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Results for “Government Regulation”

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At least 127 records · Page 7Linked to original sources
PubMed2006

Research governance: regulating risk and reducing harm?

Risk assessment can be thought of as the lens through which we anticipate the consequences of research and the impact of the actions of researchers. The way in which risk of harm is managed in research is strongly influenced by the surrounding social and political environment, leading to differences in national and local styles of regulation and review. Different research studies carry different risks, so systems for review and approval must adapt to the question being asked and the nature of the study. Researchers can never wholly guarantee safety in any research but participants and researchers must be offered reasonable protection within any study, with appropriate arrangements in place should something go wrong.

Biomedical Research↗
PubMed1985

Government regulation of occupational safety: underground coal mine accidents 1973-75.

The purpose of this paper is to determine the influence of federal mine safety inspections on underground coal mine accidents. An economic incentives model is developed to relate federal enforcement activities to accident rates. The determinants of accident rates are analyzed for 535 coal mines during the period 1973-75. Estimates based on these data when applied to the model indicate that increasing inspections by 25 per cent would have produced a 13 per cent decline in fatal accidents and an 18 per cent decline in disabling accidents.

Accident Prevention↗
PubMedDate not supplied

United States government regulation of medical device software: a review.

A brief history of the regulation of medical device software within the United States is presented, along with a discussion of the reasoning that the US Food and Drug Administration (FDA) presents for modifying the requirements for software regulation from those previously used for hardware devices. The current regulatory status is discussed for the two categories of medical device software, software used within medical devices and software used to produce or test medical devices. The published FDA documents which determine the current environment for the regulation of software are summarized and discussed. The two types of medical device software are related to the two areas of FDA regulation, good manufacturing practices and permission to sell medical devices. The expected direction of future medical device software regulation, and its relationship to the European Economic Community (EEC) and international markets is discussed.

Equipment and Supplies↗
PubMed2004

Government regulations on cellular therapy and proposed approach related with these products by KFDA.

Advances in biomedical technology has enabled the research and use of novel therapies in cellular transplantation. A number of trials using chondrocyte and autologous skin products are underway and will soon become commercially available for clinical utilization. However, the Korea Food and Drug Administration currently lack systematic regulations for efficacy and safety evaluation of the emerging therapies. Specifically, dose related studies are uncontrolled and availability of clinical research centers is inadequate. Thus, patients are receiving therapy without guidelines for indication, dose, and adequate safety profiles. We propose criteria for cases in which these therapies can be used and advocate IRB determined quality assurance for future research.

Biomedical Research↗