Outsourcing of Ethics: Biological Colonialism Approved by FDA

[T]rials performed outside the United States will no longer have to conform to the Helsinki Declaration even though they will be used to support licensing of drugs in the United States. Instead they will be regulated by the Good Clinical Practice guidelines: not an aspirational ethical code but a manual describing existing procedure for industry sponsored trials. This double standard could give the impression that the FDA “is more interested in facilitating research than respecting the rights of people who are subjects of research”.

This is rank biological colonialism, permitting human research ethical rules to be ignored if done overseas, but then allowing the company to use the test results to justify its application for a license from the FDA approval for clinical use of the products at home.

The FDA excuses this rule on the basis that it has no jurisdictional control overseas. That may be true, but it can—and should—refuse to consider giving its approval to any product or drug that has not been tested under USA standards of ethics for human subjects—and animal care for that matter.

This “outsourcing of ethics” (a term I believe was coined by my friend William Hurlbut) says, in essence, that people in foreign countries have less value and moral worth than Americans and can be used in ways in which we would not treat our own people. The FDA’s unethical move needs to receive so much adverse publicity that the FDA quickly changes course—before Obama finds out.