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During the last decade an exponential accumulation of knowledge has led to the hope that new vaccines and new drugs will emerge rapidly against tuberculosis. Thanks to initiatives of several agencies including the European Commission, a number of vaccine candidates against tuberculosis showed promising results in preclinical studies. Several of them are being tested in phase 1 clinical trials in northern and southern countries. Vaccine candidates showed promising results in preclinical studies. Several of them are being tested in phase 1 clinical trials in northern and southern countries. General rules are known such as the Declaration of Helsinki and rules of GLP for laboratory practice and GMP for the production of products for human use. However their implementations face specific problems in different settings. It is the objective of the TBETHICS project to present a state of the art concerning the new vaccines drugs and interventions issued from the biomedical research and discuss their testing and utilisation through human clinical trials.

This will be accomplished through the following initiatives

- To develop an environment for exchange of views and experiences concerning ethical guidelines for research on individuals within the context of existing international cooperation research initiatives for development of new vaccines, drugs and any new intervention to fight against tuberculosis.

 

- To bring together individuals with expertise and experience from different countries to consider key elements of ethics in research into human subjects.

- To reflect on existing international guidelines and their relevance and applicability within the realities of international collaborative research on tuberculosis.



- To identify key issues in procedures for ethical evaluation, review and monitoring with respect to international collaborative research on humans and declaration of Helsinki

Two workshops with the establishment of working groups will be organised. Here we will include the programmes of the meetings, the abstracts of the different speakers and the diaporama of their presentations.