Informed consent in research in developing countries: Is there some unfinished business?

Abstract

The application of informed consent in research in developing countries continues to be a topical and complex issue. The debate concerning informed consent has become even more relevant in light of the groundswell of international collaborative research that is conducted in developing countries. The discussion centres on the uncertainties of the application of informed consent in developing countries based on the normative criteria set out in international codes and regulations. Although the ethical and legal basis of obtaining valid informed consent is incontestable, contextual differences between developed and developing countries is a key problem. For example, it is debated if the tenets of ‘Western’ research ethics, mainly in the application of a written informed consent model can truly be applied in the African context. The question is whether the participants of research when conducted in developing countries actually are “informed” in the consent process. There are perceptions that the protective instruments that guide researchers on how to obtain informed consent from research participants are not robust and sensitive enough for developing countries needs. In literature, some have questioned the relevance of its purist application in the context of developing countries as ‘overly paternalistic’. Others have argued from the view point that the Eurocentric approach recommended in obtaining informed consent in developing countries has the potential to undermine cultural norms and traditions. In the latter argument, concerns are raised about the principle of respect for persons / ‘autonomy’ and its applicability in so-called communitarian societies. To overcome some unique hurdles, there are voices that call for tailor-made processes for obtaining informed consent to suit the prevailing context, suggesting therefore that there should be some variance in its application. The importance of the issue of informed consent becomes critical as much international collaborative research takes place in Africa where health services are often inadequate and research is perceived by participants as a means of ameliorating some of their suffering. Given the philosophical and the ‘universal’ ethical foundations at the heart of the international regulations and codes on the issue of informed consent, there is a need to further explore the foundation of these perceptions as they raise various ethical issues which need to be discussed. The question concerned in this research report is “is there unfinished business not addressed in the process of obtaining informed consent in developing countries?” In order to answer this question, it is necessary to look at some of the requisites for the application of informed consent principles. I will examine whether the content of the commonly cited ethical codes and regulations (originally initiated in developed countries) are sufficiently broad enough to explain the aims of obtaining informed consent, the steps to be taken in obtaining informed consent and the structures necessary for its facilitation. In addition I will examine whether the intent of the codes and regulations take cognizance of socio-cultural variations. In other words, is the environment sufficiently conducive to apply the concept and are the guidelines flexible enough to deal with “unusual circumstances”. In consideration of the latter, I consider the question of the adequacy of structures to ensure the essence of respect for persons is not lost in dealing with “unusual circumstances”. I contend that if the answer is in the affirmative it is only then can it be said that the principles of informed consent are being adequately addressed and meet the moral, ethical, and legal obligations of research activities.

MSc (Med)Bioethics and Health Law, Faculty of Health Sciences, University of the Witwatersrand, 2009