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

RD/QMS/SOP/001 : Preparation of Research Standard Operation Procedures
RD/QMS/SOP/002 : Obtaining R&D Confirmation for Research to Start
RD/QMS/SOP/003 : Research Study Amendments
RI/QMS/SOP/004 : Maintenance of Research Equipment SOP
RD/QMS/SOP/005 : Research Staff Training
RI/QMS/SOP/006 : Honorary Research Contract Letters of Access SOP
RI/QMS/SOP/006a External Researcher Information Form
RI/QMS/SOP/007 : Applying for NBT Sponsorship SOP
RI/QMS/SOP/007a Sponsorship Request Form
RI/QMS/SOP/007b NBT Terms of Sponsorship
RI/QMS/SOP/007c Delegation of Responsibilities
RI/QMS/SOP/007e Declaration Form
RI/QMS/SOP/008 : Writing a Protocol for ctIMPs
RD/QMS/SOP/009 Periodic Reporting to Regulatory Authorities
RI/QMS/SOP/010 : Archiving
RI/QMS/SOP/011: R&I Closing Suspending and Terminating Research
RI/QMS/SOP/012 : R&I Managing Breaches of GCP or the Protocol
RI/QMS/SOP/012a : ICH GCP NonCompliance Report Form
RI/QMS/SOP/012b Identifying & preventing noncompliance with Good Clinical Practice or the protocol
RI/QMS/SOP/012c : Protocol Deviation Review & Analysis Form
RI/QMS/SOP/013 : R&I Safety Reporting
RI/QMS/SOP/014 : R&I Monitoring
RI/QMS/SOP/015 : R&I Computer System Validation & Backup
RI/QMS/SOP/016 : R&I Research Contracts & Vendor Selection
RI/QMS/SOP/017 : R&I Data Management
RI/QMS/SOP/018: R&I Management of Fridges & Freezers
RI/QMS/SOP/020 : Management of healthy volunteers in research
RI/QMS/SOP/021 : R&I Informed Consent in Adult Research Setting

QMS TMPL 001 File Note

RD/QMS/TMPL/009: DSUR Template

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: 

• HRA guidance – Applying to a Research Ethics Committee

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

Some urinary symptoms are because of problems in the bladder or the urethra. These symptoms may include blood in the urine (haematuria), recurrent infections, difficulty urinating (peeing), or pain. To investigate further your doctor may recommend a flexible cystoscopy.

If your doctor has previously inserted a ureteric stent, this can be removed using a flexible cystoscope.

We also sometimes use the flexible cystoscope to assess a prostate before considering a prostate operation.

No special preparation is required. You can eat and drink normally, and you can drive before and after the test. There is no need to rest afterwards. You may need to provide a urine sample before your cystoscopy so we recommend coming to the appointment with a full bladder, ready to give a urine sample. Please arrive 15 minutes before your appointment time.

• You may need to provide a urine sample to test for a urinary tract infection (UTI). Please tell the nurse if you have symptoms of a UTI such as a fever, rigors (shivering), pain when urinating (dysuria), or frequent urination (going often).
• We will ask you to sign a consent form, confirming you understand the reasons for the test, the benefit, the alternatives, and the risks (explained on page 5).
• You will lie on an examination couch, and we will ask you to partially undress - usually from the waist down.
• Your genital area will be cleaned with a mild antiseptic liquid.
• Sterile drapes will be used to keep the procedure as clean as possible.
• A lubricating jelly will be inserted into your urethra.

• The doctor will pass the cystoscope through the urethra into your bladder.
• The scope may be connected to a screen, allowing you to see inside your bladder if you wish.
• There should not be much discomfort, but there can be feelings you are aware of.
• Sterile water is run through the scope to fill the bladder which allows us to see things better. This may make you feel like you need to pass urine or are passing urine backwards.
• If you cannot tolerate this test you can request to have a general anaesthetic (you will be asleep). This is unusual but is sometimes necessary.
• The test takes about 5 minutes.
• You may be given some antibiotics either before or following the test, which you should take as prescribed.
• After the cystoscopy, you will be able to discuss the results with the clinician, and any further management that may be required. Therefore it can be useful for you to bring someone with you to this appointment.

• Having burning or bleeding on passing urine is very common following the test. We advise you to increase your fluid intake to flush your bladder through. Drink 2-3 litres a day for 1-2 days (unless you have been told to restrict your fluid intake for medical reasons).
• There is a risk of a urinary tract infection (UTI) following this test, which can be experienced by 1-2% of patients. Symptoms of a UTI may include abdominal pain, pain or difficulty passing urine, and fevers/shivers/shakes. If you develop these symptoms, seek urgent medical advice (for example from your GP).

If you need any further information about the procedure before your appointment, please contact the team.

Please do not bring in valuables, jewellery, or large sums of money. If this is unavoidable, please ask a relative to take them home for you. The hospital cannot accept liability for the loss of personal items.

In this study, we are aiming to develop consensus-driven standards for the diagnosis, treatment, and ongoing management of patients with malignant upper urinary tract obstruction (MUUTO).
 

MUUTO is a blockage in the upper part of their urinary tract that some cancer patients can experience. This blockage can occur when cancer presses on or grows into the tubes that carry urine from the kidneys to the bladder. Although it is not known how common MUUTO is, it’s often linked to deterioration of the patient’s condition. MUUTO can happen in many types of cancer. To help relieve symptoms and possibly improve survival, medical staff may use treatments to relieve the blockage. Procedures such as the insertion of a tube into the kidney (a nephrostomy) or a stent can help improve kidney function, ease pain, and treat infections. Despite its seriousness, there’s little clear guidance for medical staff on how best to manage MUUTO. Different medics and hospitals may handle it in different ways, with no agreed standard on when or how to treat it, or which patients would benefit most. This makes it hard for patients and families to make informed choices with their doctors. In order to address this, we plan to distribute a series of anonymous surveys to a panel of medical experts on MUUTO to gather their opinions about how best to manage the condition. It is anticipated that by using this method we will be able to reach agreement on best practices, and create clear, expert-backed guidelines for diagnosing and treating MUUTO. These guidelines will help medical staff to make better, more consistent decisions, and improve care for patients facing this complex condition.
 

The study will utilize the Delphi methodology, a structured process designed to achieve consensus among experts in the field, and often used in healthcare studies. Service users helped develop the research topic and what research questions should be asked.
By gathering insights from experienced clinicians, we aim to improve clinical care pathways and patient outcomes. Before you decide whether to participate, it is important to understand the purpose of the study, what your involvement will entail, and any potential risks or benefits.
 

You have been selected as a participant because of your expertise in urology, oncology, radiology, nursing, or palliative care, with relevant experience in managing malignant upper urinary tract obstruction. Your contribution is vital to ensuring the recommendations are evidence-based, practical, and applicable to real-world clinical practice.

We will invite you to complete two online surveys, and attend a final face-to-face meeting. We will use the online survey platform Qualtrics to develop and distribute surveys, over approximately 1-3 rounds:
 

• First survey (Round 1/R1): We will ask you to vote on the importance of statements regarding the management of MUUTO. We will also ask you to provide your perspective on questions about the management of MUUTO where there is uncertainty amongst clinicians. Finally, you will have the opportunity to provide further suggestions for the management of MUUTO that have not been included. This survey will take approximately 15-20 minutes to complete. The survey will remain open for 2 – 3 weeks and reminders will be sent to anyone who has not responded, to ensure timely participation. After the first round, we will collate responses, and statements that have not met the pre-determined consensus thresholds will be progressed to Round 2, along with summary results from R1.
• Subsequent Rounds: For Round 2 you will have the opportunity to review anonymised summarized responses from the previous round. Also, we will invite you to consider statements that did not meet consensus criteria in R1, re-evaluate each statement's importance and relevance, and provide feedback where necessary.
• Final face-to-face meeting: The final Delphi round will be a virtual face-to-face meeting. At this meeting you will have the opportunity to discuss any statements that have not met consensus criteria in previous rounds or that require further refinement; to ratify statements that met consensus criteria; and to develop recommendations for the way forward.

The study will last for approximately 6 months, and your involvement would last for approximately 3 months.

The main sponsor for this study is North Bristol NHS Trust.

There are minimal risks associated with participation. The primary risk is the time commitment required to complete the survey rounds. While there are no direct benefits to you as an individual participant, your insights will contribute to the development of improved clinical guidelines, ultimately enhancing patient care.

Your participation is entirely voluntary, and you may withdraw at any stage without providing a reason. Withdrawing will not affect your professional standing or any future interactions with the research team. If you withdraw from the study, we will keep and continue to use all your previously collected data. We will, however not collect any further data from you.

Your responses will be treated confidentially and anonymized before analysis. Only members of the research team will have access to your data. Findings from the study may be published in peer-reviewed journals or presented at conferences, but no identifiable information will be disclosed. We may share anonymised information with others in the future. Dating sharing with other researchers is important to ensure that research is open to peer scrutiny, to optimise the use of good quality research data and to support policy and other decision-making. The Chief Investigator is the data custodian.

We will need to use information from you for this research project. This information will include your name, location and email address.
People will use this information to do the research or to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study, unless you have provided consent for this.

Your data will not be shared outside the UK.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. You have the right to ask us to remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.

You can find out more about how we use your information:
• by asking one of the research team;
• by sending an email to Helen Williamson (Head of Information Governance) at helen.e.williamson@nbt.nhs.uk, or
• by ringing us on 0117 4147934

If you have a concern about any aspect of this study, you should ask to speak to the study researcher first who will do their best to answer your questions. If you wish to complain formally, you can do this through the National Health Service complaints procedure, using the Patient Advice and Liaison Service (PALS http://www.pals.nhs.uk/). Their contact number is 0117 414 4569. This study does not involve any tests or treatment and it is highly unlikely that you will be harmed during the research. If something does go wrong and this is due to someone’s negligence, then you may have grounds for legal action for compensation against the NHS or the trial’s sponsor organisation North Bristol NHS Trust. You may have to pay your legal costs. The normal NHS complaints mechanisms will always be available to you.

The study results will be presented at research meetings, and published in scientific journals. We will also make the results widely available to the public. You will not be identified in any report or publication.

If you wish to take part, please access the link to an online consent form. After completion of the consent form please proceed to the first survey. Thank you very much for considering taking part in our research.

Choose foods which are less than 0.5g of fat per serving. Remember that most of the fat in the diet is LCT and this will be called “total fat” on the nutrition label. Be aware of the portion size on the plate, it could be different to the suggested serving size on the label.

If you are an inpatient, request a review with a Dietitian to discuss the choices from the menu.

(The menu is changed twice a year).