International guidelines regarding ethics, and in particular the ethics of clinical research, are problematic on two broad levels. First, by asserting their universality, “international” guidelines obscure real and legitimate crosscultural differences in ethical expectations. International guidelines seek to make homogeneous something which is not necessarily so. Second, existing guidelines are ambiguous about their objectives and purposes. On the one hand, guidelines are structured as a set of goals, largely aspirational in language and content. But on the other hand, such guidelines also suggest a normative function, providing a set of standards by which to judge and, if appropriate, sanction investigators’ conduct.
These criticisms are not intended to argue that international guidelines are useless. Nor are they intended to question the good faith under which such guidelines are developed. Rather, we wish to suggest that the role of present international guidelines is somewhat more limited than is ordinarily appreciated.