The Participant Information Sheet and Consent Form are key documents and a major consideration during ethical review.
You are strongly recommended to follow the guidance provided by HRA.
Where a study is initiated outside the UK, you are advised to modify the documents in accordance with UK guidance before submitting them for review.
We also strongly recommend that you involve the public in your research [internal link] in the development of the consent process for your research and the preparation of Participant Information Sheet. This is likely to help make the information to participants clearer and more understandable.