title: [Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].
abstract: 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.
authors.affiliation: Quintiles GmbH, Neu-Isenburg. joachim.schwarz@quintiles.com
authors.forename: J A
authors.initials: JA
authors.lastname: Schwarz
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D016494:Computer Security / Q000941:ethics / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies / Q000009:adverse effects* / Q000941:ethics; D004992:Ethics, Medical; D005260:Female; D019983:Guideline Adherence / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence*; D008297:Male; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D033242:Minors / Q000331:legislation & jurisprudence*; D010353:Patient Education as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D011247:Pregnancy; D019724:Presumed Consent / Q000941:ethics / Q000331:legislation & jurisprudence