How has the information I provided been kept confidential?
We have followed established ethical and legal practices. All information collected about you during the study has been kept strictly confidential, safe and secure. Data collected for the study will only be looked at by authorised persons who are organising the research and to check the study is being carried out correctly.
All data about you will have your name and address anonymised and a unique code will be used to help protect your identity. Any information collected about you will be stored in a secure location and electronically on a password protected database. All our reports will be written anonymously so no one can work out you took part in the study.
All personal and research data will be held for up to 5 years in case we need to contact you about the findings of the study unless you ask us not to contact you. Your personal and research data will be disposed of securely after it is no longer necessary to contact you.
As requested by the funder, we have asked for your consent to link the data collected from the study to routinely collected health data stored in national databases (via your NHS number), and to share this information anonymously with other researchers.
If you wish to raise a complaint on how we have handled your personal data, you should contact the research team. If you are not happy after that, you can contact our Data Protection Officer who will investigate the matter. If you are not happy with our response or believe we are processing your personal data in a way that is not right or lawful you can contact the Information Governance Team at the Sponsor’s organisation in the first instance, who may escalate the issue to either the Data Protection Officer or Caldicott Guardian. If you remain unhappy, you can complain to the Information Commissioner’s Office (ICO).
Who has organised and funded the OPAL Trial?
The OPAL Trial is organised by South Tees Hospitals NHS Foundation Trust in collaboration with the University of Nottingham and the University of York. The trial is funded by the National Institute for Health and Care Research, Health Technology Assessment Programme (NIHR133880).
Who has reviewed the OPAL Trial?
All research in the NHS is reviewed by an independent group of people, called a Research Ethics Committee (REC), to protect the interests of the patients involved in the research.
The OPAL Trial has been reviewed and given favourable opinion by the Egbaston Research Ethics Committee and approved by the Health Research Authority (HRA) (REC Ref Number 23/WM/0013; IRAS project ID 320809).