The makers of medicines must ask the government for a ‘Marketing Authorisation’ or ‘Product Licence’ if they want to sell their medicines in the UK. They show evidence to the government’s Medicines and Healthcare products Regulatory Agency (MHRA) that their medicine works for the illness to be treated, does not have too many side effects or risks, and has been made to a high standard.

To be sure that a medicine works and is safe the maker must try it first on a small number of people in what is called a ‘clinical trial’. Information from clinical trials is given to the MHRA when the maker asks for a Product  in the UK.

Due to stock shortages in the UK, we may need to buy your medicine from another country. The medicines we buy are licensed in the country we buy them from, but do not have a license in the UK. This makes them unlicensed in the UK. 

The hospital pharmacy will ensure that the unlicensed medicine has been made to a good standard and is safe for you to take.

If you are still worried after reading this information, please talk to your specialist team. They are looking after you and have thought carefully about the best medicine for you. 

Please talk to your specialist team and tell them what you are worried about. They can give you more information about the medicine. They can also tell you if there are other treatments that might be available and why they think this unlicensed medicine is the best one for you.

All medicines come with a leaflet inside the box (a “Patient Information Leaflet”) which explains about the medicine, including how to take it and what side effects might happen. For some unlicensed medicines the information in the box may be in a different language. If this is the case with your medicine, we will give you a separate leaflet with this information in English.

If you have questions after reading this information, please talk to your specialist team.

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 your local 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.

If you are eligible to proceed to the next stage of the trial you will receive an email from the study team with a link to the online consent form. 

Please contact FASTMRI@nbt.nhs.uk if you have any queries.

In this study we will use information from you and from your medical records. We will only use information that we need for the research study. We will let very few DYAMOND team members know your name or contact details, and only if they really need it for this study. This includes research staff at Royal Surrey Hospital who are providing the Consent Form website. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules.  At the end of the study, we will save some of the data for up to 5 years after the study closes, in case we need to check it and for future research (if you have given us permission). We will make sure no-one can work out who you are from the reports we write. Please contact us on the details below for more information about this. 

This study is run by Dr Lyn Jones (Consultant Radiologist) at the FAST MRI Programme Team at North Bristol NHS Trust and a Consultant Radiologist at your local Hospital.

If you agree to take part, we will use information we collect from you and your medical records. We will only collect information that we need for the research, and only people who need to contact you or to check your records will have access to your name and contact details.

North Bristol NHS Trust are the study Sponsors and have overall responsibility for making sure that your information is looked after correctly.

All information we collect about you for this research will be kept securely throughout the study. It will not be accessed by anyone outside the research team which includes your local Research Team, and researchers from North Bristol NHS Trust, Royal Surrey NHS Foundation Trust, and Warwick Clinical Trials Unit. 

When the study has ended, we will do a final check of all the information we have for you and anonymise it all. We may use your anonymised data to inform future research.

Your information will be stored for a period of 5 years. 

We expect to publish the results and some images in academic journals. It will not be possible to identify you from any of the results or images that we publish. 

To help with any future investigations or treatment you may need, a copy of your FAST MRI scan images and results will be added to your screening records and medical notes. 

In the unlikely event that something does go wrong, and you are harmed during the research study there are no special compensation arrangements. If you are harmed and this is due to someone’s negligence, then you may have grounds for a legal action for compensation against North Bristol NHS Trust but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.’

In the unlikely event that you feel that you have been adversely affected by participating in this study, you should contact the research team as soon as possible. The team will arrange to meet you as soon as possible to discuss your concerns. Please visit www.nbt.nhs.uk/patients-carers/feedback for further information about how to make a complaint or contact the North Bristol NHS Trust Hospital Patient Advice and Liaison Service (PALS) on 0117 4144569. PALS can also provide confidential advice and support to patients, families, and their carers. 

If you do not want to discuss your concerns with the research staff or their manager, or if you have tried this and are still unhappy, you can contact the Advice & Complaints Team (ACT) at Southmead Hospital. 

The ACT address is:

Advice & Complaints Team, Beaufort House, Beaufort Way, Southmead Hospital, Bristol, BS10 5NB

Tel: 0117 4144569 or 0117 4144568 or 0117 4144572

Fax: 0117 4144572 

Email: complaints@nbt.nhs.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 have already collected up to the point of your withdrawal.
• If you choose to stop taking part in the study, we would like to continue collecting information about your health from central NHS records and your hospital. If you do not want this to happen, tell us and we will stop.
• We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
• If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. 

You can find out more about how we use your information: 

• at www.hra.nhs.uk/information-about-patients/
• by asking one of the research team
• by sending an email to Helen Williamson (Helen.Williamson2@nbt.nhs.uk), or
• by ringing us on 0117 419330.

The results from the study will be published in academic journals and at international conferences. It is also important to us that members of the public and people who have taken part in this study have access to the results, therefore summaries of the results will be published on the FAST MRI website https://www.nbt.nhs.uk/FASTMRI and on social media.  At any point you can contact the research office  to find out the status of the study and any results which may have come through

The study has been funded by a grant from the Efficacy and Mechanism Evaluation funding stream, which is a partnership between the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR). The grant is overseen by North Bristol NHS Trust.

Throughout the development of the study we have listened to members of the public, NHS Breast Screening Programme clients, and to people who have been diagnosed with breast cancer. 

Women from various backgrounds have reviewed our study design and the study documents, such as this one, to make sure they are clear and can be easily understood. 

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This research study has been given a Favourable Ethical Opinion by the Yorkshire & The Humber (Sheffield) Research Ethics Committee. 

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.