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