Ethics Committees

The Role of Ethics Committees (EC) in international research

The role of Ethics Committees and their mandatory or recommending nature varies from country to country. Hella von Unger and Dagmar Simon published an overview of Ethics Committees in international comparison as RatSWD – German Data Forum Working Paper (german). Our guidance is focused on the German perspective on EC.

Under which circumstances is the approval of an ethics committee required?

Unfortunately, circumstances under which the approval of an Ethics Committee (EC)/ Institutional Review Board (IRB) has to be obtained are not clearly defined for psychological studies. As initial guide, the German Research Foundation‘s (DFG) guidance for the social sciences and humanities (available in German only) may be helpful:

The DFG states that a study requires ethical approval whenever the participants

  • have to endure high emotional or physical strains,
  • cannot be fully informed about the purpose of the study,
  • are patients,
  • undergo fMRI (functional Magnetic Resonance Imaging) or TMS (Transcranial Magnetic Stimulation) during the course of the study.

Aims of the ethics vote are (among others) minimizing risks for participants, analyzing cost and benefit of the study and checking if informed consent is  obtained appropriately (see the knowledge base’s section on informed consent).

If your research involves psychotic drugs or other substances which are designed to treat medical conditions, these substances will likely fall under the Arzneimittelgesetz (AMG, Medicines Act) or the corresponding legislation in your country. In this case, additional legal regulations like the AMG and the Guidelines for Good Clinical Practice apply and you will probably need the approval of a medical EC which means that the approval of a psychological EC is not sufficient.

In case you are not sure if you need approval (e.g. your study partially fulfills the criteria mentioned above) contact your institution’s EC and ask if approval is deemed necessary.

Further Resources