If there’s any group of subjects a scientist wouldn’t want to piss off, it would have to be Aussie-rules football and rugby players, who are tough enough to make a saltwater crocodile wish it was a belt. And when those guinea pigs are suffering from low back pain — well, we shudder to think.
The journal BMC Musculoskeletal Disorders has retracted two papers from a group of Australian researchers who appear to have lied about having received IRB approval for their studies of back pain in rough-sport athletes.
According to the first notice, for “Low back pain status in elite and semi-elite Australian football codes: a cross-sectional survey of football (soccer), Australian-Rules, rugby league, rugby union and non-athletic controls:”
The journal has been informed by the authors’ institution that, contrary to the statement in this article [1], the Macquarie University Human Ethics Committee did not receive an application for ethics approval for this study. As the study was conducted without institutional ethics committee oversight, this article has been retracted. References 1. Low back pain status in elite and semi-elite Australian football codes: a cross-sectional survey of football (soccer), Australian-Rules, rugby league, rugby union and non-athletic controls: Wayne Hoskins, Henry Pollard, Chris Daff, Andrew Odell, Peter Garbutt, Andrew McHardy, Kate Hardy and George Dragasevic. BMC Musculoskeletal Disorders 2009, 10:38.
The study has been cited three times, according to Thomson Scientific’s Web of Knowledge. As for that IRB statement, it’s unambiguous:
The study was approved by the Macquarie University Human Ethics Committee.
The second notice, for the paper “Low back pain in junior Australian Rules football: a cross-sectional survey of elite juniors, non-elite juniors and non-football playing controls,” says basically the same thing:
The journal has been informed by the authors’ institution that, contrary to the statement in this article [1], the Macquarie University Human Ethics Committee did not receive an application for ethics approval for this study. As the study was conducted without institutional ethics committee oversight, this article has been retracted. References 1. Low back pain in junior Australian Rules football: a cross-sectional survey of elite juniors, non-elite juniors and non-football playing controls: Wayne Hoskins, Henry Pollard, Chris Daff, Andrew Odell, Peter Garbutt, Andrew McHardy, Kate Hardy and George Dragasevic. BMC Musculoskeletal Disorders 2010, 11:241.
That paper does not appear to have been cited yet. Our email to Wayne Hoskins bounced back, suggesting that he has left Macquarie. Dragasevic has yet to respond to a request for comment.
The case has echoes of that of Joachim Boldt, many of whose 90-odd retractions were because he had failed to obtain IRB approval for his anesthesiology research.
What is profoundly interesting about this retraction is that, IRB issues aside, the papers’ findings may all be valid. If so, we may need a new word to characterize this kind of situation. In that light let me suggest we call what happened here a hoskins, a term to describe authors or institutions retracting a dubious methodology but not the results of that methodology.
Here here! Although I think “dubious” is not the best descriptor – I’m making the assumption that the methods would have been approved by the IRB.
How about a new journal: “The Journal of Unethical (but otherwise valid) Research”?
How about, “technical foul”? The purpose of IRBs is to protect human life. They were created in response to things that ranged from evil to not so wise. A few of them:
– Irradiating ovaries of Jews in to see if it would sterilize them.
– Deliberately not treating syphilis in poor, black people to study tertiary syphilis.
– Giving a prison psych hospital full of psychopaths LSD to heal their psychopathy. (Result: Increased recidivism. Arguably, this one might have made it through IRB though.)
That is the sort of thing that led to creating IRBs. But today, IRB bureaucracy is treated as an end in itself, as if forgetting or mis-remembering paperwork was equivalent to causing harm to patients or society. That should be the primary test. Was anyone harmed? Could anyone reasonably have come to harm?
In this paper, the answer is no. Nobody was. In fact, by attacking the paper, the reverse is happening. That lack of sense alarms me. This paper does not.
One of the hats I wear is “IRB person.” In the US this survey study might have been considered exempt from IRB review (or possibly eligible for expedited review). The procedure at the vast majority of institutions would be, submit your study to the IRB and the IRB decides whether your study is exempt from review. So, if the rules are similar in Australia, they likely could have avoided this mess by going through a relatively painless procedure. I wonder if it was ignorance on their part or just not wanting to bother?
The other day I read an article about a trial that randomized patients to receiving one of two treatments for controlling post-operative pain. The authors stated that “this was a quality assurance study” so they didn’t need to get patient consent or go through the IRB. Hmm.
Wait a minute, duh. They said in the paper they went through the IRB but then they actually didn’t, so obviously it was willful.
Not necessarily. It could be that someone was asked to do it, and forgot to, then the PI in charge didn’t think anything of it because he didn’t hear anything back. It could be there was a conversation and a verbal ok, but someone forgot to turn in the paperwork, and remembered the conversation months later.
It is not the first time that science has progressed despite a lack of ethical approval. There were lots of such experiments in Germany in the 1940s, some of which might be described as “Unethical (but otherwise valid)”. Although going through an IRB can be onerous and annoying, there has to be a strong system of ethics approval, and when scientists blatantly lie about having received approval, there should be dire consequences. Besides the issue of protecting the rights of the subjects, if these “scientists” blatantly lied about getting ethical approval, then how can we be sure that they did not fabricate their results? I’m very glad that the IRB and the journal took a stand on this. This might haunt the researchers for the rest of their career. Who’d give a job to people with a record of lying about their research?
Wayne Hoskins is, apparently, a “sports chiropractor”. As chiropractors have yet to produce any solid evidence that their modality works, any journal receiving a manuscript from a promoter of chiropractic should take extra care before publishing.
Careful, you guys (you and Grumpy): assuming I have found the right Wayne Hoskins, he currently works at the Royal Melbourne Hospital, possibly even at the Department of Surgery.
And we don’t know whether Hoskins is the one who lied. He was a PhD student at the time, doesn’t the main supervisor handle IRBs?
Why does Grumpy have to be careful?
Because he might end up on Wayne’s table. Not sure you want to be on someone’s surgery table when you have said something unpleasant about him just before that.
(more seriously: we don’t know if all authors lied, only that one did)
That is a fair point. The lack of ethical approval in the first place might just be a case of negligent supervision. But Hoskins is named as “Corresponding Author” which means that he would have had to have written the deceptive statement that IRB approval had been given, or at the very least to have approved the draft that made the statement
I guess this raises a question Doug, what do you consider “solid evidence that their modality works”?
I consider the systematic reviews finding that spinal manipulation (“their modality”) is clinically effective for low back pain, neck pain, and certain other musculoskeletal conditions to be “solid evidence that their modality works” or need one just state that old chestnut and be done with it?
Dr. Hoskins is also an orthopaedic surgical registrar… and a phd!
Toronto have an Australian rules football club?