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Clinical trial data, motivated intruders and freedom of information

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Clinical trial data, motivated intruders and freedom of information

The AmeriKat has dealt with a few
motivated intruders in her time...
Is anonymised clinical trial data exempt from disclosure under the Freedom of Information Act? This was the question facing the UK Information Tribunal recently in Queen Mary University of London v (1) The Information Commissioner and (2) Alem MattheesEA/2015/0269. The answer on the facts of this case was no - the anonymised data should be disclosed, as Kat friend Eibhlin Vardy (Stephenson Harwood), reports:  
A large scale randomised clinical trial was conducted by Queen Mary University of London (QM), to assess the effectiveness of four of the main treatments available for those suffering with chronic fatigue syndrome (CFS, also known as known as myalgic encephalomyelitis or ME). 640 patients participated in the study between 2005 to 2012, and analysis of the data continues to the present day. The results were published in the Lancet. The study continues to generate public debate because certain aspects of the trial are controversial amongst some scientists, clinicians, and patients.  
A member of the public, Mr Matthees, sought disclosure of certain data related to the clinical trial. He specifically requested that the baseline and follow-up data be disclosed on all 640 patients, with each individual row only containing data from the same (anonymised) individual participant.  This request was refused by QM, but granted by the Information Commissioner, and this decision now formed the subject of an appeal by QM.    
The key issues 
1.Should an exemption under s22A of the Freedom of Information Act 2000 (set out below) be applied retrospectively? 
s22A: Research
"(1) Information obtained in the course of, or derived from, a programme of research is exempt information if—
(a) the programme is continuing with a view to the publication, by a public authority or any other person, of a report of the research (whether or not including a statement of that information), and
(b) disclosure of the information under this Act before the date of publication would, or would be likely to, prejudice—
(i) the programme,
(ii) the interests of any individual participating in the programme,
(iii) the interests of the authority which holds the information, or
(iv) the interests of the authority mentioned in paragraph (a) (if it is a different authority from that which holds the information)"... 
Mr Matthees' request was made before the s22A exemption came into effect on 1 Oct 2014.  The legislation did not provide for retrospective application, and it could not be relied upon by QM.  However, had the relevant provision been in force at the time of the request, the Tribunal seemed to be of the view that the data would have fallen within the exemption, given that the programme was "continuing with a view to further analysis and publications". 
2. Is the data "personal data" under s40 FIA? 
The key issue on appeal was whether there was a risk that was more than remote that the disclosure would lead to the identification of an individual. Following a review of the evidence, a majority of the tribunal accepted that the risk of identification was remote.  The data did not contain fixed or direct identifiers.  QM emphasized that this research had received highly critical attention from "vitriolic" patients/activist groups. It submitted that it was possible that motivated intruders (see ICO code of practice on anonymisation here for more on motivated intruders) wanted to discredit the clinical trial, and that identification of patients could be the first step in doing so.  This was rejected by the majority.  Mr Watson in dissent agreed with QM that when the disclosed data was combined with other data available to certain employees in the NHS and/or information available on social media, it could lead to identification of a particular trial participant.  
3. Would disclosure cause sufficient prejudice to QM's research programmes, reputation and funding streams to refuse disclosure? 
QM argued that it should be exempt from disclosing the data under s43(2) of the FIA which provides as follows: "Information is exempt information if its disclosure under this Act would, or would be likely to, prejudice the commercial interests of any person (including the public authority holding it)". QM submitted that the disclosure of the information would harm its reputation, funding streams, and affect the recruitment of patients for clinical trials in the future and/or the willingness of patients to participate in follow-up studies.   The majority did not accept that there was sufficient evidence to support these arguments.  In any event, there was strong public interest in releasing the data given the continued academic interest so long after the research was first published.  
This decision will be of interest to those involved in clinical research within universities.  The main take away point is that anonymised clinical trial data may be exempt from disclosure under s22A of the FOI, but only while the research programme is continuing with a view to publication. The tribunal seemed confident on the facts that anonymised clinical trial data would have fallen within the s22A exemption had it been in force at the time Mr Matthees' request was made. It is apparent from the Information Tribunal's lengthy and detailed decision that this was a hotly contested dispute, which involved cross-examination of witnesses, written submissions, allegations of breach of confidence, issues of patient consent, and a long list of considered authorities. QM released the following statement following the decision, and it remains to be seen whether it will appeal."  

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