Core Programme 2: Governance

Prof Graeme Laurie, Dr Claudia Pagliari, Prof Sarah Cunningham-Burley

Aims

  1. To analyse the ethico-legal and cultural challenges associated with the secondary use of electronic patient records in Scotland, the wider UK and internationally, with a view to mapping the elements necessary to contribute to an optimal governance regime

GovernanceBackground

The provisioning of datasets in C1 proposes the delivery and evaluation of methods that allow linkage of third party datasets to EPRs, including SHIS-R. This will only be possible, however, if proper attention is paid to the as-yet unmet need for appropriate and effective information governance systems which need to promote essential scientific research while adequately protecting the security and confidentiality of patient and other personal data. Linkage of data sets - nationally, internationally and inside and beyond the NHS - represents one of the most promising areas of development in this field, but it also represents one the greatest challenges from the perspective of governance, law and ethics.

Research questions

This work package will address these challenges through three interrelated inquiries and associated questions:

  1. The Scottish dimension:
    1. What are the challenges and solutions for the SHIP initiative?
    2. What lessons might be learned for Scotland and from Scotland?

    We will assess the governance issues that arise from the fully-integrated approach represented by SHIP through an examination of the legal, ethical, cultural, and governance arrangements that operate within Scotland, where particular successes have already been achieved in Information Governance. One example is the operation of the Privacy Advisory Committee for Scotland, another is the UK Biobank Ethics and Governance Council (both chaired by Laurie) which have been explicit about the need for an appropriate balance of public and private interests in granting research access to sensitive data.

    The research team enjoys a close working relationship with NHS Scotland who, as custodians of NHS Scotland data and responsible for governance mechanisms, will collaborate with us to improve on those mechanisms. We therefore propose an ethico-legal analysis of the regulatory and policy context relating to the secondary uses of EPRs for research and, for comparison, other purposes (clinical and non-clinical).

  2. The international dimension:
    1. What lessons might be learned from other countries which do not rely on consent-based models for research governance?
    2. What are the particular challenges of international transfers/linkages and how might these be overcome?

    The second inquiry involves comparative analysis of other legal systems or governance regimes which have adopted alternative systems to those employed in the UK (normally typified by a consent-based approach). Two examples are the public interest mandate recently examined by the Article 29 Data Protection Working Party [19] and the approach of Western Australia which eschews consent when valid research uses are made of patient data. Additional challenges arising from the international dimension will also be examined, viz, the transfer of data outside the UK and the linkage to non-UK databases.

  3. The interdisciplinary dimension:
    1. How can public engagement findings better inform governance policies and laws?
    2. What mechanisms, bodies, and cultural conditions are required to promote access while securing adequate protection, and which represent hurdles to be reformed or avoided?

    A cross-cutting theme that links the above inquiries with C4 is the need for an interdisciplinary approach to the development of governance arrangements that builds on and responds to public attitudes and which can accommodate differing cultural sensitivities. This approach will be applied and developed here to distil synergies and effective outputs between C2 (Governance) and C4 (Engaging the Public).

Methods

Traditional desk-based legal research, textual analysis, comparative legal methodologies as well as the integration of the novel interdisciplinary methodologies discussed above.

Deliverables