2 - Maintaining ethical standards in research

Summary

What substantive ethical standards ought to apply to research conducted in developing countries? Is it acceptable to permit a double standard, one for the industrialized world and a lower standard for developing countries, justified by the hope of providing future benefits to resource-poor countries? Some people maintain that exactly the same standards should be employed the world over, whereas others contend that different standards are required because different circumstances obtain. But does “different” necessarily mean “lower”? Controversies over what ethical standards are appropriate for the conduct of research in different parts of the world are complicated by confusion over what is meant by “ethical standards.”

Debates about the justification for allowing different standards or requiring a single standard have arisen in two main contexts in international research. The first concerns what should be provided to a control group in clinical trials. Testing experimental medicines typically involves a comparison between the experimental product and an approved drug. In some situations, the experimental medicine is compared with a placebo, an inactive substance. One group of subjects receives the experimental product and the other – the control group – gets either the proven medicine or a placebo.

The ethical question focuses on what is provided to the control group. The phrase “standard of care” has been introduced in posing the question: Is it ethically acceptable to provide a control group in research with the standard of care in the developing country – whatever is routinely provided to people in that country with that medical condition? Or must a control group be provided with the best treatment available elsewhere – the “standard of care” in the sponsoring country?