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The Institute of Biometry and Clinical Epidemiology (iBiKE) is committed to the work of medical ethics committees in many respects.
- We help you to prepare your ethics proposal, so that your research project can get started quickly.
- We ourselves are active as members of the Berlin Ethics Committees both within the Charité and at the Regional Office for Health and Social Affairs Berlin (LAGeSo).
- We are committed to Germany-wide standards and guidelines for the biometric assessment of ethics applications.
Setting National Auditing Standards
The joint project group “Biometry in ethics committees” of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS) e. V. and the German Region of the International Biometric Society was founded in 2017 and aims to strengthen the work of biostatisticians in medical ethics committees by offering specific training (in methods as well as communication of statistical issues to non-statisticians), establishing a communication network for mutual support, and developing specific guidelines which allow a standardized, high quality statistical review of study protocols.
The institute is actively involved in several projects of the working group.
- In 2019 a series containing 16 articles named "Die Rolle medizinischer Ethikkommissionen in Deutschland: Gesetzliche Anforderungen und gesellschaftliche Erwartungen"was published in Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz, Volumne 6/2019.
- A comprehensive online survey was conducted among statistical members of medical ethics committees in Germany on their personal impression of completeness and correctness of biostatistical aspects of submitted study protocols.
Ethical Issues in Medical Research Projects on Humans
For almost all medical research projects on humans, you are obliged to submit an ethics application to the responsible ethics committee. You will also be invited to comment on biometric aspects of the planned research project. In particular, the study design and number of cases must be suitable to answer the research question at all. The iBiKE contributes to the observance of the highest scientific standards through its commitment to consulting and its membership in the ethics committee of the Charité.
Members of the Charité Ethics Committee: PD Dr. Ulrike Grittner, Andrea Stroux
Ethical Issues in Medical Research Projects on Animals
For certain medical research questions, especially in basic medical research, the use of animal experiments is crucial. However, the ethical problems involved are many and diverse. In particular, study design and case numbers must be suitable in order to be able to answer the research question at all and at the same time to do justice to animal welfare. The iBiKE contributes to the observance of the highest scientific standards in animal experiments through its involvement in advising on the planning of animal experiments and as a deputy member of the Ethics Commission of the Regional Office for Health and Social Affairs Berlin (LAGeSo).
- Project Manager: Prof. Dr. Frank Konietschke
- Project Members: Dr. Sophie Piper, Robert Röhle, Andrea Stroux, Dario Zocholl
- Term: since 2019