Monday, 27 December 2010

1572 in International Setting

There has been ample discussion on the FDA1572 and its use in international research. The FDA has provided some useful guidance this year. Some highlights from that today.

Local Law vs CFR
If a foreign clinical study is being conducted under an IND, investigators are responsible for complying with the applicable laws and regulations of the country in which the study is being conducted, regardless of whether the study is being conducted under an IND. The FDA recommends that sponsors obtain signed, written statements from investigators acknowledging their commitment to comply with local laws and requirements. In addition, if a foreign clinical study is being conducted under an IND, the investigator must sign Form FDA 1572 (investigator statement) and ensure that the study is conducted in accordance with the investigator statement and all other applicable regulations under 21 CFR Part 312.

Signing of the 1572 by a foreign investigator in a study under IND
We know that a foreign investigators cannot commit to all of the requirements on the form, specifically IRB membership (21 CFR 56.107). IRB review and approval is required before a clinical study can be initiated under an IND (21 CFR 56.103(a)).

FDA may waive any of the IRB requirements but only when alternative mechanisms for ensuring protection of the rights and welfare of human subjects are acceptable. In this case, typically an Independent Ethics Committee (IEC) that operates in accordance with Good Clinical Practice (GCP) is utilized instead of a U.S. IRB. Although its membership and functions for assuring human subject protection are comparable to an IRB, an IEC may not meet all of the IRB requirements contained in 21 CFR Part 56.

The sponsor should submit a waiver request to the IND under which the study will be conducted. The sponsor will be informed by the agency in writing whether the waiver request is denied or granted.

IMPORTANT: If a waiver is granted, the sponsor should have investigators attach a copy of the letter granting the waiver to the signed 1572 in the investigator’s gold