The U.S. government should create a single office to monitor both public and private research involving human volunteers, says a new report released last week by a presidential commission. The report, 5 years in the making, concludes that major changes are needed in the oversight of clinical research. But it's not clear if the new occupant of the White House is listening.
The new report by the National Bioethics Advisory Commission (NBAC) is the broadest of several the panel has issued since 1996. The panel has tackled a variety of focused issues, from how to obtain consent from people with impaired judgment to the ethics of running tissue collections. The new recommendations, which represent the commission's cumulative investigations, "reflect a dual commitment to ensuring the protection of those who volunteer for research while supporting the continued advance of science."
The biggest change would be the extension of federal jurisdiction over all private research with human volunteers. At present, privately funded research comes under government review only if it is part of a government-funded project or is being used to support drugs under review by the Food and Drug Administration. The reason for the change is that the commission "felt that the principle of respect for participants in human research is one that extends to all participants, regardless of funding source," says its executive director, Eric Meslin.
The new office, which the panel labeled the National Office for Human Research Oversight, would set policy, issue and enforce regulations, oversee research, and disseminate information. It would not fall under the jurisdiction of the Department of Health and Human Services (HHS), parent to the 1-year-old Office for Human Research Protections (OHRP), the current overseer of federally funded clinical research.
But Robert Rich of Emory University in Atlanta, Georgia, president-elect of the Federation of American Societies for Experimental Biology (FASEB), doesn't see a compelling reason for such a change. The existing OHRP "has all the tools it needs" to oversee human subjects research, he says, and a panel housed outside HHS would be subject to greater political pressures.
Another obstacle to the plan is that NBAC can't ensure that the government will pay attention to its long-debated conclusions. The president who sought this advice--Bill Clinton--is gone, and the new Administration is far from attuned to these concerns, with no science adviser and a skeletal scientific staff.
With reporting by Gretchen Vogel