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Data Access Policy: departmental guidelines for data access

Information for researchers:

For each data resource held within the department (eg cohort study, randomised trial or meta-analysis), a named principal investigator is responsible for maintaining up-to-date details of the following on the department’s website:

    • Access policy and procedures: All policies governing access to data for particular studies are consistent with the department’s overall guidelines, which will include a requirement that all requests for data access from external researchers receive a reply within four weeks.
    • Data available: This includes summary descriptions (eg data dictionaries) of what data are available and (where appropriate) a timetable for data releases;
    • Data sharing statistics: This will include the numbers of applications, data sets provided, collaborative analyses conducted, and resultant publications.

Requirements for accessing individual participant data (IPD)

Those wishing to access IPD must meet the following criteria:

    • Applicant and their institution: the applicant must be a bona fide researcher registered with an appropriate institution;
    • Research that is in the public interest: a detailed proposal must be provided for health-related research that is demonstrably in the public interest;
    • Privacy considerations: participant level data are always pseudonymised, and applicants will be required to undertake not to attempt to identify participants;
    • Data-transfer agreement: an applicant’s institution must sign a data-transfer agreement (with efforts made within the department to standardise such agreements to the extent possible) which will require that the data will be held securely and results published;
    • Return of derived data: applicants must undertake to provide to the department, within a specified period, any derived data not requiring linkage to other studies.

Constraints on access to data resources

Whilst the department encourages data sharing to maximise the value of its studies for researchers, there are some considerations that impact on access to particular data resources, especially those that were developed and recruited before data-sharing became the norm or which involved populations recruited outside the UK in collaboration with local investigators.

Where constraints exist then an explanation is provided within a particular study’s data sharing policy, along with a clear justification. Examples of constraints that limit data-sharing include:

  • Consent/legal: the scope of the consent obtained from study participants determines the extent of the ability to share data. For example, commercial usage was not commonly specified in many projects until relatively recently. There may also be legal restrictions on the extent to which certain types of data (eg material transfer agreements related to health outcome linkages) can be shared with external researchers.
  • Ownership/control: where data that the department holds are owned by, or controlled by, a third party (eg clinical trial data produced under a co-sponsoring agreement; data provided for meta- analyses by external investigators) then our ability to share these data may be restricted/prevented.
  • Capacity building: studies established in low- and middle-income countries are not only used to generate important research findings but also to help build research capacity locally. As a consequence, there may be a need to ensure that local researchers (not just those involved directly in the conduct of a study) have preferential access before the data are made available to external researchers with greater analytical capacity who could ‘scoop’ local researchers.
  • Academic return and training: a substantial amount of work often has to be put in over a prolonged period before observational studies and clinical trials yield any academic reward. There may, therefore, need to be a period of preferential access to data for investigators who have spent many years establishing and nurturing the resource, as well as for doctoral students and early career researchers developing their scientific skills while working on these cohorts. Details of any such ‘exclusivity periods’ can be found in the area dedicated to a particular study on the departmental website.
  • Political sensitivities: in some countries, there are political concerns about how data (particularly genetic data) as well as samples are made available to external researchers. Unless care is taken about the way in which data are made available to external researchers, there is a serious risk that the data will not be available to anyone.

The aim will be to minimise any delay prior to making data available for general release, but we will also give due consideration to the period required to allow for the data to be cleaned and prepared for analysis, as well as the time for analysing and writing up results (including, for example, work that forms the basis of a student’s PhD thesis and publications deriving from it). These issues are recognised in UKRI’s Common Principles on Data Policy1 (in particular, in Principle 5).

Data Access Policy v.1.0 published June 2019

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