The FDA has published a final rule modifying the requirements for acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) as support for an IND or application for marketing approval for a drug or biological product. The rule abandons the requirement that sponsors use the Declaration of Helsinki as the standard for ensuring protections for human subjects and, in its place, requires foreign studies to be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee. The rule is effective October 27.