ABSTRACT
For all research focused on the development of treatments, it is essential, first, to determine whether participation in the research holds out a reasonable of direct benefit for subjects and, second, to describe and discuss the prospect of direct benefit sufficiently to permit informed decision-making by prospective patient-subjects. Some clinical trials with patients as subjects clearly do not offer the prospect of direct benefit. Nonetheless, in many early-phase clinical trials, the prospect of direct benefit may be too small, too attenuated, too unlikely, too uncertain to hold out as reasonable to expect. There are three dimensions of potential benefit that should be described and discussed in the consent form and process, just as they are discussed with respect to risks of harm: the nature of the potential benefit; the magnitude (size and duration) of the potential benefit; and the likelihood of the potential benefit.
