Privacy

Any information that is recorded during your visit to your GP or hospitals is patient data. This can range from information regarding health problems, tests and treatments, as well as family history and lifestyle choices.

 

Identifiable information is any information that can link you to this data. That could be name, date of birth or NHS number. It is vital to all of us that your identifiable information is kept confidential to the patient and relevent staff who require particular parts of your information to provide care. There are laws that protect patient information to help keep it safe and secure.

If you agree to take part in the trial, your infomration will be anoymised. You are allowed to decline this request without your standard care being affected. You will be asked you provide samples and complete questionnaires. This information is then combined with the information form everyone in the study. This information will include demographic data, health, smoking habits, medications and quality of life. All this information will be anonymised and only research team will be able to access it. 

 

Once your information has been shared with either your GP, research nurse or resaerch team, your data will be anaymised and added to a secure database with restricted access. Only relevent research staff will have access to the clinical trial database and within the database, all patient records are given a unique patient ID. 

At any time, without giving any reason, you can stop being part of the clinical trial without affecting your standard care. Once you have either received vaccine or no vaccine, we will follow up with you at 3 months and 12 months with a questionnaire. The completion of these questionnaires are vital and we encourge completion to enable the study data to be reliable, however, you are allowed to let us know if you do not want anymore data to be collected. Once data is collected, to maintain its reliability, you will not be allowed to see or change the data.

The University of Birmingham take great care to ensure that personal data is handled, stored, and disposed of confidentially and securely. Our staff receive regular data protection training, and the University has put in place organisational and technical measures so that personal data is processed in accordance with the data protection principles set out in data protection law.

Once the trial has finished, researchers will write a report on the findings of the study. The findings will be published in a way where your identity will be concealed. The research data may be kept for several years but you can enquire with the research team exactly what data will be stored and for how long. 

Any identifiable information will be held safely and securely with strict limits on who can access it. Any physical paperwork containing identifiable data will be kept in an access-controlled and secured room inside a locked filing cabinet.

In the UK, there are strong laws to protect your personal health information.  If you agree to take part in this trial, your details and any information collected about you for this research will be handled, stored and destroyed in accordance with the General Data Protection Regulation (GDPR) and the Data Protection Act 2018. Any research that uses patient data must follow these rules. 

Participants will always be identified using their unique trial identification number on the Case Report Form in correspondence with the BCTU. Participants will give their explicit consent for the movement of their consent form if they use the paper form, giving permission for BCTU to be sent a copy. This will be used to perform in-house monitoring of the consent process.

BCTU will maintain the confidentiality of all participant’s data and will not disclose information by which participants may be identified to any third party. Representatives of the STABILISE trial team and sponsor may be required to have access to participant’s notes for quality assurance purposes, but participants should be reassured that their confidentiality will be respected at all times.

You have the right to speak up if you’re not happy with how your personal data has been handled in research.

1. Talk to the research team first
   If something doesn’t feel right, contact the the trials team. We will listen to your concerns and try to sort things out.
2. Still not satisfied? Contact the Data Protection Officer
   Every organisation has someone responsible for making sure your data is handled properly. This person is called the Data Protection Officer. The research team can give you their contact details.
3. If you still feel your data is being used wrongly or unlawfully
   You can make a complaint to the Information Commissioner’s Office (ICO). They’re the UK’s independent authority that looks after data protection.

• Visit https://ico.org.uk/
  
• Or call 0303 123 1113

Your privacy matters and there are steps to help protect it.

You can find out more about how we use your information, including the specific mechanism used by us when transferring your personal data out of the UK.

• By visiting https://www.birmingham.ac.uk/privacy/index.aspx 

• By asking one of the research team

• By sending an email to dataprotection@contacts.bham.ac.uk, or

• By ringing us on +44 (0)121 414 3916.

You can also find out more from www.hra.nhs.uk/information-about-patients/ and by reading the information available here www.hra.nhs.uk/patientdataandresearch