Managed Access to NIHR-funded Research Data ICTMC May 2017 In the wider context of innovative and efficient study development. The potential for the re-use of NIHR data needs further development – initial steps to support and develop this agenda. Particularly interested to receive comments following earlier discussions about routine data and wider e-study development – and the implications there might be for this area?

Current NIHR principles & practice NIHR is committed to transparency across its portfolio of activity. Data generated by public funding, through participation of patients and the public, should be put to maximum use by the research community and, whenever possible, translated to deliver patient benefit. Standard DH research contract: “11.2 The Contractor shall, at the request of the Authority, deposit both qualitative and quantitative Data in a relevant data archive...”. Publications in the NIHR Journals Library must provide a data sharing statement / link to data. ‘By data we mean anonymised Individual Participant Data generated from NIHR-funded research. Data sharing covers discoverability, transparency and access = focus on visibility of research, usability, appropriate access and safeguards.

Access to NIHR research data Data is already being shared so this is not a completely new activity – there is some good practice and informal networks in operation with a focus on ‘usual academic practice’ – NIHR do not want to stop this but develop and raise standards.

Why change anything? Significant activity in this area with many stakeholders thinking about it. ICJME proposal had considerable implications - in order to be considered for publication in one of the member journals, authors must share the anonymised IPD underlying the results presented in the article no later than 6 months after publication. A data sharing plan is included as part of the clinical trial registration process. Requests for exceptions or exemption, if granted, reported in the article. NIHR - major UK funder generating very large volumes of data – occupies a central position to develop this area. NIHR expectations and standards encourage and support good practice / discourage inappropriate activity. Supports development of efficient and innovative research design and delivery. Re-use of NIHR-funded data facilitates further analysis and hypothesis generation – maximizing impact of NIHR. Data Sharing is a global endeavour – support NIHR researchers and provide guidance – wider benefit.

Although the principle of greater transparency is good, funders are better placed to encourage appropriate and reasonable sharing of research data. Lancet 17 September 2016 – an alternative view of the AMS workshop and the ICJME proposal and highlighting role of funder. We await further development …….

In development ………. NIHR Data Access – Principles Anonymised datasets available for further analysis wherever possible. NIHR protocols to include a ‘Data Access Plan’ - planned data sets, specific requirements and likely conditions. NIHR publications to include data access statement / link which clearly explains the data that can be requested and any conditions. Data remains under custodianship of the NIHR Investigator / Sponsor - and access requests submitted to them. Access requests to be reasonable (scope / requirements), include a clear protocol and case for data release, and demonstrate suitability of the research question and the team. Requestors may need to cover additional data preparation costs in some cases Data release subject to appropriate data use agreement. This is rearticulating NIHR existing contract obligation and is work in progress!!!! Data Access Plan: NIHR researchers consider requirements and implications from an early stage – plan appropriate action that is proportionate / appropriate to the data being generated. Would expect appropriate preparation / anonymisation to be undertaken as part of data lock-down and storage anyway – might prove optimistic – but it should be a routine milestone activity in standard study procedure and close down. Plan to address wider issues such as HRA approval, consent, data dictionary and definitions, anonymisation. Published as per other protocol documents. Data Access statement: Appropriate reference to data availability to be considered in other publications (NIHR and external). Researchfish submissions have been extended to include data sharing – and wider impact recording. Data requests should be reasonable and include sufficient information to judge whether the request is appropriate etc. Cost recovery would be appropriate if a request is complex or requires significant additional processing. Data Use Agreement: conditions of use etc and safeguards. NIHR example will be provided but this is an exercise for the PI / Sponsor and Requestor to agree. NIHR will reserve the right to consider cases where access has been refused to ensure that all reasonable avenues have been explored.

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