Background: In view of the increasing complexity of research ethics committee applications and thus the time and expense involved in completing the forms, continual monitoring of outcome of clinical research studies for which ethics applications have been submitted is essential in determining whether resources are being effectively used, or alternatively whether significant numbers of research proposals are abandoned because of lack of funding or manpower. Previously published surveys for which data are available examined outcome of studies receiving REC approval 10 (...) or more years ago.Methods: A prospective questionnaire-based survey sent out in July 2006 to all 506 principal investigators who submitted research ethics applications to nine Greater Manchester RECs between April 2004 and March 2005. Data on the outcome of REC applications, and the status of the research study were collected and analysed.Results: 288 of the 506 questionnaires were returned. 97% of REC applications were approved, and 87% of studies were in progress or had been completed 1–2 years after approval had been granted. Researchers employed by universities, healthcare and the pharmaceutical industry had similar rates of success in initiating research studies.Conclusions: This survey suggests that most research studies submitted to RECs in Manchester, UK are approved and initiated. (shrink)

Each Local Research Ethics Committee (LREC) is expected to produce an annual report for its establishing authority. Reports from 145 LRECs were examined with regard to (a) whether the committees were working within the terms of the most recent guidelines from the Department of Health and (b) observations on the role of LRECs with particular reference to accountability. Most LRECs had produced a report, although their length varied greatly. Most reports showed how seriously the committee took its task. Most committees (...) met many of the guidelines; for example, almost all had two or more lay-members. The guideline most frequently not met was that committees should have no more than 12 members. Many committees review very large numbers of projects (maximum 351). Approximately two-thirds provide details in the annual report of individual project titles, their author and the committee decision; all reports should contain this information. Although it may in fact happen more generally, only 23 per cent of the reports referred to any form of monitoring of the eventual outcome of the research. A significant issue to arise from the reports is the extent to which the framework for the operation of LRECs has been confused by the development of the purchaser-provider split. The paper concludes with suggestions for remedying the situation. (shrink)

Background Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Methods Retrospective cohort of 976 protocols approved by a representative sample of (...) 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Results Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14–17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25–53) and 37 (95% CI: 27–46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. Conclusion The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees. (shrink)

Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial 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 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% 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. (shrink)