Adapting HREC templates for children and young people

Guidance on adapting the Human Research Ethics Committee (HREC) participant information sheet template

Similarly to research with adult participants, the child or young person participant consent form should be accompanied by a participant information sheet, displaying the current Open University logo and full contact details of the Principal Investigator (PI)/researcher as well as an alternative contact not directly involved in the research. This is important, so participants have an impartial contact if they have any concerns about the way the research project is being conducted.

The present guidance notes offer advice on how the generic adult research participant information sheet can be adapted to be suitable for use with child research participants. The accompanying guidance should be read in conjunction with these guidance notes.

Depending on the research context, it may be appropriate to also present the information sheet to the child’s parent/guardian, with or without the child present – refer to the further advice offered in the section below on how to assure valid agreement by children to participate in research. Typically, parent/guardian consent will also be appropriate.

Study title

The title should be simple and self-explanatory to a child of the relevant age group. It may be appropriate to use non-textual elements, e.g. pictures, to illustrate the information being conveyed, clearly and age-appropriately. This also applies to all other sections of the child participant information sheet.

Information on who is running the study, and the main contact person who the child can ask any question they may have about the study, should also be conveyed clearly and age-appropriately.

Invitation paragraph

This should explain that the child is being asked to take part in a research study. The same key elements need to be included as for adult participants, adapted to use age-appropriate language.

It may well be the case that child participants are pupils, and in this case it is important to carefully plan appropriate procedures and strategies to explain that they are entirely free to choose not take part in the study, and that making this choice will not have any negative impact – refer to the section on ‘Respecting CYP’s autonomy’ on how to assure valid agreement by children to participate in research.

General information about the research study and collected research data

Include the key information as outlined in the adult participant information sheet, in terms that a child can easily understand, using non-textual elements as appropriate. For young children it may be appropriate to exclude some of the information that would normally be included in an adult information sheet, for example information about funders.

What will I be asked to do if I agree to take part?

This information should be presented in an age-appropriate way, allowing ample opportunities for the child participant to ask questions.

How will the data I provide be used?

Child participants have the same rights as adults regarding ownership of their data, so equal respect should be given to their wishes regarding data management and storage. Age- appropriate ways of explaining these processes should be used in order to gain validly informed consent, covering the same general points as in adult participant research.

It may be appropriate to exclude some of the more technical details relating data storage, such as explanations of compliance with data protection regulations, but the child should be given clear information regarding what will happen to the data they provide.

Your right to withdraw from the study

The same basic information presented to adult participants should be conveyed to child participants, using age-appropriate language and presentation strategies.

How do I agree to take part?

Ask the child if they would like to take part in the study, and explain exactly how they should express their agreement, such as verbal agreement followed by a signature, or alternative (e.g. emoticon tick box), as indicated on a consent form.

Thank you

Remember to thank the child for taking time to look at the information sheet with you.

Data protection

Depending on the age of the child, it may be appropriate to exclude this level of detailed information on data protection regulations, or include it in a more accessible, simplified presentation format.

Guidance on adapting the HREC consent form for research with children

The adult research participant template consent form can be used as a general guide, following the same standard format, but will need to be tailored to the literacy and comprehension levels of the children involved; for example, using non-textual elements where helpful and appropriate.

Informed consent

Tick boxes, as used in adults consent forms, can work well for all but the youngest children. For young children, smiley and sad emoticon faces can be used as long as what they mean is explained clearly.

Age-appropriate language should be used.

Use of the information in the study

Certain items listed in the adult participant consent form template may be less appropriate for research with young children, such as requesting consent to use quotes, or explaining details of data storage processes. However, it may be appropriate to retain these for parent/guardian consent, where this is obtained.

Future use and reuse of the information by others

As with the other child consent form sections, this information should be presented in a simplified, accessible, age-appropriate manner.

Signatures

For young children emoticons (smiley or sad face) may be used in place of a signature.