GDPR guidance update for researchers and study coordinators

The Health Research Authority (HRA) have updated the recommended wording for data transparency following consultation with various stakeholders and public involvement and feedback on the initial published wording to provide a clearer more layered approach.  

The user group developed a short summary text for the patient information sheet which is supplemented by a generic leaflet. The text for both is now live on the HRA website. A word version of the leaflet – it is available on request via programme team. The reading age of the information is 13 years old.

In summary the revisions to the transparency wording are:

A single set of wording covering both commercial and non- commercial sponsors comprising of: 

• Summary information to be included in patient information sheet
• Wording for generic leaflet, to be provided alongside the patient information sheet

What does the revision in text mean for sponsors?

• Sponsors do not need to update wording if they have previously included GDPR wording.
• The revised wording is available for new studies, although the old revised wording can be accepted.
• If sponsors (commercial) have alternative sponsor level wording in place they may continue to use
• If a commercial sponsor does not wish to use the revised wording and do not have agreed wording, this should be sent to HRA.approvalprogramme@nhs.net
• Non-standard wording from non-commercial sponsors should continue to be assessed as part of the study wide review