This section is about how we store and how we use the data that we hold for the study. If you have any questions on the information given in this section please do not hesitate to contact the study team on firstname.lastname@example.org or you can ring us on 0117 342 9531.
University Hospitals Bristol and Weston is the sponsor for this study based in the United Kingdom.
We use information from you and your medical records in order to undertake this study. University Hospitals Bristol and Weston work closely with the University of Bristol on this study and both University Hospitals Bristol and Weston and the University of Bristol will act as joint data controllers and joint data processors for this study. This means that both organisations are responsible for looking after your information and using it properly. Staff from both organisations work with the study data but any information containing your name and NHS number is kept at University Hospitals Bristol and Weston. Information on how to contact the Data Protection Officers from both organisations is listed below.
The Head and Neck 5000 study will keep identifiable information about you until 31/12/2024.
The lawful basis under which we process your personal information for the Head & Neck 5000 study is General Data Protection Regulation (GDPR) Article 6(1)(e) and Article 0(2)(j). This allows for the porcessing of personal data for the purposes of medical research.
As an NHS organisation University Hospitals Bristol and Weston use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
If you wish to raise a complaint on how we have handled your personal data, you can contact the study team or our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
Further information can be found by contacting the study team on email@example.com or you can ring us on 0117 342 9531.
Details of the University Hospitals Bristol and Weston Data Protection Officer can be found here: http://www.uhbw.nhs.uk/about-us/privacy/
Details of the University of Bristol Data Protection Officer can be found here: https://bristol.ac.uk/secretary/data-protection/gdpr/data-protection-officer/
You can also find information on the use of patient data in research on the Health Regulatory Authority website at https://www.hra.nhs.uk/information-about-patients/
The questionnaires and the information collected from the medical notes are identified by your study number and your initials. The questionnaires and data collection forms are kept in a locked office on a corridor that can only be accessed by hospital staff.
Your consent form, which contains your full name, date of birth and your NHS number, is kept separately in a locked cabinet in a locked room at University Hospitals Bristol and Weston. The cabinet where the consent forms are held can only be accessed by three members of the research team.
The questionnaire and medical records data that we receive are entered in to our study database where each record is identified by your study number and your initials. Your name and address is kept so that we can send out the study questionnaires and contact you with updates on the study. We keep your name and address on a separate database to the one that holds the study data.
Access to all of our databases is limited to a small number of study staff. All databases are password protected and held in a restricted access folder on the University Hospitals Bristol and Weston NHS server. Identifiable data will be held until 31st December 2024.
Sharing and processing of data
When you agree to take part in a research study such as Head and Neck 5000, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
Linkage to NHS digital and other organisations
We would like to update our statements in the consent material about the sharing and processing of your personal data and the role of NHS Digital (previously the NHS Information Centre) and the Central Register in the study.
If you consented to linkage with national databases, your NHS Number, initials and date of birth have been sent to NHS Digital through their secure upload system to enable your records to be flagged on the NHS Digital system. NHS Digital provide updates to the study relating to your health status which includes your NHS number, notification if you die, and if you died, the recorded cause and date of death. The data returned to us includes civil registration data supplied by NHS Digital on behalf of the Office for National Statistics. This information updates the data held by the study; it ensures that members of the study are not contacted inappropriately, and the data is used for the study research.
Participants to Head & Neck 5000 can opt out of the linkage to NHS digital if they wish to do so. Opting out will not affect your healthcare. If you opt out of the linkage to NHS digital you can still remain in the study for data collection from the medical notes and / or questionnaires. If you would like to opt out of any aspect of this study please contact the study team on firstname.lastname@example.org or you can ring us on 0117 342 9531.
Automated decision-making and profiling
Automated decision-making is the process of making a decision by automated means without any human involvement. Profiling is a way of analysing aspects of an individual's personality, behaviour, interests and habits to make predictions or decisions about them. In the Head and Neck 5000 study we do not use automated decision-making or profiling. We do not link the data that we collect back to individual identifiable data, and we do not analyse or report our findings at individual level.