The Research Ethics Committee shall defend the rights, safety, and well-being of subjects who participate in clinical trials, studies, or research projects, providing them with public backing for such situations.

Characteristics

An independent body made up of health-care and non-healthcare staff whose duty is to safeguard the rights, safety, and well-being of subjects who participate in trials, providing them with public backing for such situations. The Committee makes an appraisal of the trial protocol, the credentials of the researchers, the appropriateness of the facilities, as well as the methods and documents to be used, including documents on informed consent.

Responsibilities

Its mission is to evaluate the methodological, ethical, and legal aspects behind protocols for clinical trials, observational studies, and research projects that are intended to be carried out in the hospitals belonging to its network, assessing the risks and benefits of these projects. As established by article 2.2 of Law 6/2009 of November 19 on freedom of choice in health care in the region of Madrid, the Committee's area of activity is the single health-care zone in the aforementioned region. The particular responsibilities of the Committee include:


  • Assess protocol appropriateness in terms of the study's aims, its scientific efficiency (i.e., the likelihood it will yield valid conclusions with minimum exposure for subjects) and justify the foreseeable risks and discomfort within the expected benefits for the subjects and for greater society.
  • Assess the appropriateness of the research team for the proposed study based on the team's experience and ability to execute the project. This appraisal will take into account the care obligations of the researchers as well as their other existing commitments to different research protocols.
  • Study the written documents to be provided to potential subjects on the characteristics of the study, evaluating the methods of delivering the documents and the type of consent sought.
  • Review plans for the compensation and treatment to be offered to participants in case of injury or death attributable to a clinical trial. The Committee will also revise the insurance policy and indemnity established to cover the liability called for by regulations in force.
  • Assess the compensation to be offered to researchers and subjects for their participation.

Makeup

President:

Gabriel Herrero-Beaumont Cuenca. Medical doctor (Rheumatology, FJD)


Vice President:

Macarena Bonilla Porras. Pharmacist (Pharmacology, FJD)

Secretary:

Javier Bécares Martínez. Pharmacist (Pharmacology, FJD)

Substitute Secretary:

Olga Sánchez Pernaute. Medical doctor (Rheumatology, FJD)

Members:

  • Belén Acevedo Marín. Medical doctor (Gynecology, FJD).
  • Mª José Almodóvar Carretón. Primary-care pharmacist.
  • Miriam Blanco Rodríguez. Medical doctor (Pediatrics, FJD)
  • Isabel Egocheaga Cabello. General practitioner.
  • Yann Izarzugaza Perón. Medical doctor (Oncology, FJD)
  • Alberto Lendinez Fornis. Medical doctor (Oncology, HIE)
  • Brezo Martínez-Amores Martínez. Medical doctor (Oncology, HRJC)
  • Dolores Martínez Pérez. Medical doctor (Maxillofacial surgery, FJD-HIE and HRJC)
  • Manuel Matamoros Fernández. External.
  • Maria Rosario Noguero Meseguer. Medical doctor (Gynecology, HRJC).
  • Luis Ortega Alba. FJD legal advisor.
  • Germán Peces Barba. Member of the Committee on Care Research (Pulmonology, FJD).
  • Francisco Javier Ruiz Hornillos. Member of the Research Committee and the Committee on Ethics in Health Care Medical doctor (Allergy, HIE).
  • Aránzazu Sancho López. Clinical pharmacologist, Hospital Puerta de Hierro
  • Esperanza Vélez Vélez. BS in nursing, FJD