Sonstige Forschungsvorhaben
(Beratung nach § 15 der Berufsordnung für Ärzte in BW)

Other applications - Scientific studies

Research projects that interfere with the mental or physical integrity of a person or use bodily materials or data that can be attributed to a specific person.

Doctors in Baden-Württemberg must seek advice from the ethics committee responsible for them before starting a research project that involves interfering with the psychological or physical integrity of a person or using body materials or data that can be assigned to a specific person.


The Professional Code of Conduct of the Baden-Württemberg Medical Association of September 21, 2016 (ÄBW 2016, p. 506), last amended by the statutes of April 22, 2020 (ÄBW 2020, p. 259), is amended as follows

§ Section 15 Research

(1) Physicians who participate in a research project in which the mental or physical integrity of a human being is interfered with or in which bodily materials or data that can be attributed to a specific human being are used must ensure that, before the research project is carried out, advice is given on the professional ethics and professional law issues associated with it and that this advice is provided by an ethics committee formed at the competent medical association or by another independent and interdisciplinary ethics committee formed in accordance with state law. The same applies prior to conducting legally authorized research with vital human gametes and living embryonic tissue.

(2) If consultation has already taken place in accordance with paragraph 1, doctors shall notify their participation in this research project to the ethics committee responsible for them under Land law, providing evidence of the consultation that has taken place.

(3) In publications of research results, the business relationships of doctors with the client shall be disclosed.

(4) When conducting research on humans in accordance with Section 15 (1), doctors shall observe the ethical principles for medical research on humans laid down in the Declaration of Helsinki of the World Medical Association in the version of the 75th General Assembly in Helsinki in 2024.

Complete version of the Professional Code of Conduct for Physicians in Baden-Württemberg

Digital health applications (medical apps)

Please note that standalone software such as B. a smartphone app can be a medical device depending on the intended purpose/planned application. For further information on the distinction between medical devices, see BfArM Software applications from in-house production are - like all other medical products from in-house production - according to § 3 No. 21 and 22 MPG medical devices including accessories that are manufactured and used in a healthcare facility without being placed on the market or meeting the requirements of a custom-made product. Like all other medical devices, they must meet the essential requirements of Directive 93/42/EEC.

Further reading:

The EU General Data Protection Regulation results in changed requirements and information obligations towards study participants for all research projects that involve the processing of personal data. Multicenter studies: A list of state authorities and federal authorities can be used for information on the right to complain (see BFDI information center with a complete list of all authorities or intranet: list of state authorities and contact details of the federal authority).

Mustertext: Information and declaration of consent for data protection

General information on research projects with pseudonymized data:

Does the planned scientific data collection require consultation?

To clarify this question, a short test plan must always be submitted to the ethics committee before the study begins. Professional legal advice is no longer possible if a study has already begun or been completed.

The application to the Ethics Committee consists of:

Data protection

For research with patient data, see the UKT data protection manual (Rules No. 14 and No. 22) and state data protection (LDSG, § 13) or federal data protection (BDSG, § 27) adaptation laws.

With immediate effect, please use the "Uniform application documents for applicants" of the Working Group of Medical Ethics Committees in the Federal Republic of Germany (AKEK - https://www.akek.de/sonstige-studien/).

For multi-center studies, the "one study - one vote" procedure of the AKEK will be applied in Baden-Württemberg from 01.09.2025:

The application to the Ethics Committee consists of:

- Cover letter with, if applicable, key information on the application and information on the study team

- application form

- synopsis

- Study protocol (please select the appropriate variant from the AKEK templates):

  • Variant A: prospective study, mono- and multicenter
  • Variant B: Use of samples from an existing biobank
  • Variant C: Analysis of data from an existing database/register
  • Variant D: Retrospective analysis of data from routine clinical practice

- If applicable, information text and declaration of consent for participation in the study, information and declaration of consent on data protection

- Other documents (questionnaires, recruitment materials, etc.), if applicable

- Information on the suitability of the study center and the financing of the study (please either explain in the protocol or use the AKEK templates)

monocentric studies:

Information on the suitability of the study center and the financing of the study:

These forms can be replaced in ethikPool by a placeholder with the note that information on this is provided in the protocol or in the cover letter.

Instead of the document "Suitability of the study center", in the case of registry data or internal data collection, the placeholder should explain whether the investigators and trial site are authorized to access the data and whether a data protection impact assessment pursuant to Art. 35 GDPR and an entry pursuant to Art. 30 GDPR in the UKT's register of processing activities relating to health data processing have been made. When using AI, it should be confirmed here that the data protection concept is coordinated with the data protection officer and a risk assessment of information security is carried out by the IT security officer for the use of AI before the start of the study.

Application for financial support (DFG etc.):

Please use the relevant AKEK application documents:

https://www.akek.de/sonstige-studien/ and select the application category " Application for financial support (e.g. DFG)" in ethikPool

Master's or other student thesis:

  • Cover letter
  • Examination plan - checked and countersigned by the supervisor
  • If applicable, information text and declaration of consent

Change / Amendment


Applications for amendments and supplements to applications submitted before 01.09.2025

Please submit these as a new application in order to transfer the application to ethikPool for the first time. For organizational/system-related reasons, you will receive a new project number.

Submit unmodified documents in the last approved version. All amended documents in amendment mode. Please attach the "Amendment" document (see amendment dossier: https://www.akek.de/sonstige-studien/) and the last letter/vote of the Ethics Committee to your amendment application.

For multicenter studies with study management in our area of responsibility, it should be confirmed in the cover letter that the submitted documents comply with the requirements of the AKEK (if necessary, we ask for adaptation/supplementation of the documents).

Applications for amendments and supplements for applications submitted via ethikPool after 01.09.2025

  • Cover letter
    (In the case of a response to a letter from the Ethics Committee, a point-by-point response to the Ethics Committee's comments or questions is expected).
  • Document "Amendment" see harmonized documents of the AKEK (amendment dossier: https://www.akek.de/sonstige-studien/) with amended documents.
    When applying for an extension, we request information on the status of recruitment, any safety-related events or similar and confirmation that there have been no changes in content since the last application.
  • In the case of changes to the study centers, please also submit the form on the suitability of the study center.



usually do not contain all the information that the ethics committee needs to assess the study project. Therefore, attach a short test plan to each application or mark the relevant passages in the application for financial support. Internal research funding: Please only submit projects with secured funding to the Ethics Committee.

Prüfplan

Please submit 1 copy of all study documents as a paper printout and a PDF file (electronic version - sorted as follows: cover letter, synopsis, test plan, explanatory texts and declarations of consent, other documents).

Sitzungstermine

According to Article 35 of the Declaration of Helsinki (Fortaleza, October 2013), every research project involving humans must be registered in a publicly accessible study database (e.g. in the German Register of Clinical Studies, DRKS) before being carried out. Detailed information on registration can be found at the World Health Organization (WHO).

zum Deutschen Register Klinischer Studien (DRKS)

zur Weltgesundheitsorganisation (WHO)