Anthony W

EBD Group Inc., Carlsbad, CA, USA

There is a tendency to assume that the principles of informed consent are self-evident. In fact, evidence that this is not the case comes from many sources, such as ethics committees, who are frequently dissatisfied with proposed informed consent documents, and sophisticated Western governments that, from time to time, have conducted clinical trials without it (e.g. the Tuskeegee travesty).

Informed consent was first formulated under international law through the Declaration of Helsinki, and in response to the atrocities of the Second World War. The principles of informed consent are under continuous review and discussion (e.g. Marsh, 1990). This is to be expected when reasonable standards of informed consent are dependent not only upon the design of a particular study, but also on environmental factors, the current state of medicine, and particular local characteristics of clinical trials populations, all of which are themselves continuously changing.

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