Welcome to the Health Research Authority's online guidance for researchers and ethics committees on consent, and how to prepare materials to support this process.
In this guidance you will find information on:
- The principles of consent (both ethical and legal)
- How the principles relate to preparation and use of a Participant Information Sheet (PIS) and consent form
- Recommended content of a PIS and consent form
- Design and style of an effective PIS and consent form
The guidance covers consent in adults, children, young people and adults not able to consent for themselves (in both emergency and non-emergency situations) and takes into account UK-wide requirements.
NOTE: wherever we use the terms ‘Participant Information Sheet’, ‘PIS’ and/or ‘consent form’ we are including where these materials are provided in electronic formats.
We have provided some examples and suggested text. The guidance should be considered as a framework, not a rigid template: we would encourage you to think carefully about how best to inform potential participants. One size does not fit all: you do not need to produce the same PIS and consent form to support consent for a questionnaire study as you would to recruit into a drug trial. The best way to make sure your consent documentation is fit for purpose is to test it with patient groups or other members of the public.
From this site we have provided links to other sources of information (available from our 'Links' page).
Please select the links in the menu below for more information about how this guidance has been developed or to provide feedback.