The relevance and quantity of clinical research has caused concern and regulation is claimed to hinder clinical research. This paper compares clinical research regulations in Finland to those of England, Canada, and the USA around 2010-2011.
Several approaches and data sources were used, including semi- or unstructured interviews of experts. For the analysis, a theoretical framework was made, data from various sources was synthesized, and features of the systems were simplified and classified. The various specific names and terms used in the data were changed into general ones.
Common structures for the regulation existed in all four countries, but the details and scope varied. The research regulated within the main system was determined by research type (Finland), the financer of the health system (England), or research site (Canada, USA). Only Finland had specific legislation on medical research. The overriding impression of the regulatory systems was one of complexity. All countries had extra regulation for drug research. The types of drug research covered varied from trials with unlicensed (new) products or new indications (USA and Canada), to all types of interventional drug research (England), where 'interventional' was interpreted broadly (Finland). The complexity of regulations had led to the creation of various big and small businesses to help researchers and sponsors. There was notable variation in the role played by the public research funder. The role played by health care was difficult to study and seemed to involve varying interests as researchers were also health care employees. Research ethics committees were important and their tasks also included aspects other than ethics.
This study revealed that a comparison between countries can provide useful insights into the distinctive aspects of each country's system, as well as identifying common features that require international action.
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Family physicians can play an important role in helping patients and their families to discuss life-sustaining treatments and to complete advance directives. This article reviews the legal status of, and empirical studies on, advance directives and addresses some important clinical questions about their use relevant to family practice.
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In Norway, the largest reported quantities of radioactive discharges and radioactive waste containing naturally occurring radioactive material (NORM) come from the oil and gas sector, and smaller quantities of other NORM waste are also produced by industrial or mining processes. The Gulen final repository for radioactive waste from the oil and gas industry from the Norwegian continental shelf was opened in 2008 and has a capacity of 6000 tonnes. As of 1 January 2011, a new regulation was enforced whereby radioactive waste and radioactive pollution was integrated in the Pollution Control Act from 1981. This means that radioactive waste and radioactive pollution are now regulated under the same legal framework as all other pollutants and hazardous wastes. The regulation establishes two sets of criteria defining radioactive waste: a lower value for when waste is considered to be radioactive waste, and a higher value, in most cases, for when this waste must be disposed of in a final waste repository. For example, waste containing = 1 Bq/g of Ra-226 is defined as radioactive waste, while radioactive waste containing = 10 Bq/g of Ra-226 must be disposed of in a final repository. Radioactive waste between 1 and 10B q/g can be handled and disposed of by waste companies who have a licence for handling hazardous waste according to the Pollution Control Act. Alternatively, they will need a separate licence for handling radioactive waste from the Norwegian Radiation Protection Authority. The goal of the new regulation is that all radioactive waste should be handled and stored in a safe manner, and discharges should be controlled through a licensing regime in order to avoid/not pose unnecessary risk to humans or the environment. This paper will elaborate on the new regulation of radioactive waste and the principles of NORM management in Norway in view of the International Commission on Radiological Protection's 2007 Recommendations.
