“We stand by our decisions to decline two recent applications for trial data as we believe that they did not meet these requirements.”
In a press release dated December 18, 2015 Kings College London, reiterated its refusal to release the PACE trial data.
This continued refusal is despite the PACE investigators having promised to share their data as a condition of publishing in PLOS One.
There is a notable contrast between the limited reasons now being given for refusing to release the data and the excuses claimed more recently.
PACE investigators had converted my routine requests for sharing of the PLOS data into a Freedom of Information Act (FOIA) request, which they denied in this letter.
But I never submitted a Freedom of Information Act request. I was simple exercising the rights that any reader of PLOS One has been asking the data be shared, as promised by the PACE investigators in submitting their manuscript to PLOS One. I view the investigators’ conversion of the request to a FOI as a diversionary tactic – a bureaucratic maneuver to delay simply releasing the data, as promised in agreeing to publish in PLOS One.
The Freedom of information response letter had made reference to their concerns that possible harm release of the PLOS data would do to the investigators’ reputations and careers. I cannot see this would be any more damaging than their failure to live up to an agreement made with PLOS to release the data. But we have not yet seen what is in the data, and so we should reserve judgment.
The Freedom of information response letter also denigrated my character and motives of in requesting the data. This attack was dishonest, and I continue to expect that the authors of the PLOS One article will apologize for their unprofessional behavior. Yes, so we don’t forget the authors of the PLOS One article to whom the request was addressed are
- Paul McCrone
- Michael Sharpe
- Trudie Chalder
- Martin Knapp,
- Anthony L. Johnson
- Kimberley A. Goldsmith
- Peter D. White
The December 18 Press Release
By investigators of the PACE trial:
“We have received many requests for access to individual patient data collected in the PACE trial.
We have supplied requested, anonymised data to independent scientists, as part of normal research collaboration. Among others, these include a Cochrane review group who have independently validated the trial findings on the primary outcomes, and who are now undertaking an individual patient data meta-analysis using these data.
We are however also concerned for the rights and welfare of trial participants. Participants did not give consent to the public release of their data when they entered the trial. In particular we are concerned to ensure that there is no risk of misuse of the data such as through inadvertent personal identification. The scientists who have already received data have all signed a formal confidentiality agreement, approved by the independent PACE Trial Steering Committee, which required that they respect the confidential nature of the data, and keep them secure, as agreed with trial participants when they consented to take part. We stand by our decisions to decline two recent applications for trial data as we believe that they did not meet these requirements.
We are currently seeking further ethical and scientific advice, as well as the advice of patients, on how best to provide independent decisions about appropriate access to relevant data in a way that balances the rights of trial participants, and future progress of the trial analysis and follow up, with the public interest in releasing trial data.”
Using the PACE trial investigators’ own arguments and definitions of personal data, they have already broken their confidentiality agreement with patients.
The only agreement with participants with regards to sharing of (any) data refers to personal ‘details’, personal ‘records’ and personal ‘medical notes’ rather than anonymised data. The patient information and consent forms make no mention of sharing anonymised data. The agreement with regards to personal data stipulates that the PACE trial’s research team or the relevant regulatory authorities should have access to personal data.
For example, the patient consent form (Version 3.3) states: “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.”
In a recent submission to the Information Commissioner’s Office (ICO), Queen Mary University of London (QMUL), claimed that anonymised individual data is personal data, and so sharing the requested anonymised data would break its contract with participants. The relevant ICO decision notice states: “The University went on to explain that as the release of [anonymised] individual data would cause it to break its specific agreement with the patients who consented to participate in the study on that basis, this would erode trust and cause people to withdraw from any future new studies that it might plan to undertake.”
However, the new statement from King’s College London states that the PACE investigators have already shared anonymised individual data with external research teams: “We have supplied requested, anonymised data to independent scientists […] [T]hese include a Cochrane review group who have independently validated the trial findings on the primary outcomes, and who are now undertaking an individual patient data meta-analysis using these data.”
So, either the PACE investigators believe the anonymised individual data is personal data (as per their submission to the ICO), and so (from their point of view) they have already broken their contract with the PACE trial participants, or they don’t really consider anonymised data to be personal data, and they are using the issue of privacy as a diversion.
Finally, the press release claims that King’s College is soliciting the “advice of patients.” We should be told which patients and how they were sampled. I really doubt any of the thousands of patients who are clamoring for retraction of the PACE trial and an investigation of the circumstances it was published need apply. This is reminiscent of the cheap, exploitive way in which the authors of Understanding Psychosis claim to sample the voices of service users, but response so nastily to service users who find fault with their document.
If the PACE investigators want any credibility to the claim of involving patients in the making, the methodology for eliciting and editing their opinions should be made explicit.
Come on, Paul McCrone, Michael Sharpe, Trudie Chalder, Martin Knapp, Anthony L. Johnson, Kimberley A. Goldsmith and Peter D. White, provide me the data as you said you would.
Note: Note: Although I am one of thousands of academic editors for PLOS One, I have sole responsibility for my blog posts, which cannot be construed as reflecting the opinions of any institutions with which I am affiliated, including PLOS. In requesting the data for an article that appeared in PLOS, I am exercising the same rights to anyone in the world has with respect to this open access journal committed to transparency and data sharing.
Special thanks to the professionals and patients who provided feedback on this post. All errors and excesses remain my own.