Frequently Asked Questions

Privacy and Confidentiality

What is the purpose of the study?

Who is conducting the study?

Who is funding the study?

Who has reviewed the study?

What does participation in the study involve?

How will my privacy be protected?

What happens to the information and blood samples?

What will happen to the results of the research study?

Who do I contact if I have more questions or a complaint about the study?

Can I withdraw from the study once it has started?


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 data. All participants who take part in the study will be issued a unique identifier number that will be used when collecting 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 is the purpose of the study?

Within the United Kingdom head and neck cancer services are being 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. Therefore, the aim of the Head and Neck 5000 study is to evaluate the effectiveness of centralisation in head and neck cancer. As part of the study, we have recruited 5,511 people across the UK with head and neck cancer over a period of at least 2 years. We are comparing morbidity, mortality and quality of life outcomes across different centres and describing the individual economic cost of head and neck cancer care. The study also aims to identify prognostic indicators for head and neck cancer.

Who is conducting the study?

This study is being conducted by University Hospitals Bristol and the School of Oral and Dental Sciences, University of Bristol, Bristol Dental Hospital, Lower Maudlin Street, Bristol, BS1 2LY.

Who is funding the study?

The project has been funded by the UK National Institute for Health Research.

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. Questionnaires were completed 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.

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 give us for an indefinite period so that they can be used by researchers in the future.

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. The study has been funded by the UK National Institute for Health Research and approved by Frenchay Hospital Research Ethics Committee. 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 has not answered your questions and you wish to complain formally, you can do this to NHS complaints procedure

Can I withdraw from the study once it has started?

You may withdraw from the study at any time. If you have agreed to participate and have completed the questionnaires, you can still change your mind later. Just contact us and we will destroy the data from your questionnaire and any of your samples