How well do institutional review boards work at protecting patient’s rights?

3 Feb

One factor that struck me in the interview that Brian Deer gave recently was the fact that until rather recently, he would have had no method to obtain the ethics committee (in the US institutional review board or IRB) information on Andrew Wakefield’s research. The IRB was internal to the hospital. Without the Freedom of Information Act, he may never have gotten access to these records.

He [Andrew Wakefield] could never have expected when he was doing this research that all of a sudden his funding would be exposed to scrutiny, and also the Ethics Committee. In America called Institutional Review Boards. Bodies of doctors, scientists, others associated with medical centers which give permission for research to take place. The paperwork of that body of the Royal Free Hospital also moved into the public domain by the Freedom of Information Act. I think I was the first person ever to get hold of these kinds of papers.

Andrew Wakefield clearly didn’t take ethics approval seriously. He started his program before the ethics approvals were in place. When asked to explain why he took blood at a birthday party without ethics approval, his explanation was that he didn’t think that ethics approval was needed for people who were not NHS patients.

Q Did not that difficulty, which, as I say, appears to have been encountered by researchers other than yourself, indicate to you that there were ethical considerations about undertaking this procedure on normal children?
A Yes. The ethical considerations that I considered were clearly that there was full informed parental and child consent. As I have said, my understanding at that time was that ethics committees existed for the protection of NHS patients.

In another infamous example, David and Mark Geier received approval for research from an IRB. The IRB was had David and Mark Geier, Mrs. Geier and other interested parties as members. This would not have come to light without another Freedom of Information Act (US) request. If I recall correctly, the IRB was instituted after the research began as well.

I know that these are pretty egregious examples but I am left wondering–how many researchers consider ethical approval to be just an annoyance? Just some rubber stamp they need in order to do their research? I hope the number is small. I hope that in the day of FOIA requests, institutions and researchers take this seriously.

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9 Responses to “How well do institutional review boards work at protecting patient’s rights?”

  1. sharon February 3, 2011 at 12:45 #

    I’d like to think most involved in research take the process seriously and have enough professional integrity to ensure that proper procedures are followed. Perhaps those who contemplate the shortcut of avoiding ehtics approval up front will consider that if found out via FoI, the studies findings will be compromised.
    Lets hope the legacy of Wakefield’s exposure as a fraud serves as a warning.

  2. esattezza February 3, 2011 at 20:59 #

    In my experience, most researchers take ethical considerations very seriously, both when working with humans and animals. That being said, I’ve also heard many of them complain about the actual IRB process. It’s a lot of paperwork and dealing with administration. In other words, we understand the importance of it and will gladly consider the issues involved when designing our research, but we’d much rather be in the lab than dealing with the actual procedure of it all.

  3. sharon February 3, 2011 at 22:49 #

    esattezza, I think bureacratic processes are a considerable burden in many professions (in a former life I was a clinical social worker in both justice and hospital systems so I know a little about paperwork). But they are also necessary for tranpsparancy and accountability.
    I just wonder how you ensure people are completely honest about their intentions, and actions?

  4. esattezza February 3, 2011 at 23:43 #

    @ Sharon, I did not mean to belittle the importance of transparency and accountability, I believe 99.99% of scientists understand the importance of IRBs (even if they complain because they wish things could be more efficient.) As to how the field ensures people are honest about their intentions and actions, being a student, I’m not the best person to ask (I’ve never had to write for or appear before an IRB). What I can tell you, is that, at least at my institution, IRB submission and approval, up-to-date protocols, and various yearly re-certifications of all staff on a project are required and linked to funding. There are also periodic updates to the IRB while the research is underway.

    Pretty much anyone (including the public) can anonymously report a suspected breech of IRB protocol by a researcher, which will result in an initial investigation to see whether the claims made can be substantiated and, if so, full investigation by the board. There are various levels of non-compliance with IRB approved protocol and the board can take a range of actions if a researcher is found guilty of them.

    Basic non-compliance is something simple: misdating a consent form, not updating a protocol, etc. These are things that are, in themselves, pretty harmless to the research participants, but important to the procedure to ensure that more serious ethical breeches are caught. These generally don’t make it to full board review, unless the researcher fails to correct the problem when informed of it. Repeated offenses are treated more seriously, as this implies that you’re hiding something (or just incredibly disorganized and maybe shouldn’t be doing research in the first place), but no one’s going to make a fuss if you forget to submit a form or misdate something once or twice over the course of a 5 year project.

    Serious non-compliance is defined by my institution as “Violations that have or pose a greater than minimal risk of harm or discomfort to research participants or others involved in the research”. This carries more heavy penalties, from required protocol modification or more frequent reviews, to requiring the researcher to undergo ethics training and/or informing research participants of the breech (and allowing them to leave the study if they choose… which is actually always an option), to requiring the researcher to undergo ethics training, all the way to barring of the resulting data from publication, suspension of the researcher from human-subjects research, and even referring the matter to administration who may ultimately fire the researcher.

    Of course, an unscrupulous researcher could potentially fill out all the paperwork correctly and then grossly ignore their own protocols. Since there’s not constantly someone tailing the research team every day, it’s possible that no one would find out unless someone reported it. However, there’s rarely only one or two people on a project. I would hope, if there were a serious infraction, someone in the lab would report it (remember, this can be anonymous). The situation with the Geiers stacking their own IRB is outrageous to the rest of the scientific community.

    We can never ensure that people will be “completely honest about their intentions and actions”, but we make a whole lot of effort to try.

    • Sullivan February 4, 2011 at 01:12 #

      esattezza,

      I should note: my guess is that in most cases, IRB’s are doing what they are supposed to do. In general, ethical people don’t need ethics boards, or only need them for education. I think the Wakefield’s and the Geier’s of the world are rare.

  5. sharon February 4, 2011 at 02:20 #

    esattezza, I think you are absolutey correct in that we can only put in place the procedures you outline above, and the rest comes down to hoping people will be ethical enough to follow them, and of not get caught out.
    On a broader note, research that relies on obtaining the file notes of patients and/or clients can be a but slippery. Iv’e seen atrocious records of patient care over the years. Either lacking in detail, information or simply incorrect.

  6. esattezza February 4, 2011 at 02:44 #

    @ Sullivan: Absolutely, I’d meant to make that point, but got caught up in the details. Sometimes I wish Brain Deer understood a bit better. (I say this based on his last response in the interview you posted earlier this week: https://leftbrainrightbrain.co.uk/2011/02/russ-roberts-hosts-deer-on-autism-vaccination-and-scientific-fraud/)

    @ Sharon: Out of curiosity, on the issue of record keeping, thoughts on electronic records? I like the idea (assuming it’s well implemented) but I’ve never been on the clinical side of things. Your thoughts would be appreciated.

  7. sharon February 4, 2011 at 04:44 #

    Ive only seen general info shared electronically. I know Drs are able to access pathology results electronically also. Otherwise all staff related to the care of a patient utilised a central patient file (hard copy). This is essential for all professionals to track what each other are doing and plan for discharge. This was also my experience in Justice.

    I imagine these processes were much to do with the technology available and costs at the time. I would have some concerns about information being hacked, or being lost by system failues, even if temporarily. If I need to access a client/patient file now and it isnt where it should be generally speaking I know it’s not far away. When a large system crashes, and you know they will, it could really mess with a health setting such as a hospital. As things stand currently if there was an IT issue, despite the inconvenience, you can still access and share info with little disruption. So while I cant help thinking eletronic is the way forward, I think it will carry disruption potential for those in large institutions.
    All that aside I think training for all professions about how to write ‘proper’ case notes would be in order. A bit if a bug near of mine.
    I hope this makes some sense, I did write a more comprehensive reply only to have it deleted by my 2yo.

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