[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]

(Ethische und juristische Aspekte beim Einschluss nicht einwilligungsfähiger Patienten in Akuttherapie-Studien. Beispiel einer Arzneimittelstudie zur Behandlung intrazerebraler Blutungen--das Heidelberger Verfahren.)

Full Abstract

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.

Learn Faster Today Improve your study skills

Author information

Author/s: Steiner, T (T); Walter-Sack, I (I); Taupitz, J (J); Hacke, W (W); Strowitzki, T (T);

Affiliation: Neurologische Klinik, Universität Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg. thorsten_steiner(-atsign-)med.uni-heidelberg.de

Journal and publication information

Publication Type: English Abstract; Journal Article; Review

Journal: Deutsche medizinische Wochenschrift (1946) (Dtsch Med Wochenschr), published in Germany. (Language: ger)

Reference: 2008-Apr; vol 133 (issue 15) : pp 787-92

Dates: Created 2008/04/02; Completed 2008/04/10;

PMID: 18382954, status: MEDLINE (last retrieval date: 11/6/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article (including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.

MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Cerebral Hemorrhage - drug therapy
Clinical Trials as Topic - ethics; legislation & jurisprudence
Clinical Trials, Phase II as Topic - ethics; legislation & jurisprudence
Clinical Trials, Phase III as Topic - ethics; legislation & jurisprudence
Emergencies
Ethics Committees, Research - legislation & jurisprudence
Factor VIIa - therapeutic use
Germany

Humans
Informed Consent - ethics; legislation & jurisprudence
Legal Guardians - legislation & jurisprudence
Mental Competency - legislation & jurisprudence
Randomized Controlled Trials as Topic - ethics; legislation & jurisprudence
Recombinant Proteins - therapeutic use
Risk Assessment - ethics; legislation & jurisprudence
Time Factors

Associated Chemicals: Recombinant Proteins (0) ; recombinant FVIIa (0) ; Factor VIIa (EC 3.4.21.21)

These are the highest related articles currently in the database:

See 100+ related articles.