Omonzejele Peter F
Department Of Philosophy, University Of Benin, Benin-City, Nigeria.
Med Law. 2011 Dec;30(4):497-515.
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.
在本文中，我认为国际监管准则中对脆弱性的编纂，如《赫尔辛基宣言》以及国际医学科学组织理事会发布的《涉及人类受试者的生物医学研究国际伦理准则》，并未充分保护研究受试者。当研究在发达国家设计但在贫穷（非洲）国家进行时，情况尤其如此。此外，我认为这些国际文件中的模糊性是导致准则在保护贫穷地区研究受试者方面不足的原因。因此，当富裕国家的研究人员计划在发展中国家进行临床研究时，建议除了国际监管文件之外，还应采用一种补充性保护工具。
