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University of Minnesota hires internationally recognized organization to manage review of human protections programs

June 5, 2014

To fulfill a resolution issued by the University of Minnesota Faculty Senate calling for an inquiry to examine current policies, practices and oversight of clinical research on human subjects, the Office of the Vice President for Research (OVPR) announced today that the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) was hired to logistically manage the inquiry process.

The Dec. 5, 2013 Faculty Senate resolution called for an independent inquiry to examine the U’s current clinical practices on human subjects, in particular, clinical research involving adult participants with diminished functional abilities. The OVPR was charged by University President Eric Kaler to conduct the search, in collaboration with the University Senate, for the contractor to manage the inquiry with a panel of independent, outside experts.   

AAHRPP is an independent, non-profit accrediting body and is internationally recognized as an organization that sets the highest quality and ethical standards for human protections in research programs. AAHRPP will logistically manage a team of external, independent experts that will conduct the outside inquiry of the University’s human protections program. The experts include Dr. Melissa Frumin (Harvard Medical School), Joan Rachlin (former executive director, Public Responsibility in Medicine and Research), and Dr. Jeremy Sugarman (Johns Hopkins University). AAHRPP will play no role in the substantive analysis, decision-making, conclusions or recommendations of the team.

“The University of Minnesota is committed and vigilant in maintaining the highest standards in research practices involving human subjects,” said Vice President for Research Brian Herman. “From the start, our goal has been to ensure a vigorous process that fulfills the Faculty Senate’s request and is responsive to an external reviewer that will conduct a thorough, professional, independent and transparent review of our human subjects research practices. AARHPP submitted the strongest proposal and found the best outside experts from across the country to conduct the inquiry. We look forward to their report and will utilize its recommendations to ensure the University meets and exceeds the highest research standards to ensure the public’s trust in our programs. The process must also ensure university  researchers can continue to pursue life-changing research that will benefit Minnesotans and beyond without causing undue risk to participants in that research.” 

According to the request for proposal, issued on Feb. 13, 2014, the external contractor will independently manage the inquiry, and as the managing contractor, AAHRPP will work with the Chair of the Faculty Consultative Committee to ensure the expert investigative panel can obtain any records it deems necessary for a thorough and transparent inquiry. The review will include recommendations for remedying any deficiencies found with the University’s current clinical research program involving adult participants with diminished capacity.                                                                                                                        

The review is scheduled to take six months. When the inquiry is complete, the panel’s report will be made public and reported back to the Faculty Senate by the experts serving on the investigative panel.

For more information, visit http://www.research.umn.edu/news/external-review-rfp.html#.U5X30Bn2dz9.

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