[A comparative study of autonomous communities' legislation on accreditation of Research Ethics Committees as part of the principle of good governance].

Abstract

Objective: Following a consultation received at the Legal Clinic of the University of Alcalá, it was necessary to determine whether or not a Research Ethics Committee was accredited. This led us to consider the need to determine whether the autonomous communities had reformed their legislation to establish the accreditation procedure for Research Ethics Committees, therefore adapting their legislation to Act 14/2007.

Methods: An analysis of the european, national and regional legislation regulating biomedical research in Spain was carried out to determine what the accreditation procedure for Research Ethics Committees was like in each autonomous community and whether it conformed to the provisions of Act 14/2007.

Results: Most of the autonomous communities had not reformed their legislation to establish the accreditation procedure for Research Ethics Committees, especially if they were part of universities, which could affect the principle of good administration.

Conclusions: The principle of good administration could be affected by the fact that most of the autonomous communities do not adequately regulate the procedure for setting up and accrediting Research Ethics Committees, especially those linked to universities, which undermines the guarantees that these bodies provide for clinical biomedical research and generates legal uncertainty.