Independent Ethics Committee / Institutional Review Board (IEC/IRB)
The IDIAPJGol Clinical Research Ethics Committee (CREC) was created on August 14, 1996. It was the first Ethics Commitee for Primary Care accredited in Spain. The Institute recognised that the IEC/IRB was a key element in promoting research in Primary Care, where the diagnosis of the more prevalent diseases is made and where the majority medicines are prescribed.
The IEC/IRB is composed of a president, a secretary, and a multidisciplinary team of twelve members from different professional backgrounds, including general practitioners, paediatricians, epidemiologists, pharmacologists, nurses, lawyers, and professionals from outside the health system.The IDIAPJGol IEC/IRB is the ethics committee for 87% of the Primary Health Centres in Catalonia: all Primary Health Centres of the Catalan Health Institute as well as all centres of provider entitles that request ethical approval for their research.
The Ethics Committee has adapted its Standard Operating Procedures to the new regulations for clinical trials with medicines and medical devices (RD 1090/2015 of December 4).
The established annual calendar allows for the evaluation of clinical trials under the terms established in the memorandum and the instructions document of the AEMPS.
The IEC/IRB of IDIAP Jordi Gol holds 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 human subjects for international (Non - US Institutions - FWA Number 00009235)
Josep de la Flor
- To evaluate methodological, ethical and legal aspects of the studies, as well as the balance of risks and benefits including the assessment of the protocol, the suitability of the research team, adequacy of the facilities, the information provided to the participants of the compensation systems and existence of the insurance.
- To evaluate substantial modifications of authorised studies and issue an opinion.
- To monitor the studies from the initiation to receipt of the final report.
- In case of studies involving biological samples, the Ethics Commitee must also ensure compliance with procedures that guarantee traceability, in accordance with the personal Data Protection Act.