ABSTRACT

The Research Ethics Committee (REC) is a key component of all modem regulations and declarations concerning the ethical conduct of biomedical research. Biomedical research involving human subjects is a social practice that relies on social acceptance for its continuation and flourishing. This social acceptance has to encompass both the goals of the activity and the way the activity is conducted. Those who cannot give consent will be protected, but the protection will harm them, or their group, in the long run. The concept of 'informed consent' has now almost reached the status of an infallible dogma in biomedical research ethics. It is seen as a necessary and perhaps even sufficient condition for the ethical acceptability of the enrolment of a person as a research subject. In many countries RECs have a right and an obligation to monitor how the approved research projects are actually conducted, but this monitoring role is in many cases much less developed.