Comités éticos de investigación clínica y «dictamen único» de los ensayos clínicos multicéntricos

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

“…Each of these six RECs (all local, belonging to large university hospitals, five of them located in Madrid or Catalonia) reviewed in 2000 and 2001 around 200-300 MCT protocols. 18 In this study, they required 32 and 46 days (medians) for submission to approval and for submission to reception, respectively, being statistically significantly more efficient than the rest of RECs involved in this study.…”

“…27 To ensure the fulfilment of this directive requirement, a similar approach to the British one has been proposed in Spain, although the review of the protocol by one REC and that of locality issues by the rest of the RECs involved should run in parallel. 18 The sample of RECs involved in this study can be regarded as an accurate representation of all Spanish RECs: (a) these 62 RECs are located in those regions in which 97% of all clinical trials are performed, 29 This study shows that the median time between submission and approval of a protocol was 48 days; however, the decision reached the sponsor's offices 10 days later (median) and the total median time needed from submission to reception of the approval was 62 days. These figures are very close to those observed in a study performed in the mid 1990s: 46 and 69 days (medians) for submission to approval, and for submission to reception, respectively, 3 but far from those reported in the UK with a median (submission to reception) time between 28 and 42 days.…”

“…Another approach, suggested by relevant members of 31 RECs in Spain is that the ''single opinion'' (ethical and scientific aspects of the protocol) should rely on the REC to whom the coordinating investigator of the MCT belongs, leaving the assessment of locality issues to the other RECs involved. 18 The process decided by the Italian authorities as a response to the directive is in line with this approach: the REC of the coordinating investigator will issue the ''single opinion'' on the protocol in 30 days; the RECs of the other participating centres will have an additional 30 days to approve or reject the previously approved protocol. 31 In any case, RECs in Spain should markedly improve their administrative functioning in order to be ready to comply with the EU Directive requirements.…”