To gain informed consent, participants must read an information sheet about a research study and sign a form saying they agree to participate. Below is advice for researchers to create good-quality consent forms and information sheets.
Top five tips for writing an information sheet and/or consent form
- Keep it brief. Keep the information and consent forms concise - use clear, simple language and avoid jargon. Where possible, signpost required information that few participants will read (e.g., university GDPR policy) instead of reproducing it entirely in your forms
- Give context. Explain the context of the research, for example, why you need to collect this specific type of data, what question you hope to answer and why, who is involved in the project, what taking part involves, what happens to participant's data and if you plan on sharing the results of the research with them or not
- Use multiple formats. As well as a written document, consider making an information video or audio recording of the information for participants - apply for ethical approval to use any of these formats to give you flexibility.
- Pay attention to reading age. Write your information letter and consent form for the lowest reading age, not chronological age, possible for your intended sample(s). Writing for a specific reading age is a skill that takes practice and refinement, we recommend checking the reading age of your documents using sites like readable.com or hemingwayapp.com
- Test understanding. Pilot testing information letters and consent forms with people similar to those in your intended sample(s) is an excellent way to check if they understand the information you provide. Involving the community in this process can help convince your ethics committee of the need for brief and simple forms.
When people can't give consent
- If your participant is 15 years or younger, a legal representative (e.g., caregiver or parent) must consent to their participation. It is good practice also to gather assent from the children themselves, if appropriate. Use your informed judgment to decide when this is appropriate based on the child's age, developmental ability and understanding of research and their diagnosis.
- If you use a written assent form, it should be a simplified form appropriate for the individual’s age and ability, including information similar to a consent form. Sometimes, using visuals helps to simplify forms.
- Sometimes, asking for written assent is not appropriate, in this case, a researcher should ask somebody who knows the participant to monitor their assent throughout and to let the researcher know if they think they are no longer happy to participate.
- Some people aged 16 years and older do not have the capacity to consent for themselves, for example, if they have a learning disability. In these cases, researchers must adhere to the procedures laid out in the Mental Capacity Act (England and Wales) or common law (Northern Ireland) and the Adults with Incapacity Act (Scotland)
Download example documents
Assent Form #1
Created by Dr Leadbitter at the University of Manchester
DownloadAssent Form #2
Created by Dr Leadbitter at the University of Manchester
DownloadAssent form for children aged 4 - 8 years
Created by Prof Simonoff & team at IAMHealth
DownloadBrain Imaging Information Pack
Created by Prof Leekam & Dr Jones at WARC, Cardiff
DownloadChildren's Assent sheet
Created by Aaron Giuliano et al., at UCL
DownloadCollaborator information sheet
Created by Emeline Han at CRAE
DownloadConsent Form
Created by Bérengère Digard at DART, University of Edinburgh
DownloadInformation Pack
Created by Bérengère Digard at DART, University of Edinburgh
DownloadInformation Pack
Created by by Dr Crompton & team at DART, University of Edinburgh
DownloadInformation Pack
Created by Dr Leadbitter at the University of Manchester
DownloadInformation Pack
Created by Maria Ashworth & team at CRAE, UCL
DownloadInformation Sheet #1
Created by Dr Leadbitter at the University of Manchester
DownloadInformation Sheet #2
Created by Dr Leadbitter at the University of Manchester
DownloadInformation Sheet
Created by Bérengère Digard at DART, University of Edinburgh
DownloadInformation Sheet
Created by by Dr Crompton & team at DART, University of Edinburgh
DownloadInformation Sheet for High Ability (11yrs+)
Created by Prof Simonoff at IAMHealth, KCL
DownloadInformation Sheet for Medium Ability (11yrs+)
Created by Prof Simonoff at IAMHealth, KCL
DownloadInformation Sheet for Minimally Verbal (11yrs+)
Created by Prof Simonoff at IAMHealth, KCL
DownloadInformation Sheet for Minimally Verbal (4-8yrs)
Created by Prof Simonoff at IAMHealth, KCL
DownloadInformation Video
Created by Iti Arora & team at CANDAL, University of Nottingham
DownloadInterview Consent Form
Created by Dr Crane & team, CRAE, UCL
Short Films by Dr Emma Gowen & team at the University of Manchester
Verbal Information & Consent Form
Created by Dr Crompton, DART, University of Edinburgh
DownloadVisual Timetable
Created by Professor Emily Simonoff & team, IAMHEALTH, KCL
Download