Klinische Prüfung mit einwilligungsunfähigen Erwachsenen
Rechtliche Rahmenbedingungen einer gruppennützigen Forschung
Nomos, 1. Edition 2021, 222 Pages
The product is part of the series
Marburger Schriften zum Gesundheitswesen
Description
As a result of Regulation No. 536/2014/EU and its implementation in Section 40b of the German Medicines Act (AMG), group-beneficial clinical research involving adults incapable of providing consent is now also permissible. This research is neither legally nor ethically objectionable, provided that it offers a balance between curing future patients, the study participant's right to self-determination, and his or her dignity.
The author examines the framework conditions of group-beneficial clinical research in accordance with Section 40b AMG and shows that this initially positive innovation in the Medicines Act still requires considerable amendment if its application is to be legally and ethically justifiable.
The author examines the framework conditions of group-beneficial clinical research in accordance with Section 40b AMG and shows that this initially positive innovation in the Medicines Act still requires considerable amendment if its application is to be legally and ethically justifiable.
Bibliographical data
| Edition | 1 |
|---|---|
| ISBN | 978-3-8487-7272-8 |
| Subtitle | Rechtliche Rahmenbedingungen einer gruppennützigen Forschung |
| Publication Date | Nov 26, 2021 |
| Year of Publication | 2021 |
| Publisher | Nomos |
| Format | Softcover |
| Language | deutsch |
| Pages | 222 |
| Medium | Book |
| Product Type | Scientific literature |
Reviews
»eine wirklich gute Arbeit, die zur Klarheit der Rechtslage beiträgt.«
RA Dr. Matthias Wiemers, Healthcare & Hospital Law 2/2022
RA Dr. Matthias Wiemers, Healthcare & Hospital Law 2/2022
Additional material
Product safety information
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Nomos Verlagsgesellschaft mbH & Co. KG
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76530 Baden-Baden, Germany
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www.nomos.de