SSStudyParticipantsInformedConsent object
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
The participant has to be informed by a physician or dentist (in case of medical devices defined for dentistry) about the nature, significance, risks and implications of the clinical trial and has to give its written consent to the study.
Additional Information
There are specific requirements/ regulations for minors, pregnant women and incapacitated persons (§20 subsection 4 & 5 MPG, §21 MPG).