Work

PARC General survey Info leaflet, informed consent, and withdrawal form for adults, adolcescents, and children and their legal guardians.

Year: 2026

Type: article

Abstract: The consent and information materials are a compilation of templates, which have been designed to set the critical content to be used to develop information leaflets and informed consent forms for the participants in the PARC general survey. They are intended for use in the PARC aligned studies with corresponding forms for each age range: children 6 – 11 years, teenagers 12 - 17 years, and adults 18 –39 years. The forms are based upon the materials developed in the framework of HBM4EU - Task 7.5 and were modified and adapted to suit PARC general survey description of activities -P4.1.1.2.a_Y1_GenHBMSurvey. Other considerations included aligning these documents with other health-related clusters funded by the European Commission (EC), including the INQUIRE project and the IDEAL cluster, of which the former is part. The goal was to develop common materials for these projects. The materials contain customizable forms in the English language for translation into different national languages. Templates include information leaflets, informed consent, withdrawal, and optional response forms. Templates for children are always accompanied by the “legal guardians” version, and both forms are needed for studies involving children. Each document also includes instructions on how to use the templates. Study owners may introduce changes as required by the study design and national requirements. However, it is important to note that legal provisions must not be altered. The documents were submitted to the Data and Ethics Protection Board (DEPB) for review and approval. The consent forms and other templates are compiled in the following Annexes: Annex 1.1 - Information leaflet for AdultsAnnex 1.2 - Certificate of informed consent for participants able to give consentAnnex 1.3 - Withdrawal form for participants able to give consentAnnex 1.4 - Information leaflet for AdolescentsAnnex 1.5 - Information leaflet for Children Annex 1.6 - Information leaflet for Legal guardiansAnnex 1.7 - Assent form for Children Annex 1.8 - Withdrawal form for Legal guardiansAnnex 1.9 - FAQ sheet for Children

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.19249176

Authors: Pedraza-Diaz, Susana, Namorado, Sónia, Ingelido, Anna Maria, Domínguez-Morueco, Noelia, Hartmann, Christina, Jimeno-Romero, Alba