Medizinische Fakul­tät OWL

Applications for research projects by physicians belonging to the Chamber must be submitted to the EK WL and discussed in accordance with the professional code of conduct.

• If medical members and/or members of the Medical School OWL are involved in a biomedical research project, an application must be submitted to the EK WL in accordance with the professional regulations (Section 15 (1)) of the Westphalia-Lippe Medical Association (ÄKWL).
• This applies regardless of whether the doctor involved is the (main) applicant or is only involved and regardless of whether other (main) applicants involved belong to another Faculty of Bielefeld University.
• If the project has already been reviewed by an external medical ethics committee established in accordance with state law, the EK WL has the option of obtaining a follow-up vote in an accelerated procedure.

Research projects that are legally required to be reviewed by a medical ethics committee must be submitted to and discussed with the EK WL, regardless of the constellation and affiliation of the applicants.

This includes the following cases:

• Clinical trials of medicinal products and medical devices (Regulation (EU) No. 536/2014 and AMG as well as Regulation (EU) 2017/745 and MPDG) as well as performance studies with in vitro diagnostic medical devices (Regulation (EU) 2017/746 and MPDG)
• Donor immunisation in accordance with the Transfusion Act (TFG)
• Research projects involving the use of X-rays or ionising radiation or radioactive substances for the purpose of medical research in accordance with the Radiation Protection Act (StrlSchG)

For research projects as part of qualification theses (Bachelor's, Master's and doctoral theses) that require consultation by a medical ethics committee in accordance with the above principles, the ethics application must be submitted to the EC WL.

• Candidates who are already licenced can submit the application themselves.
• For candidates who are not yet licenced, the supervising physician submits the application.

Non-physician members / non-physician members of the Med. OWL can contact the EUB for projects for which there is no legal requirement for review by a medical ethics committee (see above).

• This includes the following cases:
  • Observational studies and epidemiological studies with a psychological or health science focus
  • Projects that involve medical data and for which a favourable data protection assessment has been received from Bielefeld University. The Data Protection Officer for Medicine(datenschutz.medizin@uni-bielefeld.de) provides support in the preparation of the data protection concept.
• In borderline cases, the EUB decides on the admission of an application.
• Cases whose assessment requires the professional (medical) expertise of a medical ethics committee are generally rejected as inadmissible.
• Further information and the necessary documents can be found on the EUB website.

On the basis of a case-by-case assessment, an assessment by the EUB may also be possible in cases where medical members / medical staff of the Medical School OWL are involved, in which the exception rule of the Medical Professional Code (Section 15 (1)) applies and research projects are to be assessed that fall within the competence of the EUB in terms of content (e.g. no biomedical project and no other legal requirement for review by a medical EC). This applies regardless of whether the doctor involved acts as the (main) applicant or is only involved and regardless of whether other
involved (main) applicants belong to another Faculty of Bielefeld University.

To clarify responsibility, a one-page project description must be submitted to the EUB in advance.

• EUB review cases generally include the following cases:
  • Observational studies and epidemiological studies with a psychological or health science focus
  • Projects that involve medical data and for which a favourable data protection assessment has been received from Bielefeld University. The Data Protection Officers for Medicine(datenschutz.medizin@uni-bielefeld.de) provide support in drawing up the data protection concept.
• However, the use of the EUB's basic questionnaire is excluded in this case. The detailed questionnaire must be used.
• In borderline cases, the EUB decides on the admissibility of an application.
• Cases whose assessment requires the professional (medical) expertise of a medical ethics committee are generally rejected as inadmissible.
• Further information and the necessary documents can be found on the EUB website.