Research Regulatory Compliance

The Research Regulatory Compliance team ensures robust governance and oversight for health and social care research conducted at or sponsored by the University of Leeds (UoL).

Led by Emma Armstrong, Head of Research Regulatory Compliance and the University’s Sponsor Representative, the team provides expert guidance on the governance, regulatory requirements, and management of such research.

All health and social care research must have a sponsor—this includes any study involving NHS patients, their data, or biological samples. The role of the sponsor is defined in the UK Policy Framework for Health and Social Care Research and the UK Clinical Trials Regulations, which state that sponsors are responsible for "securing the arrangements to initiate, manage, and at times finance a study."

The University of Leeds acts as sponsor for studies where the Chief Investigator is substantively employed by UoL.

Sponsored research is typically categorised into:

• CTIMPs (Clinical Trials of Investigational Medicinal Products) – regulated under the UK Medicines for Human Use (Clinical Trials) Regulations.
• Non-CTIMPs – studies that fall outside the scope of these specific clinical trial regulations.