29/09/17

RaDaR Ethics Amendment Submitted

Following a review of our revised consent documents by NHS Digital, we have now submitted the latest RaDaR amendment to the South West – Central Bristol Research Ethics Committee.

The main changes concern clarification that RaDaR consent covers Patient View Sign-up, subject to local availability, and that patients consent to being contacted directly by a member of the central RaDaR team and/or their Rare Disease Group Lead regarding information events or further research studies.

The amendment will also allow for data linkage to other registries, including the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases. This will allow for a far more comprehensive RaDaR data-set than is currently available with manual data entry. It will also allow for longitudinal follow-up of patients who have previously consented to condition-specific research studies, or who do so in the future.

No action is required on behalf of the recruiting sites at present. Further updates will follow when the amendment is approved. For any queries please contact Melanie Dillon.