Ethical considerations of clinical trials in the developing world

With numbers of clinical trials in the developing world increasing rapidly, ethical considerations of the research and regulations on a global scale are fundamental to ensuring experiment participants are protected.

Low healthcare expenditure in developing countries corresponds to less than 1% of that of OECD countries[i], with 87% of the USD 2 trillion spent on healthcare worldwide distributed to 16% of the world’s population[ii]. Healthcare ethics on a global scale is central to redressing the inequalities in public health through improvement in medical research, healthcare provision and resource allocation.

As Angell argues, “our ethical standards should not depend on where the research is performed[iii]” and “human subjects in any part of the world should be protected by an irreducible set of ethical standards[iv]”.

With an excessive reliance on declarations, such as the Declaration of Helsinki[v], to provide clear-cut definitions on what is ethical and what is unethical with regards to clinical trials[vi], healthcare professionals require additional direction to ensure “considerations to the well-being of the human subject [...] take precedence over the interests of science and society” [vii].  A notable weakness is the lack of adequate ethics centres in the developing world. An ethical model for research and training partnerships between developed and developing countries is required[viii]. Springer and Benatar (2001) suggest a model based on the International Clinical Epidemiology Network (INCLEN) that created a network of clinical epidemiology units worldwide for bioethics[ix].

On reflection, clinical trials undertaken in the developing world present new and intricate ethical dilemmas to an already controversial issue: scientific experimentation on human subjects. An unyielding system is required to protect the vulnerable participating in clinical trials, especially in the developing world.

References upon Request