[Supervision of medical scientific research with mentally competent subjects is impossible without reviewing]

Abstract

The object of reviewing medical scientific research in humans is to offer guarantees against, especially, violations of physical integrity and privacy. Since the scientific interest is a matter of first importance, the research has to be checked for its reasonableness and for the test subject's consent. Omission of these checks in case the risk or stress to be expected is slight is contrary to these criteria. Reversion of the sequence of informed consent and randomization is contrary to the requirement of consent. Free, informed consent may be assumed if in a trial with a control group the test subject is informed beforehand about the study design and the risks, but is not told if he is to receive a standard therapy, a placebo or a test medication.