Instead, starting in October, there will be a requirement that the studies follow "good clinical practice," which includes oversight by an independent ethics committee and informed consent provisions.

This means that the approval of new drugs in the United States can be based on international drug trials that only incorporate a placebo control rather than giving all subjects access to current standards of care. It has raised concerns that the ruling will result in more "outsourcing" of clinical trials and could have negative impacts on populations from the developing world who participate in trials.