FDA sends warning letter to community hospital review board over research concerns
An institutional review board (IRB) for a hospital in South Florida has been hit with a warning letter from the FDA over concerns raised during an inspection late in 2021.
The letter, sent earlier this month to Sima Marzban, the VP of research and academic affairs for the Larkin Community Hospital Institutional Review Board, states that an inspection was conducted in November to see if the hospital’s human studies complied with FDA requirements. The site was issued a Form ‘483, however, investigators noticed after reviewing the IRB’s response that it “did not adhere to applicable statutory requirements” that govern the protection of human subjects.
Specifically, investigators took issue with how the IRB reviewed proposed research. The agency accused the IRB of reviewing and approving research at meetings in which a majority of members (including one “nonscientist”) were not present, going against requirements. In the response to the FDA, the IRB promised it would take steps to correct this, but the agency wasn’t completely satisfied.
“We are unable to perform an informed evaluation of the IRB’s written response because you did not provide a corrective action plan that, if properly carried out, would prevent the recurrence of this type of violation in the future. Specifically, you did not provide sufficient details on the procedures you are initiating and how you will ensure that a majority of the IRB members, including at least one member whose primary concerns are in nonscientific areas, will be present at convened meetings when proposed FDA-regulated research is under review,” the letter said.
The letter also said that the IRB did not maintain documentation of its activities, including a list of current members, and that it had failed to ensure its process for providing patients with information as a part of informed consent was up to code.
More specifically, investigators accused the IRB of failing to make sure that the informed consent documents for two clinical trials contained a statement notifying the patient that their trial information “has been or will be submitted for including in the clinical trial registry databank.”
The response to the FDA did note that “actions were in motion to establish best practices” and that future trial documents would include the statement. However, the letter notes that the response did not include an action plan for preventing the recurrence of this violation in the future.
“Specifically, you did not provide sufficient details on the best practices you are establishing and how you will ensure that the ICDs will contain the statement,” the letter said.
Endpoints News reached out to Larkin Community Hospital, but did not receive a response by press time.