Ethikkommission Approval and Publication in Germany: What Research Articles Must Show Before Submission

For biomedical research on people in Germany, the Ethikkommission decision, often called the Ethikvotum, is one of the first things journals expect to see documented. This guide explains what a research article must show about ethics approval in Germany before submission, which studies are affected, and how to word the ethics statement.

An Ethikkommission is an independent, interdisciplinary research ethics committee, set up for example at a state medical chamber (Landesärztekammer) or at a medical faculty. Under § 15 of the Berufsordnung (professional code), physicians must seek advice from such a committee before biomedical research on people, including research that uses body material or data linked to an identifiable person [3, 4].

The professional code is Land law, so the binding wording is each chamber’s own. The 2025 amendment for North Rhine, for example, requires advice from a committee at the chamber, at a medical faculty or established under Land law, and refers to the 2024 Declaration of Helsinki [4]. In May 2026 the German Medical Assembly made matching changes to the national model code (MBO-Ä): it now refers to the 2024 Declaration and adds a duty for participating physicians to notify their own committee [5]. Physicians must also disclose their relationships to the sponsor when publishing results [4, 5]. Both points belong in your manuscript.

A retrospective study is not automatically exempt. § 15 itself covers the use of data that can be linked to a person, such as a chart review, and the Declaration of Helsinki covers research using identifiable human material or data [1, 4]. Ask the competent committee for a written decision, including a documented waiver where it applies. For the parallel UK rules, see UK case report ethics approval.

The ICMJE recommendations ask authors to report ethics review and consent for research on people [2]. A complete ethics statement normally contains:

• Name and location of the Ethikkommission.
• Reference number and date of the Ethikvotum.
• Version of the protocol that was approved, and any approved amendments.
• How informed consent was obtained (written or oral), or the committee’s decision to waive it.
• Statement of compliance with the Declaration of Helsinki (2024 revision) [1].
• Disclosure of the sponsor and funding relationships [4].

The German Clinical Trials Register (DRKS) is the national register and a WHO ICTRP primary registry, so it meets the ICMJE requirement [7]. The Declaration of Helsinki states that research must be registered in a publicly accessible database before the first participant is recruited [1], and the ICMJE requires clinical trials to be registered at or before the time of first patient consent for enrolment [2] (see ICMJE compliance support). Include the registry identifier in the abstract and Methods; our clinical trial manuscript submission checklist covers the rest.

• When collaborative research is performed internationally, the Declaration of Helsinki requires the protocol to be approved by committees in both the sponsoring and the host countries [1].
• State how personal data were processed and protected. The GDPR (Datenschutz-Grundverordnung) applies to personal data processed in the EU; see GDPR Article 9 and patient data in manuscripts.
• Keep the consent for study participation distinct from the legal basis for data processing, and describe both clearly.

• Seeking ethical approval after data collection has begun; the protocol must reach the committee before the research starts.
• Omitting the reference number or date from the manuscript.
• Analysing a different population or aim from the one approved.
• Writing “exempt” or “not required” without a written committee decision.
• Forgetting that amendments need approval.
• Leaving out the sponsor relationship disclosure [4].