Sponsored by the U.S. Department of Energy Human Genome Program
Human Genome News Archive Edition
Human Genome News, January-June 1997; 8:(3-4)
Two of the federal bills on genetics currently before Congress are the "Genetic Information and Nondiscrimination in Health Insurance Act of 1997" (H.R.306), introduced by Rep.Louise Slaughter (D-NY), and the "Genetic Confidentiality and Nondiscrimination Act of 1997" (S.422), introduced by Sen. Pete Domenici (R-NM).
H.R.306 addresses the genetics concern voiced most often by the American people: that test results could make health insurance more difficult or impossible to obtain. The bill goes beyond the scope of HIPAA in extending protection against this use of genetic information to virtually all Americans.
H.R.306 would prohibit group health plans from denying, canceling, refusing to renew, or changing the terms, premiums, or conditions of coverage based on genetic information. It would also prevent health insurers from requesting or requiring a genetic test as a condition of coverage and would require written informed consent before the health plan could disclose genetic information to a third party.
The more-comprehensive S.422 attempts to regulate the use of genetic data by health insurers and employers, sets up a system by which the person who is the DNA sample source exercises ongoing control over release of the data it yields, and offers a plan to oversee genetic research. S.422 is believed to be the first bill to propose a specific scheme for regulating the conduct of genomic research.
Among its most important research provisions, S.422 extends Institutional Review Board (IRB) assessment to all genomic research regardless of funding source. Section 501(a)(2) sets up a balancing test for IRBs to use in assessing the value of a research proposal: Do societal benefits outweigh the risks to individual subjects? IRBs, already growing uneasy about informational risks associated with genomic research, have been admonished to safeguard individual subjects. This test would make IRBs take a hard look at such issues as the care with which investigators plan to protect the security of DNA samples and the data generated therefrom.
Section 501(a)(3)(E) of S.422 prohibits research information from being placed in clinical records, which many consider a positive step. Section (a)(3)(F) virtually creates a duty to disclose clinically relevant research findings to families of deceased persons who had been study subjects. This section tends to support the argument that researchers have a duty to recontact some individuals under certain conditions, an obligation that could be very difficult to fulfill.
S.422 strives to create a set of regulations under which genetic information generated by researchers will be used to help, not harm, individuals. At the same time, some are concerned that portions of the law could unfairly impede research.
Note: Philip Reilly (clinical geneticist, attorney, and executive director for the Shriver Center for Mental Retardation in Waltham, MA) suggests that scientists conducting genomic research read pending federal legislation, especially Title V of S.422, and consider commenting on potential impacts (access to H.R.306, S.422, and S.193: )
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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.