FDA Letters about Improper Research

May 2, 2018

Human research involving products regulated by the FDA must follow stringent guidelines. All such studies must be monitored by an Institutional Review Board (IRB) whose function is to assure the protection of the rights and welfare of the human subjects. IRBs are not required to register with the FDA, but investigators must submit a form to the FDA that includes the name and address of the IRB for their study. This enables the FDA—should it choose to do so—to conduct inspections to determine whether the research is being properly conducted and monitored. In recent years, some manufacturers and “alternative” practitioners have created IRBs and/or sponsored research in order to pretend that what they offer is part of a legitimate research project. This page indexes documents in which the FDA or an IRB issued a warning, termination letters, or other notice related to inappropriate research.

IRB Letters
Investigator Letters
Letters to Sponsors
Proposed Debarment
Debarment Orders
Additional Information

This page was revised on May 2, 2018.