Hints on New NIH COI Rules

I recently referred to a presentation by the Director of NIMH in which he referred to some new initiatives to deal with Conflict of Interest for NIH grantees.

Insel was asked about the tension between his calls for bench to bedside and bedside to practice translation and the conflict of interest scandals associated with the Grassley investigations. He responded that NIH was trying to get more authority to make rules for NIH grantees. Interesting. Of course with what we know about the most egregious cases the allegation is that the scientists in question were already failing to follow the existing disclosure requirements of their institutions. So what are new rules going to do?

I ran across an initial hint over at the Science Insider blog hosted by Science magazine.

Last week, NIH submitted a draft list of questions to the White House on which it wants public input, which will help them shape the new rules:
–How to define whether a financial interest is “significant.” Should the current definition, which exempts any financial conflict worth less than $10,000, get replaced with a more stringent limit or no lower limit at all?
–Whether NIH should strengthen its policing to make institutions comply by requiring independent confirmation of institutions’ reports?
–Whether NIH should look for conflicts involving financial agreements between universities and companies
–Whether NIH should require investigators to disclose any and all of their financial interests

On the first, I vote “no change”. Just as a frame of reference for readers, BigPharma rates for academic consulting vary but something on the order of $100 / hr or $1,000 / day is a decent start. For an average investigator, early to mid career, who comes in to present some critical advice on an assay, evaluation of some data or present some of his or her own data and methodologies. You can tell from the kind of numbers being bandied about by the press coverage of the Grassley investigations that senior people who have long term relationships might pull in $2500 – $3500 for participating in a weekend symposium on some new product. This is just by providing a bit of framework for you to consider “how involved” an investigator might be at annual compensation rates of, e.g., $1,000, $5,000 or the current reporting limit of $10,000. Again for reference, the numbers being alleged in the scandals are more substantial, in the hundreds of thousands of dollars per year range.
On the second point, heck yeah! It appears that the egregious cases that are hitting the news and blogs involve some failures to follow the established disclosure rules. So the problem lies with enforcement rather than with the limits or reporting rules. One would think, anyway.
On the third….they don’t do this already??? Oh boy. So yes, I’d vote that any institution that takes NIH funds better be prepared to disclose their contracts and licensing arrangements with for-profit companies.
I’m not entirely sure how the fourth item here differs from the first. My answer would seem to be the same, which is that the annoyance factor of doing reporting paperwork (which in some types of institutions requires advance signing of all kinds of permission documents) has to be balanced against the scope of the problem.
These observations are reported by the blog as arising from a presentation by the acting director of the NIH, Raynard Kington, so we can expect some version of this to pop up on the NIH website at some point for verification.