Proposed Ethics Amendment for RaDaR

 

The RaDaR Operational Management Board and Rare Disease Group Leads have agreed to apply for an Ethics amendment to clarify the fact that RaDaR consent covers Patient View sign-up, subject to availability at individual renal units.

The proposed 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. 

In addition, it is proposed to ask patients to consent to being contacted directly by a member of the central RaDaR team, regarding information events or further research studies. Such communication would always be approved by the patient’s Consultant before being sent out and will largely be circulated via Patient View.  

Approval will be sought from NHS Digital’s data Access Request Service (DARS). 

It is aimed to submit the Ethics amendment by the of September. Please continue to recruit patients to RaDaR in the meantime, using the current consent documents.

Further details will follow in the coming weeks but we would welcome suggestions over the proposed amendment to Melanie.Dillon@RenalRegistry.nhs.uk.