Ethical constraints of clinical trials in developing countries: Experience of the french national agency for AIDS research (ANRS)

The ethical principles of clinical research in the developing countries have recently been revised in most international guidelines. Their implementation leads to practical difficulties in the field. As an institutional sponsor, the French National Agency for AIDS Research (ANRS), responsible for research on AIDS and hepatitis in France and in the developing countries, released an Ethical Charter. It represents a commitment for the ANRS partners from the North and the South. The most important principles of the Charter are as follows: an early integration of research in the national programmes of public health; a strong partnership between North and South at any step of the research; a clear definition of rules concerning evaluation and ethical follow-up of the research; enrolment of the subjects; healthcare; care for the patients; and management of the post-study.