This research, co-funded by the Science, Technology & Society program and the EPSCoR program at NSF, examines the impacts of Institutional Review Board rulings on human subjects research. Research that advances scientific, engineering, biomedical, and technological knowledge often requires the participation of human subjects. In order to be enrolled in such research, subjects must give their voluntary and informed consent. Institutional Review Boards (IRBs) serve as the oversight bodies charged with ensuring that: risks to human subjects are minimized and reasonable, subject selection is equitable, and the informed consent documents are adequate. Yet little is known about how IRBs actually deliberate and perform these oversight functions, or about the extent to which the experiences, preferences and values of potential research subjects are incorporated into the IRB-approved informed consent process. Thus, it is not clear if the IRB oversight process for monitoring informed consent achieves its stated goal of ensuring protection and voluntarism of human subjects. This research examines the relationship between science and society as evidenced in the process of monitoring and obtaining informed consent from human subjects. The examination will focus on two distinct populations: IRB members and research participants. Using qualitative and exploratory methods, the first study examines the norms and processes that IRBs use when assessing and monitoring the adequacy of the informed consent process. The study will include representatives from a variety of current types of IRBs: academic, for-profit, hospital, and community boards. The second study examines the experiences, preferences and levels of understanding that research subjects bring to the informed consent process, focusing on human subjects from rural locations. The findings from these two efforts will bring together and compare the perspectives and levels of understanding of two key stakeholder groups. These findings will be widely disseminated in order to inform the development of a consent process that takes into account not only regulatory requirements, but also the information that prospective research participants need and want to know in order to offer true and voluntary consent.
