Providing an information sheet is just one part of seeking the consent of participants. The REC will consider the whole process.
- The level of detail should be appropriate to the complexity of the study.
- Write in simple, non-technical terms that a lay person will understand.
Discussion is the most effective way to ensure consent is 'informed'. It is important that the person seeking consent spends time going through written information and does not simply give it to the participant to read on their own. This should be outlined at the top of the information sheet, perhaps suggesting how long it may take.
Depending on your research goal, you may need to consider a number of information sheets as follows:
- participant information sheet for adults
- information sheet for parents/guardians (if involving children/young people)
- information sheet(s) for children/young people
- consultee information sheet (for consultees of adults lacking capacity to consent)
Information sheets for minors
Where the Clinical Trial Regulations apply (ie for CTIMPs), a minor is defined as someone under the age of 16. Where common law applies (all research not covered by the regulations), the law states that the age of majority is 18.
Be clear in all documentation about whether you are seeking consent or assent (seeking the child’s agreement) and, if in doubt, contact CTRG.
Consent requires a full explanation of the study. Assent requires a clear explanation (comprehensible rather than comprehensive) as consent will be sought from the parent.
Information sheets should be designed for each appropriate age range to reflect comprehension and development, for example:
- children or young people 11–15 years
- children 6–10 years
- children 5 years and under: predominantly pictorial, with very simple sentences to be shown/read to the child. Parents need to provide consent since assent is not sought from children under 5.
Ideally such material should be shorter than that designed for adults, whilst retaining all relevant information.