Trial By Error: A Letter to Archives of Disease in Childhood

Adrian said:
I do wonder if a complaint to the ethics committees would be a good idea. I think the Exeter ethic committee acted inappropriately in converting a feasibility study to a full trial (and doing so via a subcommittee of 2 people). I think the ethics committee should have bounced the changes and said its a new trial reapply. But then its not a new trial but it is being presented as one but under the same ethics approval as the feasibility study. Its all very dodgy.
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I've been thinking that it could be worth trying to get some investigation into these systems that have failed to provide effective oversight. I rather doubt that there are appropriate systems in place for assessing a complaint though, and it could backfire.
 
Oh, dear. Does this mean that this trial is going to be another one of those "beautiful ocean liner" things?

This time with the good ship "SMILE" ?

poseidonadventuer.jpg
 
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Esther12 said:
I've been thinking that it could be worth trying to get some investigation into these systems that have failed to provide effective oversight. I rather doubt that there are appropriate systems in place for assessing a complaint though, and it could backfire.
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For interest, here is the complaint made by Professor Hooper to the head of the National Research Ethics Service regarding PACE and the second link covers their response:

"On 1st March 2010 Professor Malcolm Hooper lodged a complaint with the Head of the National Research Ethics Service (NRES) – formerly the Central Office for Research Ethics Committees (COREC) which on 1st April 2007 became NRES -- about the apparent failure of the West Midlands Multicentre Research Ethics Committee (West Midlands MREC) to fulfil its obligations before granting ethical approval for the MRC PACE Trial on the grounds that it failed to adhere to Section 9.7 of the Governance arrangements for NHS Research Ethics Committees (2001) which were in place at the time it granted ethical approval for the MRC PACE Trial."


http://www.margaretwilliams.me/2010/mrec-complaint.pdf

http://www.margaretwilliams.me/2010/NRES-response.pdf

Catalogue of articles by Margaret Williams and Professor Hooper etc. 1994-2017
www.margaretwilliams.me
 
Daisymay said:
Esther, the whole letter is now available at the end of the article "Response from the National Patient Safety Agency to Complaint about the PACE Trial", just scroll down to below the article and you'll see it:

http://www.margaretwilliams.me/2010/NRES-response.pdf
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Thanks for all involved in releasing that.

It's also interesting for seeing how RECs work, as I don't know much about that. At the time there was no appeal process for REC decisions (which is something people have been considering with regards to SMILE/Crawley/etc issues.

There being no mechanism for others to make complaints seems particularly problematic if RECs have no power to investigate. What a ridiculous system. I wonder if it's still like that?

I thought I'd also link to this thread I'd started on that letter's author's (Janet Wisely) work with the National Research and Ethics Advisory Panel:

https://www.s4me.info/threads/janet...f-their-discussions-included.1770/#post-30638
 
Jonathan Edwards said:
Trish Groves@trished
Prospective registration of #clinicaltrials isn’t red tape: it’s done for sound ethical and scientific reasons. Yet unregistered trials rejected @bmj_latest still get published elsewhere as this study @bmj_open shows http://bmjopen.bmj.com/content/8/2/e020037 …

Is there a prize for hypocrisy, like the IgNobel?
I would like to make a nomination.

Edit: actually I guess that would be a seconding.
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Maybe the 'Givers Short Prize' ...as in being comparable to the John Maddox in being named after a (suitably jumbled & 'confused' ) journal editor.
 
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