Hosted research

The NHS Lothian R&D Governance team within ACCORD is responsible for granting NHS Lothian (NHSL) management permission/approval for research studies that involve:

• NHSL patients (including their data and tissue)
• NHSL staff
• NHSL facilities

These studies may be sponsored by the University of Edinburgh, NHS Lothian, or by an external organisation (including commercial companies).

For studies taking place across more than one NHS location, the team completes the UK Study-Wide Governance Review on behalf of all Scottish Health Boards.

• This is a high-level check to confirm that UK research governance requirements are met.
• It may also involve negotiating budgets and contracts with the study Sponsor.

Each Health Board involved must then carry out its own review. In NHS Lothian, this ensures:

• The study has the capacity and capability to run locally.
• Compliance with local procedures, such as Information Governance.
• That NHSL’s legal obligations are met.
• The study is covered under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS).

Once this review is complete, the R&D team issues a management permission/approval letter to the local Investigator.

A favourable NHS Research Ethics Committee opinion (where required) is conditional on R&D approval being in place.

In addition to reviewing new studies, the R&D Governance team also:

• Reviews and approves study modifications
• Supports Research Passport applications
• Helps with additional approvals, such as:
  • Caldicott Guardian approval
  • Information Governance or IT Security risk assessments