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Round Table in Rome 15-16 December 2008
International Round Table on problems of clinical trials in developing countries

UNICRI and the Italian Medicines Agency presented a research symposium on ethical and legal issues related to the various stages of clinical trials in developing countries. The Round Table event was held on December 15-16 in Rome at FAO Headquarters.

In recent years, the proliferation of clinical research on humans in developing countries has raised concerns about the ethical and legal implications associated with the improper conduct of trials. Issues include lack of care for the welfare of participants; human rights violations; inadequate ethics reviews or scientific protocols, and an absence of an adequate system for regulating medicines.

There was a particular focus on the level of protection for participants and the legislation regarding biomedical research in Africa. Countries were identified which urgently require specific training on ethics reviews, Good Clinical Practice protocols and inspections, and strengthening of relevant legislation.

The Round Table event also provided an opportunity to compare national and international experiences on the protection of participants in clinical trials. The practical needs and expectations of future training programmes and development were raised and also the role that international organisations and civil society could play in delivering on these needs. The importance of improving universal instruments in biomedicine to effectively regulate clinical trials was discussed.

Please find below the International Round Table Conclusions and Recommendations: