Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the IRB at Hennepin County Medical Center (HCMC) over IND and informed consent issues on some of their trials.

The two clinical investigators — Jon Cole and Lauren Klein — received warning letters earlier this year for initiating and conducting trials without submitting and obtaining INDs. Though the investigators contended that they didn’t need to seek INDs for their trials because the drugs administered weren’t research interventions, the agency didn’t agree.

In the case of the IRB, it received a Form 483 from an Aug. 7-23, 2018, inspection that identified multiple observations. Among those, the agency observed that the IRB should not have approved waivers of consent for the investigators’ studies. The agency also observed that the IRB had approved research “in a situation where some or all of the subjects were likely to be vulnerable to coercion or undue influence” but didn’t check to see if safeguards had been established to protect these vulnerable patients (who had an impaired ability to give informed consent).

Public Citizen wants the FDA to make an example out of the investigators, their co-investigators and the medical center, arguing that the violations are serious enough that a “slap-on-the-wrist approach for such noncompliance … will not suffice.”

Although CenterWatch Weekly asked the FDA to elaborate on the situation, the agency declined, stating that it would “review the petition and respond directly to the petitioner.”

Hennepin Healthcare issued a statement on Nov. 16, explaining that the FDA had deemed its corrective actions sufficient. The statement also includes a summary of the changes the institute made to bolster its research program.

“Hennepin Healthcare, the Hennepin Healthcare Research Institute and the researchers involved in studies approved in 2014 and 2016 have taken many actions to strengthen and improve the clinical research program across the institution since the studies were closed in 2018,” HCMC said. “These changes have been shared with the FDA in detail and in October the FDA informed the researchers that the measures taken result in compliance with FDA regulations.”

Read the Public Citizen letter here: https://bit.ly/3qK7OKm.