‘Objectionable Conditions’ in Larkin Hospital IRB

An 11/12-11/19/22 FDA inspection at the Larkin Community Hospital institutional review board (IRB) in South Miami, FL, conducted as part of the FDA Bioresearch Monitoring Program, determined that the IRB did not adhere to applicable statutory requirements or FDA regulations governing the protection of human subjects in clinical trials. A 1/11 Warning Letter says the specific violations were:

• failing to review proposed research at convened meetings at which a majority of the IRB members were present, including at least one member whose primary concerns were in non-scientific areas;
• failing to prepare and maintain adequate documentation of IRB activities, including a list of IRB members; and
• failing to ensure that information given to subjects as part of informed consent follows the regulations.

Larkin was told to respond with a list of specific steps it has taken or will take to address the violations and prevent their recurrence.