Biomedical research in developing countries and international human rights law

Abstract

At present, considerable numbers of research projects are conducted on a multinational basis. Teams of researchers based in different States may participate in a single project. Furthermore, internationally-based organizations may be able to choose the country in which a particular research project that they are conducting or funding is carried out. This has led to concerns being expressed about the possibility of fundamentally different standards of protection for participants being applied in different countries. The issue of double standards has increasingly become part of regulatory frameworks in biomedical research. This paper reviews and compares the 2008 version of the WMA Declaration of Helsinki with existing guidelines and rules on research in developing countries adopted by intergovernmental (UNESCO, WHO, Council of Europe, EU) and non-governmental (CIOMS, WMA) organisations. The paper concludes with some reflections on the issues which need to be addressed in the future to achieve solidarity, in line with the EU Charter of Fundamental Rights which proclaims in its preamble that:The Union is founded on the indivisible and universal values of human dignity, freedom, equality and solidarity. (EU Charter of Fundamental Rights 2009) Therefore, research activities involving human subjects cannot exclusively be assimilated to an economic activity subject to market rules. On the contrary, in the context of solidarity, regarding health as a public good rather than a commodity, it needs to be regulated according to fundamental principles.