No FDA Action Against Accused Researchers
FDA has denied an 11/2021 Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minneapolis, MN, who “repeatedly and deliberately violated agency regulations intended to protect human subjects.” The advocacy group said the doctors conducted a series of clinical trials that tested the general anesthetic ketamine and powerful sedatives on agitated patients without their consent. The petition also called on FDA to disqualify the medical center institutional review board for violating federal human subject protection regulations by approving the trials without ensuring that informed consent requirements for such experiments were implemented. The group says the violations involved four separate clinical trials conducted from 2014 to 2018.
In denying the petition, FDA acknowledged the “importance of the issues they raise. As with judicial enforcement, the aagency makes decisions regarding whether to pursue administrative enforcement action, including disqualification proceedings, on a case-by-case basis, considering all relevant facts and circumstances. Where appropriate, the agency considers information provided by the individuals or entities involved, as well as other information regarding the specific circumstances of the matter. At this time, we are not taking the actions you requested.”
In response to the petition denial, Public Citizen said: “The FDA’s failure to seriously sanction HCMC researchers sends a clear signal to the research community and public that the agency is not serious about protecting the rights and welfare of human subjects. Over a four-year period, HCMC researchers engaged in a pattern of repetitive egregious violations of federal regulations intended to protect human research subjects. The FDA should have required the hospital to contact the more than 1,700 patients who were unwittingly enrolled in unethical experiments and inform them that their rights were violated and that their health was potentially endangered by the medical center’s researchers… The FDA’s slap-on-the-wrist approach to such appalling regulatory and ethical violations risks emboldening other researchers to disregard the rights and welfare of human subjects.”
FDA’s response, however, did leave open other actions it may take in the future, adding that it will “continue to consider all the options available to the agency as we determine whether to pursue additional compliance actions related to this matter.”