New ethics committees start: focus on protection for test subjects!

New ethics committees start: focus on protection for test subjects!

On July 1, 2025, a new expert committee at the Federal Institute for Drugs and Medical Devices (BfArM) will begin its work to improve the ethical assessment of complex clinical trials. How b-tu.de reports, this committee is part of the Medical Research Act, which aims to strengthen drug research and development in Germany. In particular, the committee will examine ethical aspects of first-in-human studies as well as clinical trials with novel therapies and complex study designs.

The main goal of this initiative is to protect study participants and promote scientific progress. The study should be checked more quickly and with higher quality. The members of the committee will work closely with other ethics committees and scientific institutions to ensure high ethical standards. In addition, strengthening Germany as a location for medical innovations is a central concern of this reform.

The role of ethics committees in research

Ethics committees play a crucial role in medical research by ensuring that clinical studies on patients or healthy volunteers are reviewed beforehand. Again German Ethics Council emphasizes, the vote of these commissions is legally binding for studies carried out in accordance with the Medicines or Medical Devices Act. It is particularly important to consider ethically research projects that concern people who are unable to give consent, such as children or people with disabilities.

The Helsinki Declaration is a central document for the ethical conduct of research involving human subjects. She emphasizes the importance of protecting test subjects in order to prevent vulnerable groups from being excluded from medical advances. This shows that there must be a balance between the protection of these people and the need for research.

Insight into the work of Robert Ranisch

The focus of the new committee is Prof. Dr. Robert Ranisch, who has been teaching as a tenure track professor of medical ethics at the University of Potsdam since 2021. Ranisch studied at the University of Warwick, Jena and Oxford (philosophy) and completed his doctorate in Düsseldorf and Tübingen (biomedical ethics). The Brandenburg Faculty of Health Sciences, where he works, was founded in 2018 and brings together several institutions to develop innovative medical and nursing care offerings and study programs.

The Working Group of Medical Ethics Committees (AKEK), an association of 49 ethics committees, also promotes ethical integrity in medical research. Loud akek.de These commissions ensure that clinical studies can only begin with a positive vote. Under the motto “One study – one vote”, AKEK and the German Medical Association have also decided on a procedure to standardize and simplify the approval of multicenter studies.

In summary, it can be said that the new ethical commission represents a significant innovation in the German healthcare system. It aims to improve the framework conditions for clinical research while at the same time guaranteeing the protection of study participants. In this way, Germany could strengthen its position in the international comparison of medical innovations and enable faster access to novel therapeutic approaches.