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Volume 21 - Issue 2, March-April 2019
ORIGINAL
IMPACT OF THE NEW REGULATION OF CLINICAL TRIALS: A FIRST VIEW OF RESEARCH ETHICS COMMITTEES FROM CATALONIA (SPAIN)
REDONDO-CAPAFONS SUSANA, QUINTANA SALVADOR, MARCH LÓPEZ PABLO, NICOLÁS PICÓ JORDI, FERNÁNDEZ LASTRA CECILIA, MARIÑO HERNÁNDEZ EDUARDO LUIS


Objective: Spain was first European country to apply Regulation (EU) No. 536/2014 in January 2016, through publication of Royal Decree (RD) 1090/2015. The objective was to analyze impact of this RD on dynamics and activity of Catalonian Research Ethics Committees (REC) and satisfaction of its members.
Method: A descriptive cross-sectional study was carried out on the 31 REC accredited in Catalonia. A dynamic and simple questionnaire was designed. REC were informed that data would be treated confidentially.
Results: Response was obtained from 61.2%. Results showed RD has modified dynamics and activity in all REC but in different way depending on activity. Regarding satisfaction, there is greater satisfaction in period prior to new legislation, median 8 over 10 (IQR 3) in comparison to current period, median 6 (IQR 3) (p = 0.017).
Conclusions: Despite of the positive elements of new legislation as reduction in evaluations variability and reduction in administrative time for authorization, the general perception in Catalonia is not positive and, for now, negative aspects and doubts prevail over the improvements obtained. The findings of this study imply a remodelling of the way of working of committees, a change in focus and in func-tions of local committees.

CLINICAL TRIALS – LEGISLATION – QUESTIONNAIRE – RESEARCH ETHICS COMMITTEE – SATISFACTION



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