REC advice on PACE trial data changed in favour of release

I find it annoying that they are an organization that cannot admit they made a mistake or that the researchers (QMUL) didn't give them sufficient information to make a decision. It feels like as an organization they don't analyze a situation, read between the lines, ask for additional information etc. They just seem to react to what they are given and I assume normally in a positive manner.

I get the impression that ME trials (or the researchers doing them) have stretched their abilities due to the researchers willingness to present inaccurate or very one sided information as if it was a consensus view.
 
Can someone do a quick summary of exactly what has been released to JohnTheJack and by whom.

I am confused as to how PLOS One has been told to release data if they are a private organisation.

I am assuming this wasnt a FOI?

Who has been forced to release data and by which governing body?
 
large donner said:
Can someone do a quick summary of exactly what has been released to JohnTheJack and by whom.

I am confused as to how PLOS One has been told to release data if they are a private organisation.

I am assuming this wasnt a FOI?

Who has been forced to release data and by which governing body?
Click to expand...

As far as I understand this is not so much 'forcing to release', as it is taking away reasons not to.

Publishing in PLOS comes with a mandatory promise to share data on request. However PLOS has previously elected not to enforce this promise. While I'm not completely clear on the details, I suspect the RECs position was part of this decision, and this change removes cause for PLOSes previous inaction in this matter.

Edit: ah, yes, @JohnTheJack actually also said this in the OP:

JohnTheJack said:
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.
Click to expand...
 
Last edited:
Liessa said:
As far as I understand this is not so much 'forcing to release', as it is taking away reasons not to.

Publishing in PLOS comes with a mandatory promise to share data on request. However PLOS has previously elected not to enforce this promise. While I'm not completely clear on the details, I suspect the RECs position was part of this decision, and this change removes cause for PLOSes previous inaction in this matter.

Edit: ah, yes, @JohnTheJack actually also said this in the OP:
Click to expand...


Thanks. I am assuming PLOS one is a private organisation, which operates under certain policy based "promises," and the REC is a government organisation so what power do they have over PLOS one or anyone who publishes there?
 
large donner said:
Thanks. I am assuming PLOS one is a private organisation, which operates under certain policy based "promises," and the REC is a government organisation so what power do they have over PLOS one or anyone who publishes there?
Click to expand...

It's not really about having power over anyone. PLOS used the REC's previous position to justify their decision to not enforce the datasharing. Now that this position has changed, this rationale doesn't hold up anymore.

@JohnTheJack has asked PLOS to reconsider, given this change.
 
As a condition of publication by PLOS ONE, the researchers agreed to release data on request:
The PLOS ONE policy governing the sharing of data that applies to articles submitted before March 3, 2014, requires that authors agree to make freely available any materials and data described in their publication that may be reasonably requested for the purpose of academic, non-commercial research.

A number of requests were made for the data. There followed extensive discussions between PLOS ONE, the universities and the researchers, involving lawyers. In the end, PLOS ONE crumbled and decided that they could not require release of the data.

PLOS ONE did make an 'Expression of Concern' (EoC). The researchers, as is standard, were allowed to publish their response to this EoC.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0177037

There was some reaction to the EoC and response, but essentially that was where matters rested.

I have put in FOIs to the universities to get the data another way.

The response by the researchers relied upon the REC's advice:
During negotiations with the journal over these matters, we have sought further guidance from the PACE trial REC. They have advised that public release, even of anonymised data, is not appropriate.

I put in an FOI for a copy of this advice and it stated that data should be released to other researchers but not publicly. I went back to PLOS ONE with this and said make them release the data to eg Coyne. They refused.

I also asked the REC to reconsider. They did and actually changed their reasons for coming to the same decision (from 'ME is a special case' to 'can't be properly anonymized').

In the mean time, QMUL has released some of the data in question. I told PLOS ONE. It made no difference.

I appealed against the REC's decision (including pointing out that some of the data had been released). No change.

I then appealed to the HRA CoE and she upheld the appeal.

It means that the advice on which researchers were relying to refuse to release the data has been changed. The REC is now saying that the data should be released.

I have gone back to PLOS ONE and pointed out that now the ICO, the FTT and the REC all agree the data should be released. The researchers have nothing they can rely on and there is no excuse for PLOS ONE not to enforce their regulations.

PLOS ONE has gone back to the researchers and we await developments.
 
Their reasoning (edited: resining) doesn’t make sense! There are ways they can release the data without breaching patient confidentiality. Sounds to me they are worried about the backlash they are going to get. Talk about digging yourself further in a hole lol
 
Ellie_Finesse said:
Their reasoning (edited: resining) doesn’t make sense! There are ways they can release the data without breaching patient confidentiality. Sounds to me they are worried about the backlash they are going to get. Talk about digging yourself further in a hole lol
Click to expand...
Hubris has a very strong downward pull. No matter how much slack you are given, eventually it just runs out.
 
Ellie_Finesse said:
Their reasoning (edited: resining) doesn’t make sense! There are ways they can release the data without breaching patient confidentiality. Sounds to me they are worried about the backlash they are going to get. Talk about digging yourself further in a hole lol
Click to expand...

I suspect that no one has really examined how the RECs work or whether they are doing an adquate job. With ME patients looking they should be worried because there procedures don't seem to be fit for purpose. They seem too ready to allow protocol changes, with Crawley they have allowed feasibility studies to be converted to trials (by 2 people sub committees). And they seem to support data hiding on request.

The question is what are they approving in other areas? Perhaps they will be additional concern as MPs are asking questions about PACE and things are not good in their handling.
 
The real question of course is: Why are the PACE authors so terrified of expert scientific scrutiny of their data? Surely it could not be fear of exposing even more research flaws? Maybe even worse? Their behaviour makes it very clear it is very unlikely to be mere concerns about patient confidentiality, but much more likely highly selfish reasons. At the very least they should allow the scientific community access to it, and not just their trusted disciples; scientists with good track records (not 'eminence') of understanding and applying good scientific research methods.
 
Last edited:
You must log in or register to reply here.
Back
Top Bottom