From writing your initial proposal to statistical requests and patient & public involvement, here you will find all the documents, forms and standard operating procedures you will need to develop and set up your research idea at North Bristol NHS Trust.
Our Standard Operating Procedures (SOPs) should be used by Chief and Principal Investigators, Research Nurses and all other research personnel. They provide detailed guidance on all aspects of research study management from design through to completion.
If you are an NBT staff member, the current research SOPs should first be accessed via our Managed Learning Environment (MLE) in accordance with the Research Staff Training SOP. This will provide you with an electronic training record to evidence that you have read each SOP.
It is the responsibility of all staff who carry out research to ensure you are using the latest SOP.
Some of the documents are available online below. If you would like a document that is not available online, please contact: research@nbt.nhs.uk.
Policies & Guidance
R&I - (PO1) Commercial Research Policy
R&I - (PO2) Sponsorship & Central Trial Management Fees Policy
R&I – (P03) Excess Treatment Costs In Research at NBT has been suspended. All new research projects with excess treatment costs require approval from the General Manager/Clinical Director.
R&I - (PO4) NIHR Research Funding Recovery Policy
R&I - (PO5) - PPI in Research Payment Policy
RD - (P06) Research Misconduct Policy
NBT (CG-134) Adult Safeguarding Policy
NBT (CG-197) Safeguarding Children Policy
NBT (PEO-33) Fairness at Work Policy
Study Set-Up
Guidance on Allocation of Research SPA time for Consultants
R&I NBT HRA Checklist
R&I Making amendments to NBT Sponsored studies that have HRA approval
R&I Setting up new studies where NBT are sponsor
Standard Operating Procedures
Ref: RD/QMS/SOP/001 : Preparation of Research Standard Operation Procedures
Ref: RI/QMS/SOP/002 : Obtaining R&I Confirmation for Research to Start
Ref: RD/QMS/SOP/003 : Research Study Amendments
Ref: RI/QMS/SOP/004 : Maintenance of Research Equipment SOP
Ref: RI/QMS/SOP/005 : Research Staff Training
Ref: RI/QMS/SOP/006 : Honorary Research Contract Letters of Access SOP
Ref: RI/QMS/SOP/006a External Researcher Information Form
Ref: RI/QMS/SOP/007 : Applying for NBT Sponsorship SOP
Ref: RI/QMS/SOP/007a Sponsorship Request Form
Ref: RI/QMS/SOP/007b NBT Terms of Sponsorship
Ref: RI/QMS/SOP/007c Delegation of Responsibilities
Ref: RI/QMS/SOP/007e Declaration Form
Ref: RI/QMS/SOP/008 : Writing a Protocol for ctIMPs
Ref: RI/QMS/SOP/009 R&I Periodic Reporting to Regulatory Authorities
Ref: RI/QMS/SOP/010 : Archiving
Ref: RI/QMS/SOP/011: R&I Closing Suspending and Terminating Research
Ref: RI/QMS/SOP/012 : R&I Managing Breaches of GCP or the Protocol
Ref: RI/QMS/SOP/012a : ICH GCP NonCompliance Report Form
Ref: RI/QMS/SOP/012b Identifying & preventing noncompliance with Good Clinical Practice or the protocol
Ref: RI/QMS/SOP/012c : Protocol Deviation Review & Analysis Form
Ref: RI/QMS/SOP/013 : R&I Safety Reporting
Ref: RI/QMS/SOP/014 : R&I Monitoring
Ref: RI/QMS/SOP/015 : R&I Computer System Validation & Backup
Ref: RI/QMS/SOP/016 : R&I Research Contracts & Vendor Selection
Ref: RI/QMS/SOP/017 : R&I Data Management
Ref: RI/QMS/SOP/018: R&I Management of Fridges & Freezers
Ref: RI/QMS/SOP/019 : R&I RESTART During urgent public health emergencies
Ref: RI/QMS/SOP/020 : Management of healthy volunteers in research
Ref: RI/QMS/SOP/021 : R&I Informed Consent in Adult Research Setting
Research Ethics
At North Bristol NHS Trust, we are committed to ensuring that all research conducted within our organisation upholds the highest standards of ethical integrity, safeguarding the rights, dignity, safety and wellbeing of everyone involved.
We support high-quality, ethical research that contributes to improving patient care, public health, and service delivery.
Ethical Review Process
All research involving our patients, staff, data or facilities must receive appropriate ethical review and approval before it begins. This may include:
- Review by a Health Research Authority (HRA) Research Ethics Committee (REC) – required for most research involving patients or identifiable NHS data.
- Local review through the Trust’s Research & Development (R&D) Department, which ensures projects meet NHS and Trust-specific governance requirements.
We work closely with the HRA to ensure compliance with the UK Policy Framework for Health and Social Care Research and all relevant legal and ethical standards, including GDPR and the Declaration of Helsinki.
The HRA provides comprehensive guidance on the ethical review process, including the roles and responsibilities of RECs to ensure that we protect the rights, safety, dignity and wellbeing of participants.
This centralised approach ensures consistency and rigour in the ethical review of health and social care across the UK.
You can find out more information here:
Supporting Researchers
Our R&D team offers support and guidance throughout the ethical approval process. We help researchers:
- Identify the appropriate level of ethical review
- Prepare and submit applications via the Integrated Research Application System (IRAS), including development of the required submission documents such as research protocol, participant information sheets and consent forms.
- Understand key ethical considerations such as consent, confidentiality, risk, and public involvement.
If you are planning a research project, please contact our R&D team early in your planning process to ensure ethical requirements are met, as part of our sponsorship review process.
Contact Us
For further information or support with research ethics, please contact:
Research and Development
Research Sponsor
North Bristol NHS Trust
Email: researchsponsor@nbt.nhs.uk
Phone: 0117 414 9330
View Our Research
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About Research & Development
Find out more about our research and how we're working to improve patient care.
Contact Research
Research & Development
North Bristol NHS Trust
Level 3, Learning & Research building
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB
Telephone: 0117 4149330
Email: research@nbt.nhs.uk