From the MHH

In the race for contracts for the ethical evaluation of clinical trials

Dr Susan Fischer-Huchzermeyer is the new Managing Director of the Lower Saxony State Ethics Commission in the process of being established

Portrait of Dr. Susan Fischer-Huchzermeyer

Managing Director of the Lower Saxony Ethics Commission in foundation: Dr. Susan Fischer-Huchzermeyer. Copyright: Karin Kaiser/MHH

Before a new drug is launched on the market, it is tested in humans in clinical trials. In multinational Europe, these often involve numerous university hospitals and research institutions in several countries - each with their own regulations on laws and regulations for the approval, monitoring and evaluation of studies. In order to make clinical research in Europe less bureaucratic and therefore more attractive for clients from all over the world, the European Union introduced a new regulation (EU Regulation 536/2014) on January 31, 2022. This "Clinical Trial Regulation" aims to standardize the legal requirements and evaluation and monitoring procedures for the review of medicinal products throughout the EU and will thus fundamentally change clinical research in Europe. One consequence of the new regulation is that each study will be assigned to a competent ethics committee in each participating country. It checks in advance whether the research project is ethically sound and whether the study centers involved are suitable.

In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) are responsible for the approval of drugs. Until now, the ethical assessment has been carried out by a lead ethics committee in consultation with the responsible ethics committees of all university hospitals and research institutions involved in the study - a huge effort for the sponsors, usually pharmaceutical companies. With the new EU regulation, only one ethics committee from the pool of ethics committees registered with the BfArM will be commissioned for drug studies submitted after January 31, 2023. And only this ethics committee will then receive money from the Federal Institute for its work. No ethics committee from Lower Saxony is yet represented on this list. The three university hospitals in Lower Saxony - Hannover Medical School, University Medical Center Göttingen and Carl von Ossietzky University Oldenburg - now want to change this and register together as the Lower Saxony State Ethics Committee.

Amending the Medical Professions Act

In future, the day-to-day business of the universities' own ethics committees will continue to include the assessment of studies on medical devices such as implants, catheters or X-ray devices or so-called studies that are advised in accordance with the professional code of conduct for doctors. These are all other studies that have to do with patients or their data. At the MHH, there were around 500 studies last year. The three university hospitals want to pool their expertise from the various medical specialties in order to continue to have a say in the ethical safety of clinical drug trials. Before they can act as a cross-location state ethics committee for Lower Saxony, the Medical Chamber Act must be amended.

This is because it currently only provides for ethics committees at the individual universities and the Lower Saxony Medical Association. Dr. Susan Fischer-Huchzermeyer, Managing Director of the state ethics committee currently being established, is coordinating the proposal. "We are currently preparing a draft bill, which we will then submit to the responsible Lower Saxony Ministry of Social Affairs," she says. The biochemist also has to ensure that the three ethics committees involved harmonize their processes and use the same database system in which the documents for the clinical trials are processed and archived.

Broad-based expertise

Dr. Fischer-Huchzermeyer, who has previously worked as a strategy consultant for pharmaceutical companies and has also been involved in conducting clinical trials herself, has been constantly moving between the three sites and attending the meetings of the respective ethics committees since taking up her position as Managing Director in April 2024."We are well prepared for the task ahead because we have a broad professional base and many years of expertise," she emphasizes. Following successful registration, she estimates that the new state ethics committee could be assigned a new clinical trial approximately every one to two weeks according to the BfArM's business distribution plan. This would then be examined at one of the three sites on a regular basis. However, it is left to chance whether or not the study involves Lower Saxony.

The MHH Ethics Committee

In 1964, the World Medical Association formulated ethical principles for medical research on humans in the Declaration of Helsinki. On this basis, ethics committees were also gradually established in Germany. It was set up at the MHH in 1982 at the instigation of Professor Dr. Rudolf Pichlmayr, who was also its first chairman. The MHH Ethics Committee is independent and advises MHH researchers on whether a research project meets all the necessary requirements - in terms of law, ethics and data protection. Professor Dr. Bernhard Schmidt has chaired the committee since June 2021.

Text: Kirsten Pötzke