Agency relies on universities to police their own problems, a strategy that may allow conflicts to go unresolved
Hundreds of financial conflicts of interest among university researchers have not been investigated by the National Institutes of Health, an agency that should police them, according to a new audit report.
The report, by the inspector general of the Department of Health and Human Services — NIH’s parent agency — describes a dysfunctional system that falls short of public accountability. It relies largely on universities with NIH grants to police themselves, merely requiring them to notify the agency that conflicts were resolved. More than 90 percent of such notices do not explain how the institutions handled the problems.
Worse, the NIH rarely asks universities to provide these missing details, the inspector general said in the January audit.
The NIH, in a response, argued that it was following existing regulations, which provide “an appropriate framework for the effective management” of conflicts and do not require the agency to gather details from universities.
But one bioethicist observed that if universities’ reports about conflicts contain no useful information, their submission is a pointless exercise. Jeffrey P. Kahn, director of the Center for Bioethics at the University of Minnesota-Twin Cities, said the NIH “has no evidence to support their assertion that things are working fine.”
In recent years, members of Congress have called for tighter controls on financial conflicts in biomedical research. These arise, for example, when a researcher running a clinical study receives stock or consulting fees from a corporation financing the trial. Experts say this can bias findings and jeopardize human subjects.
The NIH tightened rules for its own “intramural” staff scientists in 2005 in response to this pressure. But lawmakers have put less heat on the agency about university-based researchers.
Bioethicists suggested that the NIH is itself conflicted about how to handle financial conflicts. The NIH is the largest source of money for university research and has faced pressure from the scientists it supports not to raise regulatory roadblocks to their work.
First Look at Report Details
The inspector general’s report, “National Institutes of Health: Conflicts of Interest in Extramural Research,” is the first broad evaluation of universities’ compliance with a 1995 regulation requiring them to notify the research agency when NIH-supported researchers have a “significant” financial conflict. The regulation defines this as income or equity interest of $10,000 in a company that finances the research or 5-percent ownership of its stock.
The inspector general asked the NIH for all those reports for the 2004 to 2006 fiscal years and received 438.
Among the findings, two-thirds of the reports provided not even basic information about the persons in conflict, like whether they were the principal investigators or assistants. More than 90 percent of the reports did not detail the nature of the conflicts.
And nearly 90 percent offered no explanation of how the grant recipients would handle the conflicts, only that they would be managed, reduced, or eliminated, an assertion that met only the bare minimum required by the regulation.
In one memo discovered by auditors, an NIH official said that “we can ask for additional information; however, this would only be done in rare/exceptional situations” in which a financial conflict “could harm the project.”
Another NIH official did the bureaucratic equivalent of covering his or her ears: The auditors reported that “we found five cases in which a grantee institution resubmitted reports because NIH felt that the information originally provided was too specific or detailed.”
The auditors also faulted the NIH for being unable to track all the reports it received or even count them. Of the agency’s 24 separate grant-making institutes and centers, 11 provided no reports for the three-year period, saying they would have to search through numerous paper or electronic files to find them.
In an interview after the release of the report, NIH officials acknowledged that problem and said they were already planning, before the auditors’ report, to develop a new, Web-based system to track the reports through a central office. The new system is to be unveiled in March. It will eventually allow universities to submit reports electronically.
The auditors said the NIH had power under the existing regulation on financial conflicts to seek more information. But their report also encouraged the Department of Health and Human Services to amend the existing regulation to require the additional details. (A department spokesman, Bill Hall, said that the department was still reviewing the report and had no comment.)
NIH Cites ‘Proactive Approach’
That suggestion in the report faces stiff opposition from the NIH and colleges.
The NIH is already “certainly taking a proactive approach” to help educate universities about their responsibilities under the existing regulation to effectively manage or eliminate financial conflicts, said Norka Ruiz Bravo, the agency’s deputy director for extramural research, in an interview.
The agency conducted site visits at 18 NIH-financed institutions in the 2006 fiscal year, specifically to evaluate their policies on managing conflicts and whether faculty members understood them. The agency announced in October that it planned to visit additional institutions. However, the NIH did not evaluate whether the universities it checked out in 2006 made the right calls about disclosing or limiting researchers’ conflicts.
The NIH is opposed to making those judgments because it “would effectively, if not legally, transfer the locus of responsibility” for managing conflicts “from the grantee institution to the federal government,” the NIH said in its written response to the auditor’s report. Universities are better positioned than the government to evaluate and manage conflicts, the agency wrote, because the institutions know the circumstances best and possess the authority to control their employees’ actions.
“We’re not a regulatory agency,” Ms. Ruiz Bravo said.
It would be “utterly unfeasible” for the NIH to review the universities’ judgment calls, said David Korn, a senior vice president at the Association of American Medical Colleges.
“It’s very, very hard to second-guess them from a distance without knowing every fact and circumstance that led to a decision,” which is often complex, he said. “To describe that in a report would be a voluminous pain for the reporter and the one who has to read it.”
However, his argument ignores that the Department of Health and Human Services checks up on self-policing universities when it comes to other ethically sensitive aspects of biomedical research. The Office for Human Research Protections, which monitors studies with humans as experimental subjects, and the Office of Research Integrity, which monitors scientific fraud, can and do push universities to re-examine cases that the offices believe the universities mishandled.
“Why is what’s good for the goose not good for the gander?” said Mr. Kahn, the Minnesota bioethicist.
Those two offices once resided on the NIH campus but were moved during the 1990s to the office of the secretary of health and human services to give them more independence and weight. A similar relocated group is needed to monitor financial conflicts, said Arthur L. Caplan, director of the Center for Bioethics at the University of Pennsylvania.
Such a change should not be made, however, unless Congress or a federal advisory commission offers universities guidance about how to manage financial conflicts, Mr. Caplan said. Existing guidance is vague, he said. Studies have indicated that universities have adopted differing remedies for the same kinds of conflicts.
Dr. Korn says colleges have improved their oversight of conflicts in recent years, but more remains to be done. Hoping to provide better guidance, the medical-colleges association and the Association of American Universities plan to release a new report on conflicts in the spring. It will contain case studies and offer a methodology for managing them.
However, he cautions, no “cookie-cutter approach” can dictate all such decisions.
http://chronicle.com Section: The Faculty Volume 54, Issue 21, Page A8
