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OIG Report: NIH Isn’t Keeping Tight Tabs on Financial Conflicts of Interest

NEW YORK (GenomeWeb News) – The National Institutes of Health cannot provide an accurate account of how many financial conflicts of interest its extramural grantees reported between 2004 and 2006, and it does not know what types of financial conflicts arose even among those who reported during those years, according to a report recently published by the Office of the Inspector General at the Department of Health and Human Services.
 
In addition, the OIG said that the NIH currently has no effective oversight measures for enforcing its policies on such conflicts.
 
According to the OIG, institutions receiving NIH funds must have written and enforced policies concerning financial conflicts of interest and must submit reports about them to the NIH, and any conflicts must be “managed, reduced or eliminated” within 60 days after they have been identified. When the OIG requested such information, the NIH was unable to provide an accurate count of how many such conflicts its grantees reported during the three-year period.
 
Another problem identified by the OIG is that the reporting institutions themselves are the NIH’s only source for such information, and the NIH does not require that they divulge the nature of the conflicts. “Many institutes rely on the good faith of the grantee institutions to ensure compliance with federal financial conflict-of-interest regulations, rather than directly overseeing or reviewing grantee institutions’ management of financial conflicts of interest,” the OIG noted.
 
According to the report, the NIH concurred with all three of the OIG’s findings and said it would agree to adopt OIG recommendations to address two of the issues. The NIH did not agree with a recommendation to require grantees to provide details about the nature of financial conflicts or information about the way it is managing, reducing, or eliminating these conflicts.
 
The NIH was able to hand the inspectors 438 COI reports for the three-year period. The OIG said that number is not accurate because the NIH’s Office of Extramural Research was unable to give the inspectors “all of the actual conflict-of-interest reports it had received from grantee institutions.”
 
The reports also overwhelmingly did not include descriptions as to the nature of the financial conflicts. Only around 11 percent, or 30 of the 438 total reports, provided such information.
 
According to the OIG, “These reports described cases, for example, in which the investigators have intellectual property associated with the grant research or financial interests in companies that are subcontractors on the research grants.”
 
In addition, only half of those 30 reports outlined how those conflicts would be managed, reduced, or eliminated.
 
The scale of potential conflicts and the penalties they can elicit came starkly to light just over a year ago when a senior researcher at the National Institute of Mental Health convicted of a felony, sentenced to two years of probation, and forced to surrender $300,000 for a financial conflict of interest.
 
Pearson Sunderland, who was a senior scientist at NIMH, failed to disclose to the NIH and to the DHHS $300,000 he had accepted from the drug company Pfizer for consulting services on two biomarker research projects that overlapped with his other NIH research related to cerebrospinal fluid and Alzheimer’s disease.
  
In a response to the draft report’s recommendation that it require grantees to provide details about financial conflicts of interest and how they are handled, NIH said collecting such details “would effectively, if not legally, transfer the locus of responsibility for managing [conflicts] from the grantee institution to the federal government.” It added that it believes such oversight should remain with grantee institutions.
 
The NIH, however, did agree with a recommendation requiring that the Office of Extramural Research receive and file in a database all reports it receives from grantees and to enhance its oversight policies, including developing new conflict reporting tools.