GDPR & Transparency Wording for All Sponsors

Date: 25 September 2019

The recommended GDPR wording for Participant Information Sheets for data transparency has been updated and issued by the HRA; this is particularly relevant to all Sponsorship Teams.

Summary of 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 PIS.
• Wording for generic leaflet, to be provided alongside the PIS.

What does the revision in text means 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 it.
• If a commercial sponsor does not wish to use the revised wording and do not have agreed wording, this should be sent to approvalprogramme@nhs.net.
• Non-standard wording from non-commercial sponsors should continue to be assessed as part of the study wide review.

Please also see the following link: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/transparency-wording-for-all-sponsors/

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