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.