Tasks of the Ethics Committee

The necessary advances in medicine require experiments on living people. The personal rights and health interests of the individual test subjects or patients take precedence over the pursuit of knowledge in the service of the general public.

The tasks of ethics committees - set up by the medical associations, at medical faculties and, in some federal states, by the state health authorities - are:

• the protection of healthy test subjects (volunteers) and patients from dangerous research
• the protection of researchers from exceeding the limits of what is ethically or legally permissible in the pursuit of knowledge, and
• the protection of research institutions from the adverse consequences of ethically and legally questionable research.

The Ethics Committee of the Medical Faculty of the University of Cologne is an independent institution of the Medical Faculty of the University of Cologne and is not bound by instructions. Its task is to ethically and legally assess research involving human subjects and epidemiological research projects with personal data upon request and, in this context, to advise members of the University of Cologne on professional law and ethics. Research involving human subjects includes research on living humans and on the bodies of deceased persons, on human biomaterial and on human data.

Legal basis

The Ethics Committee of the Faculty of Medicine at the University of Cologne performs the duties assigned to it under Section 7 of the North Rhine-Westphalia Health Professions Act and provides guidance on projects in accordance with Sections 40–42a of the German Medicines Act (AMG) in conjunction with Regulation (EU) No. 536/2014, Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), as well as the Medical Devices Act Implementation Act (MPDG), Section 8 of the Transfusion Act (TFG), Sections 31 et seq. of the Radiation Protection Act (StrlSchG), and Section 15(1) of the Professional Code of Conduct for Physicians in North Rhine-Westphalia, as amended, and the supplementary regulations.

The Ethics Committee is registered with the Federal Office for Radiation Protection in accordance with Section 82 of the Radiation Protection Ordinance and Section 168 of the X-ray Ordinance.

In addition to the applicable law and the Medical Code of Conduct, the revised version of the World Medical Association's Declaration of Helsinki as well as relevant national and international recommendations and guidelines (in particular, the ICH-GCP guidelines) form the basis for the work of the Ethics Committee.

The Ethics Committee acts ex officio upon request and in the cases regulated by law.
The Ethics Committee's establishment and procedures are regulated in its statutes (last amended by the revised version dated August 23, 2023, Official Notices 77/2023).

According to the Ministerial Decree of November 22, 2006, the Ethics Committee of the Faculty of Medicine of the University of Cologne is not responsible for members of the Faculty of Medicine who are not employed full-time at the University, such as private lecturers and professors employed externally at teaching hospitals or other institutions. The ethics committees at the respective medical associations are responsible for these.