3. Principles of data sharing

As the MCPS has information on many different exposures and health outcomes over a period of years, a wide range of investigators should be involved in determining which questions to address and how best to address them. As data custodian, the MCPS group must maintain the integrity of the database for future use and regulate data access. Data can be released outside the MCPS research group only with appropriate security safeguards and approvals. This policy on data access is based on the need to:

• Protect participants and act within the scope of their signed consent.
• Ensure compliance with all laws and regulations which apply to its use, storage and disposal of the data and/or samples.
• Ensure high quality research is fostered that will advance knowledge. Applications that include Mexican collaborators are particularly welcome since they would help to develop and strengthen the research capacity of local investigators.
• Ensure that the data security and participant confidentiality are maintained.
• Support local capacity building. There is a desire that the data from the MCPS are not only used to generate important research findings but also to help to build research capacity locally.
• Provide academic return and training for the investigators developing the study, in particular for doctoral students and early career researchers who are developing their scientific skills while working on the cohort.  

3.1. Key components of this Data and Sample Sharing Policy:

Collaborations

The MCPS research group is actively seeking and responding to requests for scientific collaborations on specific projects, especially when framed in ways that help strengthen Mexican research capacity. This model of facilitated collaboration with external researchers is adopted where it can increase the value and quality of the data. Collaborations are governed by a separate Collaboration Agreement, which: (i) identifies a dedicated project lead from within the MCPS group in either Mexico and/or the UK; (ii) details arrangements for co-authorship or papers; (iii) covers intellectual property issues; and (iv) details financial commitments where appropriate.

Open Access Data Availability

Before data is approved for any analysis, relevant members of the MCPS team responsible for generating the data must first undertake required cleaning, processing, quality control and integration. As soon as the data are clean, they will be made immediately available for open access sharing with researchers applying from within a Mexican institution, as long as the proposed project does not overlap significantly with projects already being conducted by the Mexico or Oxford-based investigators (see Completed and Protected Projects). This period of exclusive access for Mexican researchers will be for 2 years, after which the datasets will be made available for open access sharing with any bona-fide researcher worldwide (see Data Available for Sharing). 

Independent Oversight of Access

Initial decisions on data requests are taken by the MCPS team. The Nuffield Department of Population Health Data Access Oversight Committee provides further scrutiny and governance advice where necessary. A requestor can appeal to this committee if they disagree with a study decision on access.

Protecting the Identity of Participants

Safeguards are maintained to ensure the anonymity and confidentiality of participants’ data. Researchers will need to enter a legal agreement not to make any attempt to identify participants, and the data provided to researchers will not contain any personally identifiable variables (i.e. every data set provided will be “pseudonymised” with uniquely encrypted participant identifiers [PIDs]).

Data Security

All MCPS data is held on secure servers in a central data repository that is compliant with internationally recognised information governance standards. A data management team acts as gatekeepers and ensure that any shared data is delivered though a secure data delivery system and in an appropriate format.

Sample Preservation and Access

Only 10 ml of blood was taken at baseline and resurvey from each participant, which, in each instance, was divided into one buffy coat sample and two to three plasma samples that are stored in Oxford. At resurvey, a urine sample was collected from just under half the participants (from the latter part of the recruitment period). Given the very limited amount of these depletable resources, access to these samples needs to be carefully controlled. Consequently, rather than assay samples on a nested case-control basis (which is cost-effective for studying a particular condition but not for a resource that is to be used to study many different conditions by different researchers), assays of the samples from all participants is far preferable. Such a strategy maximises the information available to researchers while minimising sample depletion and facilitating different comparisons across the cohort since the assay methodology and quality control would be consistent. Suggestions for particular assays to be included are welcomed, and all assay values will become part of the available dataset. In general (as is the case in UK Biobank), it is not expected that requests for direct access to samples will be agreed to by the MCPS Access Committee.

Fees for data access

Open access data is available free of charge to applicants from low and middle income countries. Researchers in high-income countries will incur an access charge for each approved data request (currently £2500 GBP prior to data release). This contributes to the administrative costs incurred in managing and reviewing the application, and in preparing the individual datasets. Collaborating researchers may also be required to cover the costs of administering the data sharing (including legal fees if applicable), retrieving, processing and sending the data or samples. Estimated costs for a particular request will be provided during the development of the project proposal.