National approvals address the ethical and regulatory considerations of your project. At a local level, we need to consider feasibility and our capacity and capability to successfully deliver the study.
Contact the Research and Innovation team to discuss your project, they will advise you on:
- Feasibility review
- Assessing, arranging and confirming capacity and capability
- Contract negotiation
- Any training requirements and ensuring access to the hospital.
Apply for capacity and capability confirmation
The new HRA single submission process for the NHS in England brings together the assessment of governance and legal compliance with the independent ethics opinion. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.
For UHL sponsored studies
Send your draft IRAS application form along with all supporting documents and a completed Sponsor Application Form to email@example.com
Your study will be reviewed by a representative of the sponsor who will provide support and guidance to the Chief Investigator (CI) and study team to prepare the documentation for REC/HRA submission. Where UHL are also a research site, the study will be passed to a Study Support Officer (SSO) who will incorporate assessing, arranging and confirming the capacity and capability to deliver the study as part of this process.
For UHL hosted studies
Send your application forms and supporting documents to firstname.lastname@example.org
Your study will be allocated to a SSO who will work with the Principal Investigator (PI), site team and the sponsor organisation to assess, arrange and confirm the capacity and capability to deliver the study at University Hospitals of Leicester NHS Trust.
The Research and Innovation team strives to get every project approved as quickly as possible, in line with the national framework and the national metric of 40 days. Each project is unique and its complexity can impact on the approval time. It is important to note that the review is a two way process – we are reliant on you to respond to questions and requests to progress the project, and will assist you as best we can. The sooner you can let us know about a study the better, even if you don’t have all the documents at that time.
Amending your study
Once received, the approval is valid for the life of the project. It is the investigator’s responsibility to register any changes to the project with the Research and Innovation team. Changes to projects without prior approval will invalidate your work and constitute a breach of research governance. The Research and Innovation team will assist you with any amendment submissions. You may also check the HRA website for example scenarios to report amendments and the effect on your study.
How do I know that my project has been approved locally?
You will receive a confirmation of capacity and capability email from the Trust, listing your responsibilities as an investigator, requirements for reporting and the terms of the approval. You are expected to familiarise yourself with the terms and conditions.
You will also be required to create and maintain an Investigator Site File if one is not provided to you by the sponsor. The Research and Innovation team can provide a template Investigator Site File for you to use. This binder is used to file all study-related documents in a central location, assisting with assurance of good conduct and governance. The Research Facilitator supporting your clinical speciality can review the Investigator Site File with you and answer any questions.
Contracts and agreements
When projects are conducted across multiple sites, contracts and agreements are needed to protect the interests of the researchers and of the organisations supporting the research. You can work with your SSO to develop these agreements to clarify:
- The responsibilities of each organisation
- When funding is involved, the amounts, terms and conditions
- How the results of the work will be handled, such as data ownership, intellectual property, and publication rights
- The transfer of relevant materials under the Human Tissue Act.
I do not work at University Hospitals of Leicester NHS Trust
All staff working on site are required to have approved access arrangements in place, and the need for this will be identified during the governance review.
A Research Passport refers to the process and approach of confirming details of pre-engagement checks that researchers have undergone in the NHS and the associated HR arrangements.
It is the “system for issuing honorary research contracts (HRCs) or letters of access to Higher Education Institution (HEI) researchers who need to undertake their research within the NHS”. It also refers to “NHS to NHS arrangements for sharing and accepting pre-engagement checks between NHS organisations when NHS staff wish to undertake research within the NHS outside of their employing Trust.”
You must have received a Letter of Access or an Honorary Research Contract before you can start the research at the Trust
For more detailed information, visit the National Institute for Health Research website.
Further information can be found in the SOP section of this website.