Spain - RECs and Medical Research

History

There must be an REC in every health centre that intends carrying out a clinical trial. These are accredited by the health authority of each autonomous community and have to be notified to the Spanish Agency of Medicines and the Coordinating Centre of Ethical Committees.

Summary of Spanish RECs

of REC	Local
Where situated?	Health centres where clinical trials are held.
Who applies to them?	Researchers
Formal/Informal	Formal
National/Regional	Regional
Laws Involved	Law 25/1990 on Medicines Royal decree 561/1993 which establishes requirements for the accomplishment of clinical trials using medicines. Royal Decree 223/2004 clinical trials with medicines - Chapter III is dedicated to Ethics Committees of Clinical Research
Guidance Involved	Declaration of Helsinki
Membership requirements	At least 9 members, including a doctor, a clinical pharmacologist and a pharmacist from the hospital where the REC is based and 2 of whom must not belong to the medical professions; 1 of these 2 must be a lawyer.
Responsible/accountable to whom?	Independent institutions
Approval or Advisory powers	Approval

Not submitting research or failing to follow review

There can be administrative sanctions under Law 25/1990 and Royal Decree 561/1993. There can also be civil (and possibly criminal) liability in cases of damage to subjects of clinical trials.

Which body, if not the REC itself takes this action, and how do they proceed?

Administrative sanctions consisting of fines are the responsibility of the State Health Administration or the Autonomous Community Health Administration.
Civil or criminal liability cases would go through the court system.

Impact of Directive 2001/20 EC

This will affect protocols of tests involving minors or incapacitated adults, where expert advice will be required by RECs. It will also require follow-up procedures for protocols receiving a positive opinion (Pich et al, see reference below). Implemented by Royal Decree 223/2004, Article 60, 62 and 65 of Law 25/1990.

Legal action that can be taken against RECs

There are no legal provisions for action against RECs. There must be an REC in every health centre that intends carrying out a clinical trial. These are accredited by the health authority of each autonomous community which in turn must communicate this information to the Health Ministry. The health department of each autonomous Community determines the scope of responsibility of each committee.

Links section

Ministry of Health (in English, French & Spanish), and the Minsitry of Health Legal Section
Spanish Medicines Agency (in Spanish)
Iberlex Spanish law database (in Spanish)
Spanish Constitution of 1978 (in Spanish)
Inter-University Chair in Law & the Human Genome (in English & Spanish)

Reference section

Pich, J, et al, Role of a research ethics committee in follow-up and publication of results
Lancet: 2003; 361:1015-16
Dal-Ré, R, et al, Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?
Journal of Medical Ethics: 2005; 31:344-350

See the REC bibliography section for more links and papers and the Data Protection Page