Clinical Trials, Wrapped in Red Tape

NY Times ^ | August 8, 2009 | SALLY SATEL

[neverdem]

Op-Ed Contributor

Washington

IT’S Christmas in August for hopeful scientists. The National Institutes of Health is now sending out its annual “priority scores,” the indicators of whether grant requests will likely receive financing from the agency. And hearts are beating faster than ever, as the federal stimulus package has poured an additional $8.2 billion into the institutes’ budget specifically for research.

However, for those grant-winners whose studies will involve human volunteers, another big hurdle remains: federal ethics regulations. No one denies the need to shield human subjects from undue risk. But current regulations have become so stringent and unwieldy that the ethics oversight system often impedes the kind of careful research we should be promoting. As two highly regarded medical ethicists, Dr. Norman Fost of the University of Wisconsin and Dr. Robert J. Levine of Yale, put it in the Journal of the American Medical Association, the system regulating the use of human subjects is “increasingly dysfunctional.”

This sort of dysfunction was on display last year after the Office for Human Research Protections, a regulatory branch of the Department of Health and Human Services, halted a University of Michigan study of a simple five-step checklist to prevent infections at health centers. The checklist merely routinized procedures that should be performed anyway, including washing hands with soap and cleaning a patient’s skin with antiseptic. But because researchers intended to assess the checklist’s success, their work met the strict definition of “research,” and thus required patients’ informed consent. Because they had never obtained it, the human research office shut the study down...

[SunkenCiv]

...dysfunction was on display last year after the Office for Human Research Protections, a regulatory branch of the Department of Health and Human Services, halted a University of Michigan study of a simple five-step checklist to prevent infections at health centers. The checklist merely routinized procedures that should be performed anyway, including washing hands with soap and cleaning a patient's skin with antiseptic. But because researchers intended to assess the checklist's success, their work met the strict definition of "research," and thus required patients' informed consent. Because they had never obtained it, the human research office shut the study down...

Thanks neverdem.