There is a growing body of literature showing that subjects who consent to participate in research studies do so without the opportunity to make truly informed decisions. It may also be that potential research subjects may refuse participation in clinical research studies because they are unable to obtain satisfactory answers to questions and concerns. One of the important and documented barriers to obtaining informed consent from subjects is the disparity between the health literacy skills and abilities of subjects and the complexity of the language, both written and oral, used to communicate with them. Data from the National Adult Literacy Survey (1993) suggest that as many of 90 million Americans, 47% of the adult population, may have difficulty accessing and using health information. ? ? We propose a pilot intervention study to address the disparity between the health literacy level of subjects, clinical researchers, and the documents and tools that they use to communicate with one another. While previous studies have focused on either subjects or researchers independently, the proposed approach addresses both. ? ? We will develop and test an adult informed consent template, fine-tuned to reach those with limited health literacy skills, in conjunction with a web-based educational program intended to enhance the ability of clinical investigators to communicate with low literacy populations. Because the consent process also serves the dual purpose of protecting the institution and researchers from legal liability, we have taken special care to honor this dual function in the design of our intervention. ? ? We will evaluate the effectiveness of this approach using surrogate research subjects evaluating their response to a mock research study. Outcome measures include level of comprehension, satisfaction and rate of subject accrual. The research team includes a multi-disciplinary group of clinical researchers, health communication, legal and public health scholars. The work will take two years to complete. ? ?
