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.
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
To read more see the HRA website.