…Exempting Universities from the FOIA would achieve that. Exempting scientific research data produced by Universities and other higher educational institutes might be a workable alternative.” – Peter White, Principal Investigator, PACE trial
Little attention is being given to a serious and sustained assault on the sharing of data from research conducted in the UK. Another significant incident has largely gone unreported.
The UK Independent Commission on Freedom of Information issued a call for evidence on October 9, 2015:
…To consider whether there is an appropriate public interest balance between transparency, accountability and the need for sensitive information to have robust protection, and whether the operation of the Act adequately recognises the need for a “safe space” for policy development and implementation and frank advice. The Commission may also consider the balance between the need to maintain public access to information, and the burden of the Act on public authorities, and whether change is needed to moderate that while maintaining public access to information.
Peter White, Principal Investigator of the PACE Chronic Fatigue Syndrome Trial submitted testimony sometime between October 9 and the deadline of December 7, 2015.
He ended his testimony with an impassioned plea that science needs protection from requirement for data sharing:
Section 22a of the Act is insufficient protection for science into controversial subjects, and requires that the research is on-going, so is irrelevant to completed research. We need science in the UK to be protected or it will continue to be damaged as this trial has been (other examples include climate change science, and research into the health effects of tobacco). Exempting Universities from the FOIA would achieve that. Exempting scientific research data produced by Universities and other higher educational institutes might be a workable alternative.”
So, if we accept White’s arguments, his psychotherapy trial data and even data from pharmaceutical trials needs to be protected from the burden that was faced by researchers of climate change and health effects of tobacco. Thus, Peter White places himself on the side of the angels.
He claims damage was done to his trial by the freedom of information act (FOIA) as it is now enforced. His time spent responding to FOIA requests for data could have been better spent doing:
…Further research into the causes and treatments of this debilitating and misunderstood illness [which] has been delayed.
White cites the damage done by two patients who withdrew from the trial:
Perhaps most damaging of all have been requests by two trial ex-participants to “”destroy”” all their data collected on them during the trial because of their concern that the data will not be held securely and confidentially, something we promised them to do as part of their giving informed consent. The first such request was received after we had finished all trial data collection and had started the main analysis. After some months of trying to obtain advice on what to do, we were advised to destroy this ex-participant’s data, which we did (and which took some time to do due to the complexity of the data), but this meant that we had to restart the analysis, which caused several month’s delay in publishing the main results paper in 2011. This paper was important since it showed that there were two treatments for this condition which were safe and moderately effective. It is estimated that some 250,000 people suffer from CFS in the UK.
I doubt the Independent Commission has the context to evaluate “this most damaging” evidence without a context. We know from other sources that the PACE investigators failed to provide participants in their study with suitable protection of their data. The investigators did not separate data from identifying information and did not have lockable cabinets in which to store data. Furthermore, some audiotapes with unique patient identifiers were stolen from an unlocked desk drawer in a burglary. The PACE investigators did not notify the patients of the breach of data security.
On 31st March 2006 Peter White wrote to the West Midlands Multi‐centre Research Ethics Committee to inform them of the theft of a digital audio recording (DAR) of GET sessions from Centre 03 (which is King’s College, ie. Trudie Chalder’s Centre). This confidential information was stolen from an unlocked drawer in the therapists’ office. Peter White informed West Midland MREC that: “There are no lockable cabinets in any of the therapists’ rooms so the drawer was not locked” (cf SSMC Participant Information Sheet). His letter continued:
The burglary was reported to Southwark police on the day that it happened, which was Wednesday 22nd March 2006. The crime number is 3010018‐06. The therapist was away on leave 22nd‐24th March and therefore the DAR was not found to be missing until Monday 27th March 2006”. It was only after the theft that Professor Trudie Chalder sought advice on how to secure the data properly.
The letter also said: “The Principal Investigator for this centre, Professor Trudie Chalder, is awaiting advice from the Trust R&D as to whether the affected participants should be made aware of the theft”.
The same letter stated that recordings were being downloaded to CD only on a monthly basis, a working methodology that is not compatible with the promises of confidentiality set out in the “Invitation to join the PACE trial” leaflet.
The letter carries a handwritten annotation dated 13th April 2006: “Noted. Sad! No action needed”.
We don’t know how restricting FOIA requests would protect anyone affected by this incident. Perhaps some patients participating in the PACE trial learned that their data had been stolen by way of a FOIA request, after the investigators decided not to inform them. Perhaps the two patients withdrawing from the trial were not directly affected but felt threatened by the disregard of the investigators for the basic rights.
The patients who withdrew from this trial were well within their rights provided by their informed consent agreement to participate in their trial. Given the investigators demonstrated such indifference to patient rights, the rational action was for these patients to withdraw.
So what is Peter White’s point? That we need to seriously restrict the FOIA so that investigators will not be found out in the disregard for what they had promised so that the patients will not withdraw from a trial? This seems a very colonial view of patients as “subjects” of researchers, quite contrary to the enlightened view of the World Medical Association Declaration of Helsinki accepted in the UK as elsewhere.
I doubt much of the scientific community outside of the UK would agree that a FOIA should be required to obtain data from a publicly funded trial. As was seen with the PACE trial, considering requests for data as FOIA requests hopelessly bureaucratize the simple provision of data as requested. There is no limit on the silliness of reasons used to refuse a FOIA request. It then takes time to appeal a refusal to release data to the UK’s Information Commissioner’s Office. Then, the investigators can appeal the decision of the Commissioner against them, delaying release of the data a number of months.
If Peter White is serious about advancing knowledge of “the causes and treatments of this debilitating and misunderstood illness, ” why doesn’t he simply embrace what the rest of the international scientific community sees as a way of advancing knowledge – availability of data for others to independently evaluate claims that are being made and test their own novel hypothesis?
Hopefully PLOS One will disregard the PACE investigators vexatious conversion of my request to a FOIA for data they’ve promised would be available. I look forward to a retraction of their article if they do not provide the data immediately.