Research: Clinical

Abstract

What are the principles and values that should govern research with human beings, and what are the rights that should be respected when humans participate in research? This is the core question addressed in this entry. In the first part the difference between clinical research and other forms of research and the difference between clinical practice and clinical research are briefly discussed, followed by an analysis of the changes and modifications scientific and ethical standards in clinical research have undergone, in particular since the 1990s. Emphasis is put on the impact on international biomedical research of the global expansion of the neoliberal market model: the globalization of biomedical research and the weakening of international normative ethical frameworks. Finally, the attention is turned to the standard of care debate in international clinical research and the controversy between proponents of accepting the use of local standards and defenders of a universal ethical standard. It is argued that respect for human dignity and social justice must be at the core of such debates and that differences in cultural, social, and political conditions cannot be taken as facts outside the scope of ethical consideration when research is planned and conducted. On the contrary, it is argued that research in low income countries has to satisfy the local health conditions, the priorities and human needs, since only in this way it will be possible to research fairly in an unjust world.