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Overview
Overview
Overview
New Guidelines for Submitting Other Research Projects via ethikPool
The guidelines for submitting other research projects have been updated and adapted to the current subject areas in ethikPool.
The new version is available in the download section under “Other Research.” In addition to information on the submission process, the guidelines include practical tips and assistance regarding the required application materials and the documents that must be attached.
Compliance with the registration requirement under Section 8 of the GDNG
Please note that certain research projects involving health data are subject to a registration requirement under Section 8 of the Health Data Use Act (GDNG).
If, as part of a research project, health data is processed for research purposes without the consent of the data subjects pursuant to the GDNG, the project must be registered in a primary registry for clinical trials recognized by the World Health Organization (WHO) before data processing begins.
This registration requirement is not limited to specific study designs and may apply to both prospective and retrospective research projects, provided that the requirements of Section 8 of the GDNG are met.
Please note that registration must take place before data processing begins. Further information can be found in Section 8 of the GDNG: https://www.gesetze-im-internet.de/gdng/8.html
New application category "Qualitative Studies" with a new checklist, "Study Protocol Variant E"
A new application category for “Qualitative Studies” is now available in ethikPool.
Form 6, “Study Protocol Checklist, Variant E,” for qualitative studies has been approved by the ethics committees organized under the Working Group of Medical Ethics Committees in the Federal Republic of Germany (Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V.).
You can find the templates for this category in the download section under “Other Research.”
Depending on your research project, you may need to submit additional documents.
AKEK Forum “One Study—One Vote”
We would like to draw your attention to the AKEK forum “One Study – One Vote.”
The “One Study—One Vote” procedure has now become established nationwide. Since questions continue to arise in practice regarding the specific implementation of the procedure, the guidelines, and specific individual cases, the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK) (AKEK) is offering an online training course for physician researchers and other academic applicants.
We cordially invite you to share this invitation through your channels.
Event Details
- Title: AKEK Forum “One Study – One Vote”
- Date: Wednesday, September 30, 2026
- Time: 10:00 a.m. to 12:00 p.m.
- Format: Online event
To ensure a discussion that is as practical and focused as possible, questions may be submitted in advance by September 7, 2026, at the latest, to geschaeftsstelle@akek.de.
Registration is via the registration form on the AKEK website: AKEK Forum “One Study – One Vote” – AKEK – Working Group of Medical Ethics Committees
Please note that the number of participants in the video conference is limited for technical reasons. Advance registration is therefore required. Access details will be sent in a timely manner before the event begins once your registration has been confirmed.
Further information is available on the AKEK website at www.akek.de.
Publication by DEGRO and BfS on the Medical Research Act
The AKEK Working Group on Radiation Protection would like to draw your attention to a joint publication by the German Society for Radiation Oncology (DEGRO) and the Federal Office for Radiation Protection (BfS) on the Medical Research Act.
Here is the link:
https://link.springer.com/article/10.1007/s00066-025-02488-8
This publication is available under an “Open Access” license and can therefore be accessed for free at the link provided.
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
Please note that, as of February 1, 2026, the use of the checklist “Study Protocol/Project Plan, Version D: Retrospective Analysis of Routine Clinical Data” is required for the submission of purely retrospective medical research projects.
Applicants can find the current sample form (Variant D) in the “Application Process” tab under “Other Research” (New Applications for Other Studies).
The amendment to Section 15 of the Professional Code of Conduct for Physicians in North Rhine-Westphalia (which took effect on July 23, 2025) also applies to purely retrospective research projects. These are no longer exempt from the consultation requirement.
Consequently, purely retrospective research projects are also subject to the consultation requirement.
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.
For detailed information on this procedure and all required documents, please see "Other Research".
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:
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.