Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medical Ethics 33 (2):113-118 (2007)
Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 ethics committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
Aisling Sheehan & Hannah McGee (2013). Screening for Depression in Medical Research: Ethical Challenges and Recommendations. [REVIEW] BMC Medical Ethics 14 (1):1-4.
Arja Halkoaho, Anna-Maija Pietilä, Mari Vesalainen & Kirsi Vähäkangas (2012). Ethical Aspects in Tissue Research: Thematic Analysis of Ethical Statements to the Research Ethics Committee. BMC Medical Ethics 13 (1):20.
Similar books and articles
Franklin G. Miller (2004). Sham Surgery: An Ethical Analysis. Science and Engineering Ethics 10 (1):41-48.
P. S. Myles, K. Leslie, J. McNeil, A. Forbes & M. T. V. Chan (2004). Bispectral Index Monitoring to Prevent Awareness During Anaesthesia: The B-Aware Randomised Controlled Trial. Lancet 363 (9423).
A. Byer (1983). The Practical and Ethical Defects of Surgical Randomised Prospective Trials. Journal of Medical Ethics 9 (2):90-93.
Jakov Gather (2011). The Evaluation of Psychopharmacological Enhancers Beyond a Normative “Natural”–“Artificial” Dichotomy. Medicine Studies 3 (1):19-27.
H. Mann (2005). Controversial Choice of a Control Intervention in a Trial of Ventilator Therapy in ARDS: Standard of Care Arguments in a Randomised Controlled Trial. Journal of Medical Ethics 31 (9):548-553.
B. Arda, A. Aciduman & J. C. Johnston (2012). A Randomised Controlled Trial of Ribavirin in Crimean Congo Haemorrhagic Fever: Ethical Considerations. Journal of Medical Ethics 38 (2):117-120.
P. Allmark (2006). Improving the Quality of Consent to Randomised Controlled Trials by Using Continuous Consent and Clinician Training in the Consent Process. Journal of Medical Ethics 32 (8):439-443.
Gordon C. S. Smith & Jill P. Pell (2003). Parachute Use to Prevent Death and Major Trauma Related to Gravitational Challenge: Systematic Review of Randomised Controlled Trials. Bmj 327 (7429):1459--61.
D. D. Turner (2006). Just Another Drug? A Philosophical Assessment of Randomised Controlled Studies on Intercessory Prayer. Journal of Medical Ethics 32 (8):487-490.
Rob Reuzel (2004). Interactive Technology Assessment of Paediatric Cochlear Implantation. Poiesis and Praxis 2 (s 2-3):119-137.
R. Dal-Re (2005). Multicentre Trials Review Process by Research Ethics Committees in Spain: Where Do They Stand Before Implementing the New European Regulation? Journal of Medical Ethics 31 (6):344-350.
Ezekiel Emanuel & Franklin Miller (2007). Money and Distorted Ethical Judgments About Research: Ethical Assessment of the TeGenero TGN1412 Trial. [REVIEW] American Journal of Bioethics 7 (2):76-81.
Paul Smeyers (2008). On the Epistemological Basis of Large-Scale Population Studies and Their Educational Use. Journal of Philosophy of Education 42 (s1):63-86.
Sorry, there are not enough data points to plot this chart.
Added to index2010-08-24
Total downloads1 ( #514,100 of 1,692,412 )
Recent downloads (6 months)1 ( #184,284 of 1,692,412 )
How can I increase my downloads?