Informed consent in psychiatric research.
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AIDS presents unique problems and opportunities in jails and prisons for epidemiological research on HIV infection and its sequelae. If correctional institutions constrain inmates' access to social benefits, means exist to protect incarcerated people's rights in health studies. A reading of federal regulations indicates that research involving prisoners should be subject to scrutiny by an institutional review board (IRB); inmates participating in IRB-approved clinical trials on AIDS-related drugs should not receive placebos alone, moreover, given that some medications are partially effective against the syndrome. As in other domains of public health and public policy, HIV infection and AIDS in prisons compel new perspectives on justice and equity.
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The U.S. Department of Health and Human Services (DHHS)/USDA Dietary Guidelines for Americans is a science and population evidence-based guide on diet and physical activity, providing advice and recommendations to promote a healthier lifestyle and reduce the risk of chronic diseases, including cancer. These recommendations are supported by the comprehensive evidence-based review on diet and cancer prevention conducted by the American Institute for Cancer Research, National Cancer Institute, World Health Organization/International Agency for Research on Cancer, and others. However, influencing dietary effects are the individual genetic predispositions that are the basis for considerable interindividual variations in cancer risk within the population and in nutrient homeostasis, which is maintained by genomic-nutrient and metabolic-phenotype interactions. Although genetics is an important component, it accounts for only a portion of this variation. An individual's overall phenotype, including health status, is achieved and maintained by the sum of metabolic activities functioning under differing circumstances within the life cycle and the complex interactions among genotype, metabolic phenotype, and the environment. In this postgenomic era, high-throughput groups of technologies in genomics, proteomics, and metabolomics measure and analyze DNA sequences, RNA transcripts, proteins, and nutrient-metabolic fluxes in a single experiment. These advances have transformed biomarker studies on nutrient-gene interactions from a reductionist concept into a holistic practice in which many regulated genes involved in metabolism, along with its metabolic phenotypes, can be measured through functional genomics and metabolic profiling. The overall integration of data and information from the building blocks of metabolism-based nutrient-gene interaction can lead to future individualized dietary recommendations to diminish cancer risk.
The Dietary Guidelines for Americans, published by DHHS and USDA in 1980, have recently been reviewed by an expert committee that has recommended only minimal changes to scientifically update them. Initial efforts to develop dietary guidelines for prevention of diseases were fraught with controversy, some of which has continued. This controversy exemplifies a larger issue concerning the role that contemporary science, and specifically government, has in assuring and maintaining public health. Two broad questions need to be asked: what is the government's role in facilitating application of contemporary nutrition knowledge to public health, and what standard of scientific surety should be the basis for its application? Government's role in assuring public health and safety indirectly through information is well established. In deciding when the data are sufficient to inform the public, public health scientists must, at some point, make the leap of faith, even though some doubts may remain.
This notice is a request for comment and review of the draft document entitled Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Facilities, Second Edition prepared by the Centers for Disease Control and Prevention.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was passed by Congress with two formidable tasks: (1) reform the insurance market; and (2) simplify healthcare administrative processes. From these ambitious beginnings, HIPAA has since taken on major healthcare issues including administrative simplification, security, privacy, and patient confidentiality. In November 1997, the Secretary of Health and Human Services (DHHS) introduced the proposed "standards" for what is referred to as "administrative simplification". But, establishing the standards and guidelines necessary for administrative compliance was not an easy undertaking. DHHS estimated that 400 different formats were used in the US for healthcare claims processing. Three years later (August 2000), the Final Rule for Standards for Electronic Transactions and Code Sets was published by DHHS. The rule provided for national standardization of the most common healthcare transactions and several code sets. The compliance deadline for implementation of the new transactions and code sets was set for October, 2002. In January 2001, Congress enacted The Administrative Simplification Compliance Act to provide the industry with additional time to reach compliance. Yet, recent survey results by Phoenix Health Systems and the Health Information and Management Society (HIMSS) indicate many providers and payers are not fully compliant with the security and privacy regulations mandated by HIPAA. This issue threatens the effectiveness of administrative simplification and the integrity of healthcare information. Overall, HIPAA does offer the promise of a more efficient and effective means of sharing and disseminating vital healthcare information. But, many experts have concerns that the implementation and maintenance of HIPAA standards and policies will become a financial burden for many in the healthcare industry. Although DHHS has established mandates for the healthcare industry, many deadlines have been extended and the standards of administrative simplification continue to evolve over time. Others question whether the Department of Health and Human Services is capable of spearheading an information technology revolution in the healthcare industry. Unfortunately, it may take several years before the industry is able to realize any true cost savings from administrative simplification. Yet, few can question how HIPAA has revolutionized information technology in the healthcare industry.
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Since 1980, Dietary Guidelines for Americans have been published jointly, every 5 years, by the U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (DHHS). They benefit from the recommendations of a formally appointed Dietary Guidelines Advisory Committee. The Guidelines are an example of public health recommendations that are based upon published original research and analysis of that data by expert panels. The Guidelines are intended for healthy adults, so they might reduce their risks for certain diet-related chronic conditions. They are suggestions; they do not serve-and should not be used-as regulations. Greater individualization of dietary recommendations, for both major subgroups of the population and for individual patients, can improve our effectiveness in preventing and treating specific diet-related chronic conditions. To accomplish this objective, we need to move beyond the use of "indicators" (e.g., body mass index or blood cholesterol levels) as if they were "diagnostic," and focus on dietary and pharmacologic interventions (or, in some cases, no intervention) based on more specific diagnostic criteria (e.g., lipid patterns, fat distribution patterns, evidence of insulin resistance, and family history). Better targeting of dietary recommendations should improve their effectiveness, while reducing costs.