New consent requirements for genetic analyses

Consent must be explicit – this already applied before, as the executive order already required explicit consent. However, implied consent can still be enough if the patient clearly agrees to the treatment. Explicit consent can be given both orally and in writing, with certain exceptions. Explicit consent can still be given both orally and in writing, but not for certain genetic analyses, where consent must be in writing.

Consent to certain genetic analyses must always be in writing. The consent must also address secondary findings. The analyses covered include whole genome sequencing, exome sequencing, total RNA sequencing and several others, which are listed in annex 1.

A patient aged 15 or over must be informed before consent to genetic analysis is given. The patient must know that genetic information at the National Genome Center may be limited to the treatment of the patient and purposes directly related to it. The information is given in writing on a form from the National Genome Center.

The executive order no longer mentions "other purely private matters" in the rules on consent to disclosure and collection. The same applies to the rule on disclosure to third countries.