In the era of globalization, the diffusion of biomedical research with human subjects poses challenges at various levels. The growing number of clinical trials conducted in developing settings – in Latin America, Africa and Asia – requires the commitment from all stakeholders to ensure the correct application of internationally recognized Good Clinical Practices and adherence to the internationally recognized principles of ethics, human rights and justice.
In recent years, UNICRI, in collaboration with the Italian Medicines Agency (AIFA), the responsible agency in Italy for pharmaceutical control, has investigated the ethical and legal issues surrounding the conduct of clinical trials with human participants in developing countries, with particular regard to its criminal implications, such as the risks of fraudulent behaviour, non- compliance with the standards of ethical reviews and the lack of control on the quality of drugs and/or of the established protocols, which sometimes bring about serious consequences for participants. The research study had a particular focus on Africa and contained a survey of the current national legislations and guidelines regarding the protection of human participants in biomedical research and status of ethical review capacity in the region. The results of the research were published in the book Biomedical Research in Developing Countries: the Promotion of Ethics Human Rights and Justice (UNICRI, 2009).
Proper legislative framework, its correct application and adequate ethics training for professionals involved in research with human beings are all key factors for ensuring the protection and promotion of human rights, safety and the well being of research participants all around the world. To this regard, UNICRI has developed a training kit to support the development of effective legislative framework and governance tools to ensure the protection and promotion of human rights in the field of clinical research.
In 2012, upon specific request from Tanzania and Zimbabwe, UNICRI has delivered a training programme for Ethical Review Board Members and Clinical Monitors to build capacity in the ethical evaluation of protocols and in the regular monitoring of ongoing studies. In Zimbabwe, UNICRI is also engaging in training activities to assist in the establishment of the Zimbabwean Forum of Research Institutions (ZIMFRI), which can be used as a platform for strengthening and harmonizing health research ethics in Zimbabwe and be a focal point for the Region