© 1998 by Oxford University Press
Legislative Roundup: Protection of Human Subjects Key Issue For Congress
In addition to finalizing appropriations for the National Institutes of Health (see News, Dec. 3, 1997), the U.S. Congress passed in 1997 or is contemplating legislation that may affect cancer research.
One-Stop Shopping - The One-Stop Shopping Information Service Amendment, introduced by Rep. Rick Lazio (R-N.Y.) and Sen. Olympia Snowe (R-Maine), was enacted as part of Food and Drug Administration modernization/reform bill. The amendment requires NIH to set up a centralized database of all clinical trials. It is subject to availability of funds.
Biomedical trust funds - Several bills under consideration would divert revenue from various sources (postage stamps, income tax check-off, health insurance premiums) for research purposes. Various agencies (some specific to NIH or the National Cancer Institute) or specific diseases (such as breast or prostate cancer) would benefit.
Human subjects protection - Sen. John Glenn (D-Ohio) introduced a bill in January 1997 that would apply protections common to federal research to all participants in research studies. Research facilities would be registered with the government and could be inspected to ensure they are following the requirements of the legislation, known as the Human Research Protection Act of 1997.
The act would also create an Office for the Protection of Research Subjects within the Office of the Secretary of Health and Human Services, replacing the current NIH-level office with the same responsibilities.
The act would also prohibit federal funding for the conduct of any classified research where a board has waived informed consent of human subjects or where the research has not been reviewed by an internal review board.
It requires that persons taking part in classified research be told the identity of the federal agency providing funding, a statement that the research involves classified information, and an unclassified description of the purpose of the research.
Genetic Information - Several bills dealing with the privacy of genetic information have been introduced. The Genetic Information Nondiscrimination in Health Insurance Act of 1997, introduced by Rep. Louise Slaughter (D-Calif.) and Sen. Snowe appears to be most closely aligned to the administration's publicly stated position. No single bill has yet emerged as likely to be enacted.
Breast Cancer - Bills have been introduced that cover a myriad of breast-cancer related issues: research, mammography, prevention, treatment (drive-through mastectomy bill), and issues about environmental and genetic susceptibilities.
Tobacco - Several bills were introduced to serve as "starting points" for discussion regarding the tobacco settlement; increases in excise taxes; labeling requirements; and provide for regulation of tobacco and tobacco products.
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