Making Informed Consent Work for All

The traditional process for obtaining informed consent from potential clinical trial subjects is time-consuming, expensive and not very effective. As many as one in five enrolled subjects who complete a traditional consent process have essentially zero understanding of the risks, benefits, and goals of the trial.1 In a survey of subjects in 26 clinical trials, a large percentage showed a marked lack of understanding:2 • 57 % did not recall that the treatment they were undergoing was part of a clinical trial. • 75 % did not recall the phase of the trial. • 59 % did not recall the level of personal effort involved in participation. • 70 % did not recall the possible alternatives to the trial treatment Obviously, many study subjects are not fully informed when they give consent. In addition to the ethical ramifications, practical effects include problems with compliance, retention and relationships with study personnel, as well as implications for litigation if there is an injury. Rethinking Informed Consen