[Therapeutic trial, clinical research and therapeutic freedom--legal boundaries].
Clinical research can be therapeutic or purely scientific. The therapeutic trial is usually chosen to obtain treatment liberty. On the other hand, the physicians in controlled clinical trials have relatively little choice of treatments. In Germany, special statutes and the general law limit clinical trials. The sec. 41 AMG, 18 MPG allow therapeutical trials under special circumstances. There are requirements for clinically controlled trials, especially the provision to seek the approval of an ethic commission.
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Juristisches Seminar, Universität Göttingen.
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D017041:Ethics Committees / Q000331:legislation & jurisprudence; D004992:Ethics, Medical; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*
Heilversuch, klinische Forschung und Therapiefreiheit--juristische Grenzziehungen.