New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants’ interest

Cave, Emma; Holm, Søren

doi:10.1136/jme.28.5.318

Cited by 29 publications

(27 citation statements)

References 12 publications

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“…The first hearing of the study protocol was held before the ethics committee in Heidelberg on 8 approvals was initiated. The application was submitted to 17 ethics committees, which, in total, were responsible for 29 centres (table 1, fig 1).…”

Section: Resultsmentioning

confidence: 99%

Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial

et al. 2007

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Objective:To examine the current ethical review process (ERP) 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 (INterrupted or continuous Slowly absorbable sutures—Evaluation of abdominal Closure Techniques Trial, ISRCTN 24023541) 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 (MSU) 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 (primary approval acting as the reference standard).Results:The duration of the ERP ranged from 1 to 176 (median 31) 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 (€250) and 8 of 10 at medical chambers charged a median fee of €162 (mean €269.70). The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval (37, 39, 42 and 104).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.

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Section: Resultsmentioning

confidence: 99%

Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial

et al. 2007

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“…11 12 To improve timely and valuable MCT assessment in the UK, 13 the Department of Health has recently issued two guidelines, 26 27 one of these 27 being the UK's response to the EU directive. 28 It should be highlighted that RECs are expected to work ''efficiently to facilitate the good conduct of high quality research'', and that ''unjustified delay to such research is itself unethical''. 26 To this end, the guidelines included the Directive's requirements regarding the REC's decision for MCTs, that has to be communicated to the applicant within 60 calendar days (this time frame must include consideration of locality issues by local RECs).…”

Section: Discussionmentioning

confidence: 99%

Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?

Dal‐Ré

2005

J Med Ethics

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Objectives: To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004. Design and setting: Prospective study of applications of MCT submitted to RECs. Main measurements: Protocol related features and evaluation process dynamics. Results: 187 applications (24 protocols, 18 study drugs) to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor's offices were 48 and 62 days, respectively. In 55% (101/183) of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients' information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor's office. Conclusions: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT.

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“…In each case, however, the central challenges appear to be unaddressed. Since independent review boards are typically financed through fee-for-service review, they face similar financial conflicts of interest vis-à-vis the institution that is paying for the review (see e.g., Lemmens & Thompson, 2001;Barnes & Florencio, 2002;Cave & Holm, 2002). Moreover, both central and independent review boards may bring a moral or political agenda to their review of protocols.…”

Section: Controlling Conflicts Of Interestmentioning

confidence: 98%

The Market and Medical Innovation: Human Passions and Medical Advancement

Cherry

2005

NJMP

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New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants’ interest

Cited by 29 publications

References 12 publications

Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial

Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial

Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?

The Market and Medical Innovation: Human Passions and Medical Advancement

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