Improving the Proficiency of Research Consent Administrators

Despite increasing regulatory efforts to protect individuals who participate in research and to ensure that they are fully informed, data have consistently demonstrated that participants are often unable to recall important elements of the research such as its purpose, the potential risks, or what is expected of them, even after they have signed consent forms and discussed the protocol with research staff. The misunderstanding worsens when working with immigrant populations where low literacy and limited English proficiency further hinder individuals’ understanding of the research process. In a recent systematic review, Nishimura and colleagues found that while a number of interventions to improve participant comprehension were effective, results were inconsistent (1). A common theme, however, seemed to be the importance of the one-on-one interaction of a potential participant with the person obtaining consent (i.e., the consent administrator). Several years ago, we developed and tested a formal training program for research personnel who obtain consent from individuals to participate in a research study (i.e., consent administrators). Although the program was successful in improving the consent process, it was expensive, time consuming, and not practical in many busy settings(2). Therefore, as part of a larger NIH-funded study, we developed a short on-line video training module for research personnel designed to assess participant understanding with an emphasis on hearing from the community about their thoughts, beliefs and feelings about research and incorporating principles of health and cultural literacy and the use of the ‘playback’ method designed to assess participant understanding. This focus was of particular importance to us as we serve a predominantly immigrant Latino population with low levels of health literacy and a high percentage of participants with limited English proficiency. The aims of this paper are to describe the development and testing of the module to enhance the knowledge of research personnel regarding the importance of health and cultural literacy in the consent process.