Universität zu Köln

von Kielmansegg, Sebastian Graf, Benda, Norbert, Grass, Guido and Sudhop, Thomas (2019). Ethics committees in clinical trials involving medicinal products. Bundesgesundheitsblatt-Gesund., 62 (6). S. 706 - 713. NEW YORK: SPRINGER. ISSN 1437-1588

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Abstract

Over the years, the role of ethics committees (ECs) in the review process of clinical trial applications (CTAs) has changed from being acollegial advisory body to apatient protection organisation with an authority character. While the law governing the medical profession in Germany only provides for an obligation for physicians to ask for an EC review in biomedical research on human beings, anegative opinion on the CTA does not lead to the inadmissibility of the research project from alegal point of view. In contrast, the German Medicinal Product Act (Arzneimittelgesetz, AMG) requires afavourable opinion as an approving assessment by the competent EC.The AMG defines both the elements of aclinical trial application to be reviewed by the EC as well as the principle grounds of non-acceptance to reject afavourable opinion. ECs that assess CTAs must be constituted in accordance with the state law and must be composed of interdisciplinary medical specialists, lawyers and methodologists. The main assessment criteria are amedically acceptable risk-benefit ratio, the appropriateness of the methods used, including biometric aspects, the requirements to be met by the study participants, such as their ability to give consent, the suitability of the investigators and trial facilities as well as the appropriateness of the written information with which the study participants are to be informed and give their consent.In spite of the already high degree of regulation, the applicability of the European Clinical Trial Regulation will result in even more detailed legal requirements for the composition and working procedures of an EC with the aim of further harmonising the assessment of CTAs in the EU.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code von Kielmansegg, Sebastian Graf UNSPECIFIED UNSPECIFIED UNSPECIFIED Benda, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Grass, Guido UNSPECIFIED UNSPECIFIED UNSPECIFIED Sudhop, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-146926
DOI:	10.1007/s00103-019-02946-6
Journal or Publication Title:	Bundesgesundheitsblatt-Gesund.
Volume:	62
Number:	6
Page Range:	S. 706 - 713
Date:	2019
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1437-1588
Language:	German
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language EQUIPOISE Multiple languages Public, Environmental & Occupational Health Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14692