions of many people's medical records. Few bills have confronted this issue; in those that have sought to deal with it, genetic information is defined so narrowly that, if enacted, the bills would protect very little information about very few people. Too often lost in the discussion about genetic privacy is the point that nearly everyone would benefit from enactment of a general medical privacy law covering access to and use of all health information.
Individual Property Rights
In 1995, bills began to appear that were partly influenced by a model "Genetic Privacy Act" drafted by DOE ELSI grantee George Annas and his colleagues at Boston University. These bills asserted that tissue taken for genetic testing, as well as the test results, should remain the property of the individual tested. This principle challenges a century of practice in which discarded tissue samples have been used routinely by pathologists for research and teaching in a manner that respects the donor's privacy.
In 1995, Oregon enacted a law based on Annas's model, and the property proposal has since popped up in many other bills. In 1996, the New Jersey legislature passed a similar bill that was vetoed by Governor Whitman after 11th-hour protests from the pharmaceutical industry. Citing the bill's possible chilling effect on research, Whitman later signed an amended version that deleted the property provision but required that all genetic testing be preceded by written informed consent. A bill now before the New Jersey legislature seeks to reintroduce the property concept.
Bills that include provisions forever tying up tissue samples as property of persons from whom they were taken do raise questions about uses to which the academic and research community may put the DNA. Like it or not, given the importance of intellectual property concerns, scientists might not go forward with research if they don't have a clear right to use the samples.
IRB Oversight
The most recent trend in genetic privacy bills is the notion that genetic information is so sensitive and the threat of genetic discrimination so significant that our society needs a new level of oversight for research involving human genetics. Proponents of these provisions offer few concrete examples of studies in which genetic research has harmed human subjects; rather, they assert a potential future risk. Nevertheless, it would not be surprising to see state laws that define all research involving human gene mapping as constituting significant social risk to subjects. Any such research, regardless of its funding, thus would require the equivalent of an independent review by an institutional review board (IRB) or its equivalent. Although unlikely to become law this year, "The Human Research Subjects Protection Act of 1997" (S.193), introduced by Senator John Glenn (D-OH), proposes to extend IRB oversight to all U.S. research involving human subjects.
Federal Control
If the federal government decides to broaden its level of control over research, a comprehensive federal law could be enacted to preempt individual state regulations. Monitoring and abiding by a potpourri of varying state rules might be exceedingly expensive and time consuming for multicenter investigations.
The electronic form of the newsletter may be cited in the following style:
Human Genome Program, U.S. Department of Energy, Human Genome News (v8n3).
The Human Genome Project (HGP) was an international 13-year effort, 1990 to 2003. Primary goals were to discover the complete set of human genes and make them accessible for further biological study, and determine the complete sequence of DNA bases in the human genome. See Timeline for more HGP history.
Published from 1989 until 2002, this newsletter facilitated HGP communication, helped prevent duplication of research effort, and informed persons interested in genome research.
