All research governed in the National Health Service or Community Service is governed by the UK Policy Framework for Health and Social Care Research (“RGF”). This Framework requires that all clinical research involving human participants, their organs, tissues or data must have an identified Sponsor who takes responsibility for the initiation, management and financing of a clinical study.
For Studies falling under the Medicines for Human Use (Clinical Trials) Regulations 2004 there are additional legal requirements that the Sponsor must be responsible for.
In the context of research governance the term sponsor has different meaning to the term ‘funder’.
A research project can be co-sponsored between two or more organisations, with the responsibilities delegated in a formal co-sponsorship agreement.
As a Sponsor and/or co-sponsor, the University of Aberdeen or NHS Grampian must ensure that it takes responsibility for the following:
- Assessment of the quality of research proposed, the quality of the research environment within which the research will be undertaken and the expertise of the Chief Investigator and other key staff involved.
- Ensuring arrangements are in place for the research team to access resources and support to deliver the research proposed.
- Ensure agreements which specify the responsibilities for funding, management and monitoring of the research are in place.
- Ensure 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.