Opening Address

BRIGITTE GICQUEL

Mycobacterial Genetics Unit, Institut Pasteur, France

Three years ago, we decided to bring together people concerned with ethics together with researchers looking for new vaccines against tuberculosis. Today research has moved from biological studies using animal models to the study of human biology. The urgency to find new interventions to help the patients in need of treatment has accelerated the undertaking of tests in human beings. This implies major concerns: who could enter into a trial? Who and from what kind of community or country? Are the individuals aware of all aspects of the trial? Did they receive enough and appropriate information to enter into a trial? Do we have the insurance of inocuity for any product to be tested. Are guaranties to protect individuals against any adverse effects? Is the problem of AIDS or HIV positivity taken into account to avoid any discrimination or perturbation of social networks including family nucleus? What advantages the communities that will participate will receive and why them and not others. More generally speaking how to assure a future benefit and how to transform a specific initiative in a broader action in the context of sustainable development. The aim of this EC funded project is to discuss these aspects with experts who could confront their expertise. Although rules have been established like the Declaration of Helsinki and WHO recommendations. Before undertaking any clinical trial, one has to face problems due to the specificities of populations concerned by any trial. Because trials on new drugs and new regimen against tuberculosis have been performed and some of them are still ongoing, researchers implicated in these trials will help us to discuss successes and drawbacks.

An important issue will be to test new interventions in a context with exiting efficient interventions like the control programme based on multidrug regimen therapy and vaccination of infants at birth with BCG. Any trial should not destabilise these programmes but reinforce them. For these reasons a pilot workshop was held as an initiative of IUATLD and Institut Pasteur in 1999. This workshop has gathered experts in ethics and scientists in biomedical research. The present project aims at associating experts in Ethics, Biology, Medecine and Philosophy of science to introduce a larger prospective for future implementations of the results issued from the biomedical research.