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 firstname.lastname@example.org.
- 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/