Arzneimittelprüfung an nicht einwilligungsfähigen Erwachsenen: Kritische Bewertung der neuen gesetzlichen Regelung durch medizinische Ethikkommissionen in Deutschland [Critical evaluation of the new legal regulation of pharmaceutical trials with adults who lack decision-making capacity: a survey of human research ethics committees in Germany]

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Serval ID
serval:BIB_BAE7DF82A92E
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Arzneimittelprüfung an nicht einwilligungsfähigen Erwachsenen: Kritische Bewertung der neuen gesetzlichen Regelung durch medizinische Ethikkommissionen in Deutschland [Critical evaluation of the new legal regulation of pharmaceutical trials with adults who lack decision-making capacity: a survey of human research ethics committees in Germany]
Journal
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Author(s)
Götz S.C., Marckmann G., Hasford J., Jox R.J.
ISSN
1437-1588 (Electronic)
ISSN-L
1436-9990
Publication state
Published
Issued date
04/2020
Peer-reviewed
Oui
Volume
63
Number
4
Pages
465-474
Language
german
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
In Germany, the drug law was revised in 2016 to include new regulations on clinical drug trials with adults who lack decision-making capacity. For the first time, trials with a merely indirect benefit (benefit for other patients with similar characteristics) will be possible if several safeguards are respected. The ethical justification and practicality of this regulation are controversially discussed.
(1) Eliciting the current pertinent practice of research ethics committees in Germany regarding research with indirect benefit on adults without decision-making capacity; (2) exploring the possibilities and difficulties of implementing the new law.
Semiquantitative, anonymous questionnaire among 249 members of all 53 human research ethics committees in Germany.
Eighty-four questionnaires were analyzed (response rate 34%). The participants disagreed on assigning research projects to the categories of research with direct benefit to the subject, with an indirect benefit, and without any benefit. Moreover, the criteria of minimum risk and minimum burden were interpreted heterogeneously. More than half of the participants judged the newly introduced research advance directive to be unnecessary, given the legal safeguards in place. The applicability of these directives was doubted because of the strict requirements for anticipatory informed consent and the restricted predictability of future research.
In spite of the new legal regulation, significant ethical uncertainties remain concerning research with indirect benefit on adults without decision-making capacity. It remains an open question whether we need a better explanation of the law, additional legal regulation, practice evaluation, or a completely new law.
Keywords
Adult, Clinical Trials as Topic, Decision Making, Ethics Committees, Ethics Committees, Research, Germany, Humans, Informed Consent, Surveys and Questionnaires, Decision-making capacity, Law on pharmaceutical products, Research ethics, Research ethics committees, Research with indirect benefit
Pubmed
Web of science
Open Access
Yes
Create date
05/12/2019 23:19
Last modification date
27/04/2020 6:20
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