SSStudyParticipantsInformedConsent object
Yes
The research may only be carried out if the trial subject has consented to the research after she/ he has previously been given information on the overall plan and purpose of the research, the used methods, the consequences and risks, the identity of the sponsor and the participant’s right to revoke the consent at any time. The consent is to be voluntary, explicit and specific to particular research and is to be documented even if it not given in writing (pursuant to Section 16,17,19 LVFS 2003:460).
(The literal definition of Informed Consent is provided in Chapter 1 (3j) LVFS 2003:6, corresponding to the EU Directive 2001/20/EC.)
Section 16,17,19 LVFS 2003:460
Chapter 1 (3j) LVFS 2003:6
Special provisions apply to vulnerable persons such as minors (less than 18 years of age) or persons incapable of giving consent (in case of illness, mental disorder, weakened state of health) (pursuant to Chapter 3 (2,3) LVFS 2003:6 and Section 18 resp. 20-22 2003:460).