A controversial decision by the Department of Health and Human Services' (HHS) Office of Human Research Protection (OHRP) that many feared would stall quality improvement studies has been reversed.
The study that prompted the initial decision was led by Peter Pronovost, MD, PhD, medical director of the Center for Innovation in Quality Patient Care at Johns Hopkins University in Baltimore. That study now will be allowed to continue because OHRP officials have determined that human research protections regulations no longer apply.
In December, the OHRP had ordered Pronovost and his collaborators to halt their study evaluating the use of checklists to prevent hospital-acquired blood infections in intensive care units of Michigan hospitals. The regulators claimed that the investigators had failed to comply with federal requirements for human research subjects protection. However, the researchers and many quality improvement experts were surprised by the decision because such quality improvement . . . [Full Text of this Article]
