The FDA has updated its guidance on Form 1572, the FDA’s Statement of Investigator, to clarify what sponsors can or should do if a foreign investigator is unable or unwilling to sign the form.

The guidance was developed in response to sponsor questions on how to proceed if regional, national or local laws or regulations prohibit a foreign investigator from signing the form. One option is to request a waiver from the FDA. Another is to have the foreign site operate as a noninvestigational new drug (IND) site.

The FDA also recommended that sponsors obtain signed, written statements from investigators acknowledging their commitment to comply with any applicable regional, national or local laws.

For sponsors that choose to conduct a foreign clinical study or to operate non-U.S. sites in a multinational study under an IND, the FDA says the foreign investigators would still be in compliance with U.S. regulations if they follow International Council for Harmonization (ICH) E6 Good Clinical Practice guidelines, with two exceptions:

• FDA requirements for IRBs differ slightly under ICH E6, so sponsors would need to request an additional waiver; and
• Informed consent requirements for IRBs are more extensive under ICH E6 than under FDA regulations.

Comments on the draft guidance are due by July 19.

Read the FDA guidance here: https://bit.ly/3u79ICC.