HIV Vaccine Trial participation in the Third World : an ethical assessment

Moodley, Keymanthri (1999-12)

Thesis (M.Phil.) -- University of Stellenbosch, 1999.

Thesis

ENGLISH SUMMARY: This essay examines the issue of trial participation in the proposed my Vaccine Trials in South Arica. It is set against the backdrop of ethical issues relating to research in the Third World in general. Trial participation is examined in the context of the ethical tension that exists between international ethical research standards based on Liberal Individualism and local standards of care and cultural norms in the Third World. Two areas of conflict are inherent here: universality versus particularity on the one hand and individualism versus communitarianism, on the other. The Tuskegee Syphilis Study as well as the HIV Vertical Transmission Trials are used as a point of departure to set the stage for the controversy surrounding the proposed HIV Vaccine Trials. The important concepts of informed consent, the risk-benefit ratio and fair treatment of trial participants are framed within the Four Principle Approach of autonomy, beneficence, non-maleficence and justice. These principles form the cornerstone of the Declaration of Helsinki. This Western ethical guideline - grounded in universality - has become the mantra of all liberal democracies the world over and is chanted slavishly by the international research community. It bears the hallmark of liberal individualism with its mandate that "the concern for the interest of the individual must always prevail over the interests of science and society". Followed to its logical conclusion, any infringements of the moral interests of trial participants must be viewed using a subject-oriented approach. Such an approach sees the trial participant as being of paramount importance and views research as "highly desirable but morally optional". Clearly, this would mean the end of the road for medical research, especially in the Third World, where a truly subject oriented approach would render research tantamount to exploitation of vulnerable, educationally disadvantaged persons. In Africa, in traditional, rural communities, a moderate form of communitarianism referred to as "Ubuntu" or "communalism" is still prevalent. In such communities, the concept of personhood is embedded in the community or society. In these communities, a balancing approach, in which infringements on the rights of trial participants are permissible in the name of science or society, provided the subject is not placed at significant risk, would be acceptable. However, liberal individualism is making inroads here too. As such, the ethical tension between liberal individualism and communitarianism, which is unavoidable in research settings, is growing. This essay highlights many internal contradictions in liberal individualism - especially where research ethics is concerned in Third World countries. One of the outcomes of such contradiction is the attempt by the World Medical Association to amend the Declaration of Helsinki - in the name of ethical relativism: different standards for different countries or cultures. Surely, such liberal individualism cannot be seen as the "endpoint of mankind's ideological evolution" as Fukuyama phrases it, nor can it be the final solution to the problems of the world and, as such, "the end of history". In the context of the HIV Vaccine Trials, individual good clashes with societal good, universality with particularity and ultimately, modernism with postmodernism. In Western cultures, the individual enjoys priority; in other cultures, society is more important - somewhere in between, we need to find common ground which can be incorporated into a balancing approach with minimal risk to the individual when infringement of rights is unavoidable.

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