News

The Ethics Committee welcomes Professor Professor Bernhard M. W. Schmidt as the new Chairman of the Ethics Committee (24.06.2021)

At its regular meeting on 23.06.2021, the Ethics Committee unanimously elected Professor Schmidt, senior physician from the Clinic for Renal and Hypertensive Diseases, as its chairman.

The members, deputies and employees wish Professor Schmidt much success and all the best for the many tasks and challenges ahead and thank him sincerely for his willingness to take on this responsible task.

The management will be continued by Professor Albrecht, who has held the temporary chair in personal union with the management since January. The Ethics Committee thanks Professor Albrecht for his persistent commitment to the interests of the Ethics Committee in times of change and his service in the interest of patient protection, research colleagues and the institution.


The Ethics Committee welcomes the new members and alternates (09.06.2021)

The Ethics Committee is very pleased to announce the appointment of the following new members and alternates by the Senate.

Ms. Gentijana Xhema, student of the University of Hildesheim, Professor Dr. Bernhard M. W. Schmidt, Senior Physician, Clinic for Renal and Hypertensive Diseases and Professor Dr. Dr. Dirk O. Stichtenoth, Director of the Institute for Clinical Pharmacology, are welcomed as new members.

Professor Sabine Salloch, Director of the Institute for Ethics, History and Philosophy of Medicine, Professor Markus A. Kuczyk, Director of the Clinic for Urology and Urological Oncology, Professor Samir Sarikouch, Head of Clinical Research at the Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery and PD Dr. Christoph Schröder, Deputy Director of the Institute for Clinical Pharmacology were welcomed as alternates.

The Ethics Committee expresses its sincere gratitude for the willingness of the aforementioned persons to devote their time to the challenges of balancing research and protection interests.
 

The application procedures for clinical trials will follow the legal requirements of the MDR and the MPDG from 26.05.2021 onwards (25.05.2021)

As of 26.05.2021, the Medical Device Regulation (MDR) (Regulation (EU) 2017/745) will come into force. The national implementation is governed, among other things, by the Medizinprodukterecht-Durchführungsgesetz (MPDG). The latter replaces the Medical Devices Act (MPG) in Germany as of 26.05.2021 and is binding for manufacturers, operators and other stakeholders. 

With implementation, the legal requirements for scientific studies and IITs with medical devices will also increase.

In-house (MHH) applicants should seek advice from the KKS as the coordination center for clinical studies in the Center for Clinical Studies (ZKS) at Hannover Medical School before submitting an application for clarification of the study type and sponsor obligation.
 

Note on the processing time of studies according to professional law, §15 MBO (25.05.2021).

Studies with legal deadlines are currently processed with the highest priority, followed by research projects of all categories related to the treatment and therapy of COVID-19 disease. This prioritization may lead to the backlog of studies according to §15 of the professional code of conduct. The office of the Ethics Committee tries to process all incoming applications as quickly as possible, however, the processing time for new applications and subsequent changes can take up to six months. We kindly ask you to refrain from inquiries regarding the processing status, especially since these could lead to a further workload and thus to delays.
 

Resolution on updating the curricula for investigator courses (as of 29.03.2021) 

On 08.03.2021, the Executive Board of the German Medical Association, acting on the recommendation of the Standing Conference of the Executive Boards and the Chairpersons of the Ethics Committees of the State Medical Associations, adopted the following updated curricular courses, also approved by the Working Group of Medical Ethics Committees in the Federal Republic of Germany e.V. on 14.02.2021:

Basic Course for Investigators/Deputy Investigators and Medical Members of an Investigation Team in Clinical Trials under the German Medicines Act including Principal Investigators and Investigators under Regulation (EU) No. 536/2014 and the Medical Devices Act or Regulation (EU) No. 2017/745 and the Medical Devices Act (DOI: 10.3238/arztbl.2021.Grundlagenkurs_AMG_MPG_2021).

Advanced course for investigators/deputies or principal investigators leading an investigator group or investigator team/investigator team in clinical trials under the Medicines Act or Regulation (EU) No. 536/2014 or under the Medical Devices Act or Regulation (EU) No. 2017/745 and the Medical Devices Law Enforcement Act (DOI: 10.3238/arztbl.2021.Aufbaukurs_AMG_MPG_2021)

Refresher Course for Investigators/Deputy Investigators and Medical Members of an Investigation Team in Clinical Trials under the Medicines Law including for Principal Investigators and Investigators under Regulation (EU) No. 536/2014 and the Medical Devices Law or Regulation (EU) No. 2017/745 and the Medical Devices Law Implementation Act (DOI: 10.3238/arztbl.2021.Auffrischungskurs_AMG_MPG_2021).

The curricular continuing education courses of the German Medical Association and the Working Group of Medical Ethics Committees e.V. are available on the website of the German Medical Association:

https://www.bundesaerztekammer.de/aerzte/medizin-ethik/ethikkommissionen-der-landesaerztekammern/pruefer/

At the same time, the Executive Board of the German Medical Association has decided that the curricular continuing education courses in the version of September 16, 2016 (announcement in Dtsch Ärztebl 113; issue 40 [October 07, 2016]: A-1780 / B-1500 / C-1492) are obsolete.

(Source: https://www.aerzteblatt.de/archiv/218445/Beschluss-der-Bundesaerztekammer)
 

The ethics committee bids farewell to Prof. Dr. Stefan Engeli. Prof. Dr. Urs-Vito Albrecht takes over the function of the chairman on a provisional basis (01.02.2021)

The members of the Ethics Committee bid farewell to their chairman Prof. Dr. Stefan Engeli, Institute for Clinical Pharmacology, who has accepted a professorship at the Institute for Pharmacology at the Greifswald University Hospital. The Ethics Committee is grateful to Prof. Dr. Engeli for his many years of volunteer service to patient protection, the protection of applicants, and the institution. Professor Dr. Engeli was a member of the Ethics Committee for 11 years, which he additionally chaired since 2016. The members wish Prof. Dr. Engeli all the best for his new responsibilities.

In accordance with the decision of the Ethics Committee dated 20.01.2021, Prof. Dr. Urs-Vito Albrecht will take over the chairmanship of the Ethics Committee on a provisional basis as of 01.02.2021.
 

Attention: EU-US Privacy Shield does not provide an appropriate legal framework (28.07.2020)

Following the ruling of the European Court of Justice of 16 July 2020 [case number C3-11/18], the regulations of the EU-US Privacy Shield no longer provide a suitable legal framework, particularly against the background of the Clarifying Lawful Overseas Use of Data Act (CLOUD Act) and the Foreign Surveillance Act (FISA). Those responsible should check in each individual case to what extent personal data or data that has the potential for identifying individuals (i.e. also pseudonymised data records as defined in Art. 4 paragraph 5 DSGVO) can be transmitted in a legally secure manner, either on the basis of suitable guarantees (e.g. binding company rules, standard contractual clauses or on the basis of express consent following risk disclosure in accordance with Art. 49 paragraph 1 letter a) DSGVO). With regard to standard contractual clauses in particular, the effects of the ruling and the regulatory guidelines likely to follow remain to be closely monitored by the competent authorities. Sponsors are therefore strongly advised to consult with the competent state commissioner for data protection.
 

General Information (10.07.2020)

  • In light of the current situation, the Ethics Committee's office is returning to the old processes.
    • All studies must therefore be submitted both in paper form and electronically.
  • In order to contribute to slowing down the spread of the corona virus, the Ethics Committee asks to refrain from any visits to our  office.
  • For any inquires, please contact us by phone or e-mail. Applications should be sent to the office using in-house or regular postal service and not be delivered to our office in person.
  • Information provided by the  Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V.: Covid-19 and its effects - Information for sponsors and applicants: https://ak-med-ethik-komm.de/index.php?lang=en
  • Amendments for master studies may still be submitted electronically.