Is the codification of vulnerability in international documents a sufficient mechanism of protection in the clinical...

In this paper, I argue that the codification of vulnerability in international regulatory guidelines, such as the Declaration of Helsinki and the document issued by the Council for International Organizations of Medical Sciences on International Ethical Guidelines for Biomedical Research Involving Human Subjects, do not sufficiently protect research subjects. This is true in particular when research is designed in developed countries but conducted in poor (African) countries. Furthermore, I argue that the reason for the insufficiency of guidelines in protecting research subjects in poor settings is due to vagueness in those international documents. Hence, the need for a supplementary instrument of protection was suggested to be employed in addition to international regulatory documents when clinical research is designed to be conducted in developing countries by investigators from affluent countries.