Informed consent to biomedical research in Veterans Administration Hospitals

To illuminate the process of obtaining informed consent to research in a medically dependent population, we interviewed 156 patients and 37 physicians involved in research projects at four Veterans Administration hospitals. Most patients knew they were research subjects, had voluntarily consented, and knew the details of their medical treatment, but few understood the research well. Readability analysis indicated that consent forms required college-level education. Twenty-eight percent of patients were not aware of their participation in research although they had signed consent forms. No single act, omission, or personal attribute completely explains this unawareness, but it is associated with incomplete consent forms, the identity of the person explaining the research, the manner of the explanation, and, in some cases, grave illness.