Our standard wording for data transparency, to support compliance with the General Data Protection Regulation (GDPR) has been updated.
Following stakeholder consultation, and with public involvement, template information on how data is used in research has been updated to take account of feedback and provide a clearer, more layered approach.
A user group has developed short summary text for the Participant Information Sheet (PIS) which is supplemented by text to be used in a generic document. The reading age of the information is 13 years old. The text is available here.
The revised wording should be used by both commercial and non-commercial sponsors.
What do the text revisions mean for sponsors?
The revised wording is available for new studies. Sponsors do not need to update existing wording if they have previously included GDPR wording.
Commercial sponsors can continue to use alternative wording that has already been approved, but any non-approved wording which differs from the new template should be sent to the HRA.
Non-standard wording from non-commercial sponsors will continue to be assessed as part of the study wide review.