CEIm

Presentation.

The Ethics Committee for Research with Medicines (CEIm) of IDIAPJGol was created on August 14, 1996. It was the first CEIm accredited in the entire State in the field of Primary Care. The Catalan Institute of Health (ICS) considered it a key element to strengthen the dissemination of clinical research in the primary care setting, where highly prevalent pathologies are diagnosed and where the largest number of medicines are prescribed.

The CEIm is composed of a president, a secretary, and a multidisciplinary team of representatives from different professional fields: family doctors, pediatricians, epidemiologists, pharmacologists, pharmacists, nurses, lawyers, and other professionals outside the healthcare sector. The scope of action of the CEIm of IDIAPJGol includes all Primary Care centers of the Catalan Institute of Health, as well as other centers that have requested its oversight. In total, the CEIm covers 87% of Primary Care centers in Catalonia.

The Ethics Committee for Research with Medicines has adapted its Standard Operating Procedures to the new regulations on clinical trials with medicines and medical devices (RD 1090/2015 of December 4) and to the memorandums and instructions of the AEMPS.

The CEIm of IDIAPJGol holds the following accreditations granted byThe Office for Human Research Protections (OHRP) –U.S. 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-U.S. Institutions – FWA Number 00009235)

Functions

• Evaluate the methodological, ethical, and legal aspects of the studies, as well as the balance of risks and benefits.
• This includes assessing the protocol, the suitability of the research team, the adequacy of the facilities, the information provided to participants regarding compensation systems, and the existence of insurance.
• Evaluate substantial modifications to authorized studies and issue an opinion. Monitor the studies from their initiation until the receipt of the final report.

Supervised centers

The scope of action of the CEIm Primary Care Research Foundation Jordi Gol i Gurina (IDIAP Jordi Gol), for research projects not subject to a single opinion procedure, includes the following centers:

Hospital healthcare centers:

• Espitau Val d’Aran (H25002079)

Non-hospital healthcare centers:

• Badalona Serveis Assistencials, SL (BSA) – Primary care centers and local medical practices
• CAP Roger de Flor (E08771405)
• CAP Sardenya (E08053108)
• Can Bou Health Center (Castelldefels 2) (E08680589)
• Sitges Dental Clinic (E08613832)
• DIATROS GAVÀ (E08046492)
• DIATROS, Advanced Diagnostics and Treatments (E08869859)
• EAP Sarrià, SLP – Primary care centers and local medical practices
• Prison Primary Care Teams of Catalonia (EAPP)
• Catalan Health Institute (ICS) – Primary care centers and local medical practices (https://ics.gencat.cat/ca/Ciutadania/centres-i-serveis/)
• Marès-Riera Pediatric Institute (E17041198)
• Poal Institute of Rheumatology (E08026129)
• Vallplassa Primary Care, SLP – Primary care centers and local medical practices.

The scope of action of the CEIm Primary Care Research Foundation Jordi Gol i Gurina (IDIAP Jordi Gol), for research projects not subject to a single opinion procedure, includes the following centers:

Hospital healthcare centers:

• Espitau Val d’Aran (H25002079)

Non-hospital healthcare centers:

• Badalona Serveis Assistencials, SL (BSA) – Primary care centers and local medical practices
• CAP Roger de Flor (E08771405)
• CAP Sardenya (E08053108)
• Can Bou Health Center (Castelldefels 2) (E08680589)
• Sitges Dental Clinic (E08613832)
• DIATROS GAVÀ (E08046492)
• DIATROS, Advanced Diagnostics and Treatments (E08869859)
• EAP Sarrià, SLP – Primary care centers and local medical practices
• Prison Primary Care Teams of Catalonia (EAPP)
• Catalan Health Institute (ICS) – Primary care centers and local medical practices (https://ics.gencat.cat/ca/Ciutadania/centres-i-serveis/)
• Marès-Riera Pediatric Institute (E17041198)
• Poal Institute of Rheumatology (E08026129)
• Vallplassa Primary Care, SLP – Primary care centers and local medical practices.

Institutions or centers not registered in the Registry of Health Centers, Services, and Establishments of Catalonia, where research projects involving healthcare activities with human individuals cannot be carried out:

• Department of Health
• Avedis Donabedian University Institute – UAB
• Teaching Unit of Supervised Internship Placements of the Faculty of Pharmacy and Food Sciences – UB.