The Sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study, but is not necessarily the funder. Depending on the type of study you have there may or may not be a financial implication to running the study.

Your research team should include the following roles in line with the UK Policy Framework for Health and Social Care Research and applicable legislation:

  • sponsor
  • sponsor's legal representative
  • chief investigator
  • principal investigator
  • data controller

The HRA website describes the role of sponsor as:

The organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project.

All health and social care research should have a sponsor. This includes all research that involve NHS patients, their tissue or information.

Two or more organisations may agree to act as co-sponsors or joint sponsors. Co-sponsors allocate specific sponsor responsibilities between them whilst joint sponsors each accept liability for all of the sponsor's responsibilities.

A sponsor can delegate specific tasks to any other individual or organisation that is willing and able to accept them.

Any co-sponsorship, joint sponsorship or delegation of tasks to another party should be formally agreed and documented by the sponsor(s).

The Sponsor's responsibilities are set out in more detail in the UK Policy Framework for Health and Social Care Research.

You will need to identify an institution that is willing to take on this role. Many of the main funding bodies are willing to provide grants for research, but are not able to take on the responsibilities of Sponsor.

The HRA describes other role as:

The Chief Investigator (CI) is the overall lead researcher for a research project (Outside the UK the term Coordinating Investigator or Investigator may be used). In addition to their responsibilities if they are members of a research team, chief investigators are responsible for the overall conduct of a research project.

The Chief Investigator's responsibilities are set out in more detail in the UK Policy Framework for Health and Social Care Research.

The Principal Investigator (PI) is an individual responsible for the conduct of the research at a research site. There should be one PI for each research site. In the case of a single-site study, the chief investigator and the PI will normally be the same person.

The Data Controller will be the organisation responsible for the management and oversight of the data. More information on the role of data controllers and personal data in health and care research can be found in our guidance.

It is essential that you contact the R&I Department as early as possible if you are unsure as to who your sponsor should be or how to approach them. The sponsoring organisation may have specific templates and forms they require to consider your study to for sponsorship and the sign off process can be lengthy, depending on the complexity of your project.

Currently MPFT do not sponsor research projects, but this facility will be in place in the near future for single site, non-interventional studies developed by members of MPFT staff, please watch this space.

If you have any questions, please contact the Research and Innovation department on 01785 783180 or researchsupportservices@mpft.nhs.uk

 

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