Data access policy
The CKB is conducted jointly by the University of Oxford, Peking University and the Chinese Academy of Medical Sciences (CAMS).
The CKB Data Access Policy was developed in concordance with the general principles of data sharing promoted by various research organisations in the UK, China and elsewhere and the Data Access Policy of the Nuffield Department of Population Health, University of Oxford. It provides an overview of the CKB study and describes some constraints on certain resources. The policy sets out the core terms and conditions for data access, describes its governance framework and outlines the procedures for its implementation. The key elements include:
DATA IS ONLY SHARED WITH BONA FIDE RESEARCHERS
Requesters should be employees of a recognised academic institution, health service organisation or charitable research organisation with experience in medical research. They should be able to demonstrate, through their peer reviewed publications in the area of interest, their ability to carry out the proposed study. Their organisation should have formal policies and procedures to comply with any legal, ethical or data protection constraints and to ensure that the dataset is stored securely and used responsibly.
RESTRICTED ACCESS TO SAMPLES
As only small volumes of depletable biological samples were collected in CKB, access to them needs to be carefully controlled and coordinated. The Chinese Ministry of Health’s original approval for conditions on use of samples and the Chinese Government’s requirement for DNA to remain in China provide further restrictions.
Consideration will be given to collaborations that support an extensive range of quality-controlled assays of all, or large numbers of, samples using high-throughput and cost-effective assay methods (e.g. by low-cost sequencing of DNA samples, metabolomics or proteomic assays). Once generated, the data will also be made available to the wider research community, after a period of exclusive use by collaborative groups. Please e-mail firstname.lastname@example.org to discuss such proposals.
The CKB research group actively seeks and responds to requests for scientific collaborations on specific projects, especially when framed in ways that will help strengthen Chinese research capacity. From time-to-time calls for specific project proposals or collaborations in areas of strategic importance and/or major scientific interest will be published. This model of facilitated collaboration with external researchers will be adopted where it can increase the value and quality of the data. Such collaborations will typically involve the adoption of new methods or assays and investigations into new health outcomes; they will be governed by a separate collaboration agreement.
OPEN ACCESS TO CKB RESOURCES
Before data is approved for open release the CKB team will undertake required cleaning, processing, quality control, integration and imputation. There is a period of exclusive use for the CKB researchers and collaborators in China and the UK. Following this, other external researchers in China have priority access to the datasets for six months before they are made available worldwide. At this stage it is presumed that all reasonable requests for data from bona fide researchers will be granted. See data overview for details of currently available data.
INDEPENDENT OVERSIGHT OF ACCESS
An Independent Access Committee provides oversight and guidance on data access issues. The committee monitors the progress of all data requests and reviews any requests for access that raise particular issues (such as those relating to the use of samples). An additional Independent External Oversight Committee within the University of Oxford’s Nuffield Department of Population Health provides governance advice on data sharing for CKB and other department-wide projects.
PROTECTING THE IDENTITY OF PARTICIPANTS
Safeguards are maintained to ensure the anonymity and confidentiality of participants’ data. Researchers 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. Every data set provided will be ‘anonymised’ with uniquely encrypted participant identifiers (PIDs).
Applicants outside of China and Hong Kong are expected to pay for access to the study data. A fixed access charge of £2,500 GBP is made to cover costs associated with the application process and the preparation of the dataset for each successful data request.
All users are required to publish their findings and return their results and any derived variable data to CKB so that they enhance the resource for future health-related research in the public interest. In addition, all journal requirements for data release and deposition that are attached to publication will be complied with in full.
OWNERSHIP AND INTELLECTUAL PROPERTY
CKB remains the owner of the data and samples, but has no financial claim over any ‘Arising Intellectual Property’ developed by researchers using the study data and/or resource.
DATA ACCESS AGREEMENTS
Before any data is released a Data Access Agreement has to be signed. For applications outside China the agreements are between the University of Oxford and the requestor’s institution. In China a similar contractual agreement is made between the researcher and the Chinese Academy of Medical Sciences.