REC must be periodically accredited by the competent health authorities.

Article 10 describes the following REC functions:

• Evaluate the methodological, ethical and legal aspects of the clinical trials presented to them.
• Evaluate relevant amendments to authorised clinical trials.
• Monitor the trial, from the start to the receipt of the final report.

Committee members shall include doctors, one of whom shall be a clinical pharmacologist, a hospital pharmacist and a registered nurse. At least one member shall be independent from the centres where research projects are performed which require ethical evaluation by the committee, and at least two members shall not be healthcare professionals, one of whom will have a degree in law.

For studies affecting these populations, there should be at least one member of the Healthcare and Research Ethics Committee, if any, and professionals with expertise in surgical procedures, paediatrics or vulnerable groups. Should there be no expert member, the opinion of an experienced person shall be obtained.

The principal investigator or collaborators of a clinical trial shall not be involved in the evaluation or decision concerning their own protocol. None of the members shall either directly or indirectly receive payment from a clinical trial sponsor.

The health authorities shall provide the means required for the committee to operate. The REC shall edit a series of standard operating procedures. Minutes shall be kept of each committee meeting.

General REC evaluation procedure

A clinical trial protocol shall be evaluated by the REC of each centre where it is to be conducted. For each protocol a single approval shall be issued, so a REC of Reference is responsible for this decision for multicentre studies.
Both RD 223/2004 and the subsequent instructions edited by the AEMPS define the REC evaluation process and issuance of opinion. These instructions are developed according to European Commission Guidelines.
For the evaluation of a clinical trial, the sponsor shall present an application to the REC of reference and the other REC involved, providing at least the following documents:

• The protocol.
• The investigator’s brochure.
• The documents referring to informed consent, including the patient information sheet.
• Documents on the suitability of the investigator and his/her collaborators.
• Documents on the suitability of the facilities.
• The amounts and way in which the investigators and subjects, if applicable, may be paid or indemnified for their participation in the clinical trial, and the relevant aspects of the contracts to be signed between the sponsor and the centre.
• A copy of the insurance policy or receipt/certification of the financial guarantee for the clinical trial, when applicable.
• When there is no or only partial insurance, a signed document accepting liability for damages caused as a result of the trial.
• The procedures and material used to recruit the trial subjects.
• The commitment of the investigators programmed to take part in the trial.

• Issuing the single opinion for multicentre trials.
• Coordinating the development of a computerised communication system for REC with the autonomous regions.
• Managing the clinical trial database of the national network of REC.
• Promoting common evaluation criteria among REC.
• Promoting training for REC members.
• Promoting discussion forums among REC.
• Acting as a point of contact providing information on how the national network of REC operates.
• Providing advice to REC in procedural aspects.
• Editing an annual report.
  
  REC of reference
  
  It is the REC responsible for issuing the single opinion in the evaluation of multicentre clinical trials.
  Any of the REC involved in the evaluation of a clinical trial, corresponding to the centres in which the trial is to be conducted, can be the REC of reference.
  The appointment of the REC of reference corresponds to the clinical trial sponsor, as established in the instructions edited by the AEMPS.
  The REC of reference is responsible for verifying the suitability of each evaluation application, for receiving the reports of the other REC involved, and for requesting clarifications from the sponsor and issuing the final opinion.
  
  
  Links:
  
  Spanish standards and legislation
  Royal Decree 223/2004, of February 6, regulating clinical trials with medicinal products.
  Link to the instructions published by the AEMPS for REC evaluation processes and issuance of opinion (from documents included on the ICB digital website.
  
  
  Directory of Research Ethics Committees
  Link to the SEFC web page including the directory of REC
  
  European Union Directives
  Detailed guidance on the European clinical trials database (EUDRACT Database)
  Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use.
  Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module).
  Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use.
  Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial.