H – Requirement No. 1

The informed consent procedures that will be implemented for the participation of humans including data processing must be submitted. Since children are involved, details on how the consent of the legal representatives (and assent, when applicable) will be acquired must be included.

Templates of the informed consent/assent forms and information sheets covering voluntary participation (humans) and data protection issues (in language and terms intelligible to the participants) must be submitted. The procedures and criteria that will be used to identify/recruit research participants must be submitted. Since vulnerable individuals will be involved, the measures to protect them and minimize the risk of their stigmatization must be submitted. Details on incidental findings policy must be submitted.

H – Requirement No. 2

Copies of opinions/approvals by ethics committees and/or competent authorities for the research with humans must be submitted by all partners involved with research activities which include human participants.