Ethical conduct by US research in India?

Some of the questions about pharma’s ethics with research in India involve informed consent. To what extent are the people being enrolled truly giving informed voluntary consent rather than just signing a paper. Some are poor, some are illiterate. Some are offered $100, a small fortune to the poor, and therefore possibly undue influence. Some see it as an opportunity to get some treatment when they normally cannot afford to seek treatment. Some point out cultural differences in which most patients blindly trust that anything a doctor gives them or asks them to do will make them better, the legacy of the caste system and more. Experiences of autonomy and freedom are very different in Western culture than they are for many in Indian culture. (Pharma giants risk reputation through clinical trial cost-cutting) Candice Player in her article, Outsourcing Clinical Trials to India, points out that for many women, their role is defined by their fathers, then by husbands, and/or wishes of parents and elders.

Another question is that after determining that a person has the target illness, medication or a placebo is given for the trial, and no attention given to follow-up treatment of the patient. The drug matters more than the patient. Ms. Player makes the point of distributive justice which would make it unethical for one group to bear all the risks and inconveniences of the research, while another group is the one who receives all the benefits. She cites The Belmont Report on ethical principles in human research and the Indian Council of Medical Research’s principles of ethical research. (Ethics in Human Experimentation)

It is not just India’s responsibility to create an ethical environment for research, it is also the responsibility of the leadership of America’s and Europe’s pharmaceutical companies. And it is our responsibility as human beings to call them to ethical relationship and behavior.

Related articles:
How informed are the country's clinical trial participants? In Applied Clinical Trials

India a hotbed for clinical trial (Times of India)

Drug trials outsourced to India BBC News