[Ethical aspects of clinical trials and patient informed-consent sheet: HIV/AIDS]

The TRT-5 (Treatment and Therapeutic Research) group, created in 1992, is a coalition of eight advocacy and service-providing HIV/AIDS nongovernmental organisations (NGOs) [originally five NGOs] working together on treatment and research issues in the field of HIV/AIDS in France. After 11 years of work in the defending and advocating for the rights and the welfare of HIV+ individuals in the area of drug development and clinical research, we felt authorised to make comments and propose changes to the currently ongoing reform of the French Law (Loi Huriet) defining the legal framework of clinical research in France. Several of our proposals aiming to include into the new law solutions to many of the ethical problems we regularly face in clinical research have been incorporated into amendments submitted to Parliament during the first reading in the lower Chamber last October. Some of these amendments have been approved by the majority of deputies.