Status of healthcare studies submitted to UK research ethics committees for approval in 2004–5

Arshad, Aleena; Arkwright, Peter D.

doi:10.1136/jme.2007.020545

Cited by 4 publications

(1 citation statement)

References 15 publications

(12 reference statements)

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“…The negatively assessed percentage of clinical trials in Spain was 2.1% [14], France 1.4% [22], and in a large British BC was only 0.3% [23]. In the case of all medical research projects the percentage of negative assessment in one of the British BCs was 3% [24]. The percentage of negative assessments of medical research can be based on the method of assessing by the BCs.…”

Section: Negative Assessment Of Medical Research Projectsmentioning

confidence: 98%

Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

Czarkowski

Różanowski

2009

Sci Eng Ethics

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The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 +/- 31.7 (range: 0-131) projects of clinical trials and 71.1 +/- 139.8 (range: 0-638) projects of other types of medical research. During one BC meeting an average of 10.3 +/- 14.7 (range: 0-71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary.

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Section: Negative Assessment Of Medical Research Projectsmentioning

confidence: 98%

Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

Czarkowski

Różanowski

2009

Sci Eng Ethics

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In search of the sample: Recent experiences of a trial team in Orthodontics

Cunningham

Bearn

Benson

et al. 2011

Contemporary Clinical Trials

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Randomised clinical trials are commonly undertaken in medical and dental research.However, few authors discuss the difficulties associated with such studies, including costs, ethical issues and recruitment of an adequate number of patients. There is little information available on the number of studies which are terminated early as a result of these issues, but it seems likely that at least 10% of clinical studies never reach completion. This paper reviews two nationally funded clinical studies which were terminated early and highlights the recruitment issues which were encountered in order to bring certain issues to the attention of other researchers.3

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Research Exceptionalism

Wilson

Hunter

2010

The American Journal of Bioethics

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Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research.

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Status of healthcare studies submitted to UK research ethics committees for approval in 2004–5

Abstract: This survey suggests that most research studies submitted to RECs in Manchester, UK are approved and initiated.

Cited by 4 publications

References 15 publications

Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

In search of the sample: Recent experiences of a trial team in Orthodontics

Research Exceptionalism

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