Drug Research Ethical Committee (CEIm)

The IMO’s CEIm acts independently to ensure compliance with the regulations and prioritise the safety and well-being of patients participating in clinical trials.

At the end of 2006, the Ocular Microsurgery Institute established a Clinical Research Ethical Committee (CEIC) accredited by the Directorate General for Regulation, Planning and Health Resources of the Catalonian Regional Government Health Department.  

This accreditation was renewed in February 2008 and in July 2012, and its composition was modified in March 2013. In March 2016, the CEIC formalised a Memorandum of Collaboration and Information Exchange with the Spanish Medicine and Medical Device Agency (AEMPS). This Memorandum having been revised, in the 21/6/2017 version on the CEIm accreditation procedure, the ACCREDITATION resolution from the CEIm Ocular Microsurgery Institute, dated 12 April 2018, is received once the Composition and Internal Operating Rules have been adapted to RD 1090/2015, 4 December.

The purpose of the ethics committee is to ensure that the rights, dignity, safety and welfare of persons involved in research projects are protected, ensuring the methodological, ethical and legal correctness of such projects and their corresponding monitoring, pursuant to the principles set forth in the Declaration of Helsinki, the Clinical Best Practices of the ICH (International Council for Harmonisation) and current Spanish legislation.

Standard Operating Procedures

In order to carry out its activity, the IMO’s CEIm has Internal Operating Rules, pursuant to Spanish regulations, which detail, among other aspects, the documentation to be submitted to request the evaluation of a study or a modification of a trial.

The Spanish Medicine and Health Product Agency establishes the Instructions for conducting clinical trials and some of the documentation forms to be presented to the CEIm.

The committee meets at least once per month, during the last week of the month, to evaluate the methodological, scientific, ethical, economic and insurance aspects of the trials presented. It also evaluates the suitability of the research team responsible, the facilities used, the methods and documents for patient information, the protocols, and proposals for relevant modification, if any.

See Internal Operating Rules, Receiving Protocols and Notifications

For any information required, please contact Carmen Mas, CEIm Secretary, imo@imo.es or +34 93 253 15 03.

Composition of the CEIm

The Ethics Committee is made up of members who are internal and external to the IMO, as well as health and non-health professionals.

President

Dr Rafael Navarro. Healthcare Medicine.

Vice President

Dr Marcela Manríquez. Clinical Pharmacology.

Technical Secretary

Dr Anniken Bures Jelstrup – Medicine

Administrative secretary

Ms Carmen Mas. - Non-health

Voting members

  • Esther Canals. Bachelor’s. Nursing
  • Mr Leandro Martínez-Zurita. Lawyer
  • Ms Anna Mas Crespi – Non-health – Patients
  • Ms Carmen Mas Crespi – Non-health
  • Dr Mercé Morral – Healthcare Medicine – UAU
  • Dr Laia Pascual – Healthcare Medicine
  • Ms Carolina Rovira. Primary care pharmacist
  • Ms Pilar Sabin. Hospital pharmacy
  • Dr Cecilia Salinas – Healthcare Medicine
  • Dr Charlotte Wolley-Dod – Healthcare Medicine

Non-IMO members

  • Dr Marcela Manríquez.
  • Leandro Martínez-Zurita.
  • Ms Anna Mas Crespi
  • Ms Carolina Rovira
  • Ms Pilar Sabin

CEIm Internal Operating Rules in PDF