The federal office that oversees the safety of people participating in medical research should be significantly elevated from its current position in the lower echelons of the National Institutes of Health to a more commanding position close to the secretary of health and human services, a government panel recommended yesterday.
The Office for Protection from Research Risks (OPRR), which enforces federal regulations regarding human research, is financially and politically dependent upon the NIH -- the very agency that sponsors most of the research the office is supposed to regulate. That creates "both the appearance and the actuality of a conflict of interest," the panel told NIH Director Harold Varmus yesterday.
Moreover, the office's current position within NIH compromises its authority over other government agencies that conduct human research, the panel concluded. It warned that big agencies, such as the Defense Department, may feel less than beholden to OPRR's two dozen middle-level bureaucrats who toil in relative obscurity in Rockville, trying to keep tabs on the thousands of human research studies underway in this country.
Unless the office is moved to a position of greater stature, and is given the resources needed to do its job, the nation's biomedical research enterprise risks losing the confidence of scientists and the public alike, the panel concluded.
"There is a growing sophistication on the part of the public about the extent of the involvement of human subjects in research, the dangers that such research might present to human subjects, and the concern that the rights and welfare of human research subjects be protected," the panel told Varmus and a committee of his advisers at a meeting in Bethesda.
Varmus expressed his support for the panel's findings and said he would pass them along to Health and Human Services Secretary Donna E. Shalala, who will have final say over whether and how the report's recommendations will be implemented. A spokesman for Shalala said she would "review it quickly and make a decision."
Varmus last year asked the panel of six medical, legal and ethics experts to make recommendations after two independent federal investigations found problems with the nation's oversight of human research. Those investigations led to congressional hearings during which OPRR was at times portrayed as bureaucratically impotent.
Recently the office has taken some high-profile actions, including a shutdown of all human research at Duke University Medical Center for four days last month. But yesterday's report concludes that fundamental changes are needed nonetheless.
Specifically, the panel suggested that OPRR's director should report to either the assistant secretary for health or the surgeon general. Panel co-chair Nancy Dubler, director of bioethics at Montefiore Medical Center in New York, said panelists made the recommendation despite their recognition that there are risks in moving the office to the more politicized realm of the HHS secretary's office.
Members of Congress displeased with OPRR's actions against certain medical centers might threaten political punishment against high-ranking appointees within HHS, she acknowledged, if the office were perceived as being associated with those appointees. By contrast, she said, OPRR's current ensconcement deep within NIH has left it relatively immune to political pressures.
Co-chair Renee M. Landers, a Boston health care lawyer and former deputy general counsel at HHS, said the panel believes that such political pressures could be mitigated by creating an HHS advisory committee to oversee and protect OPRR.
The panel also determined that OPRR has all the legal authority it needs to accomplish its tasks, including educating researchers about the rules surrounding human research and enforcing existing laws. But its financial resources "may be inadequate" for its mission, the panel's report concluded.
In light of the responsibilities entailed in the position, the panel recommended that the director's job be upgraded from its current GS-15 position within NIH, which pays about $104,000, to that of Senior Executive Service member, which would pay about $10,000 more and provide added political leverage. That change would require OPRR's current director, Gary B. Ellis, to reapply for his job.
Ellis praised the panel for the level of expertise he said it had brought to its task, and said he and the office "look forward to the secretary's handling of the recommendations." Asked whether the panel's advice to elevate the personnel grade of the directorship might be a thinly veiled effort to dump him, he said: "Let's hope not."