When is a quality initiative just that? Hospitals still arent sure of the answer.
Even though HHS Office for Human Research Protections, or OHRP, backed off its initial decision that the use of an infection-control checklist constituted research, thus requiring informed consent from the patient, hospitals in Michigan plan to be much more cautious when identifying quality research in the future.
Hospitals will take a more conservative approach when deciding which quality projects must meet institutional review board approval to avoid another conflict with the OHRP, said Sam Watson, executive director of the Keystone Center for Patient Safety & Quality, the division of the Michigan Health & Hospital Association that was targeted by the office. If we want to do quality improvement right, it may look somewhat like research, he said.
The organization is thinking of implementing a surgical collaboration to reduce surgical-site infections but will submit the plan to its institutional review board before starting, Watson said.
The research offices ruling in Michigan might still have a negative impact on hospitals in general. Providers will be afraid of straying from regulations because the offices decision didnt clear up the confusion about when quality initiatives are research, said Ezekiel Emanuel, a physician and chairman of the bioethics department at the National Institutes of Health. The decision addresses the issue by evasion, Emanuel said.
The office determined that the infection-control checklist used in hospitals constitutes clinical practice, which doesnt require the more stringent research approval, although it maintained that the initial development of the list was research and should have gone through the institutional review board process.
Hospitals in Michigan are committed to rectify the unintentional error of classifying the initial phase of the initiative as quality as opposed to human subjects research. We note that the activities have evolved considerably since the inception of the project and have become the standard of practice, the office wrote Feb. 14 in its final determination letter to the Michigan hospital association.
That finding doesnt deal with the fundamental problem of recognizing the difference between zero-risk quality projects and research that could potentially harm subjects, and therefore needs greater protection, Ezekiel said. We need an entire rethinking of how we think of research, he said.