Arbeitskreis Medizinischer Ethik-Kommissionen

The Arbeitskreis Medizinischer Ethik-Kommissionen (AKEK) is a central association of 49 public law ethics committees in Germany that deal with the evaluation of biomedical research projects according to scientific, ethical, and legal criteria.

The main mission of the AKEK is to support the medical ethics committees in their activities and to ensure essential ethical standards in research involving humans. The AKEK advocates for the protection of rights and the safety of study participants as well as for the freedom of research. The preservation of ethical integrity and scientific quality in medical research is at the core of the AKEK's actions[1][2].

• Evaluation of Research Projects: The AKEK supports the ethics committees in evaluating medical research projects, including clinical studies with drugs and medical devices. Without the positive vote of an ethics committee, it is not permitted to start such studies in Germany[2].
• Training and Conferences: The AKEK regularly offers training for members and staff of the ethics committees and organizes scientific conferences to discuss current issues in research[1].
• eTIC (electronic Tool for Informed Consent documents): The software eTIC recommended by the AKEK helps researchers create ethically and legally correct and understandable documents for informed consent for studies. This tool is particularly useful for creating informational materials for various types of studies and is also available in easy language[3].
• Harmonization and Standardization: The AKEK works on harmonizing the consultation and evaluation of studies and develops template texts and recommendations to standardize the formal evaluation processes without compromising the independence of the individual ethics committees[1].

• Participant Protection: A central goal of the AKEK is the protection of the rights and welfare of study participants. This includes ensuring that all necessary information and consent forms are properly and transparently provided[1][4].
• European and National Cooperation: The AKEK is actively engaged at the European level and works closely with authorities, ministries, and other organizations to support and shape legal and regulatory requirements[1].
• Patient Representatives: The AKEK maintains contact with various patient representatives to incorporate the perspective of patients in clinical studies and to ensure that their needs and rights are taken into account[1].

• Adaptation to EU Regulations: The AKEK supports the implementation of EU Regulation 536/2014 for clinical trials and ensures that the ethics committees and researchers are informed about the necessary adjustments and deadlines[2].
• Research Award: Annually, the AKEK awards a research prize to scientists who make a significant contribution to addressing research ethics questions[1].

The AKEK plays a crucial role in ensuring ethical and scientific standards in medical research in Germany and beyond. Through its diverse activities and initiatives, the AKEK promotes the integrity and quality of research and protects the rights of study participants.

• 1 - https://www.akek.de/ueber-uns/
• 2 - https://www.akek.de
• 3 - https://www.akek.de/etic-2/
• 4 - https://www.akek.de/covid-19/
• 5 - https://www.akek.de/sonstige-studien/