- The sponsor is the individual, company, institution or organisation, which takes on ultimate responsibility for the initiation, management (or arranging the initiation and management) of and/or financing (or arranging the financing) for that research. The sponsor takes primary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.
- Any research requiring the collaboration of the NHS must have an individual or organisation willing and able to take on the responsibilities of the research sponsor. The responsibilities of sponsors are set out in more detail in the Research Governance Framework for Health and Social Care, available here. Any research outside the NHS should also have a sponsor to take on the specific responsibilities of the role.
- The sponsor is usually, but does not have to be, the main funder of the research. It can also, for example, be the employer of the chief investigator, the educational institution (e.g. for student research), or the care organisation where the research is to take place.
- Before submitting an application through IRAS, the prospective sponsor(s) must be named in the relevant section. Local R&D offices will be able to provide advice about sponsorship issues.
- It is possible that the duties of the sponsor could be shared between more than one party. If this applies, a “lead sponsor” should be nominated to receive copies of correspondence from the review bodies relating to the application. Further details of the co-sponsors, together with an explanation of how the responsibilities of sponsorship will be assigned, in particular those relating to monitoring of the research and provision of insurance or indemnity, should also be provided.
- It is the responsibility of the chief investigator to ensure that the sponsor(s) are aware of their proposal and accept these responsibilities. An authorised representative of the lead sponsor should complete the sponsor declaration in Part D of IRAS. The person making this declaration does not necessarily have to be an employee of the sponsor, but should be authorised to do so by the sponsor. For example, a Contract Research Organisation (CRO) may be given delegated authority by the sponsor to prepare and submit applications for approval on their behalf.
- Details of a contact point for the lead sponsor and each co-sponsor should also be completed in IRAS. The person named must be an employee of the sponsor organisation. The contact for the lead sponsor will often be the same person whose details are entered as the main contact point for correspondence with review bodies on behalf of the sponsor(s). However, the person could be different where responsibilities for managing applications to review bodies have been delegated, for example to a Contract Research Organisation.
- All research falling under the remit of the Secretary of State for Health must have a formal sponsor. This includes all research in health and social care that involves NHS patients, their tissue or information, etc. There are similar requirements for research involving social care practitioners, clients and resources, where this falls under the Secretary of State for Health’s remit.
- Any organisation that is a legal entity may declare itself as a sponsor. While the Clinical Trials Regulations allow for individuals to become sponsors, many institutions do not permit their staff to take personal responsibility in such areas because of the risks and legal liabilities involved.
- A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them. However, the sponsor should ensure that the delegation of responsibilities to another party is formally agreed and documented.
- In some cases, a co-sponsorship agreement may be reached. If so, one body should be nominated as the lead sponsor for the purposes of the ethics application and a sponsor letter should be provided describing the responsibilities of each sponsor. In particular, this should clarify the agreement about compensation and indemnity in the event of harm to research participants.
- It should be noted that co-sponsorship is an arrangement that is not recognised in EU states other than the UK and is therefore not applicable to multi-national studies within the EU.
Sponsorship of CTIMPs
- For any clinical trial of an investigational medicinal product (CTIMP) it is a legal requirement for the trial to be sponsored.
- If a sponsor of a CTIMP is a commercial or other non-NHS body, a copy of an insurance or indemnity certificate should normally be included with the REC application as evidence of the cover in place for the potential liability of the sponsor. This may be a certificate for a trial-specific policy or a block policy covering a number of trials conducted by the sponsor. If the certificate is not yet available, for example because proposed trial-specific cover will not be brought into effect until the trial is ready to start, the REC will require as a condition of its favourable opinion that a copy of the certificate is provided prior to the start of the trial.