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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2005
[Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].
- J A Schwarz.
- Quintiles GmbH, Neu-Isenburg. joachim.schwarz@quintiles.com
- Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005 Apr 1; 48 (4): 429-37.
AbstractWritten 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.
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