On the Institutional Review Board.
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.