After shutting down a Johns Hopkins-run trial that likely saved thousands of lives, the Department of Health and Human Services moved to reassure both hospitals and researchers that they won?t face unnecessary red tape when trying to improve patient safety.
“We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects,” said Dr. Ivor Pritchard, acting director of Office for Human Research Protections.
“HHS regulations provide great flexibility and should not have inhibited this activity. The regulations are designed to protect human subjects.”
Thursday?s clarification came after The Baltimore Examiner began asking questions about shutting down the Hopkins trial.
Johns Hopkins surgeon Dr. Peter Pronovost organized the statewide trial in Michigan to evaluate a safety checklist, which ultimately improved survival prospects of heart catheterization patients. The study, published in December 2006, showed a 66 percent drop in potentially fatal bloodstream infections.
Then came an anonymous complaint to the Human Research Protections office that patients did not have an opportunity to give informed consent.
The Human Research Protections Office ruled in December 2007 that any hospitals could implement such checklists but once Michigan and Hopkins started collecting data on their effectiveness, they crossed the line into human research that needed to be fully vetted by an institutional review board at each of Michigan?s 103 participating hospitals.
The ruling “sent a chill” through Pronovost and his colleagues, especially since he has similar large-scale studies planned.
“What it may do is, some of these hospitals that don?t have an [institutional review board], that don?t have a lot of resources, which may be in most need of these programs, are going to be the ones that we exclude,” he said. “Their response said you can do a checklist, but if you measure how it works, that?s research and needs to go through the full process.”
HHS is now reviewing the enforcement of these rules, as well as whether changes are needed to encourage similar work without compromising the rights and welfare of human subjects.
The HHS clarification letter went so far as to “strongly” encourage hospitals nationwide to adopt Pronovost?s catheterization program, “which can save thousands of lives and millions of dollars each year.”
The clarification also stated hospitals implementing the catheterization checklist may collect data on the effectiveness of clinical care for internal purposes without being subject to human research protections.
