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Gaceta Sanitaria
Print version ISSN 0213-9111
Abstract
RAMIRO AVILES, Miguel A.. Accreditation of Independent Ethics Committees. Gac Sanit [online]. 2017, vol.31, n.1, pp.53-56. ISSN 0213-9111. https://dx.doi.org/10.1016/j.gaceta.2016.08.007.
Objective:
According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated.
Methods:
National and regional legislation governing biomedical research was analysed.
Results:
No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation.
Discussion:
Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures.
Keywords : Independent Ethics Committee; Independent Ethics Committee for clinical trials involving medicinal products; Accreditation; Universities; Clinical trials; Biomedical research.
