Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective.
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PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation. (+info)
Bibliometric methods for the evaluation of arthritis research.
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This study uses bibliometric methods to evaluate the magnitude and quality of publications in arthritis research in the UK and compare this with that of other countries. Arthritis research was defined by publication in a specialist journal or by specific title key words or address. Outputs from 13 countries between 1988 and 1995 were analysed by number, research level (from clinical to basic) and potential impact on other researchers (from low to high). The UK has a strong presence in arthritis research and the highest relative commitment of all the countries studied. UK output was more clinical than that of other countries, except Spain, and was of relatively high impact. A second study examined UK arthritis papers supported by different funding sources, including government, private-non-profit and industry. Papers with funding acknowledgements were of significantly higher impact and less clinical than those without. The Arthritis Research Campaign was the leading funder in the UK with high-impact papers which, over the 8 yr period, have become more clinical than those supported by other funding sources, except hospital trusts. (+info)
Chemical wastes, children's health, and the Superfund Basic Research Program.
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Three to 4 million children and adolescents in the United States live within 1 mile of a federally designated Superfund hazardous waste disposal site and are at risk of exposure to chemical toxicants released from these sites into air, groundwater, surface water, and surrounding communities. Because of their patterns of exposure and their biological vulnerability, children are uniquely susceptible to health injury resulting from exposures to chemical toxicants in the environment. The Superfund Basic Research Program, funded by the U.S. Environmental Protection Agency and directed by the National Institute of Environmental Health Sciences, is extremely well positioned to organize multidisciplinary research that will assess patterns of children's exposures to hazardous chemicals from hazardous waste disposal sites; quantify children's vulnerability to environmental toxicants; assess causal associations between environmental exposures and pediatric disease; and elucidate the mechanisms of environmental disease in children at the cellular and molecular level. (+info)
Global and local implications of biotechnology and climate change for future food supplies.
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The development of improved technology for agricultural production and its diffusion to farmers is a process requiring investment and time. A large number of studies of this process have been undertaken. The findings of these studies have been incorporated into a quantitative policy model projecting supplies of commodities (in terms of area and crop yields), equilibrium prices, and international trade volumes to the year 2020. These projections show that a "global food crisis," as would be manifested in high commodity prices, is unlikely to occur. The same projections show, however, that in many countries, "local food crisis," as manifested in low agricultural incomes and associated low food consumption in the presence of low food prices, will occur. Simulations show that delays in the diffusion of modern biotechnology research capabilities to developing countries will exacerbate local food crises. Similarly, global climate change will also exacerbate these crises, accentuating the importance of bringing strengthened research capabilities to developing countries. (+info)
Introduction: Epidemiologic research and prevention of occupational cancer in Europe.
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Research on occupational cancer epidemiology has been an important area of occupational health in Europe since the early studies were conducted in the United Kingdom in the 1950s and 1960s. During the last decade, occupational cancer research in Europe has gained an international dimension and become increasingly interdisciplinary in nature. At present, occupational exposures might be responsible for 13 to 18% of lung cancers, 2 to 10% of bladder cancers, and 2 to 8% of laryngeal cancers in European men; among women these figures are 1 to 5%, 0 to 5%, and 0 to 1%, respectively. A notable aspect of current occupational cancer research in Europe is the decreasing importance of traditional circumstances of high exposure to recognized occupational carcinogens and the increasing importance of new industries, mainly in the service sector where possible cancer hazards are poorly known. In addition, the political changes in Central and Eastern Europe open new possibilities for the investigation of high-exposure circumstances and occupational cancer in women. (+info)
Occupational cancer research in the Nordic countries.
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Occupational cancer research in the Nordic countries benefits from certain structural advantages, including the existence of computerized population registries, national cancer registries with high-quality data on cancer incidence, and a personal identification number for each inhabitant. This article outlines the utilization of this research infrastructure in Denmark, Finland, Iceland, Norway, and Sweden, together with research examples from the different countries. Future research on occupational cancer in this region requires that national legislation on electronic handling of sensitive personal information should not be stricter than the European Union Directive on individual protection with regard to personal data. A personal identification number is essential both for keeping up the high quality of data of the registers and for the high quality of the process of linking the different data sources together. Although previous occupational research has focused on male workers, a broader approach is needed in the future, including a study of how cancer risk in women may be affected by occupational activity and the question of possible cancer risk in offspring of men and women exposed to workplace carcinogens. (+info)
Workshop summary: assessing exposure to environmental tobacco smoke in the workplace.
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Environmental tobacco smoke (ETS) is a term now widely used to refer to the mixture of sidestream smoke and exhaled mainstream smoke that pollutes air in locations where tobacco smoking is taking place. A multidisciplinary workshop was convened to address key issues related to ETS exposure in the workplace in order to prepare the groundwork for a risk assessment of the hazard ETS poses to workers. Workshop participants concluded that substantial evidence was now available on worker exposure to ETS using both direct and indirect approaches to exposure assessment and that these data could be used to project distribution of exposures to ETS in the nation's workplaces. This summary of the discussions at the workshop is an overview of the suggested approach to exposure assessment. (+info)