ArticleIntensive care medicine2009
Research ethics committees in Europe: trials and tribulations.
Article in Intensive care medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- Clinical Ethics Consultation in the Transition Countries of Central and Eastern Europe.Science and engineering ethics · 2020Article
- Application challenges of the new EU Clinical Trials Regulation.European journal of clinical pharmacology · 2017Review
- Clinical Trial Application in Europe: What Will Change with the New Regulation?Science and engineering ethics · 2016Article
- Co-design and implementation research: challenges and solutions for ethics committees.BMC medical ethics · 2015Article
- Regulatory authorities and orthopaedic clinical trials on expanded mesenchymal stem cells.International orthopaedics · 2014Review
- Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?Pharmaceutical medicine · 2013Article
- Perspectives of Egyptian research ethics committees regarding their effective functioning.Journal of empirical research on human research ethics : JERHRE · 2013Article
- ETHICAL REVIEW OF BIOMEDICAL RESEARCH IN BELARUS: CURRENT STATUS, PROBLEMS AND PERSPECTIVES.Revista romana de bioetica · 2011Article
- Twenty years of human research ethics committees in the Baltic States.Developing world bioethics · 2011Article
- Reflections on running training workshops for research ethics committee members in Spain between 2001 and 2008.Croatian medical journal · 2010Article
- Year in review in Intensive Care Medicine 2009. Part III: mechanical ventilation, acute lung injury and respiratory distress syndrome, pediatrics, ethics, and miscellanea.Intensive care medicine · 2010Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEthics committees have been an integral part of clinical research since 1975, when they were introduced through the amendment of the Declaration of Helsinki. Every proposal for clinical research on human subjects has to be submitted to an independent ethics committee for review and approval. The European Clinical Trials Directive 2001/20/EC was implemented in 2004 to harmonise the legislative framework for clinical research in Europe in order to make Europe more competitive in clinical research while at the same time improving the protection of research participants.
resultsWe have evaluated the situation of ethics committees in Europe five years after the implementation of the new law with special consideration of the number of Ethics Committees per European Member State and the number of members within the specific committees, including the selection of members, also in regard to gender aspects and training requirements, the remuneration or compensation of members in regard of their review obligations, and also issues of conflicts of interest.
conclusionInadequate 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.
Indexed as
Identifiers
19543709What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.