2009
DOI: 10.1007/s00134-009-1544-y
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Research ethics committees in Europe: trials and tribulations

Abstract: Inadequate remuneration for professional services and gender imbalance are universal concerns across Europe. As the position of ethics committees changes continuously towards greater responsibility, further guidance is needed to uniformly adapt their structures to those needs.

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Cited by 25 publications
(19 citation statements)
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“…Albeit the absence of specific directives to include women in clinical trials guidelines in Europe, female representation was higher in 2005 in international trials (32.7%) as compared to clinical studies conducted in the USA (26.7%) (Melloni et al 2010). However, guidance and regulation of ethics committee members and the participation of women in clinical trials needs to be strengthened, while greater attention is needed in gender equity and justification for the exclusion of women from particular clinical studies (Druml et al 2009). …”
Section: European Policy On Inclusion Of Women In Clinical Trialsmentioning
confidence: 98%
“…Albeit the absence of specific directives to include women in clinical trials guidelines in Europe, female representation was higher in 2005 in international trials (32.7%) as compared to clinical studies conducted in the USA (26.7%) (Melloni et al 2010). However, guidance and regulation of ethics committee members and the participation of women in clinical trials needs to be strengthened, while greater attention is needed in gender equity and justification for the exclusion of women from particular clinical studies (Druml et al 2009). …”
Section: European Policy On Inclusion Of Women In Clinical Trialsmentioning
confidence: 98%
“…Unfortunately, as showed by previous studies and inquiries (Altavilla et al 2009(Altavilla et al , 2012Atzor 2013;Druml et al 2009;EFGCP 2012;Kubiak et al 2009), CTA procedures and requirements are not yet harmonised among European Member States (MSs). The complex system based on the ''single opinion'' and the ''satellite'' committees, the huge number of Committees (Altavilla et al 2009;Druml et al 2009), and the lack of training and networking (Altavilla et al 2012) may have contributed to the increasing time and complexity to get the authorisation.…”
Section: Introductionmentioning
confidence: 94%
“…The complex system based on the ''single opinion'' and the ''satellite'' committees, the huge number of Committees (Altavilla et al 2009;Druml et al 2009), and the lack of training and networking (Altavilla et al 2012) may have contributed to the increasing time and complexity to get the authorisation. Furthermore, the differences existing among domestic legislations based on the implementation of Directive have left several aspects unclear and many criticisms have been raised.…”
Section: Introductionmentioning
confidence: 98%
“…Generally, there can be a central ethics committee, regional ethics committees and/or local/institutional ethics committees. There are currently about 1,000 RECs in Europe [16].…”
Section: Before Launching the Trial: Authorization By Regulators And mentioning
confidence: 99%