Consent and Participant Information Guidance

What's New

“What’s New” details what has changed within this site and the date these changes were made.  Please see below for a full list of all changes:

Sept 2018 - Version 6 released to incorporate further guidance about recording consent electronically and use of alterative formats for conveying information.

May 2018 - Version 5 released to include content and links related to the requirements of the General Data Protection Regulation (GDPR). For more information please refer to the HRA’s GDPR guidance for the health and social care research sector. Further changes may be made to this guidance as new information and legal interpretations emerge.

Feb 2017 – Version 4 released incorporating new sections for pragmatic trials, involvement of participant’s GP and generic ionising radiation risk statements. Please help us to continue to improve this guidance by providing your feedback.

Dec 2016 – Version 3 released to update links.

March 2016 - Updates made to guidance on Adults Lacking Capacity and losing capacity during intrusive research.

June 2014 – Version 2 released to update broken links and 'About' page.

Mar 2014 – Version 1 released (incorporating feedback from consultation in use phase). Thank you to all those who provided feedback during consultation in use; we will continue to monitor your feedback with the aim of continually improving the guidance.

Dec 2013 – Comments from consultation in use phase to be reviewed.

Oct 2013 – The Consent and Participant Information Sheet preparation guidance website is launched (consultation in use phase).