Current information
One study - one vote: Standardized procedure for professional advice on research projects
On 14/15 June 2024, the German Medical Association (BÄK) and the Working Group of Medical Ethics Committees in the Federal Republic of Germany e. V. (AKEK) adopted a procedure for the nationwide standardization of professional advice on research projects in accordance with the (Model) Professional Code for Physicians Practising in Germany (MBO-Ä).
Content of the procedural regulation
For multicenter medical studies, a single vote by an ethics committee formed in accordance with state law is sufficient.
The Ethics Committee of Hannover Medical School expressly welcomes this resolution and is working to implement it as soon as possible in its own area of responsibility.
The new procedure will apply to the Ethics Committee of Hannover Medical School from January 2, 2025.
Until then, the previous procedure will continue to apply.
The procedural regulation can be found under the following link on the AKEK website: https://www.akek.de/wp-content/uploads/2024-06-20_PM_Gemeinsame-PM_AKEK_Verfahrensvorschlag.pdf
Current information
Lower Saxony founds Ethics Committee - Dr. Susan Fischer-Huchzermeyer is the new Managing Director
...With a new EU regulation, for drug studies submitted after January 31, 2023, only one of the pool of Ethics Committees registered with the BfArM for this purpose will be commissioned 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 - the MHH, the University Medical Center Göttingen and the Carl von Ossietzky University of Oldenburg - would now like to change this and register together as the Lower Saxony State Ethics Committee. ...Dr. Susan Fischer-Huchzermeyer, Managing Director of the state ethics commission currently being founded, is coordinating the application. ...The biochemist will also ensure that the three Ethics Committees involved harmonize their processes and also use the same database system in which the documents for the clinical studies are processed and archived.
Kirsten Pötzke
Farewell to Prof. Lohff and Prof. Vogt on 10.04.2024
The Commission would like to thank Prof. Lohff for almost thirty years of service on the Ethics Committee. Over the decades, she has significantly shaped the work of the Commission. The Commission would also like to thank Prof. Vogt for his valuable cooperation.
40 years of the Ethics Committee of Hannover Medical School
The first meeting of the MHH Ethics Committee took place on June 8, 1982. This was honored with a small ceremony at the anniversary meeting on June 8, 2022.
The Ethics Committee welcomes Professor Bernhard M. W. Schmidt as the new Chair of the Ethics Committee (24.06.2021)
At its regular meeting on 23.06.2021, the Ethics Committee unanimously elected Professor Bernhard M. W. Schmidt, Senior Physician from the Clinical Department of Nephrology and Hypertension, as its Chairman.
The members, deputies and staff wish Professor Schmidt every success and all the best for the many tasks and challenges ahead and thank him warmly for his willingness to take on this responsible role.
The application procedure for clinical trials will follow the legal requirements of the MDR and the MPDG from 26.05.2021 (as of 25.05.2021)
The Medical Device Regulation (MDR) (Regulation (EU) 2017/745) comes into force on May 26, 2021. National implementation will be regulated by the Medical Devices Implementation Act (MPDG), among other things. The latter replaces the Medical Devices Act (MPG) in Germany as of 26.05.21 and is binding for manufacturers, operators and other stakeholders.
With its implementation, the legal requirements for scientific studies and IITs with medical devices will also increase.
MHH-internal applicants should seek advice from the KKS as Coordination Center for Clinical Trials in the Center for Clinical Trials (ZKS) at Hannover Medical School www.mhh.de/zks before submitting an application to clarify the type of study and the sponsor obligation .
Note: EU-US Privacy Shield not a suitable legal framework (as of 28.07.2020)
Following the ruling of the European Court of Justice on July 16, 2020 [case number C3-11/18], the provisions of the EU-US Privacy Shield are no longer a suitable legal framework, particularly in light of the Clarifying Lawful Overseas Use of Data Act (CLOUD Act) and the Foreign Surveillance Act (FISA). In individual cases, data controllers should examine the extent to which personal/personally identifiable data (i.e. also pseudonymized data records within the meaning of Art. 4 para. 5 GDPR) can be transferred in a legally secure manner either on the basis of suitable guarantees (such as binding corporate rules, standard contractual clauses or on the basis of express consent after risk disclosure in accordance with Art. 49 para. 1 lit. a) GDPR). With regard to the standard contractual clauses in particular, the effects of the ruling and the regulatory guidelines that are likely to follow will need to be closely monitored by the competent authorities. Sponsors are therefore strongly advised to consult with the competent state data protection officer.