New regulations governing DHEW sterilization funding now in effect; stress informed consent.
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A common feature of much scientific information reflected in government regulation is its passage directly from the laboratory into government decision without benefit of review and interpretation. This pattern can be attributed to a variety of factors. One is the incentives that lead government agencies to act quickly and conservatively in the name of protection of human health. Another is the relatively lengthy process of traditional review and interpretation via professional meetings and scientific publication. Yet, the case appears very strong for preserving, if foreshortening, the stages of peer review of otherwise unmatured data used in regulation. Several schemes of this sort have been tried in the past few years-some with apparent success. These are discussed alongside the proposal for a science court-a quasi-judicial vehicle for rendering judgements about scientific findings.
OBJECTIVE: To examine states' regulations governing infections and infection control in long-term-care institutions. DESIGN: Collection and examination of relevant documents from all of the states, the District of Columbia, the Joint Commission on Accreditation of Health Care Organizations, and Medicare/Medicaid. MAIN OUTCOME MEASURES: Rules governing (1) admissions of patients with infections, (2) tuberculin testing of residents, (3) employee health, (4) use of immunizations, (5) human immunodeficiency virus (HIV)-infected patients, and (6) infection control were compared. RESULTS: There were wide variations in states' policies in each of these areas and many were inconsistent with current scientific knowledge. CONCLUSION: Uniform federal standards for long-term care would probably provide a better and more economical way to ensure quality of care in these institutions.
This paper presents points brought out in a panel discussion held at the 12th Hawaiian International Conference on System Sciences, January 1979. The session was attended by approximately two dozen interested parties from various segments of the academic, government, and health care communities. The broad categories covered include the specific problems of government regulations and their impact on specific clinical information systems installed at The University of Texas Health Science Center at Dallas, opportunities in a regulated environment, problems in a regulated environment, vendor-related issues in the marketing and manufacture of computer-based information systems, rational approaches to government control, and specific issues related to medical computer science.
Administrative and legal requirements and, in particular, federal and state government health care assistance and social services program regulations all combine to add complexity to the management and operation of ambulatory and inpatient health programs. This paper describes how constantly changing government regulations and differences in interpretations and definitiions have been expensive, time-consuming and sometimes detrimental to health care delivery for two large management and clinical computer-based information systems.
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The lambda phage repressor binds cooperatively to the three sites in the right operator (O(R)) according to the following pattern. If the DNA is wild type, O(R)1 and O(R)2 are filled coordinately because of interactions between repressor dimers bound to these two sites. Site O(R)3 is filled only at higher repressor concentrations. In contrast, if O(R)1 is mutant, O(R)2 and O(R)3 are filled coordinately because of interactions between repressors bound to these sites. In this case, the affinity of O(R)3 is increased and that of O(R)2 is decreased relative to the wild type. We infer that a repressor dimer bound to the middle site O(R)2 can interact either with another repressor dimer bound to O(R)1 (wild-type case) or, alternatively, with one bound to O(R)3 (mutant O(R)1 case). We argue that these repressor interactions are mediated by protein-protein contacts between adjacent repressor dimers, because the isolated amino-terminal domains of repressor bind to the operator sites noncooperatively. The cro protein of phage lambda, a second regulatory protein, which recognizes the same three sites in O(R) as does repressor, binds non-cooperatively. Experiments performed in vivo show that regulation of gene expression by repressor can be influenced critically by cooperative interactions. We demonstrate that the effect of repressor in a lysogen on the activity of the promoter P(RM) can be changed from activation to repression by deletion of O(R)1. We explain this effect in terms of the alternative cooperative interactions described above.
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