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Till Bruckner
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By email only to: request-565242-ae2c9aeb@whatdotheyknow.com

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11 October 2019
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Dear Till Bruckner,

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Freedom of Information Act 2000

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Request for information: response

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Date of request: 30 March 2019

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Due date: 1 May 2019

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Ref: RITM0209071 & RITM0181874

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We refer to your request for information dated 30 March 2019.

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Please accept our sincere apologies for the delay in responding to your request.
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The University FOI team are aware that you requested an internal review on 13 June 2019; however, we
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ask that you first accept the response to your request.

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Our University FOI team has been under extreme pressure due to staff restructuring and IT changes,
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consequently we have been delayed with some FOI requests. An internal review will cost the public sector
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money, and will take a great deal of time for FOI team to complete; time which could otherwise be spent
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answering FOI requests. We ask that you consider whether time spent conducting an internal review, will
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outweigh the benefits of allowing the University to use its resources to answer other FOI requests.

If you still wish the University to conduct an internal review of your response and/or the procedure please
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let us know and we will conduct an internal review. If we do not receive such request within 40 working
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days of this response, we will close your request for an internal review.
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Please find your question below with the University’s corresponding response:
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Question
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Q1. Has the university put into place policies, systems and processes that ensure that in future, every
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clinical trial sponsored by the university will post its summary results on every WHO primary trial
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registry (including Clinicaltrials.gov) where it was originally registered within 12 months of trial
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completion? If yes, please state the month and year in which these were put into place. If no, if
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applicable, please state the month and year by which these are expected to be in place.
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Q2. Has the university conducted a registry-data based audit of all clinical trials it has sponsored in the
past, including all clinical trials listed on the registries EudraCT, ISRCTN, and Clinicaltrials.gov, to
identify those trials that have never reported their results (i.e. neither on a registry nor on in a peer-
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reviewed academic journal)? If yes, please state the month and year in which the audit was completed.
If no, if applicable, please state the month and year by which such an audit is expected to be completed.
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Q3. Has the university developed a plan for retrospectively reporting the results of past trials that have
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remained unreported (i.e. reported neither on a registry nor on in a peer-reviewed academic journal)?
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If yes, please state the month and year the plan was adopted, and the month and year by which the
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process of retrospective results posting is expected to be completed. If no, if applicable, please the
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state the month and year by which such a plan is expected to be adopted
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Response
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We confirm that the University holds information of the description specified in your request. The answers
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to your questions are as foll ws—

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1. The University’s Research Integrity and Governance Committee, which is chaired by our Vice-
President for Research and Enterprise, provides leadership to our research community and actively
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reviews our compl ance with legislative and best practice requirements related to research. The
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outcome of the Science and Technology Committee's Report on Clinical Trials Transparency in
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October 2018 was discussed at its meeting last November. We were very pleased to see that Dr.
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Ben Goldacre’s report and EU Trials Tracker website shows that we are complying with our reporting
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obligations in respect of clinical trials in this area. Our Code of Conduct for Research requires our
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researchers to comply with legislative requirements and our Open Access policy requires research
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outputs to be openly accessible to maximise the visibility and impact of research recognising ethical
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or contractual restrictions which may sometimes also apply. As part of our sponsorship approval,
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we remind our researchers to inform us of publications of their results. We will also be introducing
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a system which will actively remind them of these important obligations and will keep this under
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review, adapting our approach as necessary.

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2. The University has not conducted its own audit of trials but has reviewed the tracker produced by
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Dr. Goldacre and his colleagues as set out above. We do not presently anticipate carrying out a
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retrospective audit in this area but will keep this under review and consider it in light of joining the
All Trials Initiative and any policies implemented by the Health Research Authority’s Research
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Transparency Strategy Group.

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3. Please see above.

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If you do not feel that we have dealt with your request in accordance with the requirements of Part I of the
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Act, you may request a review. Your request for a review should specify in what respect you consider that
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the requirements of Part I have not been met. The request for a review should be addressed to the Chief
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Operating Officer and may be sent by email to foi@soton.ac.uk.

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The Information Commissioner is responsible for enforcing rights of access to information and the operation
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of the publication scheme. You may apply to the Information Commissioner in writing (FOI/EIR Complaints
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Resolution, Information Commissioner's Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF)
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or electronically for a decision whether, in any specified respect, your request for information has been
dealt with by the University in accordance with the requirements of Part I of the Act. The Information
Commissioner will not normally take action unless she is satisfied that the University's review procedures
have been exhausted.
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Till Bruckner 11 October 2019

FO R E he
Freedom of Information Office

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OF 07 RO a ema l: foi@soton ac.uk
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Yours sincerely,

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