Ethics Commissions
(Independent) Ethics Commissions (EC) are responsible for the ethical and legal assessment of a clinical study, its documentation such as the clinical performance study protocol (CPSP) and Informed Consent Form (ICF) before any recruitment of patients. They also provide helpful advice and feedback during the planning phase of a clinical study. They represent the European pendant to the US IRBs (Institutional Review Boards).
There are currently 49 Ethics Commissions within Germany that are also members of the so called “Arbeitskreis Medizinischer Ethik-Kommissionen der Bundesrepublik Deutschland e.V.” Before submitting a study proposal to an EC it is crucial to identify the responsible EC. In Germany, ECs are related to medical faculties of universities and university clinics, to medical associations (“Ärztekammern”) and to several state authorities (Landesbehörden).
