ECMultiCenterStudiesEthicalReview object

Ethical approval (favourable opinion) required from

Lead EC (authorised to issue a single opinion)

Submission of application required to

Lead EC + All concerned local ECs for site-specific assessment

Additional Information

The competent and coordinating lead EC depends on the location of the coordinating or principal investigator. The lead EC issues a favourable opinion after the assessment in cooperation with the competent local ECs. The local ECs evaluate the qualification of the investigator and the suitability of the study sites in their area of responsibility Their opinion should be respected by the coordinating EC. Local ECs can comment on the protocol as well, but the coordinating EC is exclusively responsible for the decision on the content of the single opinion, which it creates independently. (according to section 5 subsection 2 MPKPV)
Link to list of competent ECs: http://www.ak-med-ethik-komm.de/kommUni/ek_liste.html

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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