Independent Ethics Committee / Institutional Review Board (IEC/IRB)
The IDIAP Jordi Gol Clinical Research Ethics Committee (CREC) was created on August 14, 1996. It was the first Primary Care IRC/IRB accredited in Spain. The Institute considered the IEC/IRB a key element to promote research in primary care, where the diagnosis of the more prevalent diseases takes place and where most medicines are prescribed.
The IEC/IRB consists of a president, a secretary, and a multidisciplinary team of twelve members from different professional backgrounds: general practitioners, paediatricians, epidemiologists, pharmacologists, nurses, jurists, and outside health system professionals.The IDIAP Jordi Gol IEC/IRB is the ethics committee for 87% of Primary Health Centres of Catalonia: all Primary Health Centres of the Catalan Health Institute in addition to all centres of provider entities that apply for research ethics approval.
The Ethics Committee has adapted its Standardized Work Procedures to new regulations for clinical trials with medicines and medical devices (RD 1090/2015 of December 4).
The established annual calendar allows to evaluate the clinical trials according to the terms established in the memorandum and the instructions document of the AEMPS.
The IEC/IRB of IDIAP Jordi Gol with the following accreditacions granted by The Office for Human Research Protections (OHRP) - US Department of Health & Human Services Office of the Secretary office of Public Health &Science office for Human Research Protections (HHS):
- Institutional Review Board (IRB) - IRB00005101
- IRB Organizations (IORGs) - IORG0004303
- Federalwide Assurance (FWA) for the protection of the human subjects for international (Non - US Institutions - FWA Number 00009235)
Josep Mª Casanovas
- To evaluate methodological, ethical and legal aspects of the studies, as well as the balance of risks and benefits including assessment of the protocol, suitability of the research team, adequacy of the facilities, information to the participants of the compensation systems and existence of the insurance.
- To evaluate the substantial modifications of authorized studies and issue an opinion.
- To track the studies from the beginning until the final report is received.
- In case of studies that collect biological samples, the CIS must also ensure compliance with procedures that ensure traceability, in accordance with the provisions of the Law on the Protection of Personal Data.