The New York Times-20080127-Pointy-Headed Regulation- -Editorial-
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Pointy-Headed Regulation; [Editorial]
Full Text (446 words)How's this for a nonsensical regulatory position?
The federal Office for Human Research Protections has ruled that it is perfectly fine for hospitals to use checklists to remind doctors and nurses to wash their hands and follow other sanitary procedures -- provided the goal is to improve the quality of care given to patients. But if those hospitals want to analyze what impact the checklists might have in reducing infections, that counts as research and they must first seek approval from institutional review boards.
These review boards were set up to protect patients from being harmed -- by risky drugs or treatments -- in the course of medical research. Seeking approval is a cumbersome process that could delay studies for months. Surely, as the nation's health care system works to reform dysfunctional practices, this makes no sense. The rules intended to protect patients could instead slow organizational reforms that would benefit the patients.
This bizarre outcome came to light when Johns Hopkins researchers coordinated a study of whether bloodstream infections acquired in intensive care units could be reduced if doctors and nurses followed common-sense procedures to wash their hands, wear sterile garb and wash a patient's skin with antiseptic before inserting a catheter. The results in 67 cooperating hospitals in Michigan were astonishing. Infection rates dropped by two-thirds, and the procedures saved an estimated 1,500 lives and almost $200 million.
Then an anonymous critic complained to federal regulators that the study had not been approved by an institutional review board and had failed to obtain the informed consent of human subjects. The Office for Human Research Protections, a unit of the federal Department of Health and Human Services, forced Johns Hopkins to suspend further research until review board approval was obtained. It stressed that hospitals were free to follow the procedures if the goal was to improve patient care, and they could even monitor their infection rates. But once a research component is added, federal laws and regulations require that human subjects be protected by review board oversight.
The regulators apparently reasoned that there was at least a small chance that the procedures under study could backfire and increase the rate of infections, and a possibility that doctors and nurses might suffer adverse consequences if their performance or comments angered colleagues or employers.
The Bush administration -- which has eviscerated many regulations for no good reason -- has ample justification this time to revise a regulation in the interests of health care reform. It needs to make evaluations of programs to improve the quality of health care easier, not harder. If it does not, Congress will need to step in with legislation to expedite such studies.
