“Governance of data access” – a brand new report from EAGDA

The Expert Advisory Group on Data Access (EAGDA).

Research funders are generally interested in maximising the value from the datasets generated by research, as well as in improving data management and accessibility practices. At the moment, many UK funders are actively working together to harmonise their research data policies.

 

The Expert Advisory Group on Data Access (EAGDA) was established in 2012 by the Wellcome Trust, Cancer Research UK, the Economic and Social Research Council, and the Medical Research Council to provide strategic advice to these funders on the emerging scientific, legal and ethical issues associated with data access for human genetics research and cohort studies. EAGDA supports current and future studies and also seeks to enhance the UK’s input into international policy discussions on data access.
Research data can often be highly valuable for use beyond the original study in which it was collected, and there has been a recent shift among funders, policy makers, publishers and the research community towards encouraging and enabling the sharing of research data with secondary users.
A key challenge for researchers producing these datasets is in ensuring that the right balance can be struck between protecting the rights and interests of research participants, and maximising the value of the generated data through enabling them to be further used.

EAGDA

 The “Governance of data access” report.

EAGDA has undertaken research into the different governance mechanisms existing in the research communities supported by the EAGDA funders, to better understand what systems are in place, their fitness for purpose and the extent to which they could or should be strategically co-ordinated.
The findings reveal that the ways in which access to research data is controlled have largely built up in a piecemeal fashion, with individuals studies or consortia developing their own approaches that share many features. However, they tend to differ in ways that create a complex landscape for potential secondary users seeking and applying for access to these data.
In June 2015, EAGDA published a report examining the data access mechanisms for a cross-section of genetic, epidemiological and longitudinal studies, paying particular attention to the composition and function of Data Access Committees in controlling access to research data.
The report contains a number of recommendations to the funders, which they fully agreed with and accepted.
At the heart of the recommendations is the central role of data sharing and management plans within the grant application process:

 

    1. Research funders should require explicit data sharing and management plans as part of grant applications (even if these plans conclude that data sharing is not appropriate); and should ensure that these issues are adjudicated before funding for new studies, or renewal of existing studies, is agreed. Funders should also review existing studies: where there is a prima facie reason to think data sharing might be desirable, the study should be contacted to clarify what policies are in place.

    2. EAGDA funders should support work on: the development and dissemination of data formats and metadata standards; the promotion of interoperability across studies and datasets; and help to ensure that datasets are readily discoverable and accessible to potential users.

    3. EAGDA funders should require study leaders to make data access processes transparent to potential secondary users of data, including: how datasets can be discovered and accessed; what requirements secondary users are expected to fulfil; and how decisions about access requests are made.

    4. EAGDA funders should ensure studies establish proportionate governance procedures for data access, drawing on existing good practice and ensuring appropriate levels of independent input and oversight for access decisions, together with an independent appeals process.

    5. EAGDA funders should be clear that using collaboration with the study team as the sole means through which to allow data to be accessed is not appropriate, other than in exceptional circumstances where it can be justified. In all cases, funders should expect the origins of data to be acknowledged in publications from secondary users.

    6. EAGDA funders should work with studies to ensure that the terms of consent enable data to be accessed and used in a way that maximises its value, whilst protecting the rights of research participants. It is critically important that the consent process explains clearly and as fully as practicable, how the data may be used in future.

    7. EAGDA funders should set expectations that studies will develop clear policies on the management of depletable resources, ensuring guidance and support is provided to study leaders in this process.

    8. Funders should work with research institutions and scientific journal publishers, to develop a proportionate system of adjudication and of penalties for breaches of data sharing rules, and guidelines for their use. EAGDA funders should share information on proven cases of data misuse.

    9. EAGDA funders should actively promote and evaluate initiatives to harmonise access processes and requirements for data users. Options include:EAGDA funders should jointly consider with institutions, study leaders and other key stakeholders (i.e. Research Ethics committees) whether consolidation across several study Data Access Committees would be an efficient, effective mod el for some studies, to ensure sustainability of access over time and independently of short-term competitive grant cycles tied to specific scientific projects.
      a) Facilitating workshops of study leaders, administrators and data managers to explore options for harmonising data access processes;
      b) Developing equivalence of criteria for checking academic credentials when applying for data access for different studies, drawing on established examples of good practice and encouraging innovative work from the research community in this area;
      c) Supporting the development of uniform templates for access applications.

    10. EAGDA funders should seek to establish the costs of data access activities for different studies:EAGDA funders should also consider under what circumstances cost-recovery is an appropriate model for studies to operate for access to data and samples.
      a) in the short term (setting up access mechanisms and covering data formatting and management costs); and
      b) in the long-term (ensuring sustainable storage, curation and access beyond the duration of a grant).

    11. EAGDA funders should jointly discuss how data access and sharing infrastructure should best be supported, co-ordinated and sustained for the long term. They should agree clear expectations for study leaders on the use of established repositories with archiving facilities, in order to assure quality and ensure discoverability of data. Such repositories need to be sufficiently and sustainably funded, with clear definition of who is responsible for them.

 

EAGDA and its funders would welcome any comments or feedback on the report’s findings. To provide your views, please email Natalie Banner at the Wellcome Trust. By the way, Natalie will speak at the DNAdigest symposium on the 21st of August in London. More details coming soon!

 

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