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

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

Ref: RD/QMS/SOP/001 : Preparation of Research Standard Operation Procedures

Ref: RI/QMS/SOP/002 : Obtaining R&D 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

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

Following your first mammogram, we invited you to take part in Stage 1 of the DYAMOND study: to measure your breast density and to check your breast screening results. Your images have now been checked and we think you could be eligible to join Stage 2 of the study to have a FAST MRI scan. 

No, it’s up to you to decide whether to take part. If you choose not to, be reassured that your clinical care will not be affected. You will still be offered your routine screening mammograms every 3 years until you turn 71. 

We have designed the study to be as convenient as it can be, so that as many people can be involved as possible. If you decide to take part, we will:

• Ask you some questions about your health
• Check that you can have a FAST MRI scan
• Book a FAST MRI scan at a time convenient to you
• Ask you to complete a survey about your experience

Some people may also be invited to take part in an interview about their experience.

We expect a small proportion of people having a FAST MRI scan to be invited for another scan after a year or be referred for further investigations.

A Research Nurse will contact you to discuss this part of the study and answer any questions you may have. If you would like to join the study, they will ask you some questions about your health to make sure that you are safe to have the FAST MRI scan. They will help you complete an online consent form and book you in for your scan at a time convenient to you. This will need to be between day 6 and 16 of your cycle if you are still having regular periods.

Please let the Research Nurse know if you are affected by any of the below as these things may prevent you having an MRI scan:

• If you are or may be pregnant or if you are breast feeding
• If you have ever had a penetrating eye injury
• If you have ever had brain surgery
• If you have a pacemaker or defibrillator
• If you have an implanted neurostimulator
• If you have a cochlear implant
• If you have ever had a shrapnel injury
• If you are claustrophobic
• If you have had conditions associated with your kidneys
• If you wear a sensor to measure your blood sugars (e.g. a “continuous glucose monitor”), this will need to be removed for the scan. We will try to arrange your scan around the time when you are due to change your sensor.

We encourage you to watch this video to see what it is like to have a FAST MRI scan. 

Your FAST MRI scan appointment will take up to 45 minutes.

When you arrive, the radiographer will ask some questions to confirm that it’s safe for you to have the scan and ask you to sign a standard safety checklist. 

You will be asked to change into a hospital gown. 

You will have a cannula (a small, soft plastic tube) placed into a vein in your arm. This is necessary so that the radiographer can inject dye during your scan, which makes a cancer show up clearly if it’s there. The injection of dye is not painful. 

The radiographer will explain what is going to happen during the scan, which we expect to take between 3 and 5 minutes.

Once you have had the scan and your cannula has been removed, you will be free to go. Your scans will be sent to specialists who look at them in detail and check the findings. This means we can’t give you the results on the day of your scan.  

We will let you know the results of your FAST MRI scan 3-4 weeks after your scan date. 

If your scan is clear, you will receive your scan results by letter. 

Some people with a clear FAST MRI scan may be invited to have another scan in a year's time. This is because their scan is most likely normal but we would like to see if it has changed over time, as we are still learning which appearances on FAST MRI we can confidently call “clear”. We expect that all the people invited to have this second scan will then have a clear result.

If your scan shows that further investigations are needed, a Research Nurse will contact you by telephone to explain the results and what will happen next. The Research Nurse will arrange an appointment at the Breast Care Clinic. Appointments are usually offered within about 2 weeks of referral. This does not necessarily mean that you have a breast cancer, just that you need to have additional tests. You will receive a letter confirming the FAST MRI scan results.   

At these appointments a healthcare professional will look at your mammogram and FAST MRI scan results and will ask for more tests to be done, including another scan and possibly a biopsy. If you have a biopsy, we may ask you if we can collect an extra sample to donate to a tissue bank to help support future research. Information about this option will only be sent to you if you need further investigations following your FAST MRI.

They may also discuss your case with a team of other professionals after your appointment to help decide if more investigations are needed, which could include deciding to perform a full MRI. If you do need further tests, your care team will explain why each test is important and what having the test would involve for you. Any extra tests you may have will help the team decide if what was seen on the FAST MRI is a cancer or not.

We expect that if 100 people have a FAST MRI scan, 5 of those people will be called back for further investigations. Of those 5 people, we expect that only around 1 participant will be diagnosed with a cancer.

Taking part in the FAST MRI DYAMOND Study gives you access to a new test (a FAST MRI scan).

We do not know if your FAST MRI scan will pick up a cancer that was not found on your first mammogram. If it does, it is possible that you will have a better outcome, because the cancer will have been found earlier than it would have been if you had not taken part in the study. 

By taking part in this important study, you will be making a difference by helping us plan more research to improve breast screening for everyone in the future.

We expect that the potential advantages of taking part will outweigh any disadvantages or risks.

Having an MRI scan is painless, and it’s one of the safest medical procedures available, but there are some risks. For example, there are increased risks to people with certain implants or foreign bodies. The Research Nurse and Radiographer will ask you questions about your medical history to check that you can have the scan. 

Some patients occasionally experience a tingling sensation or feel hot from being in the MRI scanner. These effects only last a short while and should ease as soon as the scan is over.

The scan involves having an injection of dye which is used to highlight any cancer cells (if a cancer is there). The risks associated with this injection are small and are well known: 

• About 1 in every 100 people may have a mild reaction to this dye (such as pain at the injection site, nausea or headache)
• About 1 in 1000 people may experience vomiting and/or an itchy rash   
• A more severe allergic rection is very rare, affecting about 1 in 10,000 people.  The radiographers who will be looking after you during your FAST MRI scan are trained to support individuals if this happens, and appropriate medical care will be given.  The dye is not recommended for people who are pregnant or breast feeding.
• Tiny amounts of dye can stay in the body for a long time after the scan but this has never been shown to cause any problems.   

If you take part in this study, you will have had mammograms, and some may have follow-up imaging and biopsy. These will be extra to those that you would have if you did not take part. These procedures use ionising radiation to form images of your body and provide your doctor with other clinical information. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. 

We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their life. The chances of this happening to you, as a consequence of taking part in this study, are up to 0.022 %, depending on the imaging required.

If you decide to take part in the study, we will let your GP know and we will tell them the results of your scan when they are available.

You will not be paid for taking part in the FAST MRI DYAMOND study but reasonable expenses (up to £10) to attend your FAST MRI scan will be covered. Your Research Nurse will give you this information.

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).

You should allow at least 1 hour 15 minutes for the test. You can eat and drink as normal before the test, but we would like you to come with your bladder comfortably full.

If you are currently taking any of the below tablets for your bladder symptoms you will need to stop taking these 7 days before your test unless you have been told otherwise:

• Vesicare/solifenacin.
• Regurin/trospium chloride.
• Detrusitol/tolterodine.
• Oxybutynin.
• Betmiga/mirabegron.

Please complete the three day bladder diary and the questionnaires sent with your appointment letter. You must bring both of them with you to the clinic.

Before the test, please let us know:

• If you have any allergies, especially to latex.
• If you have any problems with your mobility.
• If you feel you may have a urine infection. We are unable to perform urodynamics if you have a urine infection and have symptoms (for example foul-smelling urine or a burning sensation when you urinate).

If you are prone to urinary tract infections, please ensure you get your urine checked by your GP surgery five working days before the appointment so that it can be treated before your appointment.

What the urodynamics test involves

After you arrive, a healthcare professional will explain the test to you and ask some questions about the symptoms that you have been experiencing. You can ask any questions you have about the test.

You will then be asked to sign a consent form to make sure that you understand the procedure, the reasons why it is being done and any potential side effects.

In privacy, you will be asked to change and remove the lower half of your clothing (trousers/skirt/underwear). You will be given a hospital gown to change into and once you are on the couch you will be covered with a sheet.

The healthcare professional will also ask you to pass urine into a special toilet (flowmeter). This measures how fast the flow of your urine is and allows us to check you don’t have a urine infection.

After you have done this, the healthcare professional may examine you. This will include an internal examination, with a chaperone present.

During the test

You will be lying on a couch before one or two small tubes

(no more than 3mm in diameter) will be passed into your bladder. Another small tube will be placed into your rectum (back passage). If you do not have a rectum because you have had surgery and have a colostomy or stoma then that can be used, or the vagina can also be used as an alternative.

These tubes allow us to take measurements both inside and outside the bladder. You will then be asked to sit or stand and your bladder will be slowly filled with water through the tube until you feel full. If you are unable to sit or stand then you will remain lying down on the couch.

You will be asked to cough several times during the test to check the tubes are working. You will also be asked a series of questions such as your first desire to pass urine or whether you experience any urgency.

Once your bladder is comfortably full, one of the bladder tubes will be removed. The tube in your rectum and the very tiny tube in your bladder will be left in. You will then be asked to pass urine and the healthcare professionals will leave the room during this time.

After the test

You will be given time to get dressed in privacy after the test and the results will be explained to you. At this point, you will have the opportunity to ask any questions you may have.

A report will be written and a copy will be sent to your GP, the person who referred you, and yourself.

After the test, you may experience some discomfort where the tubes have been for a short time, but this should settle down. We suggest that you drink extra water during the 24 hours after the test to decrease the chances of you developing an infection.

Video urodynamics is similar to standard urodynamics (described above please read and follow the ‘before the test’ guidance above), however, we also take X-ray pictures of your bladder. Instead of using salt water to fill your bladder, we use an iodine-based fluid (this allows us to see your bladder on X-ray).

Before the test, please also let us know:

• If there is any possibility that you are pregnant as we are unable to perform the test if you are. We may also perform a pregnancy test on the day of your appointment.
• If you are allergic to Iodine.

What the urodynamics test involves

Unlike standard urodynamics, because we need to X-ray your bladder when you pass urine, we have to remain in the room. We are as discreet as possible and stay behind the curtains when possible.

NHS website

More information about COPD.

Chronic obstructive pulmonary disease (COPD) - NHS

Asthma and Lung UK

More information about COPD.

Chronic obstructive pulmonary disease (COPD) | Asthma + Lung UK

Right Breathe

Information about how to use your inhalers correctly.

RightBreathe

Support to stop smoking

Try the NHS Quit Smoking app, speak to your local pharmacy or GP, or find out about options for support in your area.

Quit smoking - Better Health - NHS

IAPT Talking Therapies

Get help with your mental health through NHS talking therapies.

NHS Talking Therapy | Vita Health Group

If you have any concerns about the service that the nurses or doctors cannot resolve, you can contact our Patient Advice and Liaison Service (PALS).

PALS offer support and assistance for patients and their families. You can also share positive comments with them about your care.

• Phone: 0117 414 4569 (09:00 to 16:00)
• Email: PALS@nbt.nhs.uk