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In this step, guidance is provided to help you create an Informed Consent Form (ICF) and Subject Information Sheet (SIS) that are aligned with the FAIR principles. The guidance assumes you already know whether your study is subject to the WMO (Medical Research Involving Human Subjects Act) or not. If you’re uncertain, read more about this on the CCMO website, the ELSI Servicedesk (in Dutch) or contact your local experts for help.
(Praktisch gezien lijkt her op dit moment op dat we dus met name Opt-In Consent doen hier)
Why is this step importantÂ
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