Should NIH Program Staff Scoop Their Own Investigators?

April 24, 2008

As purely entertaining as it is to watch PhysioProf troll the Open Access Nozdrul, these discussions always raise at least six interesting avenues for further thought. For example a comment from bill touches on the notion that private “ownership” of one’s ongoing (less than publication quality) data is bad for science. The specific example being that results that may be annoying “noise” to one scientist might be gems to another scientist, if she only was aware of those data. To me, anyway, this links to a more interesting consideration of the back-and-forth between our scientific ideal of collaborative group effort and the reality of personal ownership of “ideas” and “results”.
In this area I want to talk about the “ownership” of our scientific effort that might be asserted by NIH Program staff within the individual ICs to be used in ways that act against the interests of individual scientists.


We can start with the specific and applied example of the U01 award mechanism. The U01 Cooperative Agreement mechanism (see here, page 29) is a tricky beast, halfway between the traditional investigator-initiated R01 and the contracts issued by the ICs. The ones I’m familiar with (i.e., noticed and half-considered applying for) were solicited by RFA and contained very comprehensive descriptions of what would be necessary to include to receive the award. Regular RFAs can be specific but these are even more detailed and, again, from the ones I’ve noticed include quite a LOT of stuff they want done. A part of these that I never fully realized until recently is that Program staff continue to be intimately involved in the conduct of the science under the U01 mechanism. They can tell you to add all kinds of experiments beyond the original proposal just because they think it might be cool. And exploring where the PO got the idea for something to add to the study is where we get into the heart of the matter.
As I think I’ve said before, one reason to schmooze your PO constantly is because “their” investigators are a primary source for the POs to keep up with the science. They read your papers, read your progress reports and listen to your advocacy of “your” science. The convene little one- or two-day focus meetings back home in Bethesda or on the road as pre-meetings attached to a regular scientific society meeting. And…..they read your grant applications. Even the unfunded ones. The triaged ones…I doubt it but really, who knows? They could be reading them.
All of this information from their stable of funded scientists funnels into the individual PO brain to shape his or her view on what is really cool or exciting or interesting in their fields of interest and responsibility. This information helps them to shape Program Announcements, RFAs….and what requirements to include in a U01 announcement/solicitation. Very likely it helps them to decide what new and SuperKewl experiments to add to an existing and ongoing U01 project. So just suppose, humble R01 supplicant, that some idea that you have included in a R01 proposal (including supporting preliminary data!) really strikes the PO as super neat-o stuff. And he or she just happens to have an ongoing U01 to which a couple of “your” experiments could be readily added in a way that would generate some really informative and interesting data.
What is the proper behavior for the PO in this case?
[As a little sidebar here, if they have official or semi-official rules within the ICs, I don’t know about it. They might. Even if they do, the notion of trying to parse “state of mind” from the published and unpublished sources of information they receive is bogglingly difficult.]
In many ways of looking at it, the IC staff are servants of the science itself. They hire us, the members of the extramural research community, to work on science topics that are of interest to them and we are expected to communicate the results to them and the public. (Let us remember as well, that the IC staff function as proxies for our real employers, the US taxpayers.) There is nothing in the extramural funding equation that lets the PI say “Well maybe I’ll publish my data and maybe I won’t”. The overwhelming expectation is that extramural researchers will make the fruits of their effort funded under NIH grants available. Data for sure. One might even extend this to intellectual property such as theories, hypotheses and experimental designs as well. Why not?
Should the PO suggest to their U01 awardee that s/he conduct a study that you have proposed? Should your PO draw some of the kewl ideas from your -01 application, shoehorn it into an RFA they are working on and (oh sorry) fund somebody else to do it while you are struggling through to your -01A2 application?
After all, what matters is that the study be conducted, right? The funding agency has no interest whatsoever in who happens to conduct a particular study. Right?

29 Responses to “Should NIH Program Staff Scoop Their Own Investigators?”

  1. Becca Says:

    The funding agency could be expected to have a large vested interest in who conducts a particular study- in one sense, they should want the person who will get the study the most positive press if it will impact taxpayer opinion. Or the one who will bring the taxpayers the most benefit.
    In reality, they also probably want the scientists they like or respect the most to do the work… thus part of the necessity of schmoozing with the PO.
    I think the way it *should* work is that POs should take every step to make sure the really compelling science gets done while simultaneously making sure the person who came up with any super neatokewl (and legetimately novel/creative) ideas has ample ability to be involved in doing that research. I could see a PO being a great person to facilitate collaborations.
    If such a simple answer is not practically- what an ethical tight spot! It really depends on so many factors.

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  2. PhysioProf Says:

    Very likely it helps them to decide what new and SuperKewl experiments to add to an existing and ongoing U01 project.

    If you are implying that a PO would take an experiment or hypothesis directly out of an R01 and tell a U01 awardee to perform or test it, respectively, I would be careful about making this kind of claim of grossly unethical behavior without adverting any supporting facts.
    The legal profession has a very elaborate set of ethical rules to deal with exactly this sort of conflict of interest. The basic principle is that if you represent multiple clients engaged in similar pursuits, you are absolutely barred from using confidential information divulged to you by one client to the advantage of another. In relation to your representation of the other client, you basically have to do your best to behave as though you are unaware of the confidential information.
    If the pursuits of the two clients are so closely related that it is practically impossible to implement this cabining, you must withdraw from representation of one of the clients.
    An even simpler conflict-of-interest situation than the U01 one you hypothesize is the case of part-time POs who also work part-time in an intramural laboratory. I am aware of at least a few of these people in at least two Institutes.
    These people are in a position to read a grant application, and then go themselves into the lab and do the fucking experiments and test the fucking hypotheses.
    I don’t know how NIH’s internal procedures treat these conflicts-of-interest, but I certainly hope they have some sort of system that seeks to minimize them. Even in the absence of an explicit system, I would consider such conflicted behavior to be very ethically suspect.
    Yo, Janet!

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  3. DrugMonkey Says:

    If you are implying that a PO would take an experiment or hypothesis directly out of an R01 and tell a U01 awardee to perform or test it, respectively, I would be careful about making this kind of claim of grossly unethical behavior without adverting any supporting facts.
    It is not clear to me that this is “grossly unethical behavior”. That’s part of my point here. Is this “unethical”? To whom and why? The taxpayer is benefited best by the experiments being done quicker and better. Is she not? So even if the ICs do have rules preventing the best possible route to the data because of “ownership” it is not entirely clear to me that they should
    And where did I say I was doing anything other than making up a not-implausible scenario out of whole cloth for didactic purposes?

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  4. DrugMonkey Says:

    An even simpler conflict-of-interest situation than the U01 one you hypothesize is the case of part-time POs who also work part-time in an intramural laboratory. I am aware of at least a few of these people in at least two Institutes.
    yowza. Now the only time I’ve heard of something like this the person did not appear to be very “active” at all. Are these people you are aware of actively engaged, publishing and all that? Perhaps there is an effort to keep their PO portfolio as far removed from their area of work as possible?

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  5. Emily Says:

    To what extent is growing and maintaining the nation’s stock of scientists part of the mandate for this funding? Isn’t that included as a secondary or tertiary role for all this grant money? While handing off the data or study idea to a U01 project might result in quicker or better results, it’s not clear that this is in the best interests of the taxpayers, at least not long term.
    This is not to say that it does or does not happen (haven’t the foggiest) and it doesn’t speak to the ethics of the issue.

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  6. PhysioProf Says:

    It is not clear to me that this is “grossly unethical behavior”.

    It’s clear to me that it is.

    That’s part of my point here. Is this “unethical”? To whom and why?

    I think it is. It is wrong to the extent that it involves confidential information being used for purposes other than the purpose pursuant to which the confidential information was provided by its originator.
    Where the fuck’s Janet when we need her?

    Are these people you are aware of actively engaged, publishing and all that?

    Yep!

    Perhaps there is an effort to keep their PO portfolio as far removed from their area of work as possible?

    If it were removed as far “as possible”, then they would either be incompetent in the lab or incompetent as a PO. I certainly hope it is as far removed as is reasonable.

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  7. juniorprof Says:

    I’m no attorney, but come from a family full of them (aside from the farmers — makes for a wacky mix at family reunions). I have struggled with issues such as the DM describes for some time (at least since the grad school days). I remember getting in a big argument with my biomed ethics prof over these types of issues. He took PPs position and argued quite reasonably that I was wrong. On the other hand, I could never quite get over my utilitarian ethics training in undergrad where I thought that the greater good was of the highest importance and that the intellectual property was only a secondary issue. Honestly, I don’t know where I stand on the issue now (but I think I lean to the utilitarian position). However, I have come to accept that I MUST work from the framework that PP describes in the present system.

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  8. Neuro-conservative Says:

    I would hope that basic common sense and simple human decency would make it obvious that PhysioProf is correct on this one. That DM even thought to raise the issue is worrisome, and juniorprof’s struggles are downright alarming. What part of Thou Shalt Not Steal don’t you understand?

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  9. juniorprof Says:

    Neuro-conservative, I think we all get that stealing the ideas of other is bad, bad, bad. On the other hand, there is a bigger issue here. Human health is at stake in much of the work that is going on and it is possible that significant advances could be made in a more timely fashion if the “its my idea” factor was removed from the equation. I’m not saying that it would yield a better research enterprise. I do think that the problem is worth some serious consideration, however.

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  10. Neuro-conservative Says:

    juniorprof — I hope you are not advocating a form of act utilitarianism in which each PO would decide at a given moment whether stealing a particular idea was going to increase the general health & happiness of society — that is a bit more power than I would like to see in the hands of any PO, thank you very much.
    Perhaps instead you are suggesting that individual investigators should shed their proprietary interests in their ideas. This would be of a piece with some of the concepts advocated in the previous thread. I think that this flies in the face of human nature. Of all the experiments that NIH could undertake, the attempt to create a New Man is one that has already yielded fairly definitive results over the last 100 years.

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  11. Markk Says:

    Neuro-conservative – For something to be stealing you must lose something. If you are the researcher in the example what did you lose? As a taxpayer funding these studies I see no “property” involved here that does not already belong to -ME- the payer. If you want secrecy – pay for the research yourself! If it was a question of prestige and publishing, then that might be too bad. If one is cut out and dishonestly said not to have done part of the work that is different – but that is not suggested here as far as I can see. There is no ethical problem.
    You could make a utilitarian point that people would not do good research under a regime like this, or would need to be paid better or something, but I am with DM.

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  12. juniorprof Says:

    Well, I most certainly would not advocate for a PO to act in the manner you have described. Nor would I advocate for any other individual to make such decisions on their own, I have little interest in autocratic actions.
    I suppose that your second suggestion is in line with what I am suggesting should be given stronger consideration (but I see little use in the open-notebook idea in its current manifestation). I agree that shedding proprietary interests flies in the face of human nature. On the other hand, although I sometimes like to think that my ideas are really my own, on closer inspection I think that I am probably wrong. Our ideas do not exist in a vacuum and I think that my notion of proprietary interest in novel concepts that I propose is rooted in self interests that are not related to the purposes of scientific discovery (especially in the medical sciences). I do not think that it is wrong to give this idea some serious thought and to strive to overcome obstacles (especially those rooted in self interest) that slow the process of the advancement of human health.

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  13. Neuro-conservative Says:

    Markk — The ideas/plans within a grant application belong to the investigator. If the grant is funded, then it could be argued that the results belong to the taxpayer, although my tech transfer office always seems to suggest that any potential profits derive to the benefit of the institution ;>)
    While NIH FOAs have been increasingly specific and demanding about resource sharing, the proprietary rights of an investigator to the fruits of his labors (both professional and pecuniary) are still recognized, as they should be.
    Which leads me to juniorprof’s final point, which I think has it completely backwards. I would submit that the pursuit of self-interest on the part of investigators is the engine of scientific advancement, not an obstacle.

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  14. PhysioProf Says:

    I hope you are not advocating a form of act utilitarianism in which each PO would decide at a given moment whether stealing a particular idea was going to increase the general health & happiness of society — that is a bit more power than I would like to see in the hands of any PO, thank you very much.

    Agreed. Now, since you characterize yourself as a “Neuro-conservative”, here’s a question for you:
    How do you feel about the Bush regime’s massive presidential power-grab, which includes dismantling of our Fourth Amendment and habeas corpus rights in the name of “security” and “The War on Terror”? Do you believe in this ahistorical, unconstitutional, and morally depraved “unitary executive” theory which turns the President into a king? Do you believe that the right-wing faction that currently controls the Republican Party is defined by their hatred for the true ideals this nation was founded on, and wants to illegally and unconstitutionally turn our nation into an oligarchy, or even, in the case of some of its sickest adherents, into a dictatorship?
    I ask, because I am interested in whether someone who is eager at this particular juncture in our political history to call himself or herself “conservative” could possible be a John Dean conservative and not just another demented fucking right-wing wackaloon authoritarian follower.

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  15. Neuro-conservative Says:

    I am insulted that you would refer to me as just another demented fucking right-wing wackaloon authoritarian follower. I am a strikingly handsome demented fucking right-wing wackaloon authoritarian follower.

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  16. juniorprof Says:

    While NIH FOAs have been increasingly specific and demanding about resource sharing, the proprietary rights of an investigator to the fruits of his labors (both professional and pecuniary) are still recognized, as they should be.

    I agree that I deserve some professional recognition as a result of my labors. On the other hand, aside from a respectable salary, I see no justification for pecuniary rewards for work that should belong to the taxpayer. I see federal research funding as an investment by the taxpayer for their future. It does not serve them if I (or my institution) reaps the rewards of these discoveries. Government can and should do a better job of managing the end results of investments the public trusts them to make when they put their money into the tax system (how idealistic can I get?)

    Which leads me to juniorprof’s final point, which I think has it completely backwards. I would submit that the pursuit of self-interest on the part of investigators is the engine of scientific advancement, not an obstacle.

    I suppose we’ll have to agree to disagree as I see it exactly the opposite. If an investigator wants to reap the financial rewards of her discoveries she should raise the money and start a company.

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  17. Neuro-conservative Says:

    juniorprof — I can certainly understand where you’re coming from. Two points, though:
    1) I think that you underestimate the role of monetary incentive in generating productivity. It serves the taxpayer just fine to have a bunch of very smart scientists working overtime for the big $$ to be had in discovering a cure for cancer.
    2) As a juniorprof, you should probably check with your institution’s Tech Transfer office to see if they share your idealism. They might be a little annoyed if you publish a novel analgesic mechanism without first protecting their interests.

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  18. I can certainly appreciate juniorprof’s idealism but the 1980 passage of the Bayh-Dole Act that gave NIH-funded researchers rights to the intellectual property of their discoveries was intended originally to promote the public good by incentivizing the commercial application of these innovations in health care, etc. Whether that aim has been an effective outcome is obviously open to debate.
    Re POs overseeing U01s, my n of 2 experience has been that POs are incredibly protective of the confidentiality of program progress meetings and, IMHO, have successfully negotiated the sticky issues of knowing about the goings-on of multiple U01s whose work might be in direct competition to one another. Again, not to say that the scenario DM describes is not possible but I’d be extremely disappointed if any of my POs behaved so unethically.

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  19. juniorprof Says:

    Abel and NC both point out, rightly, that incentivizing publicly funded science was intended to serve the public good. I do not disagree that the spirit of the idea is in the right place. However, I would argue that the implementation of this practice has pushed prices too high making outcomes of this publicly funded work too expensive for the average taxpayer, more and more of whom do not have insurance or whose insurance does not provide them with full coverage. We should be able to reach a balance here and I, for one, am perfectly willing to trade some of my IP rights for a lowering of health care costs. Perhaps this would just push many into privatizing their research enterprises earlier and with different sources of funding. Clearly there is no simple solution but I do think the research community should contribute to the conversation of getting health care costs under control.

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  20. PhysioProf Says:

    We should be able to reach a balance here and I, for one, am perfectly willing to trade some of my IP rights for a lowering of health care costs.

    You are conflating two quite different things: IP rights in inventions that arise out of research and the right of confidentiality in a research grant proposal that is submitted to NIH. The basis for my assertion that the sorts of behavior DM and I have postulated are grossly unethical arises solely out of the latter.

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  21. DrugMonkey Says:

    the 1980 passage of the Bayh-Dole Act that gave NIH-funded researchers rights to the intellectual property of their discoveries was intended originally to promote the public good by incentivizing the commercial application of these innovations in health care, etc. Whether that aim has been an effective outcome is obviously open to debate.
    One of the nasty little side-effects of this is to have a dampening effect on the conduct of science. This comes up when a tech-transfer department is a little too eager to get a finger on any “intellectual property or inventions that might result” from what used to be pedestrian collaborations. Such as “Hey, can you test our new compound in ModelY that you’ve developed in your academic lab?” The motivation for many small-time scientists is “Hey, new tools? cool, let’s do this dinky little experiment!”. The introduction of University IP interest in many cases now prevents this sort of thing because it isn’t important enough to the company to give up any part of the IP rights.
    my n of 2 experience has been that POs are incredibly protective of the confidentiality of program progress meetings and, IMHO, have successfully negotiated the sticky issues of knowing about the goings-on of multiple U01s whose work might be in direct competition to one another.
    I’m very happy to hear this type of experience. I will note, that I gave the worst case scenario. The most clear cut scenario from an ethics standpoint. Mostly because it was easy to describe. It is still the case that there might be a host of “obvious” experiments, say from paradigms that are well published in the literature. Two applicants might propose partially overlapping subsets of the available paradigms. Suppose one gets the award and the PO says “hey, why don’t you include this other well published and obvious model that you just didn’t happen to include”? So the source is uncertain. Did the PO just come up with it because in advance she knew all the available models and was hoping that the top scoring app would include her favorite model? Or did the non-funded application make the effective argument for inclusion? Even if the first scenario is “reality” wouldn’t the second applicant be seriously ticked off?

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  22. juniorprof Says:

    What, a brother can’t go off on a tangent around here :-). Yes, obviously you are correct. And, yes, I agree that breaking confidentiality on research grant proposals is clearly unethical.

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  23. bill Says:

    Whether that aim has been an effective outcome is obviously open to debate.

    Bayh-Dole, well intentioned or not, has been the engine of sweatshop science and is well past its repeal-by date.
    (PP is not the only one who can troll around here…)

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  24. PhysioProf Says:

    You takin’ my fucking bet?

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  25. bill Says:

    I’m still working on a counter-counter offer. I don’t like the Cell thing — 2% of the papers in one of the “Big Name” journals doesn’t seem like a generous consideration of “fringe” to me.
    But there’s this thing called work that keeps interfering with my internet time… if I can’t come up with a coherent counter over the weekend, I’ll step up on Monday and take the fucker as it stands. How’s that?

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  26. Neuro-conservative Says:

    If this thing is so great, why wouldn’t 1% of top researchers adopt it over five years?

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  27. PhysioProf Says:

    But there’s this thing called work that keeps interfering with my internet time…

    Work!? Sack the fuck up, dude!

    if I can’t come up with a coherent counter over the weekend, I’ll step up on Monday and take the fucker as it stands. How’s that?

    Deal!

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  28. Neuro-conservative Says:

    BTW — if this approach is adopted by

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  29. Great thread, something we can agree on! I think this is a much more general case of a problem of giving credit for work such as generating ideas (grant applications) and properly and ethically licensing the use of those ideas.
    There are two problems here. The original idea/experiment isn’t citeable and isn’t public, so the original grant applicant can’t point at a reliable third party archive and say ‘that was my idea’. The second is that there isn’t a clear set of licenses or guidelines on how those useful contributions can be re-used. I would be happy for people to adopt and carry out experiments from my unsuccessful proposals _as long as I get appropriate credit_ (and putting aside the potential issues with referees killing of your grants so that they can use your ideas and only put you as second last author).
    If I can throw in a suggestion, two things would help here: a) making grant applications citeable documents (although how you do this without making them public I am not sure – and I’m not going to push on that soldily locked door) b) lay down some clear rules. Re-use of ideas could clearly be good for the overall pursuit of science, but it clearly has a damaging potentail. That said you can imagine a person having a successful career coming up with brilliant ideas and then letting others execute them. Some (many?) people can’t do both effectively.
    But I’m with PP on this one. Under the current rules, breach of confidentiality is unethical. In the UK grants are submitted on condition of confidentiality so this is clear. Until there are clear rules in place (and it almost doesn’t matter what they are as long as they are clear – at the end of the day the funders can do whatever they like, its their money) I would say the individual’s rights trump the greater good.

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