Clinical research in Italy in adult patients unable to consent: After implementation of the European Union's Directive 2001/20/CE
Università degli Studi di Palermo, Palermo, Sicily, Italy Intensive Care Medicine
(Impact Factor: 7.21).
03/2007; 33(2):316-8. DOI: 10.1007/s00134-006-0458-1
Available from: Jan Bakker
Available from: onlinelibrary.wiley.com
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ABSTRACT: The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment.
Available from: Andra le Roux-Kemp
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ABSTRACT: Obtaining informed consent from potential research participants can be fraught with difficulty at the best of times. In emergency care research, consent procedures are particularly controversial as research subjects are usually unable to voice their wishes and unable to consider the material benefits and risks of the medical procedures, treatment and research. And, an added level of difficulty is the unique nature of the emergency situation, where time is of the essence and obtaining proxy consent from a legal representative or family member is not always logistically possible. This article will consider the deferred consent procedures and regulations of emergency care research in South Africa. A comparative overview will then be provided of the relevant procedures and regulations on emergency care research in the UK, continental Europe, and the USA. The important oversight role of Research Ethics Committees and Institutional Review Boards in emergency care research will be emphasized in terms of the difficult ethical and legal concerns that must guide them in their decision-making responsibilities.
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