COI in NIH-Funded Research

Update: NYT reports on poster child of why the NIH cannot rely on Universities to police their researchers, as does the Harvard Crimson itself (quite thoroughly). Nature takes a look as well, noting that Duke now plans to step up internal monitoring so they don’t show up on the NYT A1. Science notes that attention has turned to Stanford and has a longer piece examining the investigation and broader issues. JAMA has a nice summary as to why COI does matter.

At the institution where I now hang my, um, bike helmet, the research administration is passionately determined to ensure all work conducted serves the greater good rather than the almighty dollar. They’ll turn away or not pursue (or not allow faculty to pursue) money that may involve any conflict of interest (including pharma dollars on the health system side, but that’s another story). This is a very good thing, though it’s a bit spooky that those to whom I report seem to know better even than Santa who’s been naughty & nice, and they know even before I’ve seen an application narrative what sort of COI I should watch for and report as needed – including once to our RIO (research integrity officer), who puts the fear of God in investigators, probably because that’s who it sounds like on the phone.

So it was with more than a passing interest that I noted the Office of the Inspector General has released its report on NIH: Conflicts of Interest in Extramural Research. Unfortunately, they seem to have failed in their two stated objectives:

1. To determine the number and nature of financial conflicts of interest reported by grantee institutions to the NIH.

Finding: 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.

Finding: 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.

2. To determine the extent to which NIH oversees grantee institutions’ financial conflicts of interest.

Finding: Many Institutes’ primary method of oversight is reliance on grantee institutions’ assurances that financial conflict-of-interest regulations are followed.

Okaaaay. The OIG recommends that the NIH:

Increase oversight of grantee institutions to ensure their compliance with Federal financial conflict-of-interest regulations.

The Great Zerhouni concurs with this recommendation and promises to add a COI reporting tool to the eRA Commons, develop an online tutorial (or as GZ writes, “on-line”), and to update & expand FAQs on financial COI. Oh boy.

Require grantee institutions to provide details regarding the nature of financial conflicts of interest and how they are managed, reduced, or eliminated.

The Great Zerhouni “does not concur with these recommendations” since he feels requiring the grantee institutions to provide these details then transfers responsibility for managing FCOI to the NIH. Indeed, “It is not NIH practice to request details of the nature of conflicts reported.” So, trust & no need to verify. (AAMC agrees with NIH)

Require Institutes to forward to OER all financial conflict-of-interest reports that they receive from grantee institutions and ensure that OER’s conflict-of-interest database contains information on all conflict-of-interest reports provided by grantee institutions.

The Great Zerhouni concurs and notes the NIH has “developed a new Web-based FCOI Reporting System”, the use of which will be mandatory by March 1, 2008. Of course, this is just tracking grantee FCOI notifications – not actually doing anything beyond the bean counting (which has been beyond their grasp thus far apparently).

So – don’t be shy to admit you have a conflict of interest so long as you cross-your-heart, hope-to-die promise to manage it properly – as you see fit according to your own personal value system … or lack thereof.

4 Comments »

  1. […] – as you see fit according to your own personal value system … or lack thereof.Original post by writedit delivered by Medtrials and […]

  2. […] I realize the NIH cannot take on the burden of actually managing the financial COI reported to them, surely the Roadmap needs some sort of COI GPS to keep federally funded investigators from […]

  3. writedit said

    The NYT reports on colossal violations of NIH and Harvard University COI policies as uncovered by an investigation by Senator Charles Grassley (R, Iowa). Drs. Joseph Biederman and Timothy Wilens neglected to disclose that they had received at least $1.6 million and $1 million, respectively, in consulting fees from drug makers from 2000 to 2007. The NIH requires institutions to report earnings of $10K or more by PIs and to manage these conflicts (though the NIH doesn’t care to know how, as noted above).

    The NYT notes a specific violation: “”In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.”

    I grow more concerned that the public will increasingly view “research” as a means for self-enrichment rather than an opportunity to serve the social good.

  4. writedit said

    As noted above, the Harvard Crimson and Nature have taken note of the Grassley investigation at Harvard, while Science reports that attention has turned to Stanford, which is accused of “inadequately monitored reporting by a faculty psychiatrist who owns $6 million worth of stock in a company that’s involved in a government-funded study he oversees.” Science now has a longer piece on the full investigation and efforts by AAMC and AAU to help universities set meaningful COI guidelines.

    Two universities down, 18 to go apparently.

    In the meantime, the CBS Evening News will feature a series on: “Is your doctor taking money from drug companies? Many get thousands of dollars a year in travel and lecture fees. Are they Prescribing Under the Influence?”

    Separately, JAMA has a nice summary as to why COI does matter.

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