NHS Sponsorship

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* under the UK Framework for Health and Social Care Research.

If you would like Lancaster University to act as your sponsor, please discuss this with the Clinical Research Governance Officer at the earliest possible opportunity, so that we are aware of any potential or upcoming applications. We advise all researchers to refer to our Clinical Research and Trials webpages and ensure you are familiar with our SOPs, in particular the Sponsorship Forms and Guidance tab. When you have completed all fields on your IRAS application, finalised your supporting documents, and are ready to make a formal application for sponsorship, please follow the guidance below. Not following the guidance below may mean your application is delayed beyond the usual wait times.

It is a requirement that all researchers must complete the NIHR Good Clinical Practice (GCP) training online before applying for sponsorship. You can find out more about GCP training and how to sign up to the e-learning course on the NIHR webpage.

Please be aware that Lancaster University is unable to sponsor Clinical Trials of Medicinal Products and some Medical Device studies. Please contact email sponsorship@lancaster.ac.uk if you are planning to develop either of the above types of trials, to discuss your project.

Upon application, RSO will undertake a review of your application, confirm full sponsorship and insurance cover, and work with you to submit to the required regulators and ensure the correct documents are in place.

You should submit the following information to RSO (sponsorship@lancaster.ac.uk) to begin the sponsorship process:

  • Evidence of peer review (if applicable)
  • Draft Protocol
  • Draft IRAS form
  • Applicable draft Participant documents e.g., Participant Information Sheet, Consent Forms, GP letter
  • Details of any statistical engagement
  • CV of the Chief Investigator or Student (if applicable)
  • Draft Organisation Information Document (OID) and Schedule Of Events Cost Attribution Template (SoECAT)
  • Evidence of funding (where applicable)
  • Details of any collaborations with external parties, including commercial entities and suppliers
  • Any conflicts of interest

The sponsorship review process will commence. This may consist of support and advice in the following:

  • Study costing and financial management via RSO finance teams
  • Contractual matters via RSO teams
  • Regulatory submissions via RSO teams
  • Study management and oversight advice via RSO teams
  • Patient and Public engagement via RES teams
  • Vendor auditing via RSO teams
  • Confirmation of Insurance

Student applicants should refer to the HRA guidance here: student research. Please note that Lancaster University processes require that students who need R&D approval for one site only need to submit an IRAS form, following the guidance laid out here.

*In this context, the sponsor is the individual, company, institution or organisation which takes on ultimate responsibility for the management of the research. As part of this role, we may delegate some responsibilities to other parties, such as the Cheif Investigator or research.

Accordion

Attending NHS REC review meetings: Guidance for researchers

This guidance is for staff and Post Graduate students who will be attending an NHS Research Ethics Committee (REC) meeting because their IRAS application requires an NHS REC review.

1. Applicants: should attend NHS REC review meetings when invited to do so by the REC.All NHS REC meetings are now conducted via Zoom, so are accessible from any location. It is worth noting that members usually require clarification of some issues even in well- written applications. Attending an interview will enable you to answer REC members’ questions or concerns about your research at the meeting, clearly and clarify any misunderstandings. This can save a lot of time later in that it may avoid the to-ing and fro-ing of numerous emails after your application has been reviewed in order to supply the committee with the information that it needs to make a decision on your application. If the REC requests revisions to your application, you will have a greater understanding of what is required in order to gain ethical approval for your research.

2. Supervisors: If you supervise a student who has been invited to attend an NHS REC meeting to discuss their IRAS application we strongly recommend that you attend with them, as will the REC. If you cannot attend we recommend that you nominate a substitute, preferably a colleague who is familiar with the project or at least who has sufficient expertise in the subject. The reasons for this are that:

  • This is important because it can be very daunting for a student to attend a REC meeting and your presence will help them to feel supported. They may need your assistance to answer members’ questions during the meeting if they struggle at any point.
  • Your presence demonstrates to the REC that their supervisor and institution support the student. It gives the REC a very bad impression if students attend a REC meeting without the presence of their supervisor.

3. Before you attend a REC meeting re-read all the documents which you submitted for review; especially the IRAS form and protocol and be prepared to answer questions about the information on any of your documents. In particular, recruitment strategies and methodologies often raise questions or require clarification; especially if a project has several cohorts and/or mixed methodologies, which are very detailed.

4. Arrive for your appointment on time. This sounds obvious but worth noting, as RECs usually have a full agenda at their meetings and it will be helpful to arrive on time to avoid delays.

5. Ask questions! You will be able to ask the committee members questions when you attend the meeting. RECs comprise of many experienced members from a range of research backgrounds and often appreciate applicants asking their advice on a particular aspect of their research.

6. Relax! Remember that REC members want to ‘enable’ research. Many members work in hospitals, the health care sector or universities; they understand the research environment and its challenges and want to help you to do research which follows best practice.

7. Changes required after the NHS REC or HRA review, usually do not need to be made on IRAS itself, unless otherwise stated. Some documents may be requested as uploads on IRAS, but the queries will usually be responded to via email.

Linked icons