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Will my taking part be kept confidential?

Yes.

The study will use information routinely collected by the NHS about your labour and birth and your baby (or babies). This will all be linked together using yours and your baby’s NHS numbers in a secure database kept by the Nottingham Clinical Trials Unit (NCTU).

This routine information will be anonymised once your information and your baby’s (or babies') information has been linked and it will be deleted once the study has finished.

In addition, 130 women at your hospital will have a small amount of non-sensitive information collected which is not routinely recorded in the NHS databases. If you are part of this group, you will be assigned a trial identity code and your NHS number will be entered into the trial database. This will ensure your information is linked with the routine data collected.

Under UK Data Protection laws the University of Nottingham is the Data Controller (legally responsible for the data security) and the Chief Investigator of  this  study is the Data Custodian (manages access to the data). This means we are 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 to comply with certain laws and for the research to be reliable and accurate. To safeguard your rights we will use the minimum personally identifiable information possible.

You can find out more about how we use your information by reading The University of Nottingham privacy notice and the GBS3 trial specific participant privacy notice PDF.

The data collected for the study will be looked at and stored by authorised persons from the University of Nottingham who are organising the research. They may also be looked at by authorised people from regulatory organisations to check that the study is being carried out correctly. All will have a duty of confidentiality to you as a research participant and we will do our best to meet this duty.

All research data will be kept securely for 7 years.  After this time the data will be disposed of securely.  During this time all precautions will be taken by all those involved to maintain your confidentiality, only members of the research team who have been given permission by the data custodian will have access to your personal data and any identifiable personal data will be deleted by the end of the study.

In accordance with the University of Nottingham’s, the Government’s and our funders’ policies we may share our research data with researchers in other Universities and organisations, including those in other countries, for research in health and social care. Sharing research data is important to allow peer scrutiny, re-use (and therefore avoiding duplication of research) and to understand the bigger picture in particular areas of research. Only anonymous data will be shared in this way.