H - Requirement No. 2

The procedures and criteria that will be used to identify/recruit research participants must be submitted.The informed consent/assent procedures that will be implemented for the participation of humans including data protection issues must be submitted.Templates of the informed consent/assent forms and information sheets covering the voluntary participation (humans) and data protection issues (both in language and terms intelligible to the participants) must be submitted.Details on incidental findings policy must be must be submitted.