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Media Statement: MHA Keystone Center for Patient Safety & Quality OHRP Ruling
Date:2/20/2008

LANSING, Mich., Feb. 20 /PRNewswire-USNewswire/ --

Background: In August 2007 the U.S. Department of Health and Human Services, Office of Human Research Protection (OHRP) expressed the belief that the MHA Keystone Center for Patient Safety & Quality Intensive Care Unit (ICU) collaborative was human subjects research and not quality improvement. As a result, the collaborative required review by the Institutional Review Board (IRB) at each participating hospital.

In light of OHRP's determination, the MHA Keystone Center worked with the participating hospitals to meet the requirements of human subjects research, including IRB review, while at the same time questioning the ruling. On Feb. 14, 2008, the OHRP overturned its previous ruling regarding the ICU collaborative.

The following statement is from Spencer Johnson, president of the Michigan Health & Hospital Association (MHA):

"In light of the recent OHRP ruling, the MHA is delighted to be moving forward with the lifesaving work of the MHA Keystone: ICU collaborative. The final ruling reached by the OHRP falls in step with the MHA's original assertion that the work of the MHA Keystone: ICU collaborative represented quality improvement, as opposed to human subjects research.

"During the past months, the MHA Keystone Center for Patient Safety & Quality and its expert partner, Johns Hopkins University, worked with the OHRP to clarify the definitions of quality improvement and human subjects research and ensure compliance with all state and federal patient safety regulations.

"We believe the oversight role of the OHRP is vital in assuring that patients' needs are served. At the same time, we are hopeful that this experience will create an environment for dialogue to better support quality improvement activities without overly burdensome research oversight.

"The MHA Keystone Center is fully committed to improving quality patient care in all Michigan hospitals and is
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SOURCE Michigan Health & Hospital Association
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