Participant information sheets and consent forms
The Health Research Authority has revised the previous National Research Ethics Service guidance on the design of participant information sheets and consent forms into an online format. The online version is now the definitive version of this guidance.
The online version:
- Provides information on the principles of consent, recommended content as well as design and style of a participant information sheet and consent form.
- Covers consent in adults, children, young people and adults not able to consent for themselves (in both emergency and non-emergency) and takes into account UK-wide requirements.
- Has separate sections that provide examples, templates and useful links.
- May be downloaded as a pdf if required.
- Applying a proportionate approach to the process of seeking consent This guidance complements the existing HRA online guidance for consent and participant information sheets and reinforces the HRA’s view that people who volunteer to take part in research should be provided with succinct, relevant, user-friendly information in a proportionate manner.
- Informed consent in CTIMPs NRES information paper on informed consent in clinical trials of investigational medicinal products
- Language and Exclusion How should RECs consider and decide about the inclusion or exclusion of participants in research who may have difficulties in adequate understanding of English?
- Making written information easier to understand for people with learning disabilities [external link] Guidance for people who commission or produce Easy Read information – Revised Edition 2010
- DH consent home page [external link] National Archives document