[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].
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.
Steiner
T
T
Neurologische Klinik, Universität Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg. thorsten_steiner@med.uni-heidelberg.de
Walter-Sack
I
I
Taupitz
J
J
Hacke
W
W
Strowitzki
T
T
D002543:Cerebral Hemorrhage / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D017322:Clinical Trials, Phase II as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D017326:Clinical Trials, Phase III as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D004630:Emergencies; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence; D015942:Factor VIIa / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D007872:Legal Guardians / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D011994:Recombinant Proteins / Q000627:therapeutic use; D018570:Risk Assessment / Q000941:ethics / Q000331:legislation & jurisprudence; D013997:Time Factors
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa