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Current Debates in Standard of Care in Clinical Trials

Nida Khan

Many international regulations that govern human subject’s research have been devised keeping in mind, implications of research conducted by researchers of developed countries on human subjects living in developing countries. It is not uncommon for researchers to be drawn to undertaking research overseas. Scientists like sharing experiences, knowledge and benefits of research with colleagues from different backgrounds, and often obtain funding that is directed to specific developing countries. Another legitimate reason is that the disease (their research interest) is prevalent in that particular population. What is worrisome though is that some are driven merely to pursue academic advancement and gain commercial benefits from an enhanced international reputation at the expense of the host community. This leads them to undertake research activities in another country that would not, otherwise, be permitted in their own country, due to ethical or legal constraints. This is where the controversy arises. Is it ethical to allow international collaborative research, the sole intention of which is to benefit from a favorable regulatory scheme in a resource poor country? The answer to this question is not simple, because it poses a grave risk of exploitation of the host community. Exploitation occurs when one party receives an unfair level of benefits or unfair burden of risks as a result of interacting with the other party. Developing countries have limited resources, lack regulatory infrastructure and independent oversight processes. There are financial constraints in addition to cultural and linguistic barriers, illiteracy and limited health care services. A major ethical concern is that certain multinational pharmaceutical giants when faced with a banned drug use third world countries as their dumping ground for redeeming profits. It is unfortunate that in spite of serious health warnings and/or uncertain long term effects; such drugs continue to be widely distributed in developing countries.