# 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.

• CC says:

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. I'd say that line of analysis argues for the opposite conclusion from yours. If four-figure sums are the norm to get a basic researcher into bed with a company, that makes them "significant" to anyone concerned about such a relationship. (Yes, I realize that this whole thing is silly. In the context of the real pressures on researchers to have results go a certain way,$5K is meaningless and so is $20K. But as long as there's a need to account for money, it seems clear that$5K is "money" to a typical NIH recipient.)
I'm not entirely sure how the fourth item here differs from the first.
Judging from Cricket's objection, I think the first is the usual "List any significant conflicts" while the fourth would require you to submit a complete financial disclosure of everything you own along with your biosketch.

• DrugMonkey says:

If four-figure sums are the norm to get a basic researcher into bed with a company, that makes them "significant" to anyone concerned about such a relationship.
Right. If your a priori assumption is that any collaboration or work or help involving a for-profit company is evidence of being "in bed". By which term we usually infer someone means an undue influence based on the profit motive rather than the understanding of scientific truth. This is an interesting issue and I'd like to see it argued separately because it really is an issue that needs to be decided. Are scientists tainted by any interactions with BigPharma?
If the answer is "no, but with enough money it is a problem" then the flowing their way. The third way is that they are true believers in everything they do that benefits a for-profit and they figure they might as well get paid...

• Becca says:

"Are scientists tainted by any interactions with BigPharma?
They probably should be viewed as tainted. I mean, I know scientists are obviously smarter than physicians, but survey says (http://www.ncbi.nlm.nih.gov/pubmed/14594489?dopt=Abstract) physicans prescribing habits may be altered by gifts of even 'negible value'.
A better question is "is research effectiveness inherantly compromised by interactions with BigPharma"?

• CC says:

To reiterate, I don't think that financial interactions in that range are a major source of conflict. But other people have never been a fourth year postdoc holding their breath for a Nature-acceptable datum, don't get what really motivates researchers, do think that scientists are significantly compromised by minor industry support and these regulations exist to satisfy them. From their point of view, a "significant" sum is what it takes to get a scientist on board (as opposed to a kooshball and some sandwiches), not 3X what it takes to get a scientist on board.

• Stephanie Z says:

To give some perspective on what's required for disclosure outside academia, I supply regulatory data for some of my clients. I have to make statements not only about whether my interests could conflict with supplying accurate data, but whether they could appear to conflict.
I don't have to disclose any specific interests to any regulators, but I do have to disclose them to the people at my company who are responsible for the client relationship. That includes small things, like going to a sporting event with a group from the client. There are also certain things we can't accept at all, again, not big. We pay for their meals (rarely) at meetings. They never pay for ours.
I think disclosing even the small stuff is a good thing, if for no other reason than it makes researchers and administrators think about the relationships in a more concrete way. I also think that efforts need to be made to bring the work of disclosure down to a level that doesn't motivate people to skip it. Ridiculous amounts of paperwork to do something that should be done are never good.

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