the shrinking irb-irs gap

Northwestern faculty just received an e-mail about changes to our IRB system that included:

The IRB must be informed of all income from seminars, lectures, teaching engagements, service on advisory committees or review panels sponsored by for-profit, public, or nonprofit entities other than NU. Formerly, the IRB only asked for income that came from the study sponsor or an outside entity whose interests would reasonably appear to be affected by the research.

If I’m reading this correctly, if you give a talk at such-and-such and get an honararium, or you serve on a grant panel and get the small recompense that comes along with that, you need to report all this to IRB, at least if you do work that includes human subjects. Is this the rule at other places?

Author: jeremy

I am the Ethel and John Lindgren Professor of Sociology and a Faculty Fellow in the Institute for Policy Research at Northwestern University.

14 thoughts on “the shrinking irb-irs gap”

  1. At Wisconsin, the “conflict of interest” reporting and review system is a different system from the IRB system. We do have to respond to a quite cumbersome on-line survey for the conflict of interest stuff. In our system, honoraria from non-profits are excluded.

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  2. Odd phrasing. Using their internal logic, they want to know about income from sponsors/entities which would not reasonably appear to be affected by the research.

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  3. Illinois sounds similar to Wisconsin. We have to do a separate conflict of interest statement which goes to our “ethics” officer, which is a boondoggle for political cronies invented by Rod Blago….I don’t think they check to see if our $60 million high school football stadium was built by relatives of the BOT….ah, Illinois….

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  4. The new HHS Conflict of Interest policy is requiring all universities who have government funding to have documented COI policies in place before next Fall. By that time we (all “key personnel”) will all also be required to have completed the HHS COI online certification before we can submit any new grant applications. Given this tie-in, I think the research compliance offices are often the place where any new COI policies are being enforced.

    Universities have a lot of flexibility on establishing written COI policies. The policy here excludes having to report any expense reimbursements, small payments for activities like serving on review panels, honorariums from public and private educational institutions, and the like.

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  5. We have to fill out a separate COI certification, but it is very far from the degree of intrusiveness you detail! That’s quite amazing and inappropriate.

    Honestly I think it’s another symptom of the general phenomenon of IRB overreach. IRBs should not be offered the degree of oversight they routinely exercise over research; as it is, they constitute prior restraint against a wide variety of research much of which ought to be covered under individual investigators’ responsibility.

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  6. That is very different – and intrusive. I would refuse. The way it is worded (“all income”) would imply that you have to report income from any source that is involved in humans subjects research in any way (e.g., book royalties, or honoraria). This is definitely mission creep. The IRB is supposed to protect human subjects, not judge conflict of interests.

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  7. Fabio: You are not thinking this through, if I may say so. People cannot just refuse to follow a campus policy with sanctions attached even if that policy is ridiculous or unjust, any more than you can refuse to file your tax returns because you think a VAT would be a better system. In this case, the fact that COI has nothing to do with human subjects and is logically administered as a separate policy (as several of us said it is on our campuses) is a different point from whether you have to do it. Similarly, the fact that Northwestern is not only folding the process into the IRB but asking about things that other campus policies have decided don’t have to be reported does not mean that it is a trivial matter for someone to refuse to comply with the COI policies on their own campus.

    As Chair, I had to work with a faculty member who had reported a COI relationship that did involve a significant amount of money and in which the organization had an interest in the outcomes of the research, even though it was a non-profit and the only way to get the data was to work with the organization. The faculty member was pretty upset about having to go through the process and being subject to supervision of the COI committee, and insisted that there was nothing going on that could possibly constrain his ability to report the facts as he saw them. In fact, there wasn’t, but the COI procedure was charged with making sure there wasn’t. I think we handled it pretty well and I think he ended up being ok with the process, even though he was very offended at having to go through it.

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  8. o.w.: I realize my comment was hasty, but I think there is a real issue here. I recognize that it is fair to ask university researchers about conflicts of interest. I fill out my own COI without complaint.

    As you noted, there can be sanctions for non-compliance, so one must be careful. The idea that the university has a right to financial information that is normally confidential strikes me as problematic. How far do we let IRBs go before we actively resist? If the IRB decided they needed to see my medical records, should I just give it to them?

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    1. Come on, Fabio. Collective action to protest the policy including writing public statements or blog posts to protest the policy implementation is appropriate. Complaining that it is inappropriate to fold COI into the IRB is entirely appropriate. Complaining that your own institution’s COI system is unnecessarily cumbersome or has provided a sinecure for someone is entirely appropriate. Because of past complaints, we have had clarifications and amendments about the amount of reimbursement and the type of reimbursement that have eliminated the need to report small honoraria and book royalties.

      We had a major researcher whose complaint was that he and his wife (both of whom were university employees) had to spend hours providing duplicate information about each others’ extensive involvements in an extremely cumbersome on-line survey mechanism because the system had no way to link two reports or to accept an uploaded PDF file in lieu of clicking all the buttons and filling in all the boxes. That was, in my mind, certainly a valid complaint.

      But the basic fact is that COI has to be reported by federal law. Not only that, but I at least think COI SHOULD be reported and regulated. So do you, when you are wearing your activist hat concerned about honest science, instead of your professor hat. Do you honestly NOT want people doing drug research to have to report their payments from pharmaceutical companies?

      Trying to make a slippery slope about your medical records seems fatuous to me.

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  9. o.w.: We may be talking about two separate issues. There is bureaucratic streamlining. Folding IRB and COI reporting seems sensible. I have no beef with that. At IU we also have a COI policy where it’s clear that small sums don’t need to be reported, which is also sensible.

    We both agree that COIs or IRBs are important. What does bother me with the above statement is that you have to report income that is not directly related to research (e.g., serving on panels). Or that comes after the research is performed (e.g., getting money from a group for presenting the results of your research). For example, named lectures can carry large stipends – and it sounds like the NU requires reporting of that.

    Why does it bother me? First, it seems to exceed the mission of both IRB and COI. IRB is about protecting human subjects. If the research already has IRB approval, getting my financial information does nothing to protect people or manage risk. If the issue is conflict of interest, then that also exceeds the mission. Conflict of interest is when my financial interests do not match my dedication to produce accurate research. But how does my work for a non-profit address a potential conflict of interest if that work doesn’t involve human subjects? How does honorarium for giving a lecture after the research is done address that?

    Second, I don’t feel comfortable disclosing financial information to third parties unless it fulfills an important function. That’s information that can be abused.

    Finally, you noted that raising medical information was fatuous. All I can say is that in the two decades of IRBs that I’ve been involved with, there has been a lot of mission creep. IRBs were initially designed to manage risk related medical research. Now they try to govern social science research as well (which is ok in my view). But they also find it fit to judge whether something is real science, whether people can be paid by researchers, and all sorts of other activities. There have even been lawsuits over intrusive IRBs (http://www.institutionalreviewblog.com/2011/03/professor-sues-brown-university-over.html). The institution of the IRB has grown enormously in ways that were not anticipated by anyone.

    Let me end this comment with a question: COI is required by Federal law, but does it require the financial information indicated by NU’s new policy? I do not follow Federal law. But if the law does require it, then this is a very poorly thought out law.

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  10. Incidentally, although the quote in the original post is verbatim from the e-mail I received, when I sent an e-mail to our IRB person asking about it, she gave a response which was essentially in line with what I understood our old policy to be. So I don’t know if she’s incorrect or the e-mail was incorrect or what; I will check out what the form says next time I have to file for IRB for something.

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