Clinical Trials Committee
As outlined in Royal Decree 223/2004, regulating clinical trials and medicinal products, the Fundación Jiménez Díaz Clinical Research Ethics Committee is an independent body made up of health-care and non-healthcare staff whose duty is to defend the rights, safety, and well-being of subjects who participate in trials. To do this, 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.
The role of the Committee is regulated by applicable legislation on medicinal products (Law 29/2006 on guarantees and the rational use of medicines and medicinal devices , Decree 39/1994 of the Governing Council of the Madrid Region and Royal Decree 223/2004 on clinical trials ). 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 the IIS-FJD network, assessing the risks and benefits of these projects. The research hospitals affiliated with the IIS-FJD include Hospital Universitario Fundación Jiménez Díaz (FJD), Hospital Universitario Infanta Elena (HUIE), and Hospital Universitario Rey Juan Carlos (HURJC). 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:
- To assess protocol appropriateness in terms of the study's aims and its scientific efficiency (i.e., the likelihood it will yield valid conclusions with minimum exposure for subjects), justifying the foreseeable risks and discomfort in terms of the expected benefits for the subjects and society as a whole.
- To 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.
- To 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.
- To review plans for the compensation and treatment to be offered to participants in case of injury or death attributable to the clinical trial. The Committee will also revise the insurance policy and indemnity established to cover the liability called for by regulations in force.
- To assess the compensation to be offered to researchers and subjects for their participation.
The Committee works under a set of standard operating procedures that guarantee proper functioning and compliance with all legal requirements and ensure the availability of all means necessary to meet its aims.