Monday, March 16, 2015

In Wake of Report on University of Minnesota’s Apparent Failure to Adequately Protect Human Research Subjects, Public Citizen Calls for Investigation

Press release from Public Citizen, March 16 2015

System for Protecting Human Subjects Appears to Have Serious, Systemic Failures; Accreditation Should Be Rescinded

WASHINGTON, D.C. – Public Citizen today called on the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) to launch an investigation after a recent report revealed the University of Minnesota’s (UM) apparent failure to adequately protect human research subjects. In light of these findings, Public Citizen also calls on the Association for the Accreditation of Human Research Protection Programs (AAHRPP) to immediately rescind its accreditation of the human subjects protection program at UM.

The report was commissioned by UM through a contract with AAHRPP and prepared by an external review team comprising six experts.

“The alarming findings by the external review team echo some of the most serious instances of systemic failures of human subjects protections uncovered at major academic institutions over the past two decades,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and formerly a senior official at OHRP. “These finding also appear to represent a clear danger to the rights and welfare of human subjects enrolled in medical research studies at UM.”

Read the rest of the Public Citizen press release.  

Read the Public Citizen letter to OHRP.  

Read the Public Citizen letter to AAHRPP.

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