Frequently Asked Questions
Privacy and Confidentiality
Maintaining participant's confidentiality in the study is a priority. All participant information will be handled in strict confidence in accordance with ethical and legal practice. Only authorised study staff will have access to the personal data. All participants who take part in the study will be allocated a unique identifier number that will be used when collecting and linking data, and no data will be published in such a way that an individual could be identified. Participation in this study is entirely voluntary and participants may withdraw at any time, even after they have agreed to take part.
What was the initial purpose of the study?
Within the United Kingdom head and neck cancer services have been centralised to a smaller number of larger centres. This has implications for both users and service providers. It is therefore crucial that practice within these cost-intensive services is both clinically effective and cost effective in order to ensure that people are receiving the best quality care and that NHS resources are being used efficiently. The primary aim of the Head and Neck 5000 study was to evaluate the effectiveness of centralisation in head and neck cancer.
Who is conducting the study?
This study is being conducted by University Hospitals Bristol and Weston and the Bristol Dental School, University of Bristol.
Who is funding the study?
The Head and Neck 5000 study was originally funded by a grant from the UK National Institute for Health Research.
The H&N5000 Follow-up Study was financed from three separate sources:
• Funding transferred to us from a Cancer Research UK grant awarded to Professor Richard Martin who is working with us on some of the follow-up study data
• Funding awarded to us by the Research and Innovation Department at UHBW
• Funding from Professor Ness’ NIHR Senior Investigator Award
The 10 year Follow-up questionnaire is being funded by a grant from Cancer Research UK.
Who has reviewed the study?
This study has been reviewed by clinical staff, academic scientists and the study team has worked closely with people with head and neck cancer.
A National Health Services Research Ethics Committee has approved the study; this is an independent panel that includes scientists, clinicians, patients and carers. Ethics committees ensure that studies are performed to the highest scientific standard and in such a manner that the privacy, sensitivities and rights of each person participating in research are protected.
What does participation in the study involve?
Participation in the study involves completing a series of confidential questionnaires, which include questions about your previous medical history, lifestyle, diet, family and mood.
Samples of blood and saliva were collected at one of the initial clinic appointments. We also asked participants permission to obtain any excess tissue samples from the pathology department at the hospital where diagnosis and treatment took place.
Where we have participants permission, we also access data from health-related records including disease registries. As a part of the study, the researchers also obtain information on the date and circumstances surrounding death for any participants who pass away during the years in which the project is ongoing.
How will my privacy be protected?
- All questionnaires and samples are labelled with a unique study number. Your name, hospital number, NHS number or other identifiable information is not used.
- Data and samples are stored securely in locked cabinets and rooms.
- Any identifying information such as your full name, address, NHS number, is stored separately from the samples and from the data collected.
- Access to identifying information is restricted to a small number of members of the study team, who have signed agreements to protect your privacy and confidentiality.
- No information that could be used to identify you or your family will be included in any report on the results of the study.
What happens to the information and blood samples?
The information and samples collected for the study are used in head and neck cancer research. When this study ends we may apply to keep the information and any remaining samples that you have given us for an indefinite period so that they can be used by researchers in the future. If you would like to read more about how we store and process your information please see the ‘How we use your data’ section.
What will happen to the results of the research study?
The results of the study will be published in medical journals, presented at medical conferences and will be made available to head & neck patient groups and charities. Study results will also be posted on this website.
Who do I contact if I have more questions or a complaint about the study?
If you have any questions about the study please contact the research team on firstname.lastname@example.org or you can ring us on 0117 342 9531.
If you are unhappy about the study and feel that the research team have not answered your questions and you wish to complain formally, you can do this through the NHS complaints procedure. As the study is run from University Hospitals Bristol and Weston NHS Foundation Trust please e-mail email@example.com or telephone 0117 342 1050 mentioning the study name.
Can I withdraw from the study once it has started?
You may withdraw from the study at any time. If you wish to withdraw from the study please contact the research team on firstname.lastname@example.org or you can ring us on 0117 342 9531.
What is the current purpose of the study?
The initial aim of the study was to evaluate the outcome of the centralisation of head & neck cancer treatment. We found that there is little variation between centres, so we are unlikely to be able to evaluate the impact that centralisation has had on how well people do after their treatment.
The study also looks at:
- quality of life for people with head and neck cancer
- treatments and outcomes across different centres
- the individual economic cost of head and neck cancer
- factors that influence survival in head and neck cancer
We are also creating a resource for researchers in head and neck cancer.
How long will my data be kept?
Data and samples will be kept until 31st March 2026.