Abstract

In his influential 1987 essay, “Equipoise and The Ethics of Randomized Clinical Research,” Benjamin Freedman argued that Charles Fried’s theoretical equipoise requirement threatened clinical research because it was overwhelmingly fragile and rendered unethical too many randomized clinical trials. Freedman, therefore, proposed an alternative requirement, the clinical equipoise requirement, which is now considered to be the fundamental or guiding principle concerning the ethics of enrolling patients in randomized clinical trials. In this essay I argue that Freedman’s clinical equipoise requirement is ambiguous and can be interpreted in (at least) two different ways. I furthermore claim that, ironically, the best interpretation of the clinical equipoise requirement opens Freedman to the same objection that he leveled against Fried twenty-five years ago; namely, that it (Freedman’s clinical equipoise requirement) renders unethical too many randomized clinical trials