David Tuller: Trial By Error: How to Avoid Ethical Review

Kalliope

Kalliope

Senior Member (Voting Rights)
How to avoid ethical review

I have written many posts about BMJ Open’s 2011 school absence study,
which reported that school absence records could be useful in identifying children with chronic fatigue syndrome. However, for reasons not yet adequately explained, the investigators exempted the study from ethical review on the grounds that it qualified as “service evaluation.” To support the claim, they cited a 2007 letter from the regional research ethics committee (REC), which was unrelated to the study in question.
 
The final article in @dave30th 's list of the eleven studies currently suspected of inappropriately avoiding the ethical approval process was submitted for publication in March of this year and actually published less than four weeks ago.

I am not reliable with dates or time, but this is surely well after David's first blogging on this issue. So the Bristol group has continued publishing even after they have had this issue pointed out to them.

Perhaps not surprising of Professor Crawley, but reinforcing the idea that this research malpractice is so endemic that it being pointed out does not even cause the flutter of an eyelid.

Not only does the University of Bristol [and the BMJ etc] have serious questions to answer, but the various NHS Trusts and Education Authorities involved surely should be investigating how this happened and whether this research team should be allowed any further access to their patients or pupils until a full enquiry has been undertaken. Are potential participants in MAGENTA, FITNET, etc being warned of the research misconduct this team has be[en] involved with?
 
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We have come to expect this research misconduct from the BPS cult members, and I had assumed a contributory factor is the fundamental disrespect they seem to have for people with ME both in relation to their theories and in practice, however is it more wide spread than this?

Increasingly we are aware with such as Brian Hughes' book 'Psychology in Crisis' that these methodological difficulties are not confined to work on ME, and the rapid growth in MUS research and training is so obviously ideologically driven. Is this reflective of a much larger crisis in medical research in general and in psychological medicine research and practice in particular?
 
I emailed the HRA on this issue last year (Sept 2017):
"
please could you tell me if it is common practice for researchers to avoid the need for ethics approval by reusing a particular previously used REC (for which ethics approval was obtained).

The REC reference number (07/Q2006/48)

has been used on at least 9 other research papers but originated in a study done in 2007 (a local longitudinal pediatric study)which the REC determined was a service evaluation study.

However, as I said this REC reference number also is used on many other studies with one of the PIs is common to all of them.

In the Ethics paragraph they say

"
Ethical approval
The North Somerset and South Bristol Research Ethics Committee decided that the collection and analysis of CFS/ME patient data were part of service evaluation and as such 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)."

here are some of the others where it is used:

https://academic.oup.com/qjmed/article-lookup/doi/10.1093/qjmed/hct061

http://bmjopen.bmj.com/content/1/2/e000252.full

http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-217

http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-11-308


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3665909/ later amended to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3870018/

http://adc.bmj.com/content/98/6/425.full

http://bmjopen.bmj.com/content/5/10/e008830.full

https://www.ncbi.nlm.nih.gov/pubmed/26800634

http://adc.bmj.com/content/early/2016/09/21/archdischild-2016-311293.full

http://bmjopen.bmj.com/content/2/4/e001417

please could you clarify the issue"
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I got a fob off from them:
"I’m afraid I’m not able to comment on the specific REC decision. The REC provides independent advice, with a focus on protecting the rights, dignity and well-being of those taking part in health research and to facilitate high quality research.

I am able to point you in the direction of some of the guidance the HRA has produced, which might provide helpful context. The HRA publishes detailed guidance on when a study is considered research, details of which can be found here:

http://www.hra.nhs.uk/resources/before-you-apply/is-it-research/

Our guidance includes a clear definition of service evaluation, which you can find here:

http://www.hra-decisiontools.org.uk/research/glossary.html#S

I hope this helps.

If you do have any future media enquiries, do feel free to come straight to the comms team, and we’ll help you where we can. The general email address is hra.comms@nhs.net, or you’re welcome to contact me directly."
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I did write back to clarify but got no further reply.

hope @dave30th has more luck
 
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chrisb said:
Has it become clear what the REC knew, and when they knew it? Is it credible that they were wholly unaware of the practice? Does this practice have their tacit approval?
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Ah good point I had assumed that there would have to be a nod from some person from the REC each time to say yes you can go ahead with this one without go8ng through the process. If the researchers simply decide for themselves it doesn’t need approval and there is no policing then it is obvious to anyone that the process is not satisfactory in terms of compliance. What’s the point of a process with a loophole that big. Well I suppose if researchers reviewers and publishers all behaved within the spirit of the ethics rules it would be ok. In this case the researchers have turned that loophole into a pipeline to pump their crap out of.
 
This is a little off topic but related! It follows discussion on S4ME as Parliament say, "in another place...".

I uncovered some interesting info whilst looking up the RCP /RSM stuff to do with the event I attended at the RSM last year.
Additionally, I think MEA and Charles have used RSM and their Awards Ramsey prize in the past? I think I went to the Abhjit Chaudrai one..?
So RSM President incumbent aside... we don't want to throw the baby out with the bath water.....? It's not all bad.....

(Prizes and awards a complete list of awards and prizes open to both RSM student members and non-members unless otherwise specified.)
Also, recent, they make available lectures on line. Please note that from 1 October 2018 all RSM videos will be free to view and no longer have CPD credits.

"Developing a clinical research agenda based on routinely-collected WGS data " " Free"
Professor Ajit Lalvani looks at the research agenda and implementation of whole genome sequencing, based on routinely collected data.
https://videos.rsm.ac.uk/video/deve...-agenda-based-on-routinely-collected-wgs-data
 
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Peter Trewhitt said:
Not only does the University of Bristol [and the BMJ etc] have serious questions to answer, but the various NHS Trusts and Education Authorities involved surely should be investigating how this happened and whether this research team should be allowed any further access to their patients or pupils until a full enquiry has been undertaken. Are potential participants in MAGENTA, FITNET, etc being warned of the research misconduct this team has be[en] involved with?
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Absolutely and funding bodies should be questioning continuing to fund these researchers until this is independently investigated.
 
This seems like a very serious scandal in development. One that affects the whole of UK medical research.

How common is it to arbitrarily exclude research from ethical review with such blatant handwaving? Because if it can happen so brazenly nearly a dozen times even through repeated warnings, then it can happen every time.

And when you add up broader issues with conflicts of interest and bias, the reputation of UK medicine will take a severe hit once people understand what is happening. How much of a gold standard can Cochrane remain once it is understood they approve of small unblinded trials with self-reported outcomes as solid evidence? Or that the BMJ is fine with publishing research without ethical review?

To what end? What is it that they think is being gained here? Don't these people realize that in corrupting the process of science in medicine they will hurt themselves, their families and friends in the long run?
 
rvallee said:
This seems like a very serious scandal in development. One that affects the whole of UK medical research.
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Is this this something we should be investigating here at present or do we let @dave30th run with it and see what happens?

I had meant to start looking at the other projects that rely on the same supposed 'ethical approval waiver' as the School Absence study, but am in danger of pushing myself too much at present so need to start cutting back again. The lists of what I want or need to do is growing unhelpfully at present.

Ideally it would be something the British press should be taking up, but I am not optimistic about that happening. In political terms the most relevant people have already been copied into David's letter. Should we as individuals be asking the UK ME charities to get involved?

Should we individually or collectively be asking the relevant Health Trusts/Authorities, Education Authorities and funding bodies for comment?
 
As they used the one letter in multiple cases maybe we should send letters about each of the research cases it was used in. Ask the specific question as to why a letter from another case was used to exempt the research in each case.
They should have to answer the questions and it would mean creating a wider issue which might get more publicity.
If they don't answer then it would show what a cover-up the whole thing is. Win win for us :)
 
Sly Saint said:
I emailed the HRA on this issue last year (Sept 2017):


I got a fob off from them:


I did write back to clarify but got no further reply.

hope @dave30th has more luck
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followed this up and received a very brief reply
Many thanks for your email. Please note Dave Murphy has now left the HRA.

With regard to your query, the HRA is satisfied the independent panel conducted a thorough and rigorous investigation in a fair, impartial and objective manner. The HRA has accepted the recommendations of the panel and now considers the case closed.


Kind regards,



Stephen Tebbutt

Head of Corporate Governance & Risk

Health Research Authority

HRA Centre Manchester | Barlow House, 4 Minshull Street | Manchester | M1 3DZ

T. 0207 972 2487

M. 07810 050 292

E. stephen.tebbutt@nhs.net

W. www.hra.nhs.uk
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Sly Saint said:
followed this up and received a very brief reply
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Uh, uh. No, case not closed. Keep the file in an accessible location. When this all blows over there will be hard questions to answer about the validity of a process that greenlights and reaffirms it is OK with ethical violations and malpractice if you know the right people.

You don't actually clear away malpractice by having the regulators OK it. All you accomplish is spread failure around and raise the issue from malpractice to malfeasance.
 
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Trial By Error Oct. 30th
How Bristol Investigators Avoided Ethical Review (Reprise)

Last November 12, I published a post called “How Bristol Investigators Avoided Ethical Review.” That post addressed the series of eleven studies conducted by Bristol investigators and exempted from ethical review on questionable grounds. The lead investigator of these studies was Professor Esther Crawley, Bristol’s methodologically challenged pediatrician, whose work was the subject of a report released last week by the National Health Services’s Health Research Authority.
That investigation confirmed my argument that these studies all qualified as “research” and not “service evaluation.” Professor Crawley has now been directed to make corrections to the ethics statements in all eleven studies. While this remedy falls significantly short of what I believe is appropriate, it would nonetheless be a humbling and perhaps humiliating task for any serious investigator to have to correct so many studies at one go. And of course this mandate comes just a few months after Archives of Disease in Childhood appended a 3000-word correction to the dung-heap known as the Lightning Process trial–also from Professor Crawley and her colleagues.

I will address my concerns about the new report on Professor Crawley’s work at another time. For now, I thought it might be useful to reprise last year’s post (published in full below). The post offers an in-depth explanation of the issues involved, including the distinction between “research” and “service evaluation.”


 
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