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:

March 2021 – version 11 released to update the consent form template and update links.

November 2020 – version 10 released to update the generic ionising radiation risk statements and update links.

September 2020 - version 9 released to improve accessibility and include further minor text changes following implementation of Mental Capacity Act (Northern Ireland).

March 2020 - version 8 released to reflect the implementation of the Mental Capacity Act (Northern Ireland) and respond to feedback received.

Aug 2019 – version 7 released to clarify guidance relating to research involving adults who are unable to consent in Northern Ireland and update links.

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).