"Safari research" : clinical trials and human rights violations in low-and middle-income countries

Abstract

Participation as a trial subject in clinical trials involves inherent risks to the life and health of the participant. When clinical trials are offshored to low- and middle-income countries, these risks intensify, and broader considerations are raised regarding the fulfilment and protection of the right to health and the right to benefit from scientific progress. In the field of global health and human rights, a number of different actors incur responsibilities. In the context of clinical trials, it is most interesting to examine the responsibilities and norms applying to host States, home States and pharmaceutical companies. In order to evaluate the implementation in practice of these responsibilities, and in order to identify the governance gaps that permit human rights violations to occur, practical cases and examples of clinical trials conducted in low- and middle-income countries are examined. From this analysis, concrete and constructive recommendations are imparted to each of the actors operating in this field. The thesis contributes to current developments in this field by disclosing concrete human rights issues in the context of clinical trials offshored to low- and middleincome countries, and by taking an interdisciplinary approach to strengthening the academic links between international human rights law, State responsibilities, bioethics principles and corporate social responsibility.