Table 3

General information for informed consent and assent (agreements)

Age group in years				Legal representative(s)	Elements to consider/information which must be included into the assent/consent document	Questions to be addressed	NOTES and example methods/texts to be used
0-2	2-5	6-9	10-18	Legal representative(s)		Questions to be addressed	NOTES and example methods/texts to be used
					Language/translations/methods used for providing information/time used for information (paper or electronic) Language must be concise, clear, relevant and understandable, adapted to the age and maturity of the recipient of the information.The assent/informed consent (agreement) should be documented, and in case it is not possible to seek assent from the child the reasons for this should be explained. The target is to obtain credible informed assent/consent with unbiased approval, understanding and willingness or refusal by both parties (child and legal representative). The personnel providing the information should be competent in communicating and working with children and families, providing time and space for the discussion and decision. Ensure that children are properly informed.	Do the legal representative(s) and the child/adolescent understand the information given? Is there enough time to provide relevant information, for discussion and to answer questions? Are the facilities suitable/safe for discussion? Have the child/adolescent and legal representative(s) had time to read the information beforehand (eg, at home) prior to the discussion? Have you used correct grammar? Do you have the correct form of address (per age) for the addressee (child/adolescent) to avoid infantilisation?	Use visual and informative materials/sources (IT based or manual) to increase understanding (if appropriate) such as: Videos, DVDs Pictogram Pictures Drawings Cartoons Photographs Diagrams/charts/tables Social media contents, www-links Computer programmes physical instrument/tool/device mimics of methodology Glossary/dictionary of terms eYPAGnet⁶ notes: Max. 3 pages/3 screen views (total) for the assent/consent document. Large enough font. Clear layout. No bullet points. No pictures from ‘Clip Art’. Different colours to highlight important info. Chart for visits is helpful. Add list of additional resources if some of the information cannot fit on three pages. Support to create text to documents: Readibility: Flesch-Kincaid Readability Score testing tool. Available at: https://www.webfx.com/tools/read-able/flesch-kincaid.html Health literacy: Quick Guide to Health Literacy. Available at: https://health.gov/communication/literacy/quickguide/default.htm
					Explanation of the concept of a clinical trial and the methodology used.	What is a clinical trial? How does the clinical trial differ from normal routine care? What is randomisation/double-blind/open label etc?	NOTE: Explain only the relevant methodology—a short version—used according to the current protocol. Avoid complex terms and flowcharts with too much detail.
					Dissent/refusal/disagreement/respect for autonomy Voluntariness/right to refuse/right to dissent/free decisions	What is the explicit wish of the child/adolescent (capable of forming an opinion and assessing the information)? Has the child/adolescent understood that they may refuse participation or withdraw at any time during the trial? Is the child/adolescent’s free wish/decision respected (according to the age/maturity) by the investigator/trial personnel?	NOTE: The agreement of a child should be requested systematically, even if the assent is not legally required. Children should be provided with age-appropriate information (with supplementary visual) information where appropriate) and have the opportunity to form an opinion or decision. Their refusal or dissent should be respected, objections should be analysed (reason), and possible help sought for anticipated burden (fear, distress, etc). Resistance of very young children should be identified and discussed with legal representatives.
					Legal representative/role/sensitive issues of adolescents (not discussed with parents/ legal reps!)	Is there an opportunity for older adolescents to have a private conversation (without parents) with the trial personnel about confidential/sensitive issues?	NOTE: Legal reps. roles as empowered for decision making should be recognised, but there should be an additional option for the adolescent to express any concerns or worries so as to respect their autonomy (eg, an independent person or mailbox or other method). NOT the trial personnel, as this may create conflict.
	If literate Otherwise				Assent/consent signature/certification/re-consent after legal age (CTR:Article 32); In long-term studies, check if there is a need to re-assent the child as the child matures. Check, if assent (consent) is legally required for the child (national laws). The child/adolescent must take part in the informed consent procedure in a way adapted to their age and mental maturity. A child/adolescent capable of forming an opinion and assessing the information should also provide their assent to participate in the trial. The assent may additionally be in written form and must be according to national requirements.	Who can/must sign/write name on assent/consent forms?	For younger children, parents can explain by using “story telling” method.

Bolded texts in columns: The most important aspects, or requirement, need to be addressed per each subject element to consider.
*European Medicines Agency, 2021. Reproduced with permission.