This book is an attempt to explore the ethics of public health, specifically, ethical issues with clinical trials; it is also a reflection of the wider area, and research forays that I make in the field of bioethics. In it, I aim to re-conceptualize responsibility in clinical trials with the insight of the African notion of self. I strive to complement scholarly literature dealing with cross-cultural biomedical ethics, and emphasize the African perspective which is rare or even non-existent in some cases.

To take on this task of reconceptualization first, I recognize that bioethics as a field has continued to spread out from its American birthplace to numerous cultural milieus across the globe. Accompanying this spread is the challenge of how to integrate and apply its founding principles. Faster still is the pace at which the Global South has become the choice site for a sizeable chunk of the clinical trial enterprise from the Global North.

Of the many problems with principlism, the one that is most directly antithetical to my thesis is its excessive individualist emphasis, focusing on individual rights, his autonomy, etc., to the detriment of everything else. In so doing, much is left to be desired. Hence, its numerous revisions even in Western practice of research ethics clearly point to some inbred difficulties in its application. That, in and of itself, further buoys my argument for a robust alternative – an African perspective (a communalist set of principles, presented here as bio-eco-communalism or BEC).

Further still, it has become obvious that the assumptions implicit in the Western framework that makes claim to universal validity are not shared by non-Western cultures. If not reined in, the concern seems to be that the Euro-American approach is bound to globalize a less than global view of the world and reality. In other words, the mainstream research ethics which is grounded on principlism is itself inherently linked to Western individualistic notions of personhood, whereas the rest of the world, particularly Africa, sees the person not as an isolated individual, but as a part of the community who is embedded in kinship, group, community and the environment. Likewise, many authors have noted that the totality of the African world-view in which the people’s ethics is rooted, and the societal activities which center on the promotion of vitality and fertility of human beings, livestock, and the land on which their livelihood depends, are entirely missed by principlism.

In the face of this, I urge for a reappraisal of sorts about the place of responsibility for human subjects in research. More specifically, as many clinical trials are off-shored abroad, it provides an opportunity to weigh in on the Western emphasis on individualism and to acknowledge the cultural systems of other peoples, for instance, communitarianism (or communalism). While opposing individualism (a Euro-American mantra), the African perspective stresses communitarianism. By definition, the communitarianist philosophical view point instantly recognizes that ethical issues with biomedical studies are far more broad-based.

Therefore, responsibility in clinical trials must in tandem, be broad-based. There is no debate that research studies do impact the individual person, but that impact extends in varying degrees to everyone and everything else around him/her – family, neighborhood, community and even the physical environment. Put otherwise, responsibility in biomedical studies particularly, those dealing with human subjects (and in bioethics as a whole), must be seen to extend beyond the individual person and to encompass the community and the physical environment within which the individual resides. Because the African notion of selfhood is communalist and broad-based, it is adequately structured to address the short-comings in the mainstream individualist perspective. As such, responsibility for (and by) the individual can only make sense through the community in which he/she is rooted. Consequently, I urge that the current understanding of responsibility be re-conceptualized. When this is done, responsibility for human subjects in research (particularly in adequately suited cultural environments), will henceforth mean responsibility for the individual rights, plus, those of his family, community, and the ecosystem.

Clinical Trials and the African Person

A Quest to Re-Conceptualize Responsibility

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