"Although investigators themselves may be experts in their fields of study, the research staff who obtain informed consent may not be the most adept at answering participants' questions about a particular research study", stated Rob Hubal, Ph.D., RTI's principal researcher for the study. "The intelligent use of technology to help research staff hone their communication skills benefits both research participants and the research itself."
The study, funded through grants from the National Institutes of Health's Human Subjects Research Enhancement Programme and the United States National Science Foundation, is included in this month's on-line edition of the Journal of Biomedical Informatics.
Researchers found that participants, 24 undergraduate students at Duke University, who practised with a synthetic character were faster and significantly more skilled at answering questions posed later by a human interview candidate than were participants who only studied written materials, as is standard practice.
Participants trained by the synthetic character, a female in her 30s, better comprehended the interviewee's questions, responded more appropriately and were more likely to obtain co-operation from the interviewee.
"This is one of few studies to test the effectiveness of synthetic character training using experimental methods developed in a cognition laboratory", stated Ruth S. Day, Ph.D., director of the Medical Cognition Laboratory at Duke University where the experiments were conducted. "Most previous studies examined user acceptance or usability of applications. This experiment shows that not only do users accept the synthetic character application and use it easily, but that it can also make them more knowledgeable about informed consent information and more effective in conducting interviews with humans."
"Our goal is to help research staff satisfactorily answer participants' questions and address their concerns so that they can make a fully informed decision about being in a study", stated Wendy Visscher, Ph.D., the director of human subjects protection at RTI. "This simulation shows promise for helping us train staff members to better protect the people who take part in our studies, an important aspect of research."
During the training session, the synthetic character behaves as a potential study participant, asking questions that research participants typically ask, such as the study's content, confidentiality, duration and participant selection. If the user responds satisfactorily, the character agrees to participate, if not, the character declines to participate. The programme then provides the user with a hint and starts a new training interview.
"The results have so far been encouraging", Rob Hubal stated. "This technology could become a valuable tool for the many professional fields that require informed consent, particularly medicine and survey research, where it is crucial to all involved that participants understand the facts and implications of procedures for which they are granting consent."
RTI International, the United States' second largest independent non-profit research organisation, is dedicated to conducting research and development that improves the human condition by turning knowledge into practice. RTI has more than 2500 staff members who work in Research Triangle Park, North Carolina, eight regional offices in the United States, and five international offices. These dedicated professionals offer innovative research and technical services to governments and businesses worldwide in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, governance, economic and social development, energy, and the environment.
The Medical Cognition Laboratory at Duke University examines comprehension of medical information, including prescription drugs, medical devices, diagnostic and treatment guidelines, and informed consent. Research participants include professionals such as physicians and pharmacists, patients, and other laypersons including healthy non-patients and caregivers. The basic approach is to 1) evaluate the "cognitive accessibility" of existing information - the ease with which people can find, understand, remember, and use it; 2) test the effects of existing and cognitively enhanced versions on cognitive processes including attention, comprehension, and memory; and 3) foster better comprehension and use of medical information in everyday settings.