How does the ethical review process work in Spain and which are the designated ethics committees?
In Spain, the Clinical Research Ethics Committees (Comités de Ética en Investigación Clínica, CEIC) are the oversight bodies of methodological adequacy, ethical goodness and regulatory compliance regarding research on human subjects. They consist of an independent multidisciplinary group of people whose main role is to impartially assess, research projects involving humans in order to guarantee the protection of participants, ensuring that all projects meet the methodological requirements, respect basic ethical principles and human rights, and comply with the law.
In Spain, a Royal Decree of 1978 named these committees “Clinical Trials Committees” (Comités de Ensayos Clínicos, CEC). This is the first legal text that established that all drug clinical trials were to be evaluated by these committees and, therefore, all centres that would perform such studies should have a CEC.
The Law on Medicinal Products in 1990 and its subsequent development by the Royal Decree 561/1993 changed the name from Clinical Trials Committees to Clinical Research Ethics Committees (Comités de Ética en Investigación Clínica, CEIC) and established the basic and common aspects in terms of composition, functions and working procedures. Accreditation, scope and Standard Operating Procedures (SOPs) were at the discretion of the Autonomous Communities. So, now in Spain, similarly to other neighbouring countries such as the UK, there are institutional or local committees and others of regional level, without implying a hierarchy between them.
Since August 1994 (date of entry into force the Royal Decree 561/1993, about the CEIC) until May 2004 (when the legislation that incorporates the European Directive on clinical trials entered into force) accredited CEICs were completely autonomous, acting independently, and evaluating each and every one of the drug clinical trial protocols to be performed in its scope of action and geographic area.
In May 2004, came into force the Royal Decree 223/2004 transposing the European Directive (20/2001/CE). Although this Royal Decree partially modified some basic criteria CEIC (composition, functions and working procedures), the main change was the implementation of the “Single Opinion”, for multicentre clinical drug trials whereby it is only necessary the approval of one CEIC (CEIC of reference) for each EU Member State.
Currently, in Spain there are over 140 accredited CEIC, with many different scopes, and also highly variable levels of activity. It can be summarized in 3 types of CEIC: a first group consisting of a few highly active CEIC (evaluating over 200 drug clinical trials per year), usually acting as Reference Committee (CEIC de referencia, CEIC-Ref.); a second group with intermediate or important activity, but rarely acting as CEIC Ref, and a third group, rather large, of less active CEIC that have never or rarely been CEIC Ref. It is noteworthy that the promoter, primarily the pharmaceutical industry, is the one who chooses who the CEIC Ref. is.
In July 2007, the Law of Biomedical Research (Ley de Investigación Biomédica, LIB) was enacted. This is a very necessary law as it came to fill a legal vacuum in relation to the ethical evaluation of research projects in human subjects, different from clinical drug trials.
This law designates the Research Ethics Committees (Comités de Ética de la Investigación, CEI) for the review of all types of research projects involving humans, including drugs clinical trials and health products, studies using biological identified or identifiable samples, embryonic material, as well as when handling personal data. According to the LIB, the CEI may also act as an external ethic committee of biobank, ethically evaluating applications for the transfer of samples and data associated with them. The resolution of a CEI is binding, in case of being negative.
To obtain specific information on contact points at site-accountable CEIC’s, the Ministry of Health provides a detailed website tool including information on:
- Organization and Functions
- Scheduling Calendar
- Directory of Accredited CEIC’s
- Contact Persons
- Submission Documentation Requirements
- And more….