In recent years, the increasingly global nature of health research, and in particular the conduct of clinical trials in the developing countries involving human subjects, has highlighted a number of ethical issues. Some of these issues have begun to take the center stage because of the concern that research conducted by scientists from more prosperous countries in poorer countries that are more heavily burdened by diseases may, at times, be seen as imposing ethically inappropriate burdens on the host countries and on those who participate in research trials. Less stringent ethical review, lower risk of litigation, less requirements for informed consent, and the availability of ‘treatment-naive’ patients who are much less likely to have been previously exposed to drugs or trials make research in the developing world more attractive for pharmaceutical industries. India accounts for some 15% of worldwide clinical drug studies where costs are low and regulations less strict than in the US and Europe. This marks a titanic shift of drug trials in this country. This paper critically examines the complexity of modern-day trials in which a host of regulatory and ethical issues are involved.

The fact that we live in an unequal world with wide disparities in health is no surprise. The stark implications of the HIV/AIDS pandemic, the escalation of clinical research in developing countries, and the imbalance of only 10% of world medical research expenditure on diseases causing 90% of the global burden of disease have rekindled the concern about researchers and their subjects. Information gained from clinical trials conducted efficiently and expeditiously in developing countries has the appeal of allowing early registration of drugs, thus considerably enhancing profits. Hasty, ill-conceived studies, luring local collaborators vying for quick credibility and sponsored foreign trips compromise on ethical protocols, viz., without informed consent and non-communication of research findings. A new cult of ‘pseudo-scientists’ volunteering to smuggle blood tissue samples is a cause for alarm. Growing sensitivity to the potential for exploitation has been associated with the expectation that profits should also benefit the citizens of developing countries in which research is undertaken.

There are reasons for conducting clinical trials in developing countries. In the year 2000, the cost of developing a new drug averaged $802 mn, with time costs accounting for half of that amount. The large pool of potential research participants and the lower cost of research in countries such as China and India, provide opportunities to accelerate recruitment. Clinical testing in developing countries is also attractive to pharmaceutical and device companies because it can help them overcome regulatory barriers for drug approval in these countries in which the population size alone offers the promise of expanding markets. An important force that is moving clinical trials to developing countries is the increasing bureaucratic and expensive regulatory environment in many wealthy countries.

The chief concern is that research subjects in developing countries may be exploited because the sponsors of research employ double standards. Focus on whether the standard of care provided to subjects of medical research in developing countries should be the same as what research subjects receive in developed countries like the US and Europe, is debatable. Other concerns are: whether the process of obtaining informed consent in developing countries is adequate; and whether research in developing countries meets the international standards. Recent international developments showed that essential medicines can be made affordable and accessible to developing countries, and that double standards need not prevail.

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