The era of valid informed consent.

摘要

The concept of informed consent in clinical trials is well understood, although when viewed from the perspective of legal consent and valid consent, problems arise. Legal consent can be as simple as the signing of a document of informed consent. Valid consent, however, implies that the participant in the clinical trial is aware of the risks involved in being exposed to a new medical drug, including the risk of possible severe adverse drug reactions. Since most pre-clinical data is based largely on animal experiments, and animal data cannot be extrapolated to human beings with any degree of confidence, valid consent cannot be provided by the participant. It is therefore suggested that animal experiments be replaced with human-based methodologies, which rely on modern methods of molecular biology and human genetics.