I have just seen a report of a little hoax pulled on the media by John Bohannon. What he did was to run a small and deliberately badly designed clinical trial, the results of which showed that eating chocolate helps you lose weight.
The trial showed no such thing, of course, as Bohannon points out. It just used bad design and blatant statistical trickery to come up with the result, which should not have fooled anyone who read the paper even with half an eye open.
Bohannon then sent press releases about the study to various media outlets, many of which printed the story completely uncritically. Here’s an example from the Daily Express.
This may be a lovely little demonstration of how lazy and clueless the media are, but I have a nasty feeling it’s actually highly problematic.
The problem is that neither Bohannon’s description of the hoax nor the paper publishing the results of the study make any mention of ethical review. Let’s remember that although the science was deliberately flawed, there was still a real clinical trial here with real human participants.
What were those participants told? Were they deceived about the true nature of the study? According to Bohannon,
“They used Facebook to recruit subjects around Frankfurt, offering 150 Euros to anyone willing to go on a diet for 3 weeks. They made it clear that this was part of a documentary film about dieting, but they didn’t give more detail.”
That certainly sounds to me like deception. It is an absolutely essential feature of clinical research that all research must be approved by an independent ethics committee. This is all the more important if participants are being deceived, which is always a tricky ethical issue. There is no rule that gives an exception to research done as a hoax.
The research was apparently done under the supervision of a German doctor, Gunter Frank. While I can’t claim to be an expert in professional requirements of German doctors, I would be astonished if running a clinical trial without ethical approval was not a serious disciplinary matter.
And yet there is no mention anywhere of ethical approval for this study. I really, really hope that’s just an oversight. Recruiting human participants to a clinical trial without proper ethical approval is absolutely not acceptable.
Update 29 May:
According to the normally reliable Retraction Watch, my fears about this study were justified. They are reporting that Bohannon had confirmed to them that the study did not have ethical approval.
Also, the paper has mysteriously disappeared from the journal’s website, so I’ve replaced the link to the paper with a link to a copy of it preserved thanks to Google’s web cache and Freezepage.
Oh come on. all they had to do was eat chocolate. We all owe a huge debt to Bohannon for revealing, yet again, the extent to which science has become corrupted by perverse incentives.
This isn’t about any physical harm that might have been done to the participants. It’s about trust.
Of course there was more than eating chocolate! There were blood tests, blood pressure measurements etc done with deception.
That hoax tells us strictly nothing that any reader of, say, your blog, would not have known.
They did an intervention (diet), and collected/analyzed blood&urine. Plus Vital signs. They should have had ethics approval.
They were told it was for a TV programme. They could hardly be said to have been deceived into thinking that it was for the benefit of mankind.
And if an independent ethics committee approved what the participants were told, then I have no problem with it. But it really should not be up to researchers to decide for themselves what is ethical and what isn’t.