Janet Wisely gets on OBE after years of approving ethics of SMILE, PACE, etc at NREAP. [Minutes of their discussions included]

Esther12 · Jan 4, 2018

It's that time of year again... when they worst people in Britain are celebrated by being given the chance to grovel on their knees in exchange for a special badge. One of this years remarkable people is Janet Wisely.

I was planning to go through all the minutes of all the National Research and Ethics Advisory Panel Meetings, but I've only ended up doing a little more than a years worth. I want to come back to this, it was pretty interesting Also, it seems like @maxwhd from twitter has already done something similar here, focussing more on PACE excerpts: http://www.twitlonger.com/show/n_1so4td9

The full list of minutes are here: https://www.hra.nhs.uk/about-us/committees-and-services/nreap/nreap-meetings/

I focussed on the time when SMILE came up a lot.

10 November 2010:

7. Submissions from the ME Association and others to NRES concerning the ‘SMILE’ study
Received for discussion:
The ME Association and the Young ME Sufferers Trust joint statement NRES response letter Notes written by Hugh Davies in early response IRAS application for the „SMILE‟ study
The ME Association has raised concerns over a study of ME in young people that was recently approved by a REC. The panel were asked for comments/advice on the broader ethical issues and the actions proposed by NRES:

“…we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment.
We will also be seeking the views of our National Research Ethics Panel.”

The panel were supportive of the proposed NRES action put forward to deal with the concerns raised by the ME Association and others. It agreed that the main REC should be asked to review its favourable opinion in the light of new information (as per current NRES SOPs). The panel were in broad agreement with the preliminary notes written by Hugh Davies in response to complaints made about the SMILE study. However, the panel felt that in reviewing its decision the REC involved should limit itself to considering only the relevant new information regarding the study itself and not to consider allegations which were outside of its remit or competence to comment upon.

The panel stated that it was important to conduct impartial research into ME and that, where appropriate, it was equally important to ensure the benefits of research are extended to children in line with existing guidelines. It was noted that in the SMILE study participants were not being deprived of current care and the research question was the effectiveness of the additional tool which the study was designed to evaluate.

Agreed: The panel agreed and endorsed the proposed NRES action
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https://www.hra.nhs.uk/documents/343/2010-11-10_NREAP_Minutes.pdf

08 December 2010:

4. Matters Arising
4.1 The ‘SMILE’ Study

JW informed the panel that the main REC had now reviewed its favourable opinion in the light of new information (as per current NRES SOPs).
The main REC had voted unanimously to confirm the favourable opinion of the application with the following additional conditions:
1. PIS for Teenagers and PIS for Parents: Please add the fact that the Lightening Practitioner is
not clinically (medically) qualified (trained).
2. PIS for Teenagers and PIS for Parents: Please include the following text in the „Are there any disadvantages to taking part‟ section:
“Teenagers with CFS/ME can get worse with any intervention offered. There is no data in teenagers, see tables 1 and 2 for data in adults.”
3. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the Parliamentary Inquiry into NHS Service provision for ME/CFS include Data taken from Action for ME (AfME) and Association of Young people with ME (AYME) joint report “M.E. 2008: What progress” and reference it.
4. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the 2008 MEA survey and reference this.

The main REC also suggested (not as an additional condition) that in future Dr Crawley should consider using Lightening Practitioners who were additionally clinically qualified.
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https://www.hra.nhs.uk/documents/344/NREAP_Minutes_2010-12-08_FINAL.pdf

12 January 2011

4.2 The ‘SMILE’ study
Received for information only:
NREAP Minutes 12 January 2011 Page 2 of 5
Letter from Joan Kirkbride
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https://www.hra.nhs.uk/documents/345/NREAP_Minutes_2011-01-12_FINAL.pdf

2. Declarations of Interest:
6. The SMILE Study
Janet Wisely (NRES Director) and Hugh Davies (NRES Ethics Advisor) left the room during the discussion of this item.

...

6. The SMILE Study: Charles Warlow
Received for discussion:
Report for the National Research Advisors Panel - Charles Warlow

JW and HD left the room whilst the panel discussed this item.

Following the verbal report from CW the panel agreed that:

Whilst the panel did not feel that any "material issues" had been raised to categorically require a second review by the main REC it was felt that NRES had acted appropriately and reasonably in asking the main REC to review its favourable opinion in the light of the „new information‟ (in line with NRES SOPs). Whilst the panel were not in a position, nor had the remit, to comment upon the initial and subsequent review provided by the main REC they considered the REC‟s opinions to be entirely appropriate. If any further studies involving the lightning process are to be reviewed by an NRES REC then the panel felt it would be appropriate for the main REC involved to be appraised of the history of the ethical review of the SMILE study.

The panel supported the NRES operational view that the correspondence received after the REC meeting, in response to the REC decision not to suspend the ethical opinion, does not raise new issues that require a further review by the REC at this time.
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https://www.hra.nhs.uk/documents/346/NREAP_MINUTES_2011-02-09_FINAL.pdf

Minutes for 9th March meeting seem to be missing. What happened here?! Next they were contacting 'Understanding Animal Research'!

April 13 2011:

4.4 The SMILE Study
AG had contacted „Understanding Animal Research‟ who were happy to explore areas of common
ground in handling correspondence with regard to conducting research in contentious areas.
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https://www.hra.nhs.uk/.../NREAP_MINUTES_2011-04-13_-_revised_2012-01-11.pdf

08 June 2011

4.2. PACE Trial – Text of joint letter calling for more information, 24 May 2011
Received for information only:
PACE Trial – Text of joint letter from the ME Association together with the Young ME Sufferers Trust and the West Midlands ME Groups Consortium to Professor Peter D White (investigator, PACE Trial) calling for more information, 24 May 2011 (http://www.meassociation.org.uk/?p=6171)
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https://www.hra.nhs.uk/documents/350/NREAP_MINUTES_2011-06-08_FINAL.pdf

13 July 2011

4. Matters Arising

4.1. CFS/ME Research
Richard Tiner drew the panel's attention to a recent article in the BMJ entitled “Living with CFS/ME” 1
by Ollie Cornes which he felt would be of interest. CC would circulate the article to the panel by email.
It was also pointed out that the MRC has highlighted Chronic Fatigue Syndrome/Myalgic
Encephalomyelitis (CFS/ME) as a high priority and will be making available up to £1.5M for new
research into the mechanisms of CFS/ME. The MRC has also set up a new group, the CFS/ME
Expert Group (chaired by Professor Stephen Holgate, chair of the MRC Population and Systems
Medicine Board), to consider how new high-quality research into CFS/ME and partnerships between
researchers already working on CFS/ME and those in associated areas might be encouraged.2

4.2. Disruption of Research
Janet Wisely explained that she had met with Barbara Davies (Communications Director,
Understanding Animal Research) to discuss possible ways forward with regards ensuring that
medical research may be carried out without fear of harassment. This issue would be discussed
further at a future meeting of the panel.
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https://www.hra.nhs.uk/documents/351/NREAP_MINUTES_2011-07-13_FINAL.pdf

Esther12 · Jan 4, 2018

I probably decided to do this after looking up Trish Groves on social media. She seems to have played a role in presenting misleading info to COPE, as David Tuller as explained:

http://www.virology.ws/2018/01/02/trial-by-error-the-school-absence-study-revisited/
http://www.virology.ws/2018/01/03/trial-by-error-cope-to-bmj-open-more-details-please/

She's pleased about the level of transaparancy Wisely has achieved in medical research:

Jonathan Edwards · Jan 4, 2018

'Trish Groves (MBBS, MRCPsych) trained in medicine and psychiatry before going to The BMJ in 1989. She is now director of academic outreach and advocacy for BMJ, editor in chief of the online only journal BMJ Open, and honorary deputy editor of The BMJ.'

What a Lilliputian world we live in. It's a bit like celebrities congratulating each other on a Christmas panel game. The only difference is that it is so much more sinister.

Sometimes I do wish I tweeted, but I like the delusion that there is still a nice little old world one can live in without twitter where people behave properly (complete delusion I know).

Revel · Jan 4, 2018

Jonathan Edwards said: ↑

I like the delusion that there is still a nice little old world one can live in without twitter where people behave properly
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Hey, don't overcrowd me!

Adrian · Jan 4, 2018

https://www.hra.nhs.uk/documents/345/NREAP_Minutes_2011-01-12_FINAL.pdf said:

Whilst the panel did not feel that any "material issues" had been raised to categorically require a second review by the main REC it was felt that NRES had acted appropriately and reasonably in asking the main REC to review its favourable opinion in the light of the „new information‟ (in line with NRES SOPs). Whilst the panel were not in a position, nor had the remit, to comment upon the initial and subsequent review provided by the main REC they considered the REC‟s opinions to be entirely appropriate. If any further studies involving the lightning process are to be reviewed by an NRES REC then the panel felt it would be appropriate for the main REC involved to be appraised of the history of the ethical review of the SMILE study.
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I wonder if concerns that a future review process may be more rigorous and bring up the issues again means that Crawley went through the backdoor to approve the full trial via a protocol change on the existing ethical permission.

Esther12 · Jan 4, 2018

Adrian said: ↑

I wonder if concerns that a future review process may be more rigorous and bring up the issues again means that Crawley went through the backdoor to approve the full trial via a protocol change on the existing ethical permission.
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That's an interesting point. I hadn't thought of that.

Alternatively, they seemed to shift to the view that concern about SMILE was anti-science harassment, so maybe they'd have been keen to 'stand up for science'?

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Janet Wisely gets on OBE after years of approving ethics of SMILE, PACE, etc at NREAP. [Minutes of their discussions included]

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Janet Wisely gets on OBE after years of approving ethics of SMILE, PACE, etc at NREAP. [Minutes of their discussions included]

Esther12 Senior Member (Voting Rights)

Esther12 Senior Member (Voting Rights)

Jonathan Edwards Senior Member (Voting Rights)

Revel Senior Member (Voting Rights)

Adrian Administrator

Esther12 Senior Member (Voting Rights)

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