[独立伦理委员会的认证]

[Accreditation of Independent Ethics Committees].

作者信息

Ramiro Avilés Miguel A

机构信息

Comité de Ética de la Investigación, Cátedra 'Discapacidad, Enfermedad Crónica y Accesibilidad a los Derecho', Facultad de Derecho, Universidad de Alcalá, Alcalá de Henares, Madrid, España.

出版信息

Gac Sanit. 2017 Jan-Feb;31(1):53-56. doi: 10.1016/j.gaceta.2016.08.007. Epub 2016 Oct 29.

DOI:10.1016/j.gaceta.2016.08.007

PMID:28029466

Abstract

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.

摘要

目的

根据第14/2007号法律和第1090/2015号皇家法令，生物医学研究必须由研究伦理委员会（REC）进行评估。如果该意见是针对涉及药品的临床试验或使用医疗器械的临床研究发表的，则该委员会必须被认可为涉及药品的临床试验研究伦理委员会（RECm）。本研究的目的是确定独立伦理委员会（IEC）和涉及药品的临床试验研究伦理委员会（IECm）的认可如何进行规范。