Data Sharing Policy - OUCRU (2024)

In line with journal and sponsor’s regulations OUCRU has several options for data sharing,including but not limited to

Online open access: e.g. as supplementary files to a journal article. With this method of accessOUCRU has no oversight or control of secondary uses made of the data.
External repository without case-by-case assessment: With this method datasets submitted toa repository may be accessed by registered users who have agreed to the repository’s terms andconditions of use. With this method OUCRU has no oversight or control over secondary usesmade of the data by registered users. Uses made of the data will be restricted by the terms andconditions of the repository (such as ORA).
Data can be requested through application to the OUCRU Strategic Committee (SC). With thismethod applicants complete a request form and sign a data sharing agreement. Requests areconsidered by the SC on a case-by-case basis informed by the terms of reference and the requestform. The type of agreement that applicants are asked to complete depends on the datasetrequested. Additional specific conditions of access may be implemented including collaborationand cost- recovery for preparation of datasets.

Developing the assessment process

A number of stages may be required in the assessment process of data requested by external parties. The process for access to data should be made clear to potential applicants. A template request form is provided which includes a diagram of the default process.

Standard steps in the Assessment Process

Discussion with OUCRU project lead: This should scope the project, in terms of science, practicality and resources. This may be before the application form has been completed. Discussion of details of the project.
Review by the Strategic Committee: Discussion of the details of the project. Is OUCRU being asked to undertake the analyses? This may have resource implications. The executive body should reach a decision.
Review by the Data Monitoring Committee: Only for the use of intermediate or immature data.

Older Studies

Data requests may continue to be received long after the trial has closed. The Principal/Chief Investigator should remain reachable for as long as is feasible in order to consider such requests.

Key considerations during review

As with any application, there must be a strong scientific rationale or other legitimate reason. Key points should be considered:

RATIONALE, MERIT AND CONDUCT OF PROJECT

What is the scientific merit of the proposal?
Are the study data suitable for answering the proposed research question?
What biases might be present? E.g. cohort selection
Do the original researchers already have plans to use the data in the way proposed by the applicants?
Are the analyses sufficiently well described to allow assessment of whether the proposal is fit for purpose?
Is the team properly motivated and suitably qualified to perform the analyses?

PROTECTION OF PARTICIPANTS

How would confidentiality be maintained?
Does patient consent cover the proposal?

PROTECTION OF THE INTEGRITY OF THE ORIGINAL STUDY

Would the proposed use of data jeopardise the conduct or results of the study from which the data are derived? If so, this is likely to be unacceptable.
Is there duplication? Have these data already been requested for this purpose? Are there implications for the future conduct or interpretation of the trial?

RESOURCE IMPLICATIONS

What resources would be required at OUCRU to (1) help investigators to understand the data, (2)prepare dataset, (3) transfer dataset, (4) perform analyses?
Are resources available at OUCRU? If not, could they be made available?
What would be the opportunity costs?
Are OUCRU staff considered providers of data or full collaborators?
Are raw or summary data required?
What version of the data set is required? Are new data chasing efforts needed?

REQUEST FORM

The applicants should detail their request on a request form.

Further items may be added to this if required and variations are acceptable for particular studiesproviding the process is well documented in the SC.

Completing the request form can be an iterative process, with updates from each stage of the review. The applicants can be asked to specify the information that will allow the reviewers toconsider all relevant aspects:

FEEDBACK AND UPDATE

The comments of the reviewers should be recorded at each stage. A form for this purpose isprovided as a template, which may be sent out to reviewers. Feedback should be provided, as asummary, to the applicants.

AGREEMENTS

The contracts team should be notified at the appropriate stage of the review process so that suitableagreements can be drawn up promptly after a successful review. Agreements will be made at aninstitutional level rather than an individual level in all but the most exceptional circ*mstances.

Researchers in receipt of data must store it securely, according to Information Governance and DataProtection regulations. They are expected to process and publish reports according to their initialplans.

Agreements should specify the boundaries of use of the data, including, for example, that the datacan only be used for the purposes for which they have been released.

Applicants should not use the data to identify individual patients, unless this is a pre-specified goalfor the purpose of record linkage.

PREPARATION AND TRANSFER

The data protection legislation of all countries involved in the transfer must be considered. Particularcare must be taken in preparing or releasing identifiable or sensitive data on individuals. Identifiersshould be removed prior to disclosure wherever possible e.g. no names or detailed geographicallocations; using ages or years of birth instead of full date of birth. Consideration should be given tofurther anonymising the data by including new ID numbers and breaking the link to the originaldataset. This choice will largely depend on how the data are to be used and whether further linkagewould be required. The time and effort required to prepare the appropriate dataset should not beunder-estimated. Data should be transferred in an appropriately secure method, after discussionwith the Data Management and IT department.

DATA RECEIPT

Recipients should acknowledge receipt of data and should check immediately for any problems.

REPORTING

The recipients of data should update OUCRU SC at time of completion of their project and share arising publications.