A sponsor is an individual, organisation or group taking legal responsibility for the arrangements to initiate, manage, monitor and report on a study.
The sponsor could be Cambridge University Hospitals (CUH), the University of Cambridge, a charity, another Trust or university, or a commercial organisation. A sponsor may also finance a study; this is often the case with pharmaceutical research. However, a sponsor is not synonymous with a funder.
Cambridge University Hospitals usually sponsors studies alone or jointly with the University of Cambridge, e.g. when the protocol has been designed by a University employee, or when the University manages the funding.
Sponsorship must be confirmed before any study can be set up. CUH can solely sponsor or jointly sponsor studies with the University of Cambridge.
The Trust will solely sponsor a study when:
- the Chief Investigator (CI) is substantively employed by the Trust and has authored the Protocol.
The Trust does not produce a Sponsorship Letter for sole sponsored studies.
The Trust will jointly sponsor a study with the University of Cambridge when:
- the CI is substantively employed by the University of Cambridge;
- the Trust’s facilities, staff, patients, their data or tissues are involved in the study;
- the funding of the study is received and managed by either a University department (including RSD) or the Trust.
A Sponsorship Letter will be produced to confirm Joint Sponsorship.
To confirm Sponsorship, the Research Governance team must be contacted via cuh.research@nhs.net along with the following documents:
CUH Peer Review Committee
All research, except non-doctoral student research needs to be externally peer reviewed. The critique report needs to be submitted to the research ethics committee. Scientific review is often provided during the grant application process.
Where a study has not received peer review, then CUH has a peer review committee that carries out this function. Your research governance co-ordinator will be able to submit your protocol for peer review to our Research Advisory Committee (RAC) which is a panel of academic experts. Applicants should await feedback from the committee before proceeding to the regulatory submission stage.
Feedback may be favourable, may receive suggestions or may require some changes.
Insurance
All research studies must have insurance against potential harm to participants arising from:
- the management of the research. This is provided by the sponsor of the study;
- the design of the research. This is provided by the substantive employer of the CI (University of Cambridge or NHS Indemnity);
- the conduct of the research. Where NHS patients are participants, NHS indemnity applies.
For studies involving Healthy Volunteers or International Sites, further discussions around Insurance need to take place with the R&D Legal Team and University of Cambridge Insurance Office.
When the sponsor is CUH, usually the study will be covered by NHS indemnity schemes. If the sponsor is a university, a charity or commercial organisation, indemnity needs to be provided under their insurance policies.
Note: protocol indemnity lies in general with the employer of the author. If you are a University employee and want to set up a study you need to contact the University Research Operations Office to apply for an insurance letter.
NHS indemnity is a form of insurance for negligent harm provided via the NHS Resolution (formerly the NHS Litigation Authority, or NHSLA). This covers negligent harm caused to patients and healthy volunteers whenever they are:
- receiving an established treatment;
- receiving a novel or unusual treatment;
- a subject of clinical research.
NHS indemnity does not offer cover for non-negligent harm.
Where a study is jointly sponsored, university insurance will provide non-negligent harm; the University Insurance Office will provide evidence of provisional insurance for studies being submitted for HRA approval. This will be to cover the design of the protocol. The confirmation of insurance will be provided once ethical favourable opinion is in place and should be provided to the HRA as soon as possible. The university insurance office can be contacted via: insurance@admin.cam.ac.uk
For studies involving a Medical Device or Medicinal Product further insurance may need to be in place. For example, where a device is manufactured by the NHS, additional product liability insurance will be required.
