Government regulation of patient's rights.
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Studies show that about one and a half to two percent of total hospial costs is spent on complying with regulations. But, some observers say the costs are even higher.
Cyanotoxins are now recognised by international and national health and environment agencies as significant health hazards. These toxins, and the cells which produce them, are also vulnerable to exploitation for illegitimate purposes. Cyanotoxins are increasingly being subjected to national and international guidelines and regulations governing their production, storage, packaging and transportation. In all of these respects, cyanotoxins are coming under the types of controls imposed on a wide range of chemicals and other biotoxins of microbial, plant and animal origin. These controls apply whether cyanotoxins are supplied on a commercial basis, or stored and transported in non-commercial research collaborations and programmes. Included are requirements concerning the transportation of these toxins as documented by the United Nations, the International Air Transport Association (IATA) and national government regulations. The transportation regulations for "dangerous goods", which by definition include cyanotoxins, cover air mail, air freight, and goods checked in and carried on flights. Substances include those of determined toxicity and others of suspected or undetermined toxicity, covering purified cyanotoxins, cyanotoxin-producing laboratory strains and environmental samples of cyanobacteria. Implications of the regulations for the packaging and air-transport of dangerous goods, as they apply to cyanotoxins and toxigenic cyanobacteria, are discussed.
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The history of zoo animal welfare legislation extends back to 1876, and is often tied to general animal welfare regulations. As knowledge and societal values have changed, so have the focus of zoos and the regulations governing them. Today, the issues involved in zoo animal welfare are complex and broad-based. Building on the basic welfare tenets of adequate feed, water, shelter, sanitation and veterinary care, current issues include the following: handling and training of captive animals, psychological well-being and environmental enrichment, enclosure design, species preservation, environmental and conservation issues, captive-breeding programmes. Complicating the matter further, government regulations try to assimilate all aspects of zoo animal welfare into the laws to provide humane care and handling for all species concerned. Zoo animal welfare will remain a challenging area, as increasing demands are placed on zoos and regulatory agencies to manage this diminishing resource.
A model of cytoplasm-governed transcription is presented. The nuclear membrane has a selective permeability towards nuclear pre-mRNA molecules which are provided with group-specific non-translated "passwords". RNA transcription on the chromatin proceeds under a dual control. One of them is gene regulation according to the Britten-Davidson and Georgiev models. The other is cytoplasm-governed regulation mediated through the selective transport of mRNA from nucleus to cytoplasm. Pre-mRNA molecules which are not "in immediate demand" by the cytoplasm and therefore accumulating the nucleus repress their own synthesis by end-product inhibition. The interrelationship of the two types of regulation in the course of cell development is discussed.
The Canadian Food Inspection Agency (CFIA) regulates environmental releases of plants with novel traits, which include transgenic plants such as Bt crops. Bt crops are regulated in Canada because they express insect resistance novel to their species. Commercialization of crops with novel traits such as the production of insecticidal Bt proteins requires an approval for environmental release, as well as approvals for use as feed and food. Environmental factors such as potential impacts on non-target species are considered. Insect resistance management (IRM) may be imposed as a condition for environmental release of Bt crops to delay the development of resistance in the target insect. Bt potato and European corn borer-resistant Bt corn have been released with mandatory IRM. The CFIA imposes an IRM plan consisting of appropriate refugia, education of farmers and seed dealers, and monitoring and mitigation. Industry, regulators, government extension staff and public researchers provide expert advice on IRM.
The federal regulations governing confidentiality of alcohol and drug abuse patient records are examined with respect to their applicability to mental health and other medical records. The analysis focuses on the purpose, scope, restrictions, and penalties of the federal statutes, and compares them to the pertinent legislative recommendations of the Privacy Protection Study Commission.
The Convention on Human Rights and Biomedicine developed by the Council of Europe, now undergoing ratification, is the first international treaty focused on bioethics. This article describes the background of the Convention's development and its general provisions and provides a comparison of its requirements with those of federal regulations governing research with human subjects. Although most provisions are comparable, there are significant differences in scope and applicability, for example, in the areas of compensation for injury, research participation by persons with limited capacity to consent, assisted reproduction, organ transplantation, and research in emergency situations. The Convention represents a milestone in international bioethics and protection of human rights that will probably be referred to with increasing frequency.