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.

 

He has been kept up to date with developments.

 

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.

 

Will they have the cheek to try “the dog ate my homework”. I wouldn’t put it past them.

 

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.