Consent and Participant Information Sheet
Preparation Guidance

About Us

This HRA on-line resource is based on Participant Information Sheet (PIS) and consent guidance developed by the Central Office for Research Ethics Committees (COREC) and amended by the National Research Ethics Service (NRES) and the HRA. The original PIS and consent guidance was developed by COREC who established and funded two working parties to provide guidelines for applicants to Research Ethics Committees (RECs). One, in 2002, chaired by Dr Carol Barton, was asked to draw up recommendations for applicants when considering how to provide information for children entering research projects. The other, in 2003, co-chaired by Dr Sandra Evans and Dr Gordon Taylor was asked to update the general guidance for patient information sheets. This guidance was subject to a period of consultation including discussion at three public meetings held across the UK.

In 2012 NRES and the HRA agreed to undertake a substantial review of the guidance headed by the Ethics Advisor Dr Hugh Davies. A working group was established with the following membership: Alison Eden, Roy Staley, Jenny Newman, Paula Hewitt, Peter Knapp, Craig Gilbert, Corinne Scott, Siobhan Mcgrath and Elaine Peill. One member, Roy Staley, sadly died during this review and we would particularly like to acknowledge his work. He was a keen, friendly member of our group, committed to the work of RECs and the need to improve how we seek consent.

The Medical Research Council (MRC) Regulatory Support Centre worked in partnership with the Health Research Authority (HRA) to develop this website as part of a secondment to the HRA to support the improvement of advice provision for the research community.

This online version of the guidance has been developed with input from the research community. We would like to thank all those who have contributed. We will continue to monitor your feedback, with the aim of continually improving the guidance provided.

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