The Research Ethics Committee of Hospital Universitario Puerta de Hierro Majadahonda is an independent body, made up of healthcare professionals and non-healthcare members, responsible for ensuring the protection of the rights, safety and well-being of patients taking part in clinical research projects and for providing public assurance in this regard, through an opinion on the study protocol, the suitability of the researchers and the adequacy of the facilities, as well as the methods and documents to be used to inform study participants in order to obtain their informed consent.<\/p>\n\n\n\n
The Committee is currently accredited by the Community of Madrid as a Research Ethics Committee for Medicinal Products (CEIm) for the functions regulated by Royal Decree 1090\/2015.<\/p>\n\n\n\n
Its scope of competence includes clinical trials with medicinal products or medical devices, post-authorisation studies with medicinal products, and any biomedical research project that involves the direct participation of human beings or that uses samples of human origin or personal data.<\/p>\n\n\n\n
All its actions are governed by the regulations in force in Spain on biomedical research, research with medicinal products, medical devices and biological samples, personal data protection regulations and other applicable regulations, as well as by internationally accepted Ethical Codes and Recommendations and its own Standard Operating Procedures.<\/p>\n\n\n\n
As regards its scope of action, the Puerta de Hierro CEIm is responsible for evaluating and approving any biomedical research project carried out at the Instituto de Investigaci\u00f3n Sanitaria Puerta de Hierro-Segovia de Arana, and acts on request for any project carried out in other settings that require evaluation by a Research Ethics Committee. Its scope of action includes primary and specialised care and publicly or privately owned centres.<\/p>\n\n\n\n
For more information, please go to the following link:<\/p>\n\n\n\n