Ethical and legal issues in biomedical research

Rome, 9 September 2008. UNICRI, in collaboration with the Italian Medicine Agency, GCP Promotion Unit, GCP and Pharmacovigilance Inspectorate, has undertaken research into procedures used for clinical trials, which utilize human participants.

In recent years, the practice of clinical trials with human participants in developing countries has become widespread. UNICRI and the Italian Medicines Agency, concerned by the proliferation of such activities, have undertaken extensive research into the ethical and legal implications of conducting biomedical research in resource-limited countries, in particular Africa. The results of this research are to be presented during an international round-table event in Rome, on the 15 & 16 December 2008.

The overall objective of this research is to identify those countries in which there is an urgent necessity for education and training in ethical review and in drug regulation activities. In order to do this, a survey into the main training and educational activities at an international level, and of the current national legislations and guidelines regarding the protection of human participants in biomedical research has been carried out.

Furthermore, the review process and protocols involved in the clinical trial process comes under scrutiny, enabling the research to tackle the pressing and difficult issues of ethical and legal issues affecting both the investigators and the participants.

The round-table discussion presents the opportunity for internationally renowned experts in the field to present their own analyses of various intricate details of the issues, as well as to examine and debate the issues raised by this research.

Specifically, the round table will be a platform for the discussion of the international instruments which have been developed by the United Nations and other national and international organizations dealing with the ethical and legal protection of human participants in biomedical research. In this way, the objective is to increase the knowledge of this subject matter among the relevant parties.

Through this important discussion of issues which affect so many lives, UNICRI and the Italian Medicine Agency aim to ameliorate the current system of clinical trials and to protect the most vulnerable people from exploitation. Through awareness of ethical issues and from a strong legal perspective, UNICRI's policy of action-oriented research is actively working towards a more vigorous approach to issues of ethics, both in the rule of law and in the protection of human rights.

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