Still unresolved is whether Hopkins and other research institutions are required to undergo the same intensive reviews to studies on improvements in care, like checklists, as they now give to clinical trials where patients are given experimental drugs or treatments, he said.
"We are reviewing quality improvement activities as thoroughly as possible, but would welcome more clarification from the Office of Human Research Protection," Ford said in an e-mail yesterday.
Rules regarding the types of studies involving human subjects are currently being revised, according Kevin Schweers, a spokesman for OHRP.
The OHRP investigation, prompted by an anonymous complaint, sparked criticism among quality care experts concerned that requiring lengthy reviews of studies evaluating improvements in care would chill such research. Some experts expressed relief over the OHRP decision yesterday.
"All of us reacted strongly to what the OHRP initially did, but I think they've backed off to where they should be," said Dr. William Minogue, executive director of the Maryland Patient Safety Center.
Maryland hospitals with ICUs made checklists standard practice in 2005 with help from a group that included Pronovost, Minogue said.
OHRP's decision to conclude the federal review clears the way for Pronovost and other researchers to continue evaluating the checklist as well as other patient safety measures.
"We feel really happy that we'll be able to continue with this work," said Sam R. Watson, executive director of the Michigan-based Keystone Center for Patient Safety and Quality that is working with Pronovost.
In a letter released this week, the OHRP said Pronovost's research probably would have qualified for a waiver of patient consent requirements because of a minimal risk of harm. The work also would likely have been eligible for an "expedited IRB review," which experts say can be completed in a few weeks, depending on the hospital or medical school, experts say.
Pronovost said he has no problem with completing expedited IRB reviews.
"I think, if you look at their latest decision, they're being more reasonable," said Pronovost, a Hopkins professor and medical director of the Center for Innovation in Quality Patient Care.
dennis.obrien@baltsun.com
