- From the Editor
Benjamin Freedman’s 1987 paper on equipoise in clinical trials not only changed the way scholars discuss clinical trials but also led to changes in the regulations that apply to the use of human subjects in research. Other writers (e.g., Henry Beecher) in research ethics have had this kind of influence, but unlike them, Freedman did not make his splash by playing the role of whistle-blower; instead, he proposed a new look at an old problem surrounding informed consent.
The fact that it is difficult to state precisely what that problem is helps to explain the controversy ever since. We know this much: the problem concerns the acceptable threshold of risk in the trial (and what is known about the trial), and the threshold at which, in simple terms, the researcher can ethically recruit volunteers or even continue with the trial. Freed-man asked us to imagine a situation in which the researcher would need to explain to a patient, perhaps one who is considering whether to enroll in the trial, how one arm of the trial compares to another. Summarizing a great deal, we could say that Freedman’s solution was that the researcher would need to be able to claim that, in terms of risk, there were no clearly preferable alternatives.
It was said to be an ethical requirement that the opinions about those alternatives are in “equipoise.” There has been enough agreement that this state of equipoise should be a necessary (though hardly sufficient) condition for the ethical conduct of human-subjects research that regulations to that effect are now in place. Yet what an equipoise standard might really involve, or what it might come to in terms of practical information, has never been clear. On a narrow interpretation, and one that seems most consistent with the position taken by Freedman and some of his early commentators, the researcher would be saying that no preferable alternatives exist among the experimental treatments, the arms of the trial, and so [End Page vii] on. On a broader interpretation, however, we can imagine the researcher being asked much more. Going beyond the reassurance that there is still no clearly better choice of treatments, for instance, a patient (or an over-sight body, such an irb) might raise ask how the “alternatives” are being represented. Those questions will sound very familiar, as they will themselves relate to the usual concerns in ethics that someone has included too much in deliberation or not enough.
Not surprisingly, commentators since Freedman have differed on how we might integrate the notion of equipoise into a rule governing the interaction of researcher and subject. It has never seemed helpful to point out that the equipoise standard is only one parameter among many to be considered; hence we are left wondering what weight to give it. This is so despite the tendency for all sides to agree that the ritual of informed consent will have to include complicated projections about risks and benefits. Skeptics can grant that something like an equipoise guideline could help bring the assumptions behind those predictions out into the open, yet it can seem that too many important questions remain about which considerations should count and what should be done once we agree on that.
Skeptics might also complain that we have been here before and that it makes the most sense to view the questions associated with equipoise within the wider debate over such things as how information should be distributed in the research (and clinical) encounter, when it should be shared, and who should be in on the conversation. But then, for such skeptics, we must avoid trying to force equipoise rules to do much more than they ever could. The mention of consensus and expert opinions, for example, can hint at Aristotle’s account of endoxa and all of the ambiguity surrounding that. The references to choice and outcomes might remind some of the utilitarian’s classic dilemma: How can it ever be ethical to act in the second-best way? (And who ranks these things?) The idea that there is an ethical distinction between the known and what can be known (and...