[Benefits from clinical research: for both patients and test subjects?].
The Convention on Human Rights and Biomedicine, its Additional Protocol, the European Parliament's Good Clinical Practice (GCP)-Directive as well as the German Medicines Law and GCP-Decree all require certain forms of "benefit" for participants of clinical trials and other forms of clinical-evaluative research. However, they do not provide any attempt to define e. g. "direct benefit" or group benefit -- contrary to our text. It additionally discusses qualitative and quantitative aspects and the inherently probabilistic nature of any benefit from clinical research. Clinically most relevant study types and designs (such as placebo-controlled trials; diagnostic studies of phases 1 - 3) do not offer any potential individual benefit at least for parts of the samples, they are at best beneficial for the group of similarly affected patients. At present those trials if including incapacitated adults not able to give informed consent are forbidden by German law, a situation different from that of trials involving minors.
Institut für Sozialmedizin, Universitätsklinikum Schleswig-Holstein, Campus Lübeck. heiner.raspe@sozmed.uni-luebeck.de
H
H
Raspe
D035843:Biomedical Research / Q000145:classification / Q000941:ethics / Q000592:standards*; D006801:Humans; D010919:Placebos / Q000592:standards; D011379:Prognosis; D035842:Research Subjects; D018570:Risk Assessment
D010919:Placebos