• Clinical trials on humans, e.g. drug trials, including phase IV or therapy optimization studies or application observations of approved drugs or medical devices and the application of new diagnostic and therapeutic procedures.
  Examples:

  • Testing of non-approved drug X on patients

  • Randomized comparison of approved medication X against Y in patients

  • Pharmacokinetic studies with substance X in healthy volunteers

  • Comparison of the new diagnostic procedure X against the established procedure Y

  • Comparison of the new therapeutic procedure X against the standard therapy

• Epidemiological studies in humans with personal data, e.g. prospective studies with personal data (e.g. with questionnaires, interviews, etc.), surveys of patients, relatives, treating physicians, etc.
  Examples:

  • Investigation of the long-term outcome of two different reconstruction procedures for inguinal hernias, in which all patients operated on in the Clinical Department are sent a questionnaire.
  • Investigations into the long-term course of patients with a chronic illness, in which the patients are questioned annually about their condition (as are their general practitioners).
• Studies on material taken from the body (e.g. blood, surgical material, autopsy material) with a personal reference, e.g. for human genetic questions or for tumor banks, etc.
  Examples:
  • Genetic characteristics of the removed tumor are determined from surgical specimens or autopsy specimens and correlated with the course of the disease in the patient.
  • In the course of a sepsis, a new laboratory parameter is determined in the blood, which is intended to provide information about the severity of the infection.
  • A part of the bone marrow biopsy from each leukemia patient is preserved for later examination.

• Treatments with new drugs or applications of new procedures in individual cases, i.e. not in the context of systematic studies (therapeutic trials), must also be submitted to the Ethics Committee - also to safeguard the treating physician (e.g. in the case of planned publication).

• Studies on anonymized biomaterials: Studies on material taken from the patient's own body that no longer allows any conclusions to be drawn about the identity of the associated patient (anonymized data) and that is not used for commercial purposes are not subject to consultation. It must be ensured in advance that the use of this biomaterial for the purpose of research is lawful. As a rule, this requires the written informed consent of the patient donating the sample. Projects that are to be carried out using biomaterial banks may require consultation, depending on the procedural rules of the Facilities or Institutions or the nature of the project (see point 3).
• Retrospective data analysis: In the opinion of the Ethics Committee, a retrospective anonymized analysis of internal departmental data does not require consultation. However, it is recommended that the project be submitted in advance, as a statement from the Ethics Committee is regularly requested by third parties (e.g. scientific journals prior to publication). It is not possible to provide advice or issue opinions on studies that have already been carried out! The application must always be submitted before the start of the study.

  Submit a non-AMG non-MPDG application with cover letter, application form and meaningful study synopsis via the online database "ethikPool" (see Application).

  Please note: Only patients/test subjects who have consented to the use of data for scientific purposes (e.g. as part of the enrolment contract or via separate consents) may be included. A statement from the data protection officer can also be helpful in cases of doubt. In the case of work by cross-departments, a data use agreement is also required.

If there is any doubt as to whether the project should be submitted to the Ethics Committee, enquiries can also be made by telephone via the office (Tel. 3443, Ms. Lange, Tel. 6061, Ms. Kloos or Tel. 9812, Ms. Ideker).