Call for Crackdown on Research Conflicts

Financial and other conflicts of interest have been thrust near the top of the agenda of the National Institutes of Health in recent years, put there by lawmakers concerned about whether the conflicts distort researchers' findings in ways that may not be in patients' best interests. But for the most part, the attention has focused on the extent to which the NIH monitors and restricts the biomedical research agency's own internal researchers, rather than the university and other researchers who receive billions of grant dollars from the agency each year. That may be about to change.

On Friday, the inspector general of the Department of Health and Human Services, of which the NIH is a part, released an audit in which it found that the NIH did relatively little to gauge the extent of financial conflicts of interest among academic researchers.

The inspector general's office called on the agency to significantly ramp up its internal oversight of what universities report and to seek to change federal rules so that the NIH can do more to judge whether research institutions are appropriately managing and eliminating conflicts of interest. The latter recommendation was immediately opposed by the NIH itself and by university research officials.

Requiring the NIH to "become involved in research institutions' own management of specific conflict of interest cases," the Association of American Medical Colleges argued in a news release Friday, is both "unfeasible and beyond the NIH's existing statutory authority."

But the HHS report was welcomed by U.S. Sen. Charles Grassley, an Iowa Republican who last summer called for a national reporting system of drug company payments to doctors. “Universities receive NIH dollars with the understanding that they will manage their researchers’ conflicts of interest," Grassley said in a statement Friday. "However, my investigations have uncovered several instances where grant-funded doctors also have taken money from pharmaceutical companies and not reported it to their institutions.

"Universities need to take this issue more seriously, and the NIH should monitor its grants more closely for this problem.”

The NIH is the biggest provider of federal funds for academic researchers, and under its existing rules, universities whose scientists receive money from the agency must have a written policy for identifying financial conflicts of interest (with drug companies, as a prime example) and for ensuring that those conflicts are "managed, reduced or eliminated."

Before a grant recipient spends any NIH funds, his or her university must inform officials at the institute that provided the funds (National Cancer Institute or National Institute of Mental Health, for instance) of any conflicts identified and whether the university eliminated the conflict, reduced it, or otherwise "managed" it. The NIH's individual institutes are encouraged, but not required, to forward those conflict of interest reports to the NIH's Office of Extramural Research.

When the Office of Inspector General asked all 24 institutes that provide external grants for copies of the conflict of interest reports they had received from university grantees from 2004 to 2006, however, they found that nearly half the institutes could not provide any such reports. In addition, the NIH could not provide an accurate count of how many conflicts reports it had received from institutions, the audit found.

The inspector general's office also concluded that the information the NIH did receive from institutions offered little insight into the nature or extent of financial conflicts. Most did not explain the nature of the conflict, identify which individuals were potentially conflicted, or say how the institution planned to eliminate or manage the conflict. (Of those that did identify the nature of the conflicts, some of the potential problems included researchers who had financial interests in companies that were subcontractors on the grant, and universities holding patents on technology used in the research and licensing the intellectual property for that technology exclusively to a company whose owners are investigators on the grant, the inspector general's report found.)

In addition, the IG's report found that most of the NIH institutes relied primarily on assurances from universities that they were following conflict of interest rules, rather than directly overseeing universities' compliance with the rules.

Those findings led the inspector general's office to recommend that NIH:

• Increase its internal oversight to ensure that universities that receive its grants are complying with federal rules on conflict of interest, either by increasing site visits or more aggressively collecting and reviewing institutions' own conflict of interest policies.
• Require (rather than encourage) its own institutes to send the conflict of interest reports they receive from grantees to a central repository, and that the new collection system capture information such as the name of the researcher responsible for the financial conflict and a description of how the conflict was managed, reduced or eliminated.
• Seek to change federal rules to require that institutions report to the federal agency significantly more information about the nature and resolution of financial conflicts. "Enough details should be provided so that NIH can identify concerns and adequately monitor whether grantees are complying with the regulatory requirements to identify and manage conflicts."

In their comments on the inspector general's audit, NIH officials embraced the overall thrust of the report but disputed the last recommendation, which they said would "effectively, if not legally, transfer the locus of responsibility for managing [financial conflicts of interest] from the grantee institution to the federal government."

Academic researchers agreed that that would be a mistake. Susan Ehringhaus, associate general counsel for regulatory affairs at the Association of American Medical Colleges, said that it would be difficult if not impossible -- not to mention inappropriate -- for the NIH to try to second guess whether institutions have made the right call in how they dealt with a particular financial conflict.

"Evaluation of potential conflicts of interest is very difficult and context specific, so highly dependent on an awareness of exactly what role the investigator plays and the nature of the study in question," Ehringhaus said. "That's why you want, on conflicts of interest committees, senior respected institutional faculty who understand those things and are able to bring that kind of contextual awareness to their judgments. There is no way, in my view, that the NIH could possibly duplicate those capacities."

For the NIH to begin consistently reviewing universities' decisions about how to handle conflicts, if federal rules were changed to mandate that, would "require an enormous new staff with new training -- a whole new regulatory apparatus," she said. "And this in a day where we have excellent science going begging for funding. That seems like a strange scenario."

AAMC officials insisted, however, that those reservations were not meant to suggest that they oppose appropriate federal oversight, or that they believed universities have the problem fully under control.

"The Inspector General's report is an important reminder that a robust, credible, transparent system of monitoring potential financial conflicts of interests in federally funded research is critical to protecting patients' interests and scientific integrity and maintaining the public's trust," Darrell G. Kirch, the association's president, said in a prepared statement. "The implementation of conflict of interest management programs at academic medical centers has been a challenging undertaking, and the AAMC acknowledges that there is opportunity for improvement."

He added: "The AAMC supports federal regulations requiring that both the NIH and the grantee institution be vigilant in fulfilling their obligations to identify, disclose, and manage researchers' financial conflicts of interest. A system in which both entities share responsibility for the oversight and management of such conflicts is the most effective way to ensure transparency, public accountability, and responsible stewardship of federal resources."