Parliamentary Questions | release of research data from medical trials | 12 December 2012

The Countess of Mar, the cross-bencher who chairs the Forward ME group of charities that includes The ME Association, has used a series of written questions to advance her campaign to expose weaknesses in the published results from the controversial PACE Trial, which so far have appeared in The Lancet on 18 February 2011 and in PLoS|One on 1 August 2012.

Without naming the PACE Trial, the Countess tabled more questions on the subject which were answered on 12 December 2012 by Conservative peer Lord Marland, the Minister who specialises in Intellectual Property Rights at the Department for Business, Innovation and Skills.

In her first question, the Countess asked the Government for its policy on access to research data from trials, including past trials, funded by them and the Medical Research Council.

She also asked, in cases where the results of medical trials funded by them or the Medical Research Council or both are published with only selected data, what mechanism is in place for independent scrutiny of the trial data and assessment of the quality of the publication; and, if there is no such mechanism, whether they will propose one.

And she asked whether, in the light of their commitment to open up publicly funded research, the Government plan to alter the remit of the Medical Research Council to make publicly funded data available for scrutiny; and if not, why not.

Lord Marland replied:

Publicly funded research is already made available by the Research Councils in conformity with the Research Councils UK (RCUK) Common Principles on Data Policy. This policy can be viewed at this website: www.rcuk.ac.uk/research/Pages/DataPolicy.aspx

RCUK’s policy on the release of data recognises that there are legal, ethical and commercial constraints on its release and which need to be considered at all stages in the research process to avoid an inappropriate release of data.

Within this data policy framework and the Research Councils’ open access policy for publicly funded research, the Medical Research Council (MRC) considers publicly funded research data a public good, produced in the public interest, to be made openly available with as few restrictions as possible in a timely and responsible manner. To maximise the benefit and impact of MRC-funded research, responsible sharing of pre-publication data to support new research is also encouraged.

To support the sharing of research data from population and patient studies, including clinical trials, the MRC has developed additional guidance to illustrate some of the issues investigators should take into account when assessing requests to access research data for new research. Research data should be shared responsibly and ethically to maximise both their value and the benefits for research and health.

Any further opening up of access to data, in the context of the wider open data agenda, would be the subject of future discussions with the research councils and other parties including the Data Strategy Board and representative university bodies. These policy issues would also be considered as appropriate by the Research Sector Transparency Board which is chaired by David Willetts. There are no proposals to change the research councils’ policy on access to data at this time.

In relation to scrutiny the scientific journal in which the research is published is responsible for the independent scrutiny of the data included in the paper and assessment of the quality of the publication. Journals use peer-review to assure quality and reviewers can and do ask to see more data if they consider those presented are insufficient. These policies are consistent with those of leading funders in the UK and elsewhere. The policy and guidance are available from the MRC’s website.

The Countess had also tabled a written question that asked further to the Written Answer by Lord Marland on 26 November (WA 15), whether the refusal of Queen Mary, University of London to publish the analyses complies with the policy of Research Councils UK to make publicly funded research data openly available.

Lord Marland replied:

The Research Councils UK (RCUK) Common Principles on Data Policy provide an overarching framework for individual research council policies on data sharing and access. The RCUK principles recognise that publicly funded research data are a public good, produced in the public interest, and should be made openly available with as few restrictions as possible in a timely and responsible manner. The principles also recognise that there are legal, ethical and commercial constraints relating to the release of research data, either through data sharing for new research or publication.

The Medical Research Council (MRC) policies on data sharing and data management are entirely consistent with the RCUK principles. The MRC strongly encourages the publication and dissemination of the findings of all MRC-funded research. To maximise the benefit and impact of MRC-funded research, responsible sharing of pre-publication data to support new research is also encouraged. To support the sharing of research data from population and patient studies, including clinical trials, the MRC has developed guidance which specifically addresses this type of research. The guidance aims to illustrate some of the issues investigators should take into account when assessing requests to access research data for new research to ensure research data are shared responsibly and ethically so as to maximise both their value and the benefits for research and health. The guidance also recognises there is a balance to be struck between the interests of researchers undertaking the research and who manage the data and those who wish to access the data.

In her Question, the noble Countess refers to a study which was funded by the Medical Research Council through a grant to Queen Mary, University of London and the university’s response to a request for research data made under the Freedom of Information Act. The response to the Freedom of Information request is a matter for the university.

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