Using research data from NHS Lothian
Do you use NHS Lothian data in your research? Find out more about new requirements that apply to access, security and information governance.
The University has amended its existing Framework Agreement with Lothian Health Board (the legal name of NHS Lothian) governing our partnership for clinical research.
The Framework Agreement applies no matter in which College or other part of the University a researcher may be based, and:
- covers clinical research involving humans, their tissue, data or NHS resources such as clinical support services or facilities;
- sets out how the University and Lothian Health Board share the tasks of a Sponsor (the organisation required by law and regulation to take responsibility for securing arrangements to initiate, manage and finance a study, including provision of insurance and/or indemnity for all types of clinical research);
- defines Patient Data as "such of the Input Data and Output Data which comprises information relating to the identity, condition or medical history of any person (including without limitation in relation to the Board, NHS patients or staff and the Recently Dead) whether identifiable or not".
Changes to University processes are being phased in. Some requirements apply immediately and others within 12 months. You must now cost appropriately secure infrastructure into all new grant applications, which may be different from your current technical infrastructure.
Please note the ACCORD website remains the key resource for all clinical research carried out at the University, providing Standard Operating Procedures, policies and guidance documents to ensure that clinical research is conducted and reported in compliance with the principles of Good Clinical Practice, current legislation, regulatory requirements and the UK Policy Framework for Health and Social Care Research.
The New Research Information Governance Team
ERO is establishing a new Research Information Governance team for the University. While these roles are recruited, information about some aspects of local compliance with the NHS Lothian data sharing requirements may be available from your local IT Team. Advice on security is also available from the Information Security Team.