“Standard literacy is very different from health literacy,” says Dr. Romain. “People do not always know much about how their bodies work and cannot easily appreciate what the implications are of different side effects and interventions.”
Structured interventions such as audio-visual presentations or brochures have not been shown to be effective in achieving informed consent. However, most of the experts agreed that questionnaires can find holes in a subject’s understanding. Allowing subjects to take the forms home and discuss them with their family and friends is useful as well.
“The most meaningless question an investigator can ask is, ‘Do you understand?’ ” says Dr. Matteson. “That isn’t really a question, but rather a statement designed to get a yes. You gauge understanding by having them repeat in their own words the various concepts as you both go through the protocol.”
Kurt Ullman is a freelance writer based in Indiana.
References
- Getz KA. AMCs rekindling clinical research partnerships with industry. Boston: CenterWatch, 1999.
- Thompson CenterWatch. State of the Clinical Trials Industry. Boston: CenterWatch, 2007.
