General information about
patient information and declaration of consent


Ethics Commissions, which have to consent to a clinical study in their area of responsibility, have especially high requirements for a comprehensive, correct and balanced information of an experimental subject (= healthy study participant) or study patient in respect of all aspects of their possible participation, especially in respect of risks and particular problems.
 

The content of such an information form and the experimental subject’s or patient’s declaration of written consent to participate in a clinical study is laid down by the German Medicines Act (“Arzneimittelgesetz”), Section 40 paragraph 1 No. 3, the currently applicable version of the Helsinki Declaration (Code of the World Medical Association regarding ethical principles in medical research) and the European GCP (Good Clinical Practice) guidelines.
 

For individual research projects, the GKF Berlin also uses the internet in its search for study participants and describes the corresponding experimental subject or patient profile on its homepage.

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