The Ethics Committee examines research project proposals by members of the University of Konstanz that could affect the health, human dignity or personal rights of human test subjects.
When does the Ethics Committee (not) get involved?
The Ethics Committee does not address questions of ethical animal treatment, dual-use issues or general research ethics questions, which do not affect the health, dignity or personal rights of human test subjects. It is very important that those performing scientific studies take responsibility for their actions and abide by the respective ethical norms for their field of study (politics, educational sciences, etc.) For example, research in the field of sports science that is non-invasive and mainly addresses sport-scientific questions is not supervised by the Ethics Committee. However, we still ask researchers of such projects to take particular care to provide test subjects with ample information, to explain the experiment in everyday language, to inform about the corresponding risks and benefits and to address privacy requirements.
Submit an application to the Ethics Committee
To assure that the Ethics Committee is aptly informed and can decide quickly, the application should include the following documents:
Application text (approx. 2 pages)
Your text should provide a concise but informative description of your project (basic rationale and approach chosen); usually half a page will be sufficient. Please keep the language simple, since members of the Ethics Committee come from different scientific fields and are not necessarily experts in your discipline. The following issues/items should be addressed briefly under separate subheadings:
- which methods, technical devices, psychotherapy approaches, etc. will be used,
- how exactly data protection requirements will be fulfilled,
- are any invasive methods used,
- are any medication/s administered, how have the used dosages/application routes been decided,
- which risks for the human test subjects can be expected, and which precautions you will take to reduce risks or avoid/minimise problems that might arise during the experiment, give information in tabular format with the following aspects
- Potential hazard causes
- Effects of the hazard / severity of consequences
- Your assessment of respective hazard probability
- Measures to minimize risks
- based on the given information, summarise briefly why the Ethics Committee is being consulted for approval of this research project
Applicant’s Curriculum Vitae
- The applicant has to hold a doctoral degree or have at least three years of research and work experience after completing his/her education.
- There can be only one applicant who is responsible for the entire study. He/She can, however, delegate certain sub-projects to another person. At any rate, this applicant remains responsible for the entire project.
- Supervisors will need to apply on behalf of their master’s or doctoral students. If a specific student is strongly involved in a project, he/she shall/may be mentioned by name.
- Projects in the application phase and complex projects with several individual studies: here a quick pre-assessment of the project strategy is possible, with the issuing of an IRB number for indication to the funder. Usual documents are submitted as for full proposals, but specific subject information sheets etc. are not necessary at this stage. A normal full proposal should be submitted if concrete individual studies are actually to be started.
- Here you can see the process flow for the appraisal process.
Attachment: Information sheet for human test subjects
Please include a copy of the information sheet that will be given to the test subjects in your application.
Descriptions of experiments are often not written in everyday language that the test population will understand and/or these descriptions fail to include an explicit description of the experiment’s risks and benefits for the test subjects.
Attachment: Declaration of consent for human test subjects
Please include a copy of the informed consent form that human test subjects will sign (example).
Attachment: Project application
Please include a copy of the project description or research proposal that the Ethics Committee is to provide a decision on.
Process and basis for decision-making
The chair of the Ethics Committee is responsible for deciding on the subsequent procedure.
- Generally, the documents are circulated among the committee members for approval. In approximately six to eight weeks, you will receive notification of the committee’s final decision.
- Only in exceptional cases will the committee make its decision in a meeting. In this case, you will receive notification of the decision shortly after it has been made.
- Minor changes to a current project shall be communicated via a simplified procedure (providing notice). In one to two pages, summarise the project (including the reference to the corresponding application), its current status, the proposed changes and the reason/s why these changes will most probably not affect the original ethical assessment. The changes are considered approved, as long as the Ethics Committee has not raised an objection within three weeks of the notice.
- If a project involves experiments on human test subjects, the Ethics Committee will decide in accordance with the principles of the Declaration of Helsinki (in the 2008 Seoul version).
The applicant is solely responsible for fulfilling data protection regulations - the Ethics Committee does not supervise this aspect of research projects. For extensive information on this subject, please visit the “Zentrale Datenschutzstelle” (ZENDAS) website. This institution provides legal, technical and organisational support to universities in Baden-Wuerttemberg. Comprehensive information on the topic is available on their website (in German). For further legal questions, especially those involving informed consent, data storage, handling of data keys, protection of storage media and the separation of personal from other data, please contact Anuschka Haake-Streibel for legal advice, or Dietrich Dornbusch for IT-specific issues.
For projects involving experiments on children, please check the guidelines and recommendations (in German) published by the Zentrale Ethikkommission (ZEK).
Tips for informed consent forms and information sheets
It is very important for you to use clear, easy to understand wording and explanations. Please avoid using medical/technical terms which are too advanced for your test subjects’ expected educational background.
Please be sure to get all approvals required by German law in time as well as to observe all other relevant requirements stated in the following laws:
- Experiments involving human test subjects or human materials: Embryonenschutzgesetz (embryo protection), Stammzellgesetz (stem cells), §§ 40 - 42 Arzneimittelgesetz (pharmaceutical products), §§ 17 - 19 Medizinproduktgesetz (medical products)
- Animal testing: Tierschutzgesetz (animal protection)
- Genetic experiments: Gesetz zur Regelung der Gentechnik (genetic engineering)
- Research subject to the Convention on Biological Diversity (CBD): Convention on Biological Diversity CBD and the DFG’s Supplementary Instructions for the CBD
For DFG proposals, please follow the instructions listed under 4.1 in the guidelines to writing proposals.