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On the Institutional Review Board.

26 November 2013

Did you know, dear reader, that your humble narrator has had an official finding of research misconduct levied against him? I was guilty too. Let me go back and describe it:

I was a newly hired engineer at my previous institution, prior to my promotion to PI. I was working directly for the Chief of Staff, who is kind of a “Big Science Deal”. More than twenty years of uninterrupted funding, hundreds of papers in very good journals. Contributions to both medicine and engineering. Full professor in both a medical school and a school of engineering. That sort of thing. He hired me to be his concierge engineer solving problems for his medical center. I worked on quality improvement. In fact, I had essentially the same job I have now.

One of my first projects, which was only very peripherally related to the patient experience at all, ended up with a neat little result. At this time in my career, I had published only one paper, and though I was first author, I didn’t write it, or submit it. The senior author did all that. I just did the work. So I really had no idea whatsoever how publishing worked. And, since I was trained as an engineer – even though I had been working in health care a long time – I had no understanding of human subjects research. I was always strictly on the quality side of things. I’d had HIPAA training, but no research training.

When we came up with the neat little result, my boss told me we should publish it. It was exciting. I’d never been interested in publishing, really. I had no designs, at that time, on being an academic at all. So I wrote a paper about what I did, and submitted it. Well this set off klaxons of alarm. Publishing is research! Manuscript preparation is research! The Institutional Review Board (IRB) sent me a grim memo. I went to my boss. He took responsibility for it. It was his fault I hadn’t been oriented to research; if he wanted me to publish, he had a responsibility to ensure I knew the rules.

The project and the paper involved only retrospective, deidentified, aggregated data. Those reading this familiar with human subjects research will immediately recognize what that means: it’s exempt from IRB review. There was no harm, actual or potential, to patients or to their protected health information. But because I had prepared and submitted a manuscript prior to securing a decree of exemption, I had technically engaged in research misconduct. The official finding was that the misconduct was neither serious nor continuing, and a memo was placed in my file. And I believe it has since been expunged.

I tell that story because I want to emphasize that I understand that IRBs are imperfect instruments. However, they are the fundamental structure we use to ensure that research is conducted ethically and safely. So that research subjects are informed about the risks and benefits of the research. So that research is carried out only on subjects who consent to be researched. It’s not a small thing.

I’m not a lawyer, and I’ve never served on an IRB. But I have had multiple protocols reviewed and approved, and multiple protocols reviewed and exempted. Most of my research is exempt from review, because it is quality improvement work based on retrospective, aggregated, deidentified data. But even then: only the IRB can determine if the IRB needs to review the protocol. That means that your protocol must be reviewed in order to determine if it must be reviewed.

Yes it sounds circular and silly. But this is how we do human subjects research. Scientists have biases and blinders. If you’re a scientist, you have them. Hell, if you’re a person, you have them. We all like to believe we would only conduct safe and ethical research. But when we think we have great ideas, we all – every one of us – will rationalize a little bit about it. I do it. You do it. That’s why we have systems for independent oversight.

The IRB is intended to safeguard patients’ persons, and their information. The basic document regarding ethical research, sort of like a constitution and bill of rights for researchers and subjects, is The Belmont Report. IRBs use this document and the principles found therein to guide them when reviewing proposed research. IRB oversight of research is required for all federally funded studies in the United States, and nearly every institution requires IRB oversight whether they receive federal funds or not.

I had a long conversation on twitter yesterday in which it was asserted that “IRBs are only for publication.” This is not only wrong, it is dangerously and disturbingly wrong. Yes, in order to publish the results of research respectable academic journals will require a statement of appropriate IRB oversight. No, that is not what IRBs are for. IRBs are to protect patients so that Tuskegee doesn’t happen again.

My opponent in last night’s debate laments that this essentially prevents private citizens from conducting and publishing research. Well, sort of. As a researcher at a medical center, I have access to a large and streamlined IRB which reviews all of my work so that I can do my work as research and publish the results. Private citizens don’t have that. There are, however, IRBs-for-hire. They may be expensive, or they may be free of charge, but they exist.

But I am unmoved by restrictions upon private citizen-science when it comes to human subjects (or animal subjects, for which the equivalent body to the IRB is the IACUC). Human subjects research has a deplorable history of subjects ending up as victims. Doing ethical research requires oversight, standards, ethics, and accountability. All of those things cost money. And if you can’t afford appropriate oversight and accountability for your research, then you can’t afford to do research. And that’s a good thing, not a bad thing.

The idea that IRB oversight is simply a regulatory hoop that a scientist must jump through in order to publish their results in a peer-reviewed journal is, frankly, vile. It was asserted in the argument that if a citizen (or corporation!) wanted to conduct their own human subjects research and publish it on a blog, that that would be fine, ethically. That is absolutely, categorically untrue. That is exactly how excrescent lapses in ethical behavior result in serious harm to research subjects.

When safety, ethics, and oversight are seen as regulatory impediments to science, instead of part of the core principles of scientific research involving human or animal subjects, humans and animals suffer. Those who see regulatory oversight as bureaucratic box-ticking reveal themselves bereft of the concern for respect, beneficence, and justice which must be at the core of medical and scientific exploration.

20 Comments leave one →
  1. 26 November 2013 11:49

    Yeah….but. A significant problem with IRBs as they are currently structured you don’t mention. It’s a subtle, but critical difference in terms of operations: IRBs are not structured, in fact, to ensure that ethical research is conducted. They are there to stop unethical research from moving forward. They have no gas pedal to help research get done. Getting research done is not on their agenda, and that puts them as enemies in a way of researchers, not the other way around. IRBs are like cars that only have a brake pedal. The dynamics I observed being on several, is that like study sections, an IRB member “proves” his/her value and intelligence by bringing up reasons to delay or deny. You must be slow if you can’t think of a criticism. I am not strictly anti-IRB like your opponent, but the fact that IRBs only tools are delay and denial means that good, ethical research is also slowed down. Some times significantly. And, ironically, I find that unethical.

    • 26 November 2013 12:10

      Well, there’s expedited review, and exempt protocols. Those are sorts of accelerators. But in general, you’re right. But the existence of dysfunctional IRBs doesn’t excuse circumventing them.

  2. drgunn permalink
    26 November 2013 12:01

    My claim wasn’t that ethics aren’t needed, but rather that an IRB isn’t the only source of ethical blessing. Think of all the websites around the world that have user polls. None of them have IRB approval, yet they are, in a real sense, gathering and analyzing data on human subjects. That’s all fine until they go to publish, whereupon the journal will ask for IRB approval. That’s really the core of what I was saying.

    The claim is a simple one. How do we make it easier for the public to engage in research and thereby become more scientifically literate? Expensive IRB services are for corporations or institutions who have grant funding. If a group of folks in the neighborhood want to do research, they should by all means behave ethically, but they’ll need a volunteer ethics board and there should be a route to establish one.

    • 26 November 2013 12:05

      If the intent is generalizable human knowledge, from the outset, then, no. It isn’t “all fine until they go to publish.”

      It’s research. And research has ethical restrictions.

      • drgunn permalink
        26 November 2013 12:53

        This http://blog.xkcd.com/2010/05/03/color-survey-results/ is, without question, research. Yet there’s no mention of an IRB or even possible ethical implications anywhere. It’s also been read about a million times more than the average scientific paper. Should that not have been done?

      • 26 November 2013 13:04

        You are really showing that you don’t understand what constitutes human subjects research.

        If the data involved in a survey cannot be considered “private” then the survey does not constitute human subjects research.

      • drgunn permalink
        26 November 2013 13:14

        A person’s individual “color vocabulary” seems like private info to me.

      • 26 November 2013 13:15

        Well, luckily, sensible people have actual definitions for these things.

      • 26 November 2013 13:37

        So humor me for a sec. Who are these sensible people and where have they written down these rules?

      • 26 November 2013 13:49

        Jesus Christ, really? Well, if you’re employed by an institution that does HSR, you’re oriented to it before you’re allowed to participate in research. (And yes, I know that excludes so-called “citizen scientists” from conducting HSR, to which I say, “THANK GOD.”)

        But you might want to try just putting “protected health information” into the googler machine.

        You know, even if there are scientists out there, somewhere, who can magically do research without oversight, YOU, sir, are not one of them.

      • 26 November 2013 14:02

        OK, I think I’ve gotten all the usefulness I can out of this thread. Neither you nor your institution have any authority or standing to stop private citizens from conducting research on that which interests them. Somehow people behave themselves despite not begging their local ivory tower for the right to do research. My whole point was that the only control points are at funding and at publishing, and as the XKCD example shows, publishing is becoming less of a control point.

        What I would find useful, if you want to continue the discussion, and why I kicked off the thread on Twitter to begin with, is a discussion of how to engage the public in research by getting them involved and empowering them to publish in academic journals.

      • 26 November 2013 14:04

        But what you’ve *demonstrated* is that you have no understanding of how to conduct ethical human subjects research, or how to interpret others doing so.

  3. 26 November 2013 12:01

    The fact that *some* IRB functions could be improved at a tactical level is hardly a valid indictment of all of their work. Importantly for the current debate, it is critical to replace the oversight *function* and do the FIRST. Claiming IRBs are broken as an excuse to avoid ethical oversight at all is utterly wrongheaded.

  4. 26 November 2013 12:02

    “Do that FIRST”

  5. 26 November 2013 12:04

    There is no reason a local group of citizen researchers cannot establish an IRB. Tiny colleges without prior IACUCs frequently start them up with little cost and institutional investment once a new prof shows up that needs one. Seen it happen regularly. All it takes is the will

  6. 26 November 2013 12:30

    I have served on a well-functioning IRB panel that wanted to promote research in a safe and ethically responsible manner. Not all are mismanaged.

  7. 26 November 2013 13:30

    The pervasive attitude among academics that “if it isn’t going to be published it doesn’t need IRB” can (and does) cause real harm. We had a professor, now retired, who had students determine their own genotype as part of his senior molecular biology lab. What gene, you ask? CCR5 Delta 32. I wish I was kidding. After freaking the fuck out at the prospect of telling sexually active 21 year olds that they might have increased resistance to HIV-1 infection, I asked if he had submitted the lab module to IRB. You can guess the answer.

  8. Jeff permalink
    27 November 2013 21:56

    I don’t the public conducting research anymore than I want them practicing medicine. There is a reason behind the 21 plus years of education PhDs obtain and one is to know how to conduct sound research. I used to think IRBs were obstructionists until serving on one and then I realized most members are sincere and dedicated and we do our best to protect subjects. A lot of effort is volunteered and we try our best to remember the thousand pages of guidelines to help researchers get their job done ethically and legally.

  9. 28 November 2013 10:21

    I think this contempt for IRBs may be an unintended consequence of far-reaching and sometimes insane laws, rules, and standards that we are forced to comply with or even enforce every single day in healthcare.

    But the IRB is a vital safeguard. That is, if we don’t care to repeat our sordid history.

  10. 4 December 2013 11:22

    I do understand human subjects research and have approved IRB protocols for the kinds of research that XKCD was doing. Indeed, my institution would consider people’s “color preferences” non-exempt research. And, even if the information was going to be anonymized, required me to file protocols to insure that the information would stay anonymous.

    There’s clearly a growing body of research being done (most recent example, MIT computer scientists analyzing email interactions, Luminosity looking, Dateline episodes doing social psychology experiments on bullying, French reality shows reproducing the Milgram experiments, . . . .). These things are happening, out of the purview of IRBS. Some of them are dangerous, but they are not currently within the purview of any regulatory body. Arguing that “the public shouldn’t conduct research” or that a reality show can get IRB approva (from a IRB for hire?) l isn’t going to change the way those “experiments” are done.

    My point? that unless we come up with a set of guidelines different from the fairly onerous and strict ones that are applied by many university-based IRBs, we will have one set of standards within academia, where compliance can be monitored by employment & publication rules, and a wild west of no rules int he rest of the world (of gaming, entertainment, computer software, journalism, . . . ).

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