J. A. Schwarz’s scientific contributions

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Publications (2)


[Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].
  • Article

May 2005

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6 Reads

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

J A Schwarz

Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subject's legal representative is mandatory. The subject's presumed or expressed wish must be considered.


Patienteninformation und Einwilligung bei Gesch�ftsf�higen, Gesch�ftsunf�higen und Minderj�hrigen vor der Teilnahme an klinischen Pr�fungen

January 2005

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7 Reads

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3 Citations

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Geschftsfhige Probanden und Patienten sind vor einer Teilnahme an einer klinischen Prfung mit Arzneimitteln oder Medizinprodukten grundstzlich mndlich und schriftlich aufzuklren. Ihre Einwilligung zur Studienteilnahme mssen sie schriftlich erteilen. Bei nicht Einwilligungsfhigen und Minderjhrigen muss die schriftliche Einwilligung durch den gesetzlichen Vertreter nach dessen Aufklrung erteilt werden. Dabei ist der Wille Einsichtsfhiger, nicht Einwilligungsfhiger und Minderjhriger zu bercksichtigen.Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subjects legal representative is mandatory. The subjects presumed or expressed wish must be considered.