FDA 483 - Human Subjects Research Committee - August 23, 2018

An FDA inspection conducted from August 7-23, 2018, at the Human Subjects Research Committee, part of Hennepin County Medical Center (Hennepin Healthcare System, Inc.), identified significant deficiencies in its oversight of human subject research. The inspection revealed that the Institutional Review Board (IRB) failed to ensure proper informed consent for research participants, specifically approving studies with waivers of consent without meeting the stringent requirements of 21 CFR 50. This included studies involving vulnerable subjects, such as those with impaired ability to give informed consent, where no additional safeguards were documented or implemented to protect their welfare. Furthermore, the IRB improperly utilized expedited review procedures for research that did not qualify under FDA guidelines, including requests for emergency use of experimental products and studies using unapproved devices. A critical finding was the absence of written procedures for the IRB's initial and continuing review of research. This procedural gap extended to determining safeguards for vulnerable populations and managing their study tracking database. To address these issues, the Human Subjects Research Committee must establish robust written procedures, ensure rigorous adherence to informed consent regulations, and implement appropriate protections for vulnerable research participants, aligning all processes with federal human subject protection requirements.