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.
Research projects in accordance with Section 15 of the Professional Code for Doctors
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.
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
Research projects with digital health applications
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.
Weiterführende Literatur:
- DIGA-Leitfaden BfArM
- Verordnung über das Verfahren und die Anforderungen zur Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung (Digitale Gesundheitsanwendungen- Verordnung - DiGAV)
- § 139e SGB Verzeichnis für digitale Gesundheitsanwendungen; Verordnungsermächtigung
Data protection information (EU General Data Protection Regulation)
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
Scientific studies on samples from a blood or tissue bank
General information on setting up biobanks and using samples
Scientific data collection
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:
- A Cover letter,
- a short test plan : prospektive Datensammlung, retrospektive Datensammlung
- Prospective data collection: an information text and a declaration of consent or a justification as to why the data is collected without the consent of the person concerned (information and declaration of consent - data protection)
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.
Notes on genetic research
Der Antrag an die Ethik-Kommission besteht aus:
- a cover letter, signed by the applicant, with the applicant's address and their telephone, radio and fax numbers (if there are several people, please indicate who the contact person for the Ethics Committee is)
- a Synopse (for applications with more than 10 pages )
- a Prüfplan (German or English) with additional information: date and version number, declarations of consent from the medical directors of the departments involved, a list of the abbreviations used, numbered pages, information on the financing of the study
- an information text and a declaration of consent for the main study and an information and declaration of consent for the Datenschutz
Applications for financial support (DFG, AKF or fortüne application)
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.
Number of copies to be submitted
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).