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FINE Trial team remove raw data file: pressure from PACE Trial team?

Yogi

Senior Member
Messages
1,132
http://www.manchester.ac.uk/research/environment/governance/misconduct/

Research misconduct

The University of Manchester is committed to the highest standards of research integrity and takes very seriously any concerns raised about the conduct of research undertaken by any of its staff or students.

Our Code of Practice for Investigating Concerns about the Conduct of Research (Word document, 127KB) outlines the process that we follow when we receive any allegations of research misconduct.

Any concerns about the conduct of research or complaints about potential research misconduct should be made to:

Mrs April Lockyer
Research Governance and Integrity Manager
University of Manchester
Oxford Road
Manchester
M13 9PL

April.Lockyer@Manchester.ac.uk
Tel 0161 275 8093
Fax 0161 275 2445

http://www.manchester.ac.uk/research/environment/governance/
 

TiredSam

The wise nematode hibernates
Messages
2,677
Location
Germany
It took them 5 months to notice this ethical breach after it being in the public domain where "motivated intruders" and "vexatious ME activists" had access to it and risked "de-anonomysing the data" ?
Might I be permitted to note that in those 5 months, vexatious ME activists did nothing vexatious with the data at all, thus demonstrating that the PACE authors' claims about what would happen if their data were made available are completely unfounded.

I would like to thank the FINE authors for making their data available for 5 months in order to provide proof of no untoward consequences.
 
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Sasha

Fine, thank you
Messages
17,863
Location
UK
David Tuller on FB said:
So, this is an interesting twist, if you're interested in the data-sharing saga. The authors of the FINE study have actually withdrawn anonymized data they had previously released as part of a paper published by PLoS One. They are now claiming that their consent forms did not provide them with explicit permission to share such data. This is the argument at the core of the PACE authors' refusal to share their own data--or one of their arguments, at least, since they've raised quite a few different ones. PLoS One, of course, is already party to James C. Coyne's PACE-related data request. That case has now dragged on for six months. .

FINE was the PACE trial's "sister trial," also funded by the UK government in 2003 to prove that ME/CFS patients could be "rehabilitated" with exercise and some cognitive readjustments. The FINE trial, whose investigators were colleagues of the PACE authors, reported null results in 2010. (They misrepresented these findings by making some unjustified positive claims, as I reported last fall.) The PACE authors failed to mention this "sister trial" and its inconvenient null results when they published their own purportedly successful work in The Lancet in 2011.

Last December, the FINE team published a paper in PLoS One called "Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome." Whatever.

The point is, on Wednesday they suddenly posted a "correction" in which they removed the graph that included the anonymized trial data. The release of that information by the FINE researchers had clearly undermined the rationale for the PACE authors to withhold similar kinds of data. So I'm not surprised the FINE data has now apparently been disappeared. I've just never heard of trial data being withdrawn after already being released into the public domain. What's going on at PLoS One?

https://www.facebook.com/david.tuller.1/posts/10153412511771829
 

Yogi

Senior Member
Messages
1,132

user9876

Senior Member
Messages
4,556
I think it is worth saying that the data did bring the analysis of the FINE trail into question in that there were patients who both improved and got worse using the CFQ depending on the marking scheme. The FINE trial used one marking scheme which was in their primary outcomes but seem to have promoted the alternative scheme at times as the results were more in line with their desired outcomes.

Fundamentally it raises questions about the trial design because having two sometimes contradictory schemes for the CFQ is strange and suggests that their choice of a measurement scheme was flawed from the start. But the flaw is obvious.
 

Yogi

Senior Member
Messages
1,132
What I do not understand is that they have removed the "anonymised patient data, in a public forum" because of "ethical" concerns......

Data Availability: Our ethical permission did not expressly permit us to share patient data, even anonymised patient data, in a public forum. Data will be made available to bona fide researchers on application to the principal investigator, Alison Wearden or the trial statistician, Graham Dunn. Alison Wearden can be contacted at: Alison.wearden@manchester.ac.uk. Graham Dunn can be contacted at: Graham.dunn@manchester.ac.uk.

.......However as psychologists are they not aware of the Streisand effect especially as the data was publicly available? These researchers have compounded their original "error" and ethical violation especially if this found itself onto social media!

https://www.mediafire.com/?rvh3brmgoaznude

The Streisand effect is the phenomenon whereby an attempt to hide, remove, or censor a piece of information has the unintended consequence of publicizing the information more widely, usually facilitated by the Internet. It is an example of psychological reactance, wherein once people are aware something is being kept from them, their motivation to access the information is increased
https://en.wikipedia.org/wiki/Streisand_effect
 
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sarah darwins

Senior Member
Messages
2,508
Location
Cornwall, UK
These researchers have compounded their original "error" and ethical violation especially if this found itself onto social media!

I think we're all in agreement that this move has nothing to do with patient privacy or ethical concerns. It's political manoeuvring in support of their buddies (and their buddies' lawyers) in their rather surreal attempts to negotiate a retroactive opt-out with PLoS ONE.
 

TiredSam

The wise nematode hibernates
Messages
2,677
Location
Germany
The authors contacted the editorial office about possible restrictions for the public availability of the data in relation to the information outlined in the consent form for the trial.

Why do they keep using a dodgy consent form that gives them an excuse to withhold data later on? What efforts have they made to draft a more suitable consent form, and then ask the original trial participants to sign it now so that the data can remain in the public domain? I'm sure the participants would all agree. If any don't, then the FINE authors can retract the whole paper because they are no longer able/willing to meet their data sharing obligations through their own incompetence.

Ditto the PACE trial - why haven't the authors tried to draft a proper consent form and send it to the participants?
 

Seven7

Seven
Messages
3,444
Location
USA
I hope somebody will post that data in every imaginable public place avaliable. So any maneuvering they are planning will fail.
 

taniaaust1

Senior Member
Messages
13,054
Location
Sth Australia
What I dont understand is even the need for there to be specifically stated on a consent form permission to release "anonomous" data. If it doesnt point to any person as such, why need that?

and besides when someone consents and signs something to take part in a study, isnt there an rational expectation there that it will probably get published with anonomous supporting evidence? I personally think they are letting the studies participants down by not publishing this as Im sure the participants would of expected this study to be done well and have the supporting info with it. (is that a grounds for a court case to get it published by some of those who were in this study? couldnt they say this was a reasonable expectation they had when they joined it?).

If people are going to be this fussy with consent forms, I would suppose 90% + of the studies out there should be then pulled due to privacy breaches. Why go and do things differently when it comes to our studies?
 

Aurator

Senior Member
Messages
625
This reaction, like the PACE data shenanagins, divests the research of the very credibility the investigators are trying to salvage for it.

I don't know about letting them carry out research, if the PACE or FINE team worked at my university (actually the FINE team do) I wouldn't trust them to competently sweep floors even. I've a suspicion that half the dirt would end up under the carpet.
 

eastcoast12

Senior Member
Messages
136
Location
Long Island ny
Might I be permitted to note that in those 5 months, vexatious ME activists did nothing vexatious with the data at all, thus demonstrating that the PACE authors' claims about what would happen if their data were made available are completely unfounded.

I would like to thank the FINE authors for making their data available for 5 months in order to provide proof of no untoward consequences.
This whole thing is turning into a fucking embaresment. Outside of their bubble they are quickly losing whatever credibility they thought they had. This is a classic example of that Streisand effect.
The Lancet is slowly turning into a pseudoscience journal. Between Wakefield, that Italian guy who's killing people with the trache transplants, that jerkoff who claimed depressive moods cause cancer (funded by tobacco companies) and a number of others, the whole thing is just so bizarre.