Whether you are developing your own research idea or bringing an externally sponsored study to University Hospitals Birmingham NHS Foundation Trust (UHB), Research and Innovation (R&I) can support you from early planning and feasibility through to study set-up, confirmation and delivery.
Is my project research?
Research is managed differently from clinical audit, service evaluation, quality improvement and other non-research activity. Before starting, you should establish whether your project is research and what approvals may be required.
The Health Research Authority (HRA) provides a decision tool to help determine whether a project is classed as research. You can find our more via the HRA website:
If your project is not research, it may still require registration or approval through the appropriate UHB route. If you are unsure which route applies, contact R&I before the project begins.
Developing a research idea or funding application
If you are developing your own research idea, applying for funding or need support with an academic study, the Research Application Support (RAS) team can help at an early stage.
RAS can support with areas including:
- developing grant applications and identifying funding opportunities
- research costing and NHS cost attribution
- signposting to specialist teams, facilities and research infrastructure
- letters of support and organisational sign-off
- UHB Sponsorship requests
- pre-award advice and support through the application process
Researchers planning a grant application should contact RAS as early as possible. Visit the Research Application Support (RAS) page for more information.
Bringing an externally sponsored study to UHB
If a Sponsor or Contract Research Organisation (CRO) would like UHB to take part in a study, the first step is Feasibility. This allows UHB to consider whether the study is suitable and deliverable before formal site set-up begins.
Please engage with the UHB Feasibility route before sending a study directly to Governance for set-up.
If you are a UHB Principal Investigator and receive formal correspondence from the Sponsor or CRO confirming that UHB has been selected as a site, please forward that correspondence to R&I promptly. This helps us record the correct site-selection date and start the next stage of set-up without avoidable delay.
How study set-up works at UHB
Once a study has progressed through Feasibility and UHB has confirmed that it should move forward, R&I will coordinate the local set-up process.
FEASIBILITY → ARRANGE → CONFIRM
Feasibility is where UHB considers whether the study is suitable and deliverable, including local interest, capacity and service implications.
Arrange is where R&I coordinates the proportionate local requirements needed to set the study up, including contracts, costs and relevant support arrangements.
Confirm is where once the necessary local arrangements are in place, UHB issues confirmation that the study can proceed locally. Research activity must not begin before the appropriate confirmation is in place.
During Arrange, the exact requirements will depend on the study. These may include:
- review and execution of the appropriate site agreement
- confirmation of study costs and financial arrangements
- pharmacy, radiology, laboratory or other support service arrangements where relevant
- researcher access arrangements where external staff will work at UH
- local information governance, digital or technical arrangements where a study introduces a specific
UHB-facing requirement:
- confirmation that the local research team and services are ready to deliver the study
UHB takes a proportionate approach to site set-up and relies on national HRA/HCRW assurances where these have already been completed. We do not routinely repeat study-wide checks locally unless there is a specific UHB requirement or risk that needs to be addressed.
What should I send?
The Sponsor/CRO and local research team should provide the information needed for the study to progress, and R&I will confirm any study-specific requirements during set-up.
Depending on the study, this is likely to include the current protocol, relevant HRA/IRAS documentation, Sponsor confirmation, site agreement and costing information, together with any documents needed for specific local services.
UHB sponsorship
Every research study must have an organisation that takes responsibility for the appropriate sponsorship functions under the UK Policy Framework for Health and Social Care Research and, where applicable, clinical trials legislation.
UHB may agree to sponsor eligible studies led by UHB researchers, subject to review and formal approval. Sponsorship is not automatic and should be discussed early, particularly where a funding application is planned.
UHB does not sponsor commercially funded studies. Commercially sponsored research should have an appropriate external Sponsor in place.
Requests for UHB Sponsorship are coordinated through the Research Sponsorship Team and are reviewed through the UHB Sponsorship process.
To discuss a Sponsorship request, contact:
Approvals and regulatory requirements
The approvals required depend on the type of research. The Sponsor is responsible for ensuring that the appropriate study-wide approvals are obtained and maintained. These may include:
- HRA and Health and Care Research Wales (HCRW) Approval
- NHS Research Ethics Committee (REC) review
- Medicines and Healthcare products Regulatory Agency (MHRA) authorisation for relevant clinical trials
- other specialist review bodies where applicable
Applications and study-wide approvals are managed through the national systems and processes set out by the HRA and relevant regulators. UHB site set-up should run alongside these processes where appropriate so that unnecessary delay is avoided.
For current national guidance, please visit:
Changes to an approved study (modifications)
Changes made to an approved study are now referred to nationally as modifications. The Sponsor is responsible for categorising the modification and obtaining any review or approval required from the relevant bodies.
UHB should be notified of modifications that affect the Trust or the way the study is delivered locally. The Sponsor/CRO should provide the approved modification documentation and clearly identify any actions required from UHB or the local research team.
Do not implement a modification at UHB until the Sponsor has confirmed that it may be implemented and UHB local approvals have been given, unless an urgent safety measure requires immediate action to protect participants.
Current national guidance is available from the HRA modifications guidance.
Once your study is open
Once UHB has confirmed that a study can begin, the Principal Investigator and local research team are responsible for ensuring that it continues to be delivered in line with the approved protocol, Sponsor requirements and UHB procedures.
Please make sure R&I is informed of relevant changes during the life of the study, including:
- modifications that affect UHB
- changes to the Principal Investigator or key local arrangements
- temporary halts, early closure or study closure
- changes that affect contracts, costs, data, systems or support departments
- urgent safety measures or other significant issues affecting local delivery
The Sponsor should also ensure that UHB receives current study documentation and clear implementation instructions throughout the study.
Training and researcher requirements
Research teams must have the training, experience and delegated responsibilities appropriate to the activities they undertake. Training requirements should be proportionate to the study and the individual’s role.
For information on UHB research training requirements or to request the current Training Matrix, contact:
Contact Research and Innovation
If you are unsure which route applies to your study or project, contact Research and Innovation and we will direct you to the appropriate team.
Last reviewed: 29 September 2026