SSStudyParticipantsInformedConsent object
Yes
Definition is provided in section 2(10) of the Committee Act.
It is a decision to participate in a research project which has been made upon due information on the nature, significance, implications and risks of the project and receipt of suitable documentation. The decision is made voluntarily by a person who is capable of giving his or her consent. The consent shall be in writing, dated and signed or provided using an electronic signature.
Specific requirements apply to vulnerable populations.
The requirements on written information, application, notification and reporting is described in detail in the 'Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics'.
The procedures of how to inform and obtain consent from subjects participating in clinical trials are regulated by:
(1) Executive Ministerial Order No 806 of 12 July 2004 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects
(2) Committee Act