Acceptance of Foreign Clinical Studies - Information Sheet

Information Sheet - Guidance for Institutional Review Boards and Clinical Investigators (Acceptance of Foreign Clinical Studies)

The Food and Drug Administration (FDA) may accept clinical studies conducted outside the United States in support of safety and efficacy claims for drugs, biological products and medical devices.

All drug, biologic and device studies conducted under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) are governed by the FDA informed consent and IRB requirements. [See 21 CFR part 312 IND regulations and 21 CFR part 812 IDE regulations.]

Under 21 CFR 312.120(c)(1), FDA will accept a foreign clinical study involving a drug or biological product not conducted under an IND only if the study conforms to whichever of the following provides greater protection of the human subjects:

• the ethical principles contained in the 1989 version of the Declaration of Helsinki, or
• the laws and regulations of the country in which the research was conducted.

Under 21 CFR 814.15(a) and (b), FDA will accept a foreign clinical study involving a medical device not conducted under an IDE only if the study conforms to whichever of the following provides greater protection of the human subjects:

• the ethical principles contained in the 1983 version of the Declaration of Helsinki, or
• the laws and regulations of the country in which the research was conducted.

Also see these FDA Information Sheets:
"Non-Local IRB Review"
"Waiver of IRB Requirements for Drug and Biologic Studies"
"Informed Consent and the Clinical Investigator"
Declaration of Helsinki--the 1983 and 1989 versions