Did you know that up to now, every ethics committee has decided according to its own standards?

Before starting, every clinical trial must be discussed by an ethics committee before subjects or patients can be approached or even included in such a study. Up to now, the various ethics committees have all had their own standards and requirements.

overview

The Federal Medical Association (BÄK) and the Working Group of Medical Ethics Committees (AKEK) have for the first time created binding standards for the assessment of examiners, chief examiners, heads and medical members of examination teams by ethics committees. This guideline came into force on July 12, 2025 and marks a milestone in the harmonization of the German research landscape.

background

The new guideline is based on the Medical Research Act, which came into force in 2024. It represents the first binding guideline in accordance with Section 41d AMG and Section 32a MPDG and replaces the previous recommendations with legally binding requirements. The guideline brings more transparency for applicants for clinical trials in Germany and ensures uniform standards in the evaluation of investigator qualifications. What is new is that in future investigator training will no longer differentiate between drug and medical device courses.

The planned transitional provisions should give all stakeholders and doctors sufficient time to adapt to the new requirements. The requirements shown below apply until the Directive expires (30.6.2026).

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Specific requirements for auditors and audit teams

Basic qualification assessment

The ethics committees assess the qualifications of auditors and audit team members (See more here) in three key areas:

1. Professional qualification (study-related)
2. Regulatory and methodological knowledge (as examiner/audit team member)
3. Impartiality (Circumstances that could affect impartiality)

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Medical qualification requirements

When conducting clinical trials, the investigational team must ensure medical specialist standard.

The following applies:

• A specialist qualification is not mandatory for each individual examiner
• It is necessary to organise the investigational team to ensure the specialist standard
• In the case of non-specialist doctors, the documents submitted must show that the staff is sufficiently qualified

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Special requirements

In specific cases, higher qualification requirements may be required:

• Additional continuing education for specific studies
• Special experience with special investigations/treatment methods
• Higher requirements for vulnerable groups of people
• Special qualification for first-in-human studies

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Curricular continuing education requirements

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• Members of the investigational team must have completed a basic course in accordance with European Regulations (EU) No 536/2014 (medicinal products for human use), 2017/745 (medical devices) or no. 2017/746 (in vitro diagnostics), which comprises at least 8 teaching units (UE).
• Chief investigator or investigator in accordance with European Regulations (EU) No 536/2014 (medicinal products for human use), No 2017/745 (medical devices) or no. 2017/746 (in vitro diagnostics) 4 or MPG), must provide evidence of an advanced course of at least 8 units for this task.
• If a basic or advanced course has already been completed in accordance with Regulation (EU) 536/2014 and participation in a clinical trial in accordance with No 2017/745 (medical devices) or no. 2017/746 (in vitro diagnostics) is planned, participation in complementary supplementary courses or refresher course (4 or 2 units) for medical devices or IVD must be proven.

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Documentation requirements

For investigators

The medical qualification of investigators is based on the following documents:

• Current resume
• Relevant documents (in accordance with EU Regulation 536/2014, Annex I Section M point 65)
• Evidence of regulatory knowledge
• Declaration of impartiality

For investigational team members

There are simplified requirements for investigational team members:

• Presentation in the requirement profile
• Site eligibility form
• No personal documents required
• Justification of qualification required

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Legal bases

The Directive is based on the following European and national legislation:

• EU regulation 536/2014 (medicines for human use)
• EU regulation 2017/745 (medical devices)
• EU regulation 2017/746 (in vitro diagnostics)
• Medical Device Law Implementation Act (MPDG)
• I-GCP 3.1.3

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In parallel with the Directive, other important developments have been initiated:

• Specialised Ethics Committee for Special Procedures (SEKbV) since 01.07.2025
• Europe-wide harmonization in planning
• Non-medical exam team members will be considered in future revisions

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For our clients, this means a significant improvement in planning security and efficiency when advising on studies of their innovations. Feel free to contact us for a first non-binding consultation!

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Source: https://www.akek.de/wp-co ntent/upl oads/2022-01-14_Empfehlungen.pdf, https://www.b undesärztekammer.de/pr esse/aktuell es/detail/public-consultation-qualification-from-examines-and-examiner-in-clinical-exams, https://www.bundesaerztekamm er.de/press/act uelles/detail/research-clinical-examines-by-ethics commission-akek-und-baek-legen-first-guideline-before (spaces for remove link)

(as of July 2025)