All research which falls within the scope of the Research Governance Framework for Health and Social Care requires a sponsor. This includes research that involves NHS patients, their tissue or information, staff, equipment or other resources of the NHS. The sponsor organisation agrees to act as guarantor for the research ensuring that it is designed, conducted and reported to internationally recognised principles of Good Clinical Practice (GCP) and relevant legislation1.
Sponsorship should be discussed and agreed in principle as early as is possible in the study set-up. Ideally a sponsorship request should be made at the time the research protocol is being developed or at the grant application stage. Formal declaration from the designated sponsor is required before any application to the Research Ethics Committee (REC), NHS R&D and other regulatory authorities can be made.
If no organisation is willing to take on the sponsor role, the study cannot proceed.
- Who should sponsor?
For non-commercial health research the most appropriate sponsor may be the funding organisation, the organisation that will administer the funding, the employer of the Chief Investigator or the lead care organisation where the research is to take place.
Noclor provides sponsorship support services to its partners; it is not a legal entity and cannot be named as the sponsor organisation
If the Chief Investigator (CI) identifies one of the Noclor partners as the most appropriate sponsor for their study, s/he should submit an online request for sponsorship
The sponsor can formally delegate responsibilities to the Chief Investigator, Clinical Trial Unit or another third party (though contracts and agreements), but remains accountable for all aspects of sponsorship whether delegated or not.
It is also possible (not necessarily preferable) for the responsibilities of the sponsor to be shared between more than one party. Only one sponsor should be approached in the first instance (the most relevant organisation to the Chief Investigator/administration of funding). If the proposed sponsor (or co- sponsor) is a Noclor partner then a formal assessment would be carried by Noclor prior to agreeing to co-sponsorship arrangements. Responsibilities of both parties (whether responsibilities are joint or allocated) will be documented in a contract issued per trial or as an overarching master agreement where there may be several clinical trials with a particular programme of work.
- How to request sponsorship from a Noclor partner
Requests for sponsorship by a Noclor partner should be made online by submitting a completed sponsorship request form.
The online form comprises of a series of questions about the proposed research which will help inform the initial risk assessment to be conducted by Noclor prior to a decision on sponsorship being made
Documents may also need to be uploaded (as pdf’s) where evidence is required to support the application.
On-line guidance is available where you see a i symbol. If you need further assistance in completing the online form please contact a Noclor Research Facilitator.
The Noclor Sponsor Representative may contact the Chief Investigator after an online request has been submitted to request further information or to arrange a face-to-face meeting to discuss.
Valid sponsorship requests will be reviewed and responded to by Noclor within 5 working days of receipt.
- What won’t be sponsored
Noclor will not consider applications where the project is not classified as research under the Research Governance Framework for Health and Social Care. To help you decide whether your project is classified as research you should refer to the HRA Decision Tool.
Noclor will not process a request for sponsorship where the request is made solely over the telephone, email or via request for sponsorship declaration through IRAS.
Noclor will not process a request for sponsorship if the request is made by someone other than the proposed Chief Investigator.
Noclor will not consider a sponsorship request for 'stand alone' student research, this should be sponsored by the educational institution. Where the educational project sits within a larger study or program of work, it may not be appropriate for the educational institute to sponsor and sponsorship requests of this type of project will be considered by Noclor on a case by case basis.
 It is a criminal offence to conduct a Clinical Trial of an Investigational Medicinal Product (CTIMP) without a sponsor having been identified and formally agreeing to take on the sponsorship responsibilities. This type of research is regulated in the UK by The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) as amended which implements The Clinical Trial Directive (Directive 2001/20/EC).