Tasks and responsibilities

In principle, the Ethics Committee of the Faculty of Medicine of the University of Cologne (EK Köln) is responsible for all application procedures submitted by members of the University of Cologne [i]. In accordance with Section 9 of the Higher Education Act, members of universities include, among others, university staff who are not only temporarily or temporarily employed on a full-time basis, professors who independently perform university tasks in research and teaching, doctoral candidates and enrolled students. The Ethics Committee of the University's Faculty of Medicine is not responsible for the following persons unless they are employed full-time at the University of Cologne or the University Hospital of Cologne. These are in detail

• part-time, discharged or retired or
• adjunct professors as well as
• honorary professors and
• private lecturers.

For the aforementioned exceptions, an application must be submitted to the ethics committee responsible for these persons (e.g. the relevant medical association) in the event of a professional or statutory duty to consult.

Licensed physicians are subject to a professional consultation obligation for all biomedical research projects [i]with the exception of exclusively retrospective epidemiological research projects.

Since the doctoral regulations published on September 3, 2018 came into force, doctoral candidates for the Dr. med. or Dr. med. dent. at the Medical Faculty of the University of Cologne are also required to submit an application for purely retrospective research projects on humans. If the Ethics Committee of the Faculty of Medicine at the University of Cologne has already approved the research project, the doctoral candidate is not required to resubmit it to the Ethics Committee, provided that the doctoral project does not go beyond the approved research project or deviate significantly from it.

Research on humans includes research on living humans and on the bodies of deceased persons, on human biomaterial and on human data.

Eligible applicants to the EK Cologne

• Full-time [i] Staff employed at the university

• Doctors
  • who are employed full-time at the University Hospital or University of Cologne
  • In principle, no responsibility for doctors who are employed full-time at the academic teaching hospitals,

• non-approved registered doctoral candidates at the University of Cologne within the framework of the doctoral project in the case of purely ret rospective research projects (Note: For research projects that are not purely retrospective, the supervisor is generally obliged to provide advice; the application must then be submitted to the ethics committee responsible for the supervisor).

• registered doctoral candidates at the University of Cologne
  • who are employed full-time at the University Hospital or the University of Cologne
  • for purely retrospective research projects (note: for research projects that are not purely retrospective, the supervisor is generally obliged to provide advice; the application must then be submitted to the ethics committee responsible for the supervisor).
  • for research projects that are not purely retrospective and are carried out at the University of Cologne or the University Hospital (note: the supervisor may have a separate professional duty to consult with the ethics committee responsible for him/her)

• Private lecturers and private lecturers
  • who are employed full-time at the University Hospital or University of Cologne
  • no responsibility for private lecturers who are employed full-time at academic teaching hospitals
  • no responsibility for private lecturers who are employed full-time at other institutions

• Associate professors
  • who are employed full-time at the University Hospital or University of Cologne
  • no responsibility for adjunct professors who are employed full-time at academic teaching hospitals
  • no responsibility for associate professors who are employed full-time at other institutions

• Part-time professors at the University of Cologne who are dismissed or retired
  • generally no responsibility, unless the research project can be assigned to the university sector [i]

• Honorary professors
  • generally no responsibility, unless the research project can be assigned to the higher education sector [i]

Special notes

For bicentric studies conducted within the area of responsibility of the Cologne Ethics Committee and the Ethics Committee at the Medical Faculty of the University of Bonn (Bonn Ethics Committee), the application for professional advice can be submitted to both ethics committees at the same time. It must then be clear from the accompanying letter that a joint consultation by both ethics committees is desired. The same applies to applications for professional advice for research projects that are carried out in the area of responsibility of the ethics committee of the North Rhine Medical Association.