Title |
La acreditación de los comités de ética de la investigación
|
---|---|
Published in |
Gaceta Sanitaria, January 2017
|
DOI | 10.1016/j.gaceta.2016.08.007 |
Pubmed ID | |
Authors |
Miguel A. Ramiro Avilés |
Abstract |
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. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Spain | 1 | 33% |
Unknown | 2 | 67% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 2 | 67% |
Scientists | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 123 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 23 | 19% |
Student > Master | 21 | 17% |
Student > Postgraduate | 12 | 10% |
Professor | 11 | 9% |
Student > Ph. D. Student | 7 | 6% |
Other | 20 | 16% |
Unknown | 29 | 24% |
Readers by discipline | Count | As % |
---|---|---|
Nursing and Health Professions | 25 | 20% |
Medicine and Dentistry | 18 | 15% |
Social Sciences | 12 | 10% |
Economics, Econometrics and Finance | 10 | 8% |
Engineering | 8 | 7% |
Other | 17 | 14% |
Unknown | 33 | 27% |