SSStudyParticipantsInformedConsent object
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements
The provisions related to the informed consent form and the patient information sheet is provided in Article 7 Circular 7/2004 & Royal Decree 1090/2015 (articles,4 ,5, 6)
Applicable national legal framework/ Reference
The aspects on ethical principles, methodologies and protection of trial subjects are also applicable to clinical investigations with MD (pursuant to Art 30.1. RD 1591/2009) (refer to Royal Decree 1090/2015).
Additional Information
Informed consent obtained from vulnerable subjects (e.g. minors and incapacitated adults) who are potentially involved in the clinical investigation is specifically covered in Royal Decree 1090/2015.