Participant Information Sheet

IRAS Approval Reference: 367419

Welcome and thank you for considering taking part in UnityBC!

UnityBC is a new and important research study designed to collect information from women with breast cancer, with a focus on women from certain ethnic groups.

This Participant Information Sheet is designed to inform you about the research study, how we will collect and store information you provide us with and what we will do to protect that information throughout the lifecycle of this research study.

Before you decide whether to take part or not, it is important that you understand why the research is being done and what it would involve for you. Please take time to read this information, and discuss it with others if you wish.

If anything is not clear, or you would like more information, please contact the UnityBC team:

Email: unitybc@ndph.ox.ac.uk.

WHAT IS THE UNITYBC RESEARCH STUDY, AND WHY IS IT IMPORTANT?

Breast cancer is the most common cancer in women, yet outcomes are not the same for everyone. Around 50,000 women are diagnosed with breast cancer each year in UK, of which around 2150 women are from Asian backgrounds and 1300 women from Black backgrounds.

In the UK, women from minority ethnic backgrounds are diagnosed with breast cancer less often than white women but they generally have poorer outcomes. We want to find out why.

Other studies have shown that women from Asian and Black backgrounds are under-represented in health research, but the reasons why are not fully understood.

To improve breast cancer outcomes for all women, it is very important that women from all backgrounds have equal opportunity to take part in breast cancer research studies.

WHAT ARE THE AIMS OF UNITYBC?

The overall aim of UnityBC is to improve breast cancer outcomes for women, particularly those from different ethnic groups, through understanding variations in breast cancer care and outcomes.

To achieve this, we will collect information using an online questionnaire from women with breast cancer from all backgrounds, but we particularly want women from the five large ethnic groups in England to take part. These ethnic groups are Black African, Black Caribbean, Indian, Pakistani and White British.

We will test different ways to make women aware of the opportunity to take part, as we want to make taking part in a research study a straightforward and positive experience for women from different ethnic backgrounds.

We want UnityBC to become a large, inclusive research study that helps improve breast cancer care and outcomes for all women.

CAN I TAKE PART?

You can take part if you are a woman aged 18 years or over, living in the UK, who has been diagnosed with breast cancer in the last 13 months.

We particularly want to encourage women from Black African, Black Caribbean, Indian and Pakistani backgrounds to take part because they are underrepresented in breast cancer studies. If you are a member of these communities, taking part will help the study and may improve breast cancer outcomes in the future by increasing our understanding of the variations in breast cancer.

DO I HAVE TO TAKE PART?

No, taking part is entirely voluntary.

If you decide to take part and change your mind at any time, you can withdraw from UnityBC. You won’t have to give a reason why you’ve decided to withdraw. To withdraw, please email unitybc@ndph.ox.ac.uk from the email you used to register.

If you withdraw from UnityBC, unless you state otherwise, any data you have provided up to that point will still be stored for future research as detailed in this participant information sheet. If you do not want your data to be stored, you are free to request that it is deleted.

WHAT WILL HAPPEN TO ME IF I DECIDE TO TAKE PART?

If you take part in UnityBC, your normal medical care will not be affected, and you will not need to attend any extra medical appointments.

• Taking part in UnityBC means providing consent and completing the online questionnaire.
• To take part in UnityBC, you must have access to the internet via a smartphone or tablet or computer and an active email account.
• If you do not have direct access to the internet or a device, you can ask a family member or friend, who has access, to help you enter your information.
• We need you to have access to an email address because the study team will email you to confirm your participation and provide with your study participation number.
• We need you to have access to the internet because the questionnaire can only be done online.

ONLINE CONSENT FORM

To take part in UnityBC you will complete an online consent form. Six of the consent questions are compulsory and you need to agree to them to take part in UnityBC.

There are further optional consent questions which you can choose to accept or not. You will be asked if:

• The research team can contact you again by email to share study updates and you agree to providing relevant contact information to do so.
• The research team can contact you again by email to tell you about opportunities to participate in related but different studies and you agree to providing relevant contact information to do so. Contact about any related but different studies will only come from the UnityBC research team in the first instance. Agreeing to be contacted does not oblige you to take part in future research. You would also be able to withdraw from email recontact at any time.
• You are happy to share your medical reports summarising your diagnosis and treatment with us yourself by scanning and uploading them to the UnityBC database. You can still sign-up and complete the UnityBC questionnaire without agreeing to upload copies of your reports. You can remove your name, date of birth, NHS number and any other personal identifiers prior to uploading the documents.

After you have completed and signed the consent form you will be able to download a copy for your records.

ONLINE QUESTIONNAIRE

After you have given your consent, you will be able to complete the online questionnaire.

The questionnaire consists of 9 sections which cover a range of topics including information about you, your family background and your health, including your recent breast cancer diagnosis and treatment, and your views on taking part in research.

The questionnaire should take about 30-40 minutes to complete, and no more than 60 minutes in total. It can be completed on any computer, tablet or smartphone. Please give yourself enough time to complete the questionnaire in one sitting, however if needed you can save your progress and return later.

The questionnaire has been developed with individuals who have lived experience of breast cancer and members of the public. This is to help ensure that the questions being asked in UnityBC are relevant, easy to understand, and acceptable.

ARE THERE ANY POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART?

UnityBC does not involve any procedures or tests and so the risks of taking part are minimal.

We recognise that answering questions about a recent breast cancer diagnosis may be a little upsetting and we provide links on our website to relevant support services.

If you do not wish to continue you may withdraw at any point for any reason, by contacting the research team (details below) and asking to withdraw your submission based on the email address you submitted.

Your participation in UnityBC will not exclude you from participating in any other breast cancer research studies.

WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART?

We do not know what the results of our research will be and you may not directly benefit from taking part in UnityBC but you will become part of a research community.

The information we gather from you may benefit other women with breast cancer in the future by improving understanding of variations in breast cancer care and outcomes.

WILL MY TAKING PART IN THE STUDY BE KEPT CONFIDENTIAL?

Yes. When you register to UnityBC and agree to participate, our database will generate a code that is unique to you. All records of your consent, registration, questionnaire responses, and any other information you provide will only ever be labelled by your unique code and never by identifiable information such as your name.

Information that could identify you will only be held securely on trusted research servers monitored directly by the UnityBC team based at the University of Oxford. Identifiable information relating to you will only ever be used for the purposes of UnityBC and will never be shared.

Further information about how your personal data is used is provided in the “What will happen to my data” section.

WHAT WILL HAPPEN TO MY DATA?

Data protection legislation requires that we, the University of Oxford (whose legal name is The Chancellor Masters and Scholars of the University of Oxford), state the legal basis for processing information about you. In the case of research, this is a ‘task in the public interest’. The University of Oxford is the sponsor for this study and is responsible for looking after your information and using it properly.

We will need to use information from you collected on the UnityBC questionnaire for this research project. We will share your information related to this research project with the following types of organisations such as responsible members of the University of Oxford and relevant regulatory bodies.

We may use third party service providers or subcontractors to help with some of the research activities we carry out (e.g. IT provision, survey provision, transcription services etc.). We may therefore share your personal data with these providers when it is necessary to do so to allow them to carry out the services we require them to provide. However, we require all our third-party providers to have appropriate security measures in place to protect your data and we only allow them to process your data for the specific purposes we have stated in our instructions.

 This information will include your:

• Name
• Email address 

People will use this information to do the research or to check your records to make sure that the research is being done properly. Responsible members of the University of Oxford, [and] regulatory authorities [and the relevant NHS Trust(s)] may be given access to data for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations.

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 by:

• Strict adherence to the UK GDPR regulations
• Storing information on secure servers within the UK
• Ensuring that access to the data is only available to authorised members of the UnityBC study team

International Transfers

Your personal data will not be shared outside the UK.

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.

After the study ends, the retention period (this means the length of time we keep your data for) will begin and we will keep your data for a minimum of 5 years in line with the University Policy on Management of Data. Once the retention period has finished, the study data will be kept in a way that does not identify you.

What are your choices about how your information is used?

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, including the specific mechanism used by us when transferring your personal data out of the UK by:

• Asking one of the research team by emailing unitybc@ndph.ox.ac.uk
• Sending an email to unitybc@ndph.ox.ac.uk
• Calling us on 01865 289390 · contacting the University’s Data Protection Officer data.protection@admin.ox.ac.uk
• Looking at the University’s privacy notice available at: https://compliance.admin.ox.ac.uk/research-data.

If you would like to find out more about the use of confidential data in research, the HRA has developed a general information leaflet which is available at: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/template-wording-for-generic-information-document/.

HOW HAVE PATIENTS AND THE PUBLIC BEEN INVOLVED IN UNITYBC?

The UnityBC study is supported by a dedicated Ethnicity and Breast Cancer Patient and Public Involvement Group. This group is hosted by the Cancer Epidemiology Unit and the Oxford Cancer Centre.

Members of this group were involved in reviewing the participant materials and questionnaires and will continue to be involved in the study.

WHAT WILL HAPPEN TO THE RESULTS OF THIS STUDY?

The results will be published in scientific journals once data collection and analysis are complete. UnityBC participants will not be identifiable from any publication in the public domain. UnityBC researchers will publish in journals that are “open access” meaning that the journals do not require payment for access to the papers and therefore anyone can access those papers.

Summaries of these papers will be made available to participants, community groups and anyone else who might be interested, online via the UnityBC website. The summaries will be written in as accessible language as possible so that people who are not scientists or medically trained can understand them.

We also make social media posts to communicate our main findings to our communities of interest.

The results will also be presented by researchers at conferences internationally. We aim to present findings at events attended by participants, breast cancer patients and survivors.

WHO IS ORGANISING AND FUNDING UNITYBC?

The University of Oxford is the research Sponsor. This means the University of Oxford is legally responsible for organisation and for overseeing the work of the researchers.

UnityBC is funded by Cancer Research UK.

The Chief Investigator responsible for leading UnityBC is Associate Professor Toral Gathani at the University of Oxford.

UnityBC is managed by the research team based in the Cancer Epidemiology Unit, Nuffield Department of Population Health.

WHAT IF THERE IS A PROBLEM?

If you wish to complain about any aspect of the way in which you have been approached or how your information is handled during the course of this study, you should contact the UnityBC team using these contact details Associate Professor Toral Gathani unitybc@ndph.ox.ac.uk and they will do their best to answer your questions.

Or you may contact University of Oxford Research Governance, Ethics & Assurance (RGEA) at rgea.complaints@admin.ox.ac.uk.

The investigators recognise the important contribution that volunteers make to medical research, and will make every effort to ensure your safety and wellbeing. The University of Oxford, as the research sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your taking part in this study. If something does go wrong, you are harmed during the research, and this is due to someone's negligence, then you may have grounds for a legal action for compensation. While the Sponsor will cooperate with any claim, you may wish to seek independent legal advice to ensure that you are properly represented in pursuing any complaint.

WHO HAS REVIEWED THE STUDY?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect participants’ interests. This study has been reviewed and given a favourable opinion by North West - Liverpool Central Research Ethics Committee [26/NW/0128].

The principles of the study were reviewed by scientific experts on behalf of Cancer Research UK before awarding funding.

PARTICIPATION IN FUTURE RESEARCH:

We will seek consent from you to approach you about other research in future. Please note that:

• All contact will come from the research team of UnityBC in the first instance
• Agreeing to be contacted does not oblige you to take part in future research
• You can request to be removed from this register at any time they wish.

FURTHER INFORMATION AND CONTACT DETAILS

If you have any questions, please contact the UnityBC team at unitybc@ndph.ox.ac.uk or in writing to the UnityBC Team, Cancer Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Oxford OX3 7LF.

Thank you for your interest in this study. Our aim is to make your participation a worthwhile experience, while helping us and others to improve outcomes for women with breast cancer.

UnityBC Participant Information Sheet, Version 1.0, April 8 2026.