Pointed observations in a judgment which are not directly related to the matters pleaded are usually worth noting. Those in a recent case involving the PACE trial and Queen Mary, University of London, are essential reading for academics and support staff who deal with FOI
In a ruling handed down this week the First-tier Tribunal (Information Rights) (“FTT”) has upheld the Information Commissioner’s (IC) decision that Queen Mary, University of London, was entitled to rely on the exemption at section 36(2)(b)(1) and (2) of the Freedom of Information Act 2000 in refusing to disclose minutes of the Trial Steering Committee and Trial Management Groups of the Pace Trial. The trial had been set up to compare and test the effectiveness of four of the main treatments currently available for people suffering from chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME), but it attracted considerable criticism from some quarters. In the words of the FTT
There has been a storm of comments about this study. There had been deeply wounding personal criticisms of individuals concerned and over the years individuals in this field of research and treatment have withdrawn from research in the face of hostile irrational criticism and threats.
The FTT found that the exemption was engaged:
it is pellucidly clear that the progress and conduct of research in this area would be hampered by the publication of minutes of meetings such as sought by this request because individuals would be less willing to engage in research, participate in steering committees, provide guidance, debate issues about the conduct of research as fully and frankly as they otherwise would; as fully and frankly as would most benefit the research and the patients it is intended to help
and the public interest favoured maintaining the exemption:
the appellant’s arguments in favour of disclosure of the minutes when so much has been made available publicly in relation to this research and been subjected to such high levels of independent scrutiny do not outweigh the considerable weight to be given to the public interest in maintaining the safe space for academic research
But the FTT then made wide-ranging and significant observations about the concept of academic freedom and its relation to FOI. The decision cites Article 13 of The Charter of Fundamental Rights of the European Community:
Freedom of the arts and sciences The arts and scientific research shall be free of constraint. Academic freedom shall be respected.
and section 202 of the Education Reform Act 1988 which places an obligation on the University Commissioners to
ensure that academic staff have freedom within the law to question and test received opinion, and to put forward new ideas and controversial or unpopular opinions, without placing themselves in jeopardy of losing their jobs or privileges they may have their institutions
and the FTT stresses the “profound importance” of academic freedom, noting that the IC has an obligation, as an emanation of the state, to give effect to Article 13. The judgment notes that the purpose of universities is to disseminate and generate knowledge and that disclosure of information is their primary purpose (“the activity which imbues the University with its moral significance”). In rather remarkable terms, the seeking of and disclosure of information (from academic institutions) under FOIA is unfavourably compared to this academic dissemination:
A parallel process of dissemination through FOIA is unlikely to be as effective or robust as the process of lectures, seminars, conferences and publications which are the lifeblood of the University. They are likely to be a diversion from the effective evaluation, publication and scrutiny of research through the academic processes. All too often such requests are likely to be motivated by a desire not to have information but a desire to divert and improperly undermine the research and publication process – in football terminology – playing the man and not the ball
One might pause to question whether this unfairly overplays the likelihood of FOIA requests being detrimental to academia, and also overstates the amount of information which is disseminated to the general public through academic research. Part of the reason for FOIA is that it enables the public to access information that public authorities specifically choose not to proactively disclose. One sees similar arguments at play in the apparent prioritising of the “transparency agenda” over FOIA disclosure.
There follows, though, a sensible suggestion for what researchers might consider at the outset of projects. With a view to the obligation to publish and maintain a publication scheme, institutions are advised that
it might well be worth considering at the start of a major project such as this setting out a publication strategy identifying what materials will be produced in the course of the project, which materials will be published and when (this will enable s22 to be considered if FOIA requests are received for such material), and which are unlikely to be published under FOIA as exemptions may be engaged
and the IC is (again with a nod to his Article 13 obligations) prompted to issue guidance on this.
Finally, the judgment suggests that the University missed a trick with this specific request
properly viewed in its context, this request should have been seen as vexatious- it was not a true request for information-rather its function was largely polemical and as such in the light of recent Upper Tribunal judgements might have been more efficiently and effectively handled if treated as vexatious
The Tribunal Judge, Christopher Hughes, has a wealth of experience in the field of academic and medical research. These are crucial observations about the relationship between FOI and academia. We already have a new exemption on its way specifically for academic research (by way of clause 19 of the Intellectual Property Bill) but this decision appears to reinforce the protection that academic research and associated information will be given from FOIA disclosure.
Postscript:
The BMJ has an article on this judgment (behind the paywall, but letters in response are here (thanks to Zuton who has commented below for drawing this to my attention).
informationrightsandwrongs 
“Pellucidly clear?” er – of course its clear
Transparently so!
“it might well be worth considering at the start of a major
project such as this setting out a publication strategy identifying
what materials will be produced in the course of the project, which
materials will be published and when (this will enable s22 to be
considered if FOIA requests are received for such material), and
which are unlikely to be published under FOIA as exemptions may be
engaged” This seems a strange comment from the judge, considering
the fact that this request was largely focussed on getting
information about why the researchers had changed their views on
what data would be released in the middle of the trial. The PACE
trial had published a protocol which laid out how results were to
be released, but they are now refusing to release data in this
manner:
https://www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po
The most worrying part of this judgement is that it now seems
acceptable to treat a FOI request as vexatious because it is
related to CFS, rather than because anything the person making the
request has said or done. CFS is a controversial area, and some of
those working in this area have been trying to promote the view
that their critics are just unreasonable and militant. It seems
that this viewpoint is now being accepted as accurate by judges
based upon articles and opinion pieces which lack any good evidence
to support the claim – circular justifications reinforcing one
another. An earlier judgement on this matter had presented the view
that another individual who had made a similar request as having
some anti-psychiatry views, but that Mr Mitchell’s submission was
well cited and reasonable, albeit not enough to overcome the
arguments in favour of keeping these transcripts private. That
Christopher Hughes is now claiming that Mr Mitchell’s complaint
“was not a true request for information-rather its function was
largely polemical”, without providing any evidence to support this
claim, seems deeply unfair on Mr Mitchell, and potentially, on any
other CFS patient interested in gaining access to more information
about their condition and how it is treated through the
FOIA.
An earlier judgement concerning the same trial came to a
different view conclusion about academic freedom.
http://www.bailii.org/uk/cases/UKFTT/GRC/2013/2012_0229.pdf Para 22
“To the extent that the University’s argument includes an assertion
that disclosure under FOIA would impinge upon academic freedom and
that those collecting the data should have academic freedom to
choose what to publish, where and when for reasons of academic
prestige regardless of the public interest; where the research has
been conducted with the use of public funds, we reject this. We
consider academic freedom to relate to the freedom to pursue
research wherever the evidence takes a researcher and the freedom
to disseminate, publish and teach no matter how unpopular and
controversial the conclusions. That academic freedom must be viewed
in the context of the public interest is clear from the structure
of s22 FOIA which is subject to the public interest test” On the
judges suggestion that what will be published should be defined
early, some of this is specified in the trial protocol. One of the
reasons this trial has been challenged and FoI requests made is
that what was published was not what was specified in the published
trial protocol. The reason for prepublishing the protocol is to
prevent scientists and drug companies cherry picking results to
publish. Hence the all trials campaign by Ben Goldacre to insist
protocols are registered and published. However this is pointless
if academics are simply allowed to rewrite the trial endpoints and
change the protocol. Queen Mary’s say it is notrmal to change the
protocol but I believe that the type of changes that are normal are
things like changing which significance test is used after looking
at the distribution of the data rather than changing the endpoints.
The scary thing about this ruling is it seems to give academics the
freedom to cherry pick which results they report without the need
to worry about FoI requests.
There is a continuing discussion of these matters at the
BMJ here: http://www.bmj.com/content/347/bmj.f5963?tab=responses
(All open access). Most recent example: It is wrong to prevent
patients from making informed decisions about their medical care 26
November 2013 Sean Lynch reports that, in his view, the protocol
changes for the PACE trial appear well justified[1]. However, the
accuracy of the factual claims used by the PACE trial researchers
to explain their post-hoc outcome measures should be checked. The
PACE trial’s published protocol defined ‘recovery’ as requiring an
SF-36 Physical Functioning (SF36-PF) questionnaire score of at
least 85 out of 100, while the trial’s entry criteria required a
score of 65 or under, which was taken to indicate that patients’
fatigue was disabling[2]. The post-hoc criteria for recovery
allowed patients with an SF36-PF score of 60 to be classed as
recovered. This change was justified by the claim that a threshold
of 85 would mean “approximately half the general working age
population would fall outside the normal range.”[3] In fact, the
data cited showed that the median score for the working age
population was 100, less than 18% of the general working age
population had a score under 85, and 15% had declared a long-term
health problem[4,5]. An SF36-PF score of 60 was claimed in the
Lancet PACE paper to be the mean -1sd of the working age
population, and thus a suitable threshold for ‘normal’
disability[6]. They had in fact used data which included all those
aged over 65, reducing the mean physical function score and
increasing the SD[4]. For the working age population the mean -1sd
was over 70, requiring patients to score at least 75 to fall within
this ‘normal range’[5]. Also, the trial’s protocol makes it clear
that the thresholds for recovery (including ≥85 for SF-36 PF) were
intended to be more demanding than those for the mean -1sd,
reporting that: “A score of 70 is about one standard deviation
below the mean… for the UK adult population”[2]. The post-hoc
criteria for recovery so clearly overlapped with the trial’s own
criteria for severe and disabling fatigue that an additional
element needed to be introduced, mandating that ‘recovered’
patients not also fulfil every aspect of the trial’s criteria for
CFS[3]. Even so, patients could still have been classed as
recovered when reporting no change, or even a decline, in either
one of the trial’s primary outcomes. Even using the loose post-hoc
criteria for recovery, only 22% of patients were classed as
recovered following treatment with specialist medical care and
additional CBT or GET[3]. Regardless, the BMJ had reported that
PACE showed CBT and GET “cured” 30% and 28% of patients
respectively[7], a Lancet commentary claimed that about 30%
recovered using a “strict criterion” for recovery[8], and a paper
aimed at NHS commissioners stated PACE indicated a recovery rate of
30-40% for CBT and GET[9,10]. It is wrong for such misstatements of
fact to be allowed to go on affecting how doctors treat their
patients, how funding decisions are made, and the information that
patients are provided with before deciding whether to consent to
particular interventions. The changes to the outcome measures used
in the PACE trial may not be “representative of a hidden
agenda”[1], but they were misguided, justified by inaccurate
claims, and have been misleading to others. The refusal to allow
patients access to data on the outcome measures laid out in the
trial’s protocol reflects a sad dismissal of their right to be
informed about the medical treatments they are being encouraged to
pursue[11,12,13]. Lynch goes on to recommend the use of pragmatic
trials as a way forward for CFS/ME research[1]. This is unlikely to
be helpful. In response to the paper cited by Lynch, professor of
complementary medicine Edzard Ernst pointed out that: “drawbacks
might mean that the cmRCT generates false positive results. I can,
for instance, imagine a pure placebo, like homeopathy, coming out
of such a test smelling of roses.”[14] There was a time when it was
claimed by some that homeopathy was a promising medical treatment.
It is now more widely recognised that homeopathy can simply affect
how patients report their symptoms in non-blinded trials, and that
it is not ethical to promote it as a legitimate form of medicine.
In the case of cognitive and behavioural interventions for CFS/ME,
we have evidence from the PACE trial that they are able to lead to
modest improvements in patient questionnaire scores in a
non-blinded trial, without leading to improvements in real world
outcomes such as employment rates, or claims for disability
benefits[15]. A meta-analysis of actometer data from CBT trials for
CFS also found that CBT was able to lead to improvements in
questionnaire scores in non-blinded trials, but not to improvements
in the amount of activity that patients were actually able to
perform[16]. Sadly, the PACE trial dropped actometers as an outcome
measure, although they were purchased and used at baseline[17].
Recent evidence from a large study of NHS CFS/ME specialist
services indicated that reported results for CBT and GET are poorer
than those reported in PACE, and that centres offering CBT and GET
achieved marginally worse results than centres offering ‘activity
management’[18]. We do not currently have compelling evidence that
CBT or GET are more effective medical interventions for ME/CFS than
homeopathy, despite some of the claims made by proponents. It
should be seen as no more acceptable for those with financial,
professional or ideological interests in promoting CBT or GET as
treatments for ME/CFS to exaggerate the value of these
interventions than it is for others to exaggerate the value of
homeopathy. Anyone with a real interest in helping patients with
ME/CFS, and in allowing them to make informed decisions about their
own health care, should now call for the release of results for all
of the outcomes laid out in the PACE trial’s published protocol[2].
[1] Lynch S. Re: PACE trial authors’ reply to letter by Kindlon.
BMJ Rapid
Response.http://www.bmj.com/content/347/bmj.f5963/rr/671093 [2]
White PD, Sharpe MC, Chalder T, DeCesare JC, Walyin R: Protocol for
the PACE trial: a randomised controlled trial of adaptative pacing,
cognitive behaviour therapy and graded exercise as supplements to
standardised specialist medical care versus standardised specialist
medical care alone for patients with the chronic fatigue
syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol
2007, 7:6 [3] White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe
MC. Recovery from chronic fatigue syndrome after treatments given
in the PACE trial. Psychol Med 2013;1-9, published online 31 Jan.
doi:10.1017/S0033291713000020. [4] Bowling A, Bond M, Jenkinson C,
Lamping DL. Short form 36 (SF-36) health survey questionnaire:
which normative data should be used? Comparisons between the norms
provided by the Omnibus Survey in Britain, The Health Survey for
England and the Oxford Healthy Life Survey. J Publ Health Med 1999,
21: 255–70. [5] Office of Population Censuses and Surveys. Social
Survey Division, OPCS Omnibus Survey, November 1992. Colchester,
Essex: UK Data Archive, September 1997. SN: 3660,
http://dx.doi.org/10.5255/UKDA-SN-3660-1 [6] White PD, Goldsmith
KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess
M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M,
O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M. Comparison of
adaptive pacing therapy, cognitive behaviour therapy, graded
exercise therapy, and specialist medical care for chronic fatigue
syndrome (PACE): a randomised trial. Lancet 2011;377:823-36. [7]
BMJ Short Cuts: ‘All you need to read in the other general
journals’ BMJ 2011;342:d1168 [8] Knoop H, Bleijenberg G. Chronic
fatigue syndrome: where to PACE from here?. Lancet 2011; 377:
786-788. [9] Collin SM, Crawley E, May MT, Sterne JAC, Hollingworth
W: The impact of CFS/ME on employment and productivity in the UK: a
cross-sectional study based on the CFS/ME national outcomes
database. BMC Health Serv Res 2011, 11:217. [10] Interview with Amy
Chesterton and Esther Crawley. Available at
http://www.thenakedscientists.com/HTML/content/news-archive/news/2384/
[11] Freedom of Information request
http://www.meassociation.org.uk/?p=6171 [12] Freedom of Information
response
http://www.meassociation.org.uk/wp-content/uploads/2011/06/FOI from
Queen Mary.pdf [3] [13] Follow up Freedom of Information request:
https://www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po
[14] Ernst, E. The cmRCT BMJ Rapid Response.
http://www.bmj.com/rapid-response/2011/11/02/cmrct [15] McCrone P,
Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD.
(2012) Adaptive pacing, cognitive behaviour therapy, graded
exercise, and specialist medical care for chronic fatigue syndrome:
a cost-effectiveness analysis. PLoS ONE 7: e40808. [16] Bleijenberg
G, Prins JB, Wiborg JF, Knoop H, Stulemeijer M,. ‘How does
cognitive behaviour therapy reduce fatigue in patients with chronic
fatigue syndrome? The role of physical activity.’ Psychol Med. 2010
Aug;40(8):1281-7. [17] PD White, MC Sharpe, T Chalder, JC DeCesare,
R Walwyn, for the PACE trial management group: Response to comments
on “Protocol for the PACE trial”
http://www.biomedcentral.com/1471-2377/7/6/comments#306608 [18]
Crawley E, Collin SM, White PD, Rimes K, Sterne JA, May MT; CFS/ME
National Outcomes Database. (2013) Treatment outcome in adults with
chronic fatigue syndrome: a prospective study in England based on
the CFS/ME National Outcomes Database. QJM. 106:555-65. Competing
interests: I believe that the current tolerance for preventing
patients from accessing data on the efficacy of the treatments
available to them will be looked back upon with a sense of real
shame.
I thought I would provide an update on these issues, as comments on this blog have now been cited by QMUL as evidence of the vexatious campaign against the PACE trial in a new decision notice: https://ico.org.uk/media/action-weve-taken/decision-notices/2016/1623988/fs50600710.pdf
Also, there have been a some recent developments in academia, with a number of prominant researchers speaking out about problems with the PACE trial. Some of these are summarised and linked to here: http://www.centreforwelfarereform.org/library/by-date/in-the-expectation-of-recovery.html
Additionally, a commentary piece in The Psychologist has briefly used the lack of transparency around the PACE trial as an example of the sort of problems holding back psychological research: https://thepsychologist.bps.org.uk/volume-29/may-2016/our-struggle-between-science-and-pseudoscience
We are also awaiting the ruling of a new tribunal hearing on a request for PACE data:
https://valerieeliotsmith.com/2016/04/28/qmul-v-the-information-commissioner-and-matthees-tribunal-hearing-and-open-justice/
https://www.whatdotheyknow.com/request/selected_data_on_pace_trial_part
Also, it seems that the PACE trial’s PI played a leading role in the recent campaign to exclude universiteis from the FOIA: https://jcoynester.wordpress.com/2016/01/31/further-insights-into-the-war-against-data-sharing-the-science-media-centres-letter-writing-campaign-to-uk-parliament/
As a further up-date, data on this trial released under the FOIA has now caused something of a scandal:
General audience piece: https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/comment-page-7/#comments
Statistical re-analysis: http://www.virology.ws/2016/09/22/trial-by-error-continued-the-real-data/
Comment from investigative journalist who has been looking into this trial for a number of years now:
http://www.virology.ws/2016/09/22/trial-by-error-continued-the-real-data/
Piece about the tribunal ruling written when it was thought QMUL may appeal:
http://www.centreforwelfarereform.org/news/major-breaktn-pace-trial/00296.html
It is now quite clear that Judge Hughes’ 2013 decision was founded upon unpleasant prejudices about ME patients and a misguided faith in academia’s commitment to openness, honesty and accuracy.
Thw PACE trial is now being used as an illustration of the danger of bad science in the international media. To those aware of the details, Judge Hughes ruling was clearly founded on prejudice rather than evidence, and it is becoming ever more of an embarassmnet. I think that this should be used as a case study of the way in which British insitutions can bluff the ICO and tribunals with their assertions of authority. It was only when American academics started speaking out on this issue that patient’s concerns started being taken seriously in the UK.
Here is the New York Times covering PACE: https://www.nytimes.com/2017/03/18/opinion/sunday/getting-it-wrong-on-chronic-fatigue-syndrome.html
An example from Australia praising a patients fight to use the UK’s FOIA: http://www.news.com.au/technology/science/human-body/how-alem-matthees-letter-helped-solve-chronic-fatigue-syndrome-mystery/news-story/eb566e1a0f6bcaadb362818a12c2e386