Application procedure

Overview

Before conducting clinical trials of medicinal products and medical devices as well as projects involving the use of radioactive substances, ionizing radiation or X-rays for research purposes, the approval or opinion of an ethics committee must be obtained.

In addition, physicians in the North Rhine region are obliged under Section 15 (1) of the Professional Code of Conduct for North Rhine Physicians to obtain advice from an ethics committee set up by the Medical Association or the Faculty of Medicine on the ethical and professional issues associated with the project before carrying out biomedical research on humans - with the exception of retrospective epidemiological research projects.

Furthermore, members of the University of Cologne may also seek advice from the Ethics Committee on research projects involving humans other than the following.

Electronic submission via ethikPool

All new studies are submitted via our application portal ethics pool This applies to all application types (with the exception of medical device trials, which will continue to be submitted via the DMIDS portal as usual). If you wish to submit a study and are not yet registered with ethikPool, please follow the link and register on the portal homepage.
For some users, the office has already created an account as part of the conversion process to the new portal. If you have forgotten your password after the corresponding notification, you can have a new password sent to you by clicking on "Forgot your password?

Obligation to register clinical studies

According to Article 35 of the Declaration of Helsinki in the 2013 version, every clinical trial must be registered in a publicly accessible
database before it begins
(Microsoft Word - WMA DoH translation DE_Rev 190905 (bundesaerztekammer.de)):

"Every research project involving trial subjects must be registered
in a publicly
accessible database before the first trial subject is recruited."

Many scientific journals only publish articles on
interventional clinical studies if they have been registered prior to the inclusion
of the first study participant. Please refer to the website of the International
Committee of Medical Journal Editors (ICMJE) for details.

In German-speaking countries, the German Registry for Clinical
Studies(DRKS) (DRKS - Deutsches Register Klinischer Studien) is recognized by
the WHO as a primary registry and meets the requirements of
ICMJE.

Meeting dates of the Ethics Committee

The Ethics Committee meets every Thursday at 3 p.m. (excluding public holidays and Weiberfastnacht).

The meetings are currently held as video conferences.

For further information, please contact the office.