The Clinical Research Ethical Committees (CEICs) are independent Committees made up of researchers and research promoters (such as pharmaceutical companies and other institutions). The Committees' aim is to ensure that any methodological, ethical or legal aspect of a research project that may imply any physical or psychological risk to human subjects is corrected (RD number 223/2004 dated February 6, 2004 and Order October 24, 2006).
The Clinical Research Ethical Committee of the Parc de Salut Mar(CEIC-Parc de Salut Mar) was created and accredited on November 11, 1993 by the General Management of Health Resources of the Generalitat de Catalunya, in accordance with an "Ordinance dated October 26, 1992". Reaccredited on 19 December 2008 and 27 October 2014 on Order October 24, 2006
The principal duties of CEIC-Parc de Salut Mar, which are regulated by current legislation and approved by the Administrative Council of Parc de Salut Mar, are as follows:
- To evaluate the suitability of study protocols in regards to the objectives of the studies, their scientific efficiency and the justification of the foreseeable risks weighted against the expected benefits for research subjects and society (risk-benefit ratio).
- To evaluate the suitability of the research team in regards to its experience and their capacity to carry out the study.
- Clinical care requirements and commitments previously made to other research protocols are taken into consideration.
- To evaluate written study information to be given to participating research subjects (or to their legal representative); to evaluate the procedure by which such information will be given and the type of consent to be obtained.
- To check the compensation and treatment being offered to research subjects in case of injury or death resulting from the study and to verify liability insurance to cover the funding agency, researchers, collaborators and the individual responsible at the center where the research is to be carried out.
- To be aware of and to evaluate the compensation to the study researchers and compensation to the subjects for their participation in the study.
- To monitor studies from the time of their inception and to follow them up until completion of the final report.