BETWEEN May and July of 2013 two significant reports were published that concentrated, first, on the role of sports science practice within the Essendon Football Club (the Switkowski Report in May) and then more generally in Australian sport (the Senate’s Rural and Regional Affairs and Transport Reference Committee: Practice of sports science in Australia).
Both reports highlighted what was categorized in the following ways: “pharmacological experimentation”, “pioneering science”, “unconventional practice”, “dodgy science”, “exotic treatments”, and “athletes being used as experimental models for untested practices via the behaviour of a rogue medical team”.
Similar statements can be found reflected in the AFL Notice of Charge Rule 1.6 from August 2013.
The Australian medical research community, whose pursuit of research follows the procedures dictated in the National Statement on Ethical Conduct in Human Research (2013 update), was legitimately alarmed by what had occurred.
One way of probing that alarm was to investigate whether Essendon players had really been subjected to a clinical trial that went on without the required approval of a Human Research Ethics Committee (HREC); if so then the players were accorded less protection than guinea pigs who are covered by Animal Ethics Committees.
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Central to this probing would be an analysis of the consent forms that were presented to the players by “sports scientist” Stephen Dank at a meeting in January of 2012. Those forms are discussed in the AFL Notice of Charge and in the recent Court of Arbitration for Sport arbitral award where they play a role. Sadly, and this is a matter of some consequence, the exact nature and quality of the consent documentation does not get adequately covered in either place.
I was asked by the AFL Players Association to provide an opinion on the quality of the consent documentation in relation to the Essendon case in September of 2013. My opinion was provided at no charge through Bellberry Ltd, a not-for-profit working in the HREC domain where I am one of several HREC chairs.
Despite what some of the principals were saying about protocols, information sheets and consent forms it was immediately obvious that no clinical trials were overtly undertaken.
The players were presented with patient information/informed consent forms that sought their consent to undergo four proposed treatments. There was no scientific protocol to back up any of the four proposed “treatments” and indeed one member of Essendon’s group, nutritionist Benita Lalor, pointed out the complete lack of evidence for any of the proposed treatments.
With no protocol there was no presented science behind the interventions and that was just the beginning. Since Antoine-Laurent de Lavoisier, the role of quantitative data in research has been obvious; the data acquisition and entry at Essendon appears to have been at best shambolic.
What took place was not an experimental intervention, pioneering or otherwise; it bears the same relationship to science that Groucho Marx does to Marxism.
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The forms used at Essendon were headed with the word “patient” not “participant” and what they most closely resemble is a patient information sheet for use where significant interventions are proposed in elective settings.
And here is where the real complexity starts to emerge. Stephen Dank, the author/signatory on the forms, is not a health practitioner and so not someone who has any patients. The club doctor, Bruce Reid, does have patients and does hold patient records.
So where the forms tell the “patients” that treatments will be tailored for them based on “the visual examinations I have performed, on any x-rays, models, photos and other diagnostic tests that have been taken, and on my knowledge of your medical and physiological history”, the inference is obvious: only Dr Reid could be in a position to make that claim.
All four substances are covered by one template that makes exactly the same claims about safety data for each. As it happens the claims that are made are contradictory in all four cases.
“The risks of the treatment are nil”, it says in one place, and then, 15 lines later: “There are some complications that tend to occur with some regularity”. Nobody can consent to a contradiction, especially one that is so utterly central to garnering consent in a clinical setting.
The fact that treatments are proposed for ailments and no illnesses or ailments are in play further reinforces that fact that consent to treatment is misplaced.
A lot of attention has turned to Dr Bruce Reid and there might be some tendency to think that an enhanced role for medical practitioners at sporting clubs is warranted.
What is important to note here is that the AFL is an Australian sporting organisation subject to the Australian Sports Commission’s Sports Governance Principles, a mandatory subset of which is that boards – and this will mean individual club boards — must embed the Australian Institute of Sport’s Best Practice Principles on research.
Club boards need to create a framework robust enough to evaluate the nature of interventions, supplementary or otherwise, that partitions them into categories: full-blown research subject to HREC approval and medical treatments being only the two under discussion here.
Associate Professor Brian Stoffell is Head of the Social Health Sciences Unit at Flinders University. The focus of his teaching and research is the legal and ethical governance of health care practice in Australia.