Frequently Asked Questions
Privacy and Confidentiality
Maintaining the 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. Consequently, 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. Between 2011 and 2014 we recruited 5,511 people across the UK with 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, Lower Maudlin Street, Bristol, BS1 2LY.
Who is funding the study?
The Head and Neck 5000 study was funded by the UK National Institute for Health Research. The H&N5000 Follow-up Study was financed from three seperate 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
Who has reviewed the study?
This study has been reviewed by 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. The committee is satisfied that your rights are being respected and you have been given enough appropriate information to make an informed decision on whether to participate or not.
What does participation in the study involve?
Participation in this study required you to complete a series of confidential questionnaires, which included questions about your previous medical history, lifestyle, diet, family and mood.
You were asked to complete questionnaires at diagnosis, 4 months later and again 12 months later.
Samples of your blood and saliva were collected at one of your initial clinic appointments. We also asked your permission to obtain any excess tissue samples from the pathologist who diagnosed your cancer.
We also asked you to complete a further questionnaire at 3 – 5 years after consent to Head & Neck 5000.
Where we have your 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 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 (your full name, address, your consent form, etc.) is stored separately from the samples and information you provide.
- Access to this 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?
After we have finished this particular study, we will keep the information and 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 click here to contact the research team on firstname.lastname@example.org or you can ring us on 0117 342 9531.
The Head & Neck 5000 study was approved by Frenchay Hospital Research Ethics Committee. The H&N5000 Follow-up Study has been approved by the HSC RECC B (Office for Research Ethics Committees Northern Ireland). 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.
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?
We successfully created a clinical cohort of over 5,000 people with head & neck cancer that we are now following up. We described the centralised multi-disciplinary head and neck cancer service in the UK. However, preliminary analysis suggests 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. We have established a resource for head and neck cancer research and the information gathered from the study is making an important contribution to research in to the cause, development and outcome of head and neck cancer.
How long will my data be kept?
Data will be kept until 31st December 2024.