When must the Ethics Committee comment on the project?

The ethics committee's consent statement for a given project must always be submitted by the applicant or coapplicant to whom the legal obligation applies, i.e. in the case of (i) healthcare delivery, (ii) research with human subjects, and (iii) research with questionnaire survey methodology and qualitative investigations with persons affected by or at risk of disease in accordance with the International Ethics Committee for Biomedical Research with Human Participants CIOMS/WHO, 2002.

In the case of research on biological material (patient samples) that was collected e.g. within another project, it is also necessary to attach the opinion of the ethics committee including the informed consent that was used in the collection of this biological material, in this informed consent should then be explicitly stated that the samples will be further used e.g. in subsequent projects, etc.

The Ethics Committee will here explicitly confirm the accuracy of the attached "Informed Consent of the Patient/Subject" and will be responsible for its compliance with the regulations if Informed Consent is required under the relevant law. In addition, in the case of anticipated work with human beings, a statement from the Ethics Committee on the protection of human beings must be provided.

When submitting a project, a copy is sufficient; when concluding a contract, it is necessary to provide the original, a certified copy or a document with electronic conversion.