All research studies taking place within health and social care and/or involving NHS patients, their tissue or information (data) must have a Sponsor.
A ‘Sponsor’ is the organisation, which takes ultimate responsibility for the initiation, management (or arranging the initiation and management) and/or financing (or arranging the financing) for that research. The sponsor takes primary responsibility that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.
The Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) will typically sponsor studies where the investigator has a substantive or honorary contract with the institution and where there is at least one UK site. The decision as to which institute should sponsor a study is determined by the Newcastle Joint Research Office (NJRO) during the sponsorship approval process.
Healthy volunteer studies which are clinical trials of investigational medicinal products (CTIMP) will also require sponsorship. Other types of healthy volunteer studies may not require sponsorship but will require a review by Newcastle upon Tyne and North Tyneside ethics committee. The NJRO will confirm full sponsorship and insurance cover and work with you to submit to the required regulators and ensure the correct documents are in place.
Assess, arrange and confirm
When research is taking place on NHS premises and/or involves NHS patients or staff then The Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) needs to ensure they have Capacity and Capability to undertake the study. The Trust has to ensure adequate contracts and any cost implications are covered.
The Health Research Authority (HRA) refers to this process as “Assess, Arrange and Confirm“.
A feasibility assessment will cover the following:
Assess – assessing whether or not the NHS organisation has the capacity and capability to participate in the study
Arrange – putting practical arrangements in place to provide the capacity and capability to deliver the study
Confirm – confirming that the NHS organisation has the capacity and capability in place to deliver the study and will deliver it. The confirmation is given through an email.
As part of this review the following checks and arrangements are completed:
- Service Department feasibility assessments (e.g. pharmacy, radiology) Email confirmation required from service department.
- Team Lead authorisation
- Finance review to ensure costs are identified and covered
- Where required, a Contract review to ensure financial appendix matched costing tool
How to apply for Assess, Arrange and Confirm at NUTH
The minimum document (first core documents) set required for studies where NUTH is a Research Site or a PIC, is defined by the HRA as the following:
- Copy of IRAS Form (combined REC and R&D form) as submitted for HRA Approval Protocol
- Any substantial or non-substantial amendments
- Participant information and consent documents
- Statement of Activities relevant to the participating NHS organisation (non-commercially sponsored only) Relevant template contract/model agreement Costing template (commercially sponsored only) or Schedule of Events (non-commercially sponsored only)
- Copy of HRA Initial Assessment letter (if one is issued) and (when issued) HRA Approval letter, and final versions of study documents.
Further information can be found on the HRA website.