NIH Faulted for Lax Oversight of Financial Conflicts

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January 19, 2008

NIH Faulted for Lax Oversight of Financial Conflicts

Chronicle of Higher Education*

http://chronicle.com/news/article/3777/nih-faulted-for-lax-oversight-

of-financial-conflicts

The National Institutes of Health has failed to adequately oversee

hundreds of financial conflicts of interest among university

biomedical researchers, partly because the reports universities have

sent the agency about the conflicts have lacked any details,

according to a new audit.

The NIH rarely asks universities to provide missing details about

the nature of the conflicts and how they were resolved, information

that the agency needs to determine whether universities acted

properly, said the inspector general of the Department of Health and

Human Services. The agency " should take a more active role " and

obtain and evaluate that information more often, the inspector

general said in the audit, released Thursday. (The department is the

NIH's parent agency.)

The NIH disagreed in a response. The existing system for reporting

conflicts, which largely relies on universities to police

themselves, provides " an appropriate framework for the effective

management " of them, the agency said. NIH officials asserted, and

the audit report agreed, that the agency was following the letter of

existing regulations, which require only reporting of the conflicts'

existence, without details.

But if universities' reports contain no useful information, their

submission is a pointless, bureaucratic exercise, said P.

Kahn, director of the Center for Bioethics at the University of

Minnesota-Twin Cities. What's more, the NIH " has no evidence to

support their assertion that things are working fine, " he said.

Financial conflicts 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.

Bioethicists suggested that the NIH is itself conflicted about how

to handle financial conflicts of interest. 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.

The agency has also faced countervailing pressure recently from

Congress, mostly to police large financial conflicts among the NIH's

own, " intramural " staff scientists. In response, the agency

tightened rules for employees in 2005. Lawmakers have also

periodically asked the NIH about conflicts among the academic

researchers it finances but have yet to hold hearings or raise the

heat.