SSStudyParticipantsInformedConsent object
Yes
Templates for Participation Information and Consent is available in Norwegian and English on the REK website in section Deadlines and Forms > Templates for Participation Information and Consent
'A written, dated and signed statement about participation in a clinical trial which is given by a person who is capable of giving consent. The statement must be made voluntarily after the trial subject has received full information about the nature, significance, scope and risk associated with the trial. If the person is not capable of giving consent, consent is given by the person who can give consent on behalf of the person concerned'
Specific requirements regarding to informed consent (including vulnerable populations) are stipulated by Chapter 2 of Regulation 2009 for clinical trials (en) and Chapter 4 of The Health Research Act.
Chapter 1, Section 1(5) Regulation 2009 for clinical trials (Definition)
Chapter 2 of Regulation 2009 for clinical trials Chapter 4 of The Health Research Act
The EC will approve the Informed Consent Form.