REC advice on PACE trial data changed in favour of release

J

JohnTheJack

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I pursued this after the failure of PLOSONE to make the researchers hand over the data in compliance with the journal policy. The researchers relied on the REC.

See Expression of Concern and Response here:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0177037

I asked the REC to reconsider. They did but confirmed the decision. I appealed. The decision was confirmed. I appealed to the Chief Executive of the HRA. I received the decision this morning.

The REC advice now is that data should be released. I have emailed PLOSONE asking them in light of this change to enforce their conditions of publication and require the sharing of the data.
 

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Great work John.

I assume in this bit
Having reviewed the First-Tier Tribunal (FTT) and discussed this with the REC Chair, the REC accepts that this provides more detailed guidance on how the balance between participant confidentiality and the public interest in transparency should be struck. The REC has therefore reconsidered its initial advice and accepted the majority decision finding from the FTT which supported the Information Commissioner’s ruling requiring the disclosure of the data.
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the FTT referred to was Alem's appeal?
 
Great work, @JohnTheJack

I liked the way the letter ended:

Your appeal has therefore been upheld.

Please accept my thanks for bringing this to our attention. As you may be aware, the HRA is consulting on transparency and openness in health and social care research and would be keen to hear your views on the development of the final transparency strategy.
 
JohnTheJack said:
The REC advice now is that data should be released. I have emailed PLOSONE asking them in light of this change to enforce their conditions of publication and require the sharing of the data.
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Well done John! Interesting to see how this will develop. This is a bit embarrassing for PLOS ONE as well I suppose. I hope that they will now require the sharing of the data but I really don't want that McCrone et al. 2012 paper to be retracted because it contains some of the objective data of the PACE-trial.
 
Thanks for the kind words everyone. I won't really reply to individual posts but I have read them all.

Michiel Tack said:
This is a bit embarrassing for PLOS ONE as well I suppose. I hope that they will now require the sharing of the data but I really don't want that McCrone et al. 2012 paper to be retracted because it contains some of the objective data of the PACE-trial.
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Yes, I agree it is, especially as we have been pressing them on this for some time. I first responded over two years ago https://johnthejack.com/2017/05/04/a-response-to-the-blog-by-puebla-and-heber-of-plos-one/ and then had an email exchange with Heber this year, first after an FOI request revealed the actual REC advice and then after QMUL released some of the data in question. He refused to budge. Now, surely, they must.

I think McCrone will now release the data rather than have the paper retracted.
 
JohnTheJack said:
I would put sharing data 19:1.

The data is gradually coming out and they must see that so better that than suffer the indignity of a retraction.
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I guess that's one of the lessons from the first release of PACE data: it made almost no difference to have their BS exposed. If inflating the efficacy of their treatment 6x and basically cherry-picking the outcome they wanted had little impact, it's probably a safe bet that it will make little difference again, in the short term anyway.

There's some relief in knowing they'll eventually face retraction anyway. It's just a question of how much time and how many more lives are broken in the process.

James Coyne was one who made a lot of noise about this dataset. Is he still interested?
 
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