Abstract

VILARDELL NAVARRO, N.; REDONDO-CAPAFONS, S.; GIMENEZ, N.  and  QUINTANA, S.. Perception and satisfaction of main researchers on the management of a Clinical Research Ethics Committee. Farm Hosp. [online]. 2013, vol.37, n.4, pp.300-306. ISSN 2171-8695.  https://dx.doi.org/10.7399/FH.2013.37.4.595.

Purpose: To analyze the main researchers (MR) perception and satisfaction associated to face-to-face project presentation as well as Clinical Research Ethics Committee (CREC) functions related to administrative and advisement aspects. Methods: Descriptive study performed during nine months (January to September 2011) through voluntary participation questionnaire given to MR who assisted to CREC meetings. The questionnaire contained a numeric range (1-10) and open issues to evaluate the presentation process, the satisfaction of CREC functions considering bureaucratic aspects, ethics, scientific-methodological, legal recommendations and its global function. Descriptive statistics and Student test were performed. Results: The questionnaire was answered by 36 (95%) of total MR. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9). In reference to legal issues an average punctuation of 7.1 (DE 0.4) was obtained, whereas ethics and scientific-methodological aspects scored 8.2 (DE 0.2 and 0.4). Global average evaluation about CREC tasks was 8.6 (SD 1.0). A positive assessment related to attend to the project presentation was made for 22 (61%) of the MR. Conclusions: The study showed a high satisfaction of CREC operation and a high evaluation of face-to-face project presentation. There were detected further improvement aspects to optimize CREC meetings, taking into account the effort developed by MR and CREC members.

Keywords : Ethics Committee; Clinical protocol; Research personnel; Questionnaires; Personal satisfaction.

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