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Source
Lancet. 1989 Aug 5;2(8658):340-1
Publication Type
Article
Date
Aug-5-1989

Actors involved in the regulation of clinical research: comparison of Finland to England, Canada, and the USA.

https://arctichealth.org/en/permalink/ahliterature269574
Source
Health Res Policy Syst. 2015;13:20
Publication Type
Article
Date
2015
Author
Elina Hemminki
Source
Health Res Policy Syst. 2015;13:20
Date
2015
Language
English
Publication Type
Article
Keywords
Administrative Personnel
Biomedical Research - legislation & jurisprudence
Canada
Conflict of Interest
Drug and Narcotic Control
England
Ethics Committees, Research
Finland
Government Regulation
Interviews as Topic
Qualitative Research
United States
Abstract
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.
Notes
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Cites: J Med Ethics. 2014 Jun;40(6):409-1323665856
PubMed ID
25888977 View in PubMed
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Advance directives in family practice.

https://arctichealth.org/en/permalink/ahliterature221091
Source
Can Fam Physician. 1993 May;39:1087-93
Publication Type
Article
Date
May-1993
Author
N. Kohut
P A Singer
Author Affiliation
Centre for Bioethics, University of Toronto.
Source
Can Fam Physician. 1993 May;39:1087-93
Date
May-1993
Language
English
Publication Type
Article
Keywords
Advance Directives - legislation & jurisprudence
Attitude of Health Personnel
Attitude to Health
Canada
Communication
Decision Making
Family Practice - methods
Government Regulation
Humans
Internationality
Judicial Role
Patient Education as Topic - methods
Physician's Role
Abstract
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.
Notes
Cites: CMAJ. 1992 Jun 1;146(11):1937-441596842
Cites: J Am Geriatr Soc. 1992 Mar;40(3):269-731538048
Cites: Am J Med. 1989 Jun;86(6):645-811659207
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Cites: Adv Intern Med. 1991;36:57-792024588
Cites: J Am Geriatr Soc. 1993 Feb;41(2):112-68426030
PubMed ID
8499789 View in PubMed
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Advances in NORM management in Norway and the application of ICRP's 2007 recommendations.

https://arctichealth.org/en/permalink/ahliterature119562
Source
Ann ICRP. 2012 Oct-Dec;41(3-4):332-42
Publication Type
Article
Author
A. Liland
P. Strand
I. Amundsen
H. Natvig
M. Nilsen
R. Lystad
K E Frogg
Author Affiliation
Norwegian Radiation Protection Authority, P.O. Box 55, No-1332 Osteras, Norway. astrid.liland@nrpa.no
Source
Ann ICRP. 2012 Oct-Dec;41(3-4):332-42
Language
English
Publication Type
Article
Keywords
Chemical Industry
Environmental Policy - legislation & jurisprudence
Extraction and Processing Industry
Government Regulation
Guidelines as Topic
Humans
International Agencies
Norway
Oil and Gas Fields
Radiation Protection - standards
Radioactive Waste - prevention & control
Waste Management - standards
Abstract
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.
PubMed ID
23089033 View in PubMed
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472 records – page 1 of 48.