|
rdf:type |
|
|
lifeskim:mentions |
umls-concept:C0013227,
umls-concept:C0030705,
umls-concept:C0087111,
umls-concept:C0184661,
umls-concept:C0205178,
umls-concept:C0220868,
umls-concept:C0332257,
umls-concept:C0442111,
umls-concept:C1511481,
umls-concept:C1707959,
umls-concept:C2603343
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|
pubmed:issue |
15
|
|
pubmed:dateCreated |
2008-4-2
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|
pubmed:abstractText |
Clinical trials in patients who cannot sign an informed consent are only possible under certain circumstances. The present paper explains the legal prerequisites and ethic rationales, which may allow including patients in such a trial without having signed informed consent. Translation of these prerequisites into practice needs the implementation of special inclusion procedures. These procedures will be explained using the example of the recombinant factor VIIa (rFVIIa) trials for intracerebral hemorrhage.
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|
pubmed:language |
ger
|
|
pubmed:journal |
|
|
pubmed:citationSubset |
IM
|
|
pubmed:chemical |
|
|
pubmed:status |
MEDLINE
|
|
pubmed:month |
Apr
|
|
pubmed:issn |
1439-4413
|
|
pubmed:author |
|
|
pubmed:issnType |
Electronic
|
|
pubmed:volume |
133
|
|
pubmed:owner |
NLM
|
|
pubmed:authorsComplete |
Y
|
|
pubmed:pagination |
787-92
|
|
pubmed:meshHeading |
pubmed-meshheading:18382954-Cerebral Hemorrhage,
pubmed-meshheading:18382954-Clinical Trials, Phase II as Topic,
pubmed-meshheading:18382954-Clinical Trials, Phase III as Topic,
pubmed-meshheading:18382954-Clinical Trials as Topic,
pubmed-meshheading:18382954-Emergencies,
pubmed-meshheading:18382954-Ethics Committees, Research,
pubmed-meshheading:18382954-Factor VIIa,
pubmed-meshheading:18382954-Germany,
pubmed-meshheading:18382954-Humans,
pubmed-meshheading:18382954-Informed Consent,
pubmed-meshheading:18382954-Legal Guardians,
pubmed-meshheading:18382954-Mental Competency,
pubmed-meshheading:18382954-Randomized Controlled Trials as Topic,
pubmed-meshheading:18382954-Recombinant Proteins,
pubmed-meshheading:18382954-Risk Assessment,
pubmed-meshheading:18382954-Time Factors
|
|
pubmed:year |
2008
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|
pubmed:articleTitle |
[Ethical and legal aspects of including patients unable to consent in acute therapy studies. Example of a medication study for the treatment of intracerebral hemorrhage--the Heidelberg procedure].
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|
pubmed:affiliation |
Neurologische Klinik, Universität Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg. thorsten_steiner@med.uni-heidelberg.de
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|
pubmed:publicationType |
Journal Article,
English Abstract,
Review
|
