Privacy Statement for Patients

Will my taking part in ROSSINI 2 be kept confidential?

If you decide to take part in ROSSINI 2, we will need to collect information about you and some of this information will be your personal data. Under data protection law, we have to provide you with very specific information about what we do with your data and about your rights.

The University of Birmingham is the sponsor for this trial based in the United Kingdom. The University will use information from you and your medical records and will act as the data controller for this trial. This means that the University of Birmingham is responsible for looking after your information and using it properly.

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 trial, 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.

More information on how the University processes personal data can be found on the University’s website on the page ‘Data Protection – How the University Uses Your Data’ (

Your hospital will use your name, NHS number, date of birth and contact details to contact you about the ROSSINI 2 trial, and make sure that relevant information about the trial is recorded for your care, and to oversee the quality of the trial. Individuals from The University of Birmingham and regulatory organisations may look at your medical and research records to check the accuracy of the research trial. Your hospital will pass these details to the University of Birmingham along with the information collected from you and your medical records. The only people at the University of Birmingham who will have access to information that identifies you will be people who need to contact you to complete questionnaires or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details. The legal justification we have under data protection law for processing your personal data is that it is necessary for our research, which is a task we carry out in the public interest. These data will not be used to make decisions about you.

Your hospital and the University of Birmingham will keep identifiable information about you from this trial for 10 years after the trial has finished.

Your GP and the other doctors involved in your clinical care will also be notified of your participation in the ROSSINI 2 trial and kept informed of your progress. Also, the research staff involved in the trial may, in the future, access electronic data from your central NHS records, for example through NHS Digital. This will provide researchers with information that is routinely gathered and stored during your visits to primary care and hospital, and will allow researchers to find out about your health after the trial has ended and the long-term effects of the treatments. By using routinely collected data we will be able to do this without needing to contact you further. In order to do this, we would need to send your name, gender, date of birth and NHS number with any request for information.

The University takes great care to ensure that personal data is handled, stored and disposed of confidentially and securely. Staff have received regular data protection training and the University has put in place organisational and technical measure so that personal data is processed in accordance with the data protection principles set out in data protection law. With regards to ROSSINI 2, information about your operation and follow-up will be sent by your doctors to the ROSSINI 2 Trial office at the Birmingham Clinical Trials Unit (BCTU), University of Birmingham on paper and/or electronically, where it will be securely stored.

The manufacturers of all the interventions for the trial will review limited information about any complications experienced by anyone in ROSSINI 2. This data will be anonymised and will not identify you.