Project 171149

Ever since the development of the Nuremberg Code in response to Nazi war crimes, informed consent has been a cornerstone of the ethical practice of healthcare research. Despite the fundamental importance of this principle, however, there is increasing evidence of a failure of current informed consent processes to apprise participants of even the most basic components of the research in which they are involved. This study seeks to learn whether patient decision aids, tools originally developed to help patients make tough treatment choices, can be used to help potential research participants be better informed about the possible risks and benefits of participation, and make appropriate choices. We propose to develop this new decision support tool by 1) examining the extent to which current informed consent procedures fall short of standards; 2) interviewing research participants about ways in which the recruitment procedures can be improved; 3)developing a new tool using innovative, iterative design methods, and 4) conducting an initial study of the new tool. This pilot work will provide the groundwork for a larger evaluation study. The larger goal of this work is to change the way research recruitment is typically implemented, away from (barely) informed consent towards high-quality decision-making.

developing and pilot testing a patient decision aid to improve the quality of informed consent for clinical trial participation