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Trial By Error: No Ethical Review of Crawley School Absence Study

Snowdrop

Rebel without a biscuit
Messages
2,933
I think it just sounds like incompetence to me. I suspect Crawley was doing the clinics and thought that she could push her views as a research paper and it was too late for ethics approval but seemed like it could go under a different heading.

Its not like a UK ethics committee would stop any project. I suspect if someone proposed a project to look at bleeding times post decapitation then the ethics committees would approve it as long as the right forms are filled in. They certainly don't do an in-depth look at ethics of a proposal.

Vague memory of this being done by journalists or other interested parties--that is filling in all the forms with a totally bogus and silly project -- and then having it approved. Might be worth trying to highlight the problems.
 

CFS_for_19_years

Hoarder of biscuits
Messages
2,396
Location
USA
Its not like a UK ethics committee would stop any project. I suspect if someone proposed a project to look at bleeding times post decapitation then the ethics committees would approve it as long as the right forms are filled in.
And just as long as a method for the proper calibration for the stopwatches was included, everything would be fine.
 

lilpink

Senior Member
Messages
988
Location
UK
This particular study may or may not be sinister, but a failure in the system that is supposed to be a watchdog has very broad implications.

Our ethics committee took a particular close look at any studies involving children. What was often passed off as routine care quite often was not. If there is a chance of these patients being identifiable either by themselves or others there are major issues.

I think the point in this case is that either the study proposal wasn’t put to the REC at all, or it was and the REC gave Crawley and colleagues carte blanche to do what they wanted.

The REC number quoted in this paper was not for this study, but it was for a previous study application that WAS passed as service evaluation. That would indicate that REC reference numbers can be issued for studies that are passed as service evaluation when approval has been sought / when an application has been made. That might imply then that no formal written application was made to the REC regarding this study, or presumably they would have supplied that REC decision reference number in the paper and everything would have been squeaky clean from the author’s point of view.
Perhaps they were given ‘the nod’ for this study via a telephone conversation, a friendly chat with someone on the REC. Maybe they tried the - “The project has been of great interest to the Department of Education…..etc….” type of approach on the REC. Or maybe they decided themselves from the outset that this was service evaluation and they didn’t need to approach the REC.

WE simply do not know.......but there are questions here which need answering, questions which the BMJ Open have NOT answered ……..despite the BMJ’s motto apparently being “Answering questions, Questioning answers” !


Well done to Joan Byrne for tweeting the BMJ and requesting a response to the issues raised here……they really DO need to provide a full explanation now.
 

Dolphin

Senior Member
Messages
17,567
I did think a fun research project would be to get various academics to submit spoof trials to ethics committees and see which (or who) got through. I think someone did something similar with papers which were written by a paper generator. I also remember that someone submitted the call for papers to a conference and got accepted.

Both are discussed in this article:

 

lilpink

Senior Member
Messages
988
Location
UK
To get back to the main thrust of this post - Crawley and the apparent misuse the REC number - I have a bit more from my 'contact' to add to this story:


One of the published studies that used the REC reference number was by Esther Crawley and Peter White - https://academic.oup.com/qjmed/article-lookup/doi/10.1093/qjmed/hct061 - adults this time, not children. So how can that REC number possibly fit? And yes, a complaint was made to the journal – QJM- about this paper too….and the journal’s response (after 3+ months to investigate) - “no corrections to this article are required at this time”. No more, just that. They gave no explanations regarding this REC number and didn’t address the concerns raised in the complaint about the apparent lack of informed consent of at least some patients who would have contributed to the National Outcomes Database. Badly done, I’d say.


This is an extract of the email sent in reply to the Editor of QJM:

“I am both surprised and disappointed that, following your long and 'substantive' investigation, you have not provided any explanations or evidence to me to allay my concerns over the matters that I raised about the above paper.

It is astonishing that you have failed to offer me any explanation regarding the apparent misuse of the REC number.

To use common parlance - as it stands, this stinks.”


NB We are being offered this information on a plate by someone (who doesn’t have ME and who doesn’t want the limelight) who has gone to great lengths to help our cause for no personal gain. I think it’s a pity that PR members don't seem to be taking more of an interest in this. I think we have a lot to lose by ignoring contributions from less prominent sources.
 
Messages
2,158
I imagine most people, like me, are horrified that Crawley, if I understand it correctly, is playing fast and loose with ethical approvals for studies. This certainly needs to be investigated properly. My problem is I haven't a clue how I can contribute in any useful way except to express my horror.

Should we be writing to the ethics committees concerned, or to the vice chancellor of Bristol University... Any suggestions?
 

lilpink

Senior Member
Messages
988
Location
UK
Should we be writing to the ethics committees concerned, or to the vice chancellor of Bristol University... Any suggestions?

I can say with some conviction that if you wrote to Bristol University I don't believe you would get any response, this has been tried. Likewise it's unlikely that the REC/HRA would respond to you either. I think we just need to let as many people know about this as possible and keep the profile of it raised......these journals do need to answer these questions. IF there are legitimate explanations then we need to hear them, and hear them soon.

I think it's possible that the Bristol Cable https://thebristolcable.org/ may be interested if anyone wants to let them know. ( https://thebristolcable.org/2017/07...bristol-university-and-controversial-science/ )
 

lilpink

Senior Member
Messages
988
Location
UK
first thing I got was this : http://bmjopen.bmj.com/content/5/10/e008830

"
Ethical approvals
UK cohorts
The North Somerset and South Bristol Research Ethics Committee decided that collection and analysis of CFS/ME patient data constituted service evaluation and did not require ethical review by a NHS Research Ethics Committee or approval by NHS Research and Development offices (REC reference number 07/Q2006/48).
"
You're now chasing the head rather than the tail..back to where we came in...
 

Molly98

Senior Member
Messages
576
@lilpink thank you for posting this. I am following this thread with interest but to be honest have very little understanding of it or the implications but am intrigued all the same.

The basics I am getting is that Crawley and co have either been negligent or sneaky or dishonest, could have broken ethical rules, I will watch to see how things develop, I am sure others have more of an understanding on here and can help look into things further.
 

Invisible Woman

Senior Member
Messages
1,267
I'm guessing it's use of the same data for which there was initial ethics approval being reused in subsequent research?

Nope (at least that's not how I understand it). It's having approval for one thing and getting the REC no for that and then going off on what appears to be a fishing expedition for something completely different and reusing the number.

Like being a schoolkid and getting a note from your mum saying you will be missing maths on Tuesday 'cause you've gotta go to the dentist and then using the same note on Friday when you want to spend the afternoon smoking fags at the back of the bike shed.

Except much, much more serious.
 

user9876

Senior Member
Messages
4,556
The only things I've picked up on is that there appear to be more that one REC(?):
"The North Somerset & South Bristol Research Ethics Committee decided that the collection and analysis of data from children and young people seen by the CFS/ME specialist service were part of service evaluation and as such did not require ethical review by the NHS Research Ethics Committee or approval from the NHS R&D office".


The point is that this wasn't collection of data from the routine service but a test of a new outreach programme hence their quote is not relevant. They may well have been given misleading information.

The HRA site Says:
The National Research Ethics Service (NRES) and the NHS R&D Forum have issued guidance on the categorising of research, clinical audit and service evaluation. All three types of study require the approval of host Trusts, however, systems for approval for each type of study vary and only research requires REC (Research Ethics Committee) review.

  • Research - is designed and conducted to generate new knowledge and should follow the systems for approval of NHS Research.
  • Audit - is designed to answer the question "Does this service reach a predetermined standard?"
  • Service evaluation - is designed to answer the question "What standard does this service achieve?"

The point could be debatable but the way the paper reads is that this was designed and conducted to generate new knowlegde. That is it was asking the question whether a new school based outreach approach would find/help patients. It could be considered an evaluation of a service but I think if you argued this you could do a lot of CBT type research under that banner.