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Pigeot, I.* ; Foraita, R.* ; Frömke, C.* ; Haller, B.* ; Hoffmann, V. ; Zapf, A.*

Ethical consideration of studies involving human subjects outside the regulatory framework: not mandatory, but of high relevance.

Ethical consideration of studies involving human subjects outside the regulatory framework: Not mandatory, but of high relevance.

Bundesgesundheitsbl.-Gesund. 62, 722-728 (2019)

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Open Access Green as soon as Postprint is submitted to ZB.

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According to the Declaration of Helsinki, ethics committees are obliged to evaluate any type of medical research involving human subjects in order to ensure an objective view on ethical considerations. This does not only mean considering whether the risks to study participants are ethically justifiable or not, but also checking whether the scientific quality of astudy is sufficient. However, the role of ethics committees differs depending on whether the study to be considered is, for example, an approval study according to the German Medicines Act (AMG) or whether the study is outside the regulatory framework. For these so-called unregulated studies it is not always mandatory to obtain approval from an ethics committee or an institutional review board.In this paper, we first explain the term unregulated studies in detail and elaborate for which types of unregulated studies an application for ethical approval is required before we deal with the application for ethical approval as such and in particular with the study protocol as one of its major components. Registry studies, postmarketing surveillance studies, analyses of secondary data, surveys, intervention, and prognostic studies serve as examples to illustrate the broad range of unregulated studies.Finally, we discuss crucial aspects of the role of ethics committees with respect to the consideration of unregulated studies. In our conclusion, we point out the necessity of having ethics committees at each university in Germany that are also responsible for unregulated studies. In addition, the German legislature should define astricter regulation such that unregulated studies also have to adhere to the vote of the ethics committee.

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Publication type Article: Journal article

Document type Review

Corresponding Author

Keywords Biometrical Aspects ; Ethical Approval ; Ethics Committee ; Study Protocol ; Unregulated Studies; Events

ISSN (print) / ISBN 1436-9990

e-ISSN 1437-1588

Journal Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Quellenangaben Volume: 62, Issue: 6, Pages: 722-728

Publisher Springer

Publishing Place 233 Spring St, New York, Ny 10013 Usa

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Institute of Diabetes Research Type 1 (IDF)