Public Citizen Urges FDA to Disqualify Minneapolis IRB, Investigators from Trials

Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the institutional review board (IRB) at Hennepin County Medical Center (HCMC) over investigational new drug (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.

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.”

Hennepin Healthcare issued a statement on Nov. 16, explaining that the FDA had deemed its corrective actions sufficient.