To gain informed consent, participants must read an information sheet about a research study and sign a form saying they agree to take part. Below is advice for researchers to create high quality consent forms and information sheets.
Top 5 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 aged 15 years of age or younger a legal representative (e.g., caregiver or parent) must give consent for their participation. It is good practice to also gather assent from the children themselves if appropriate (an informed judgement is needed to decide when this is appropriate based on the child's age, developmental ability and understanding of research and their diagnosis)
- If using a written assent form, it should be a simplified form that is appropriate for the individual’s age and ability that includes similar information as 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 research know if they think they are no longer happy to take part
- Some people aged 16 years and older do not have the capacity to consent for themselves, for example, if they have a learning disability, and 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)