• 作者：M. Concepció ; n Martí ; n-Arribas ; ^{comartin@isciii.es} ; Isabel Rodrí ; guez-Lozano ; Javier Arias-Dí ; az
• 关键词：CEI ; comité ; de é ; tica de la investigació ; n ; CEIyBA ; Comité ; de É ; tica y Bienestar Animal ; LIB ; Ley de Investigació ; n Biomé ; dica
• 刊名：Revista Espa?ola de Cardiolog篓陋a
• 出版年：2012
• 期刊代码：pca308_03008932
• 类别：med
• 出版时间：June, 2012
• 卷：65
• 期：6
• 页码：525-529
• 文件大小：150 K

Introduction and objectives

Since the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples. The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessment of research proposals involving human subjects.

Methods

A descriptive study of the observations made on research projects registered between June 1, 2009 and June 30, 2010.

Results

About two thirds of the projects evaluated in this period needed some type of amendment. Most of the comments were aimed at improving informed consent and procedures to ensure confidentiality (153 observations, 57.6%). Fifty (18.9%) observations related to the principles of beneficence and nonmaleficence. The remaining observations involved incomplete or incorrect documentation, or requests for additional information.

Conclusions

The largest number of observations related to the autonomy of research participants. It is important for researchers to be aware of the principle of autonomy in their interaction with study participants. Research ethics committees should therefore promote greater understanding of ethical issues on biomedical research.

Full English text available from: