Medicaments Research Ethics Committee - CEIm

Presentation

The CEIm is an independent interdisciplinary body made up by health professionals and other non-medical staff and it safeguards the protection of the rights, safety and well-being of the participants of clinical trials. Its approval of trial protocols constitutes a public guarantee of the aforementioned.

It also assures the staff are adequately qualified, the installations adequate and the documents informing the patient subjects of the nature of the study are well redacted so that the patient consent is valid.

Quality Policy

The CEIm is an independent body responsible for the safeguarding of the correct application of the ethical and legal principles in the clinical trials given to it to assess. Our goal is to guarantee a brisk and efficient evaluation process that meets the existing legal requirements and the expectatives of the regulatory bodies (the European Comission, The Ministry of Health, AEMPS - Spanish Medicaments Agency, Conselleria de Sanitat - Autonomous Health Authority), hospitals and other health centres, clinical trial sponsors, CROs and researchers.

To be able to meet this goal, a quality control system is in place, based on the UNE-EN ISO 9001 normative.

Responsibilites

General:

  • Assess the methodological, ethical and legals aspects of the submitted clinical trials, based on the Royal Decree 223/2004 of Feb 6 and the subsequent current legislation.
  • Assess the relevant modifications to already authorized clinical trials.
  • Monitor the authorized clinical trials from their commencement till the issue of the final report.

Specific:

  • To make sure the proposed study is relevant, i.e. that it is of a specific interest to the research subjects.
  • To assess the adequacy of the protocols in relation to the aims of the trial, its efficiency (the possibility to reach valid conclusions with the lowest possible exposure of the subjects) and the justification of the anticipated risks and discomforts for the subjects and society.
  • Assess the research team's adequacy for the proposed study taking in account its experience but also other professional duties of individual members (teaching, working and/or being already on other research teams) that might intervene with their performance in the submitted research study.
  • Assess the trial characteristics information that is to be given to the subjects or their legal representatives, the form the information will be given in and the type of patient consent that will be obtained.
  • Check the estimated compensation and/or treatment to be offered to the subjects in case of the event of injury or death attributable to a clinical trial and the insurance or indemnity to cover the liabilities specified in the Royal Decreet 223/2004, Art. 8. of February 6, 2004.
  • Check the scope of payment to be offered to the researchers and subjects for their participation in the trial.
  • Monitor the authorized clinical trials from their commencement till the issue of the final report.
  • Safeguard the correctness of the proposed protocols from the methodological, ethical and legal points of view.
  • Aprove the internal rules of operation.
  • Inform the Clinical Trials Programme under the Conselleria de Sanidad of all the trial protocols that have been approved and passed onto the competent authority for its authorization and also of those that have been rejected. This is based on the Annex I of the Order 94/5127 of the Conselleria de Sanidad. The report will be composed according to the regulation of the General Office of Pharmaceuticals and Health Products (Dirección General de Farmacia y Productos Sanitarios).
  • Pass a copy of the issued ethical adequcacy certificates onto the Clinical Trials Programme (in case of trials that include testing on humans)
  • Making reports on the modifications in trial protocols according to the Annex II of the order 94/5127 of the Conselleria de Sanidad.
  • To know about and then report to the Clinical Trials Programme any SUSARs that take place during the trial - by sending a copy of the researcher's or sponsor's report of such event.

Members

The CEIC is composed respecting the Good Clinical Practise Normative (CPMP/ICH/135/95) and the Royal Decree 1090/2015.

Chair:  
Dra. Adela Cañete Nieto (Pediatric Oncology)

Vicechair:
Dr. Salvador Aliño Pellicer (Clinical Pharmacologist)

Secretary:
D. Serafín Rodríguez Capellán (Rights of Third Parties lawyer, specialised in health)

Members:

  • Dr. Mónica Almiñana Riqué (GM of the Dpto. de Salud Valencia-La Fe)
  • Dr. José Vicente Castell Ripoll (Experimental Hepatology)
  • Dr. Marino Blanes Juliá (Infectious Diseases Unit)
  • Dr. Sara Brugger Frigols (Radiodiagnosis)
  • Dr. Bonaventura Casanova Estruch (Neurology)
  • Dr. Felipe Querol Fuentes (Rehabilitation)
  • Dr. Santiago Domingo del Pozo (Gynecologic Oncology)
  • Ms Ana María Vivas Broseta (Graduate in nursery)
  • Dr. Isabel Izquierdo Macián (Neonatology)
  • Dr. Paula Ramírez Galleymore (General ICU)
  • Dr. José Ivorra Cortés (Rheumatology)
  • Dr. María Ángeles Canós Verdecho (Pain Unit)
  • Dr. José Vte. Solanas Prats (Primary Attention)
  • Mr. Miguel Ángel Cano Torres (ASLEUVAL secretary) (patients' representative)
  • Ms Pilar Robles Villalba (The Miastenia association vicechair) (outside the health profession)
  • Dr. César Díaz García (Reproduction) (Research Comission member)
  • Dr. Máximo Vento Torres (Neonatology)
  • Dr. Javier Lluna González (Pediatric Surgery) (Healthcare Ethics Committee member)
  • Ms María Victoria Paricio Gómez (Nursing care)
  • Dr. Joaquín Hinojosa de Val (Digestive unit - Manises Hospital)
  • Dr. Luis Martínez Dolz (Cardiology)
  • Dr. Matteo Frasson (General Surgery and Digestive System)
  • Dr. Oscar Juan Vidal (Oncology)
  • Dr. Esperanza Ferrer Ferrándiz (Nursing School Headmaster)
  • Dr. María Tordera Baviera (Pharmacologist)
  • Dr. Eugenia Pareja Ibars (General Surgery and Digestive System)
  • Dr. María Luisa Martínez Triguero (Clinical Analyst)
  • Dr. Juan B. Salom Sanvalero (Brain Circulation Experimental Unit)
  • Dr. José Vicente Cervera Zamora (Hematology)
  • Dr. Inmaculada Calvo Penadés (Pediatric Rheumatology)
  • Dr. Luis Almenar Bonet (Cardiology)
  • Dr. Esther Zorio Grima (Cardiology)
  • Dr. Maria Jose Gómez-Lechón Moliner (Researcher in the Accredited Group in Experimental Hepatology)
  • Dr. Jose Lopez Aldeguer (Infectious Diseases)
  • Dr. Javier Pemán Garcia (Researcher in the Accredited Multidisciplinary Group for the study of severe infection)
  • Dr. Alfredo Perales Marín (Ginecology and Obstetrics)
  • Dr. Pilar Sáenz Gonzalez (Neonatology)
  • Dr. Begoña Polo Miquel (Gastroenterology and Pediatric Nutrition)
  • Dr. Iratxe Zarragoikoetxea Jauregui (Anesthesiology and Reanimation)
  • Dr. Jaime Sanz Caballer (Researcher in the Accredited Group in Hematology and Hemotherapy)
  • Dr. Pilar Sepúlveda Sanchis (Specialists of the Cardiovascular System)
  • Dr. Enrique Viosca Herrero (Physical Medicine and Rehabilitation)
  • Dr. Rafael Botella Estrada (Dermatology)
  • Dr. Oscar Diaz Cambronero (Anesthesiology and Reanimation)

Contact

Serafín Rodríguez
Legal advisor to the Clinical Research Ethics Committee at the La Fe Hospital
rodriguez_ser(ELIMINAR)@gva.es

Beatriz Alcayde Torres
Clinical Research Ethics Committee Secretary
ceic(ELIMINAR)@iislafe.es
(+34) 96 124 66 05 - Ext. 246605