Patient Information - Fair Processing Information (Privacy Statement)

This information is important for anyone who has agreed for their data and samples to be used for research studies that have been approved HCV Research UK. It also describes how anyone can withdraw their consent for being included in any research studies.

How We Use Your Information

What we do

HCV Research UK is a consortium of doctors and scientists who have formed a project to study what happens to individuals infected with hepatitis C virus in the UK.  Approximately 12,000 individuals have signed a consent form to join this Research Project.  This allows us to collect data so that we can study how individuals contracted the infection, how long they’ve had it, their health complications as a result of the infection (including liver disease), and the treatments they have received to clear the infection.  If you have signed the consent form to join our study, we can say that we take the collection and use of your personal information very seriously.  Any personal information we hold is processed in accordance with the requirements of the EU General Data Protection Regulation 2016 (GDPR).

Fair Processing Notice

This Fair Processing Notice (or sometimes called Privacy Notice) tells you about the information we collect and hold about you, what we do with it, how we will look after it and who we might share it with.  It also explains the choices you can make about the way in which your information is used and how you can opt-out of any part of the study if you wish.  It covers information we collect directly from you or collect indirectly from other individuals or organisations for the HCV Research UK study.  This notice is not exhaustive. However, we are happy to provide any additional information or explanation needed. Contact details can be found below.

Can I withdraw from the study?

YES - You can withdraw at any time.  If you withdraw your consent (or you lose the ability to give consent), we will stop collecting information from you and you will not be asked for any more blood.  Any information or stored samples already collected will continue to be used unless you or your family specifically request that they are destroyed.  If you would like to withdraw, you are free to do so without giving a reason by doing either of the following:

  1. Contact the doctor or nurse either at the hospital where you were originally recruited or at the hospital where you are currently being cared for and let them know.  We have included a list of Hospitals which recruited individuals into HCV Research UK here.

  2. Contact a member of the HCV Research UK Project Co-ordinating team

What happens to the information collected about me?

We are collecting information on individuals so that we can learn more about hepatitis C virus infection.  The information we need for the study is gathered either at your standard clinic visits by asking you directly or by taking it from your clinical records.  The staff at the hospital where you enrolled into the study, complete forms with this information and then enter it onto our central database.  On enrolment into the study cohort, you are allocated a unique Study Number specific to you and the information or ‘data’ collected about you is entered under that Study Number. Your name or address is not stored in our database, however, other bits of personal information are. These are listed below:

  • NHS Number (in England and Wales) or CHI Number (in Scotland)

  • Initials (first & last)

  • ‘Soundex’ of surname. This is a method of indexing names using letters and numbers.  It is used in censuses (for example) as a way of grouping similar surnames together.  This can help in population studies but means we do not know what your actual surname is

  • Date of Birth

  • First part of post code (eg LE12, NG7 etc) so that we know the broad area where our study participants have come from

  • Gender, Ethnicity & Country of Birth.

Research

The data you provide to HCV Research UK is stored and made available to both academic and commercial groups for present and future research purposes. The time it is stored will be as long as it is suitable for use and could be as much as 10 years or longer.

In order to carry out research into hepatitis C virus infection and liver disease, researchers anywhere in the world can apply to HCV Research UK for data held within the HCV Research UK Database.  Each application is reviewed by a Tissue and Data Access Committee (TDAC) for ethics and suitability.  The members of the TDAC are recruited from a wide range of backgrounds including Patient Representatives and Scientific Experts.  If the application is approved, The Data Processors provide the data to the researchers under strict conditions and the researchers sign an agreement to ensure the data is only used for the specific purpose of the study they wish to carry out.

To date, there have been over 100 applications for data and samples approved through this TDAC. These applications have been received from a range of organisations including universities, pharmaceutical companies and commercial diagnostic and research organisations. There is a list of the research projects which have been approved in the Approved Research Studies section of this website. The Publications section provides a summary of findings that have been written up in specialist research journals.

STOP-HCV Cirrhosis Study

One project currently underway is a 5-year study investigating whether:

  • there are new (or existing) diagnostic tests which, when measured repeatedly over time, could be used to predict which individuals with HCV cirrhosis progress to specific symptoms (including fluid in the abdomen, confusion and bleeding) that indicate the development of more severe disease within 5 years of follow up.

  • the new HCV therapies change long-term outcomes in addition to curing the infection.

  • other co-morbidities associated with HCV-cirrhosis (especially alcohol and diabetes) are linked to other worsening conditions such as cardiovascular disease.

Approximately 1200 individuals have signed an additional consent form to join this study called ‘STOP-HCV: Prognostic biomarkers in HCV cirrhosis’. As part of the study, researchers are collecting information from individuals about their liver disease (results of liver scans or investigations, alcohol questionnaire and any treatments they receive), and will combine this with information from NHS Digital and ONS (see below) to provide a more detailed dataset for use in the analysis. The data from NHS Digital and ONS will be retained for at least 2 years after the end of the study to enable analysis and publication of the findings.

Who has access to the information you have collected about me?

Data Controller and Data Protection Policy

It is the Data Controllers’ responsibility to ensure that the information from HCV Research UK is collected, stored, and processed under strict conditions and in line with the law.  The legal basis for processing this data is Public Task.

The role of Data Controller for HCV Research UK is shared across two organisations - Nottingham University Hospitals NHS Trust R&I Department and University of Glasgow.

Nottingham University Hospitals NHS Trust (NUH) is the Clinical Sponsor for HCV Research UK. As an NHS organisation, they use personally-identifiable information to conduct research to improve health, care and services. As a publicly funded organisation, they have to ensure that it is in the public interest when personally-identifiable information is used 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 NUH have to demonstrate that their research serves the interest of society as a whole. They do this by following the UK Policy Framework for Health and Social Care Research.

If you wish to raise a complaint on how your personal data has been handled, you can contact the Data Protection Officer who will investigate the matter. If you are not satisfied with the 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).

For more information about Nottingham University Hospitals NHS Trust Data Protection Policy and Sponsor Statement, please visit their website here.  There is also more general information for individuals involved in research on the Health Research Authority (HRA) website here.

The contact details for the Data Protection Officer at University of Glasgow and NUH are as follows:

University of Glasgow:

Data Protection Office, Gilbert Scott Building, University of Glasgow, Glasgow, G12 8QQ. Email address: dp@gla.ac.uk

Web address: https://www.gla.ac.uk/myglasgow/dpfoioffice/

Nottingham University Hospitals NHS Trust:

Data Protection Office, QMC, Derby Road, Nottingham, NG7 2UH. Tel: 0115 924 9924 ext 63975.

Email address: DPO@nuh.nhs.uk

They have agreements in place with two other organisations to process the information collected – The Data Processors.

Data Processor

University of Nottingham, Asckey Data Services Ltd and University of Glasgow process the information that is collected on behalf of HCV Research UK.

Access to your information is limited in a number of ways:

Local Hospital Staff

Doctors and nurses involved in your care, as well as members of your local hospital research team have access to all of the information collected during the study including your name, address and other contact details. This is important so that they can contact you at any time throughout the study if needed.

Database Administrators

The company who runs the database on behalf of HCV Research UK is Asckey Data Services Ltd.  The database is held in a secure location under the same conditions that other NHS organisations hold data.  The Data Co-ordinator who works at the University of Nottingham also has full access to the database and the data within it, while the biobank staff who work at the MRC-University of Glasgow Centre for Virus Research have very limited access. None of the above have access to your name, address or contact details, but do have access to other personal information as listed above.  However, they are bound by the same confidentiality principles as NHS staff.

Other NHS organisations

In order to help us gather accurate data about your HCV infection, treatments and health complications as a result of the infection we use your NHS (England & Wales) or CHI number (Scotland) and Date of Birth to link with NHS Digital, the Office for National Statistics (ONS) and/or the Public Benefit and Privacy Panel for Health and Social Care (Scotland). NHS Digital and/or PBPP Scotland will provide notifications of any hospital visits you make including the date of attendance, the length of stay and the reason(s).  It will also include results of any imaging investigations you have such as MRI scans, X-rays etc.  ONS will provide mortality data (date and cause) if applicable.

Researchers

Researchers may come from academic institutions (eg universities) or commercial industry such as pharmaceutical companies either within or outside the UK. Researchers do not access the data directly, but are provided with computer files containing the data in two ways depending on what they need:

  • Aggregated data – grouped information about many individuals that has been combined to show general trends or values.  In this kind of data, they would not have individual information about you.

  • Pseudonymised information – individual-level information where you are only identified by a new second coded reference number, which does not reveal your real identity.  Your full Date of Birth, NHS/CHI number, Initials and Soundex of Surname or Study Number are never released to researchers.