From Margaret Williams : further details about PACE Trial data security. Permission to repost.
"Two points merit further consideration: (i) the matter of guaranteed confidential storage of PACE trial data and (ii) the Principal Investigators’ undeclared conflict of interest until after the consent forms were signed by participants.
The PACE trial Protocol published in BMC Neurology on 8 March 2007 was an abridged version
but, as noted by Alem Matthees, the Full Protocol (226 pages) states on page 110:
“Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study” http://www.meactionuk.org.uk/FULL-Protocol-SEARCHABLE-version.pdf
What Matthees did not mention was the fact that one of the organisations funding the study was the UK Department for Work and Pensions (DWP). How many participants looked at the funding bodies before signing the consent forms and realising to what they were giving their consent?
Quite how “confidentiality” could be guaranteed if the DWP had access to the data has never been explained, especially as ME/CFS is known to be a targeted disorder for the withdrawal of state benefits, with patients being harassed by the DWP who required a 60-page form to be completed because the DWP menacingly informed such patients: “We have reason to believe that you are capable of work”.
If the PACE trial therapists and Investigators deemed a participant “recovered” enough to resume work, then might that participant quickly discover that the DWP stopped paying benefit? The PACE Trial has been described as a “Trojan horse” for the DWP.
Regarding the secure storage of data, the Full Protocol is unambiguous:
“Will you keep my details confidential?”
“Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research”.
The DWP was not involved in research but still had participants’ signed permission to access their records/data.
From the outset, recordings were not kept in a locked filing cabinet: some were stolen and thus lost to review (see previous post on 19th December 2015: https://jcoynester.wordpress.com/2015/12/18/kings-college-london-stalls-some-more-reiterating-refusal-to-release-the-pace-trial-data/#comment-1375
The Consent Form 1 for baseline assessment which participants were required to sign was clear:
“3. I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research.
4. I give permission for these individuals to have access to my records.
14. I understand that information collected about me for the trial, including my personal details, a copy of this consent form and all of the questionnaires I complete for the trial, will be held securely by the local trial staff and at the PACE trial centre at Queen Mary, University of London. I give permission for this to happen”.
The PACE PIs obtained participants’ consent on the promise of keeping trial data secure, yet they had made no provision to do any such thing.
When the PACE Trial had been running for two years, the Participants’ newsletter (Issue 1, June 2006) reaffirmed that the trial data was safe: “The information is being entered onto a large and secure database, designed and maintained by an independent clinical trial unit at King’s College, London”. This was provided for participants even though the PIs knew that trial data had already been stolen (see previous post #comment
In relation to the PIs’ undeclared conflict of interest, one of the pre-trial assessments was at Baseline Visit 1; this set out to collect personal data that seems to have little bearing on a clinical trial but could be of value to the DWP and the permanent health insurance industry because the collected data included not only the customary demographic details, date of birth, age, sex, ethnicity, marital or partner status, years of education, occupation (the latter would obviously afford information about a participant’s earnings) but also very detailed questions about participants’ permanent health insurance payments, for example, questions on page 172 ff of the Full Protocol included the following:
“Do you currently receive income protection benefit (income protection or total and permanent disability)?”
“ If yes, how much annually do you receive? £”
“If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the letter [an alphabetical letter designating an income bracket] that corresponds to the participant's income”.
“Do you currently receive a private medical / retirement pension?”
“If yes, how much weekly do you receive? £
If yes, how much monthly do you receive? £
If yes, how much annually do you receive? £”
“If the participant chooses not to give an answer, please use the prompt card to show income brackets, and record the (alphabetical) letter that corresponds to the participant's income”.
“In the past six months, have you received any one-off payments from income protection or insurance schemes as a result of your health?”
Such specific questions have no clinical relevance but would be of interest to the Chief PI of the PACE trial in his dual role as the re-insurer Swiss Re’s Chief Medical Officer.
As detailed by David Tuller, participants could not give fully informed consent because the PIs’ Iong-standing involvement with the permanent health insurance industry was never disclosed to them. Indeed, it appears that this significant conflict of interest was not initially disclosed even to the Trial Steering Committee: at the meeting on 22nd April 2004, all members present were asked to declare any conflict of interest. It was minuted that no financial conflicts of interest were declared and it was agreed that no-one present had any other substantial or material conflict relevant to their work on the PACE Trial. Amongst those present were Professors Peter White, Michael Sharpe and Trudie Chalder, all of whom worked for the permanent insurance industry. There was a brief mention of paid consultancy work done by the PIs in the BMC Neurology version of the Protocol, which was long after signed consent forms had been obtained."