Protecting vulnerable subjects from exploitation in the medical research context: A developing world perspective

In the last decade, cases of exploitative medical research trials carried out in developing countries have been discussed by bioethicists around the world. This thesis contributes to the discussions by establishing whether the codification of vulnerability in international regulatory documents is sufficient to protect the interests of research subjects in developing (African) countries. The thesis is in three parts. The first part defines the concepts of vulnerability and exploitation. In the section on vulnerability special categories of research subjects are discussed, which have high relevance in developing (African) countries (e.g. women who fall under the bride-price tradition). In the section on exploitation a definition is derived, which can be applied to medical research in developing countries. The second part of the thesis surveys international guidelines to assess existing mechanisms of protection for research subjects. We show in this part of the work that existing guidelines are ineffective in protecting research subjects in developing countries because of their inherent ambiguities. The third part of the research project argues for a new system of compensation that is compatible with international guidelines and African traditional ethics as a way of protecting vulnerable research subjects in African countries from exploitation. The suggested compensation model is called compensation-incommunity. Fieldwork in three African communities was undertaken to test the acceptability of this new model