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6ER-025 Impact of the new european regulation on clinical trials in the activity and dynamics of research ethics committees from catalonia
  1. S Redondo1,
  2. S Quintana2,
  3. S Cassany Pou3,
  4. T Martí Guixà3,
  5. P March López1,
  6. J Nicolás4,
  7. C Fernández Lastra5,
  8. EL Mariño Hernández6
  1. 1Hospital Universitari Mútua Terrassa, Pharmacy, Terrassa, Spain
  2. 2Hospital Universitari Mútua Terrassa, Research Ethics Committee, Terrassa, Spain
  3. 3Department de Salut – Generalitat de Catalunya, Servei de Control Farmacèutic I Productes Sanitaris, Barcelona, Spain
  4. 4Hospital Universitari Mútua Terrassa, Research Ethics Committee- Pharmacy, Terrassa, Spain
  5. 5University of Barcelona, Clinical Pharmacy and Pharmacotherapy Unit, Barcelona, Spain
  6. 6University of Barcelona., Clinical Pharmacy and Pharmacotherapy Unit, Barcelona, Spain


Background Clinical research proposals on humans as clinical trials (CT), post-authorisation studies or any project must be submitted to an independent research ethics committee (REC). Different legislation has regulated CT in Spain, the last two European transpositions significantly modified the dynamics of REC, especially the most recent one, currently in force. Spain was the first European country to apply Regulation (EU) No 536/2014 with publication in December 2015 of Royal Decree 1090/2015.

Purpose The objective was to analyse and quantify the impact of Regulation (EU) No 536/2014 on the dynamics and activity of RECs from Catalonia regarding CT evaluation.

Material and methods Through an official request to the Catalonian Health Service, annual activity reports that RECs from Catalonia have to present to competent government agency, were analysed.

Two periods were established: period 2007–2015 (under Directive 2001/20/CE) and period 2016 (under Regulation No 536/2014).

RECs were classified into three groups: high (Group 1), medium (Group 2) and low (Group 3), according to their annual evaluation activity.

Meetings number and evaluation activity were recorded. Descriptive statistical analysis was performed using SPSS.v.19. No normal distribution was resulted (Kolmogorov–Smirnov test), so the Mann–Whitney U test was used, statistical significance p<0.05.

Results Three-hundred and seventy-four reports from 47 RECs were reviewed. The median number of meetings per period, analysed by type of REC were:

Abstract 6ER-025 Table 1
Abstract 6ER-025 Table 1

Median REC evaluation activity

Conclusion Regulation (EU) No. 536/2014 has not modified the dynamics in RECs, nevertheless activity has been significantly altered, but in a different way depending on its activity. Most affected RECs are low and medium activity because of the drastic decrease in the number of CT evaluated per year because only one REC currently evaluates for all centres involved. Current legislation has caused CT evaluation to focus on RECs of large hospitals.

References and/or acknowledgements Regulation (EU) No 536/2014.

No conflict of interest.

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