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Publikation von DEGRO und BfS zum Medizinforschungsgesetz
Die AG Strahlenschutz des AKEK möchte Sie auf eine gemeinsame Publikation der Deutschen Gesellschaft für Radioonkologie (DEGRO) und des Bundesamtes für Strahlenschutz (BfS) zum Medizinforschungsgesetz aufmerksam machen.
Hier der Link:
https://link.springer.com/article/10.1007/s00066-025-02488-8
Diese Publikation unterliegt „Open Access“, ist dort also frei verfügbar.
Authorization to submit an application
Please note: The consent of the clinic management to the use of data in the context of a research project can also be given by the deputy clinic management. This must be in writing.
NIS studies (Non-Interventional Studies) are subject to prospective requirements
Applicants with NIS projects are advised that NIS studies must be classified as prospective studies with immediate effect. There is no longer a separate "NIS" application category in ethikPool. Instead, NIS applications must be submitted under the category "Prospective" (variant A).
Requirements for NIS applications:
- Submission with checklist study protocol variant A - prospective
- Compliance with all requirements for prospective research projects
- Complete documentation according to the prospective standards
- Application in ethikPool under the category "Prospective", not under a separate NIS category
The relevant documents and checklists can be found in the tab "Application procedure" → "Other research" under the section "New applications for other studies"
Changes to the submission of purely retrospective studies from February 1st, 2026
Please note that the use of the checklist “Study Protocol/Project Plan Variant D: Retrospective Evaluation of Data from Routine Clinical Practice” will be required for the submission of purely retrospective medical research projects from February 1, 2026.
Applicants can find the current sample form (Variant D) on the website of the Working Group of Medical Ethics Committees (AKEK) at the following link:
From January 2026, we will participate in the harmonized "One study - one vote" procedure
In the "one study - one vote" procedure, a single application from the overall study management to the responsible ethics committee is sufficient. After this committee has given its vote, all other local study centers notify the ethics committees involved of their participation in the research project.
Accordingly, there are different application categories in the course of this procedure:
- Application dossier (overall study management to the responsible EC)
- Notification dossier (other participating local study centers to participating/local EC)
- Amendment dossier (for amendments )
Please note the Guidelines for submitting applications of the AKEK.
Detailed information on this procedure and all documents to be submitted can also be found on the website of the Arbeitskreis Medizinischer Ethik-Kommissionen in der BRD e.V.
Please note the legal changes in radiation protection law from 01.07.2025!
From July 1, 2025, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) will be responsible for the notification procedure. It will no longer be possible to submit initial notifications to the Federal Office for Radiation Protection (BfS) from this date.
ATTENTION: This also applies to change notifications, regardless of whether the original / initial notification for the corresponding research project was received before or after 01.07.2025.
EXCEPTION: Notified radiation applications that become applications requiring approval from 01.07.2025 (because the research project is not a clinical trial within the meaning of Section 4 para. 23 of the German Medicinal Products Act (AMG), within the meaning of Art. 2 no. 45 of Regulation (EU) 2017/745 or another clinical trial within the meaning of Section 3 No. 4 of the Medical Devices Implementation Act (MPDG)), remain valid as a notification (i.e. do not have to be subsequently transferred to the approval procedure). For significant changes to these notified radiation applications, the radiation protection regulations continue to apply in the version valid until June 30, 2025; these studies therefore remain subject to notification to the BfS. The documents for change notifications for such individual cases can be found on the BfS website.
For further information, as well as the associated and therefore relevant documents, please visit the AKEK website:
"One study - one vote": Information on simplified consultation for multicenter studies in accordance with Section 15 of the Professional Code of Conduct
On 14/15 June 2024, the Working Group of Medical Ethics Committees and the German Medical Association adopted principles for a procedure for the nationwide standardization of professional advice on research projects in accordance with the (Model) Professional Code of Conduct for Physicians Practising in Germany (MBO-Ä). For multi-center medical studies, a single vote by an ethics committee established in accordance with state law is to be sufficient. Information on the resolution and details on the procedure can be found in the press release of the German Medical Association and the AKEK.
The Ethics Committee of the Faculty of Medicine expressly welcomes this decision and is working on implementing it as soon as possible in its own area of responsibility. However, this first requires a change in the legal basis for the activities of the Ethics Committee and the corresponding regulatory approval.
Until then, the current procedure will continue to apply.
Declaration of assumption of costs required for applications for amendments to "other clinical trials"
Please note when submitting substantial amendments to studies that are advised according to professional law or statutes ("other studies", in ethikPool: "other medical research") that from 01.01.2025 a declaration of assumption of costs must be submitted subsequently, unless this has already been submitted with the initial application. This is also required if a fee waiver has been granted.
Note on the auditor qualifications
We would like to point out that for clinical trials conducted in accordance with EU Regulation 536/2014, the principal investigators, investigators and medical members of the trial team must provide evidence of appropriately updated regulatory knowledge. If participation in the basic or advanced course took place before 12.06.2020, proof of participation in an update course in accordance with the curriculum of the German Medical Association is required in addition to the basic or advanced course (see announcement of the German Medical Association. Dtsch Arztebl. 2022;119(19):A-888). Please note that a "refresher course" does not necessarily reflect the contents of this curriculum.