Sponsorship

All research conducted in the Health Service or Community Service is governed by the Scottish Executive document, Scottish Executive Health Department (SEHD) Research Governace Framework for Health and Community Care. This requires that all clinical research involving human participants, their organs, tissue or data must have an identified research sponsor. The document defines a research sponsor as an 'individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage, monitor and finance a study.'

In addition, research involving the use of medicinal products must comply with the Medicines for Human Use (Clinical Trials) Regulations 2004 which defines a sponsor, in relation to a clinical trial, as ‘the person who takes responsibility for the initiation, management and financing (or arranging the financing) of a trial’.Further information on this can be obtained from the College of Life Sciences and Medicine Research Governance Manager.

The SEHD Research Governance Framework for Health and Community Care stipulates that any research requiring the collaboration of the NHS or Community care services in Scotland must have an organisation willing and able to take on the responsibilities of research sponsor.

The research Sponsor takes responsibility for:

  • Assessment of the quality of the research proposed, the quality of the research environment within which the research will be undertaken and the experience and expertise of the Principal Investigator and other key research staff involved.
  • Ensuring that arrangements are in place for the research team to access resources and support to deliver the research as proposed.
  • Ensuring that agreements are in place which specifies responsibilities for the funding, management and monitoring of research.
  • Ensuring that arrangements are in place to review significant developments as the research proceeds, particularly those which put the safety of individuals at risk, and to approve modifications to the design.

These responsibilities are not new, but the SEHD Research Governance Framework for Health and Community Care requires collaborating organisations to be clear about how the responsibilities are allocated between partners.

For sponsorship guidelines for researchers, please contact the College of Life Sciences and Medicine Research Governance Manger.