SSStudyParticipantsInformedConsent object
A detailed guidance for the preparation of appropriate written patient information material and Informed Consent Forms are provided on the Swissethics website in section Templates > Study information and Informed Consent for Research Projects in Humans (HRA 7,16).
Informed consent of study participants must be obtained in writing before (exemptions possible) the commencement of a clinical trial.
The persons concerned must receive comprehensible oral and written information on the nature, purpose, duration, procedures, foreseeable risks, burdens and expected benefits of the research project as well as the measures taken to protect the personal data collected and their rights.
The trial participants must be given an appropriate reflection period .
Art 16 -18 HRA; Art 7-9 KlinV/ClinO
Specific provisions apply to vulnerable groups of persons (Art 11 and 21-31 HRA; and15-17 KlinV/ClinO) as well as for research on imprisoned persons (Art 28-29 HRA).