Data Linkage
At the time of recruitment for these trials we did not ask for consent for linkage to health records held by national data providers (such as NHS England). As these trials have now closed to further follow-up and some participants have moved away from their hospital or have died it is not possible to contact them.
Any trial participant who withdrew consent for further data to be collected will not be included in the study.
We asked the Health Research Authority, who take advice from the Confidentiality Advisory Group (CAG), for permission to obtain follow-up information through a linkage with NHS England. This involves sharing a limited amount of personal data (NHS Number, date of birth and sex) with NHS England to obtain linked healthcare systems data.
You can find out more about the CAG from
https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/
CAG provide advice to the Health Research Authority on the use of confidential patient information without consent under ‘Section 251’ of the NHS Act 2006. This linkage will be undertaken with ‘Section 251’ support from the Health Research Authority on advice from the CAG. The national data opt out will be respected.
After linkage has occurred, the data is de-identified and researchers will not be able to see identifiable data.
We spoke to a group of patients with myeloma about accessing linked health records of trial participants without explicit consent. The group felt it was acceptable and were supportive of using existing data to monitor trial outcomes.
If you wish to opt-out of the BLISS study, please click here