“I’m sure if there were anything to report they’d have sent it in.”

The National Institutes of Health does not like to play cop. Several years ago, it was caught neglectfully unaware of conflicts of interests among some of its own senior administrators and researchers. Several had received hundreds of thousands of dollars from pharmaceutical firms while on the NIH payroll. With Congress glaring in disappointment at the tarnished halo of its favorite agency, NIH management saw no choice and hurriedly imposed harsh restrictions on outside dealings by staff members.

Now, as periodically happens, the spotlight has turned to conflicts of interest in the ranks of NIH grantees. For identifying a conflict, federal regulations set a threshold of $10,000, in equity or annual payment, that might affect the design, conduct or reporting of NIH-supported research. Foolishly, NIH has responded that universities and medical centers should police themselves.

At latest count, some 325,000 researchers at 3,000 universities shared nearly 50,000 NIH grants. Too many for us to monitor, NIH says; our role, as specified in federal regulations, is to be kept informed.

The anti-cop sentiment is in the genes of the Bethesda bureaucracy. In 1993, with NIH’s blessings and gratitude, enforcement of scientific misconduct rules — a particularly messy and contentious endeavor — was removed from NIH and placed elsewhere in the parent Department of Health and Human Services (HHS). But management, or non-management, of conflict of interest remained at NIH.

In harmony with its distaste for the police function, NIH takes a minimalist approach to checking on conflict of interest among its grantees — so minimalist, that any less would be none. This has roused the attention of the HHS Inspector General. In a report, “National Institutes of Health: Conflicts of Interest in Extramural Research,” the IG says NIH should do its duty in regard to the conflict-of-interest regulations. NIH, predictably, says it would rather not, though members of Congress frequently growl about tawdry dealings between academic scientists and pharmaceutical companies. And NIH is very dependent on Congressional goodwill.

For coping with conflicts of interest, the regulations governing the responsibilities of NIH and its beneficiaries are an obfuscatory wonderland. As the IG notes, “NIH is not aware of the types of financial conflicts of interest that exist within grantee institutions because details are not required to be reported and most conflict-of-interest reports do not state the nature of the conflict.”

Abbreviated as they are, the number of conflict reports forwarded to NIH by grantee institutions is amazingly small, given the many recipients of NIH’s money. “NIH could not provide an accurate count of the financial conflict-of-interest reports that it received from grantees during fiscal years 2004 through 2006,” the IG reported.

“NIH provided us with 438 conflict-of-interest reports for fiscal years (FY) 2004 through 2006,” the report continues. “However, this number does not represent the total number of conflicts of interest reported by grantee institutions because NIH’s Institutes and OER [Office of Extramural Research] were unable to provide us with all of the actual conflict-of-interest reports they received from grantee institutions.”

OER’s lack of a complete collection of conflict reports was attributed to their dispersal among the 24 grant-making institutes in the NIH family. “OER asks, but does not require, Institutes to forward to it the financial conflict-of-interest reports that they receive,” the IG explained. “Because the Institutes are not required to provide OER with conflict-of-interest reports, OER maintains that its database is not the official repository for all financial conflict-of-interest reports and that Institutes are responsible for maintaining documentation.”

The IG noted that 11 of the 24 institutes provided no conflict-of-interest reports from their grantees. The majority of the reports that were received “did not list which individuals associated with the grants had the reported conflicts of interest.”

In a touching testimonial to the trusting relationship between NIH and its grantees, the IG found that “Many institutes rely on the good faith of the grantee institution to ensure compliance with the federal financial conflict-of-interest regulations, rather than directly overseeing or reviewing grantee institutions management of financial conflicts of interest.”

The IG recommended changing the regulations to require grantee institutions “to provide details regarding the nature of financial conflicts of interest and how they are managed, reduced, or eliminated.”

NIH responded that “responsibilities for identifying and managing conflicts of interest must remain with grantee institutions.”

NIH’s trusting manner will eventually change. But we’ll have to wait for the next scandal.

(Image from the Photobucket account of Mage49_photo)