Development of an Informed Consent Multimedia Tool for Research

Standard research practice has been to protect the rights of human subjects by providing an informed consent document that explains the study in clear and concise language. The problems inherent in writing this document are considerable and it is not known how effective these documents are in providing information and enhancing understanding about research participation. I have selected a clinical research trial involving older men to illustrate the challenge of providing sufficient information so that a person can make an informed choice. I describe the many human, educational and technological aspects that must be considered in developing an alternative method to the written informed consent process. I have developed a tutorial that can be tested within the clinical trial to compare the differences in informed consent methods. The research community is obligated to improve the informed consent process and these preliminary efforts are worthy of further development.