Letter to HHS Secretary Regarding Failure of OHRP to Launch Investigation of University of Minnesota’s Human Research Protection Program

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View HHS’s September 18, 2015, response.

Public Citizen expressed alarm regarding the Office for Human Research Protections’ (OHRP) recent decisions (a) not to launch a formal investigation into the human subjects protection program at the University of Minnesota (UM); and (b) not to require UM to suspend enrollment in all ongoing human subjects research, particularly high-risk clinical trials, that had inadequate review by the UM institutional review board.