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

Andere Anträge - Wissenschaftliche Untersuchungen

Forschungsvorhaben, bei denen in die psychische oder körperliche Integrität eines Menschen eingegriffen oder Körpermaterialien oder Daten verwendet werden, die sich einem bestimmten Menschen zuordnen lassen.

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.


Excerpt from the professional regulations for doctors in Baden-Württemberg § 15 Research 

(1) Doctors who take part in a research project that involves interfering with the psychological or physical integrity of a person or uses body materials or data that can be assigned to a specific person must ensure that before carrying out the research project Advice is provided that is aimed at the related professional ethics and professional law issues and is carried out by the ethics committee responsible under state law. The obligation to provide professional advice no longer applies if a vote from an ethics committee according to the AMG or MPG is available.

(2) The business relationships between doctors and the client must be disclosed in publications of research results.

(3) When conducting research on humans in accordance with Section 15 Paragraph 1, doctors shall observe the ethical principles for medical research on humans set out in the Declaration of Helsinki of the World Medical Association in the version of the 59th General Assembly in Seoul in 2008.

Excerpt from the professional regulations of the State Medical Association of Baden-Württemberg amended by statutes of September 17, 2014 (ÄBW 2014, p. 501).

Vollständige Fassung der Berufsordnung für Ärzte 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.

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).

 

MustertextInformation 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.


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)