Understanding Research Risk: A Cautionary Tale

Research consent forms are often a jumble of complex information describing study risk with qualitative and quantitative terms, and sometimes comparator scenarios. IRBs advise investigators on the expression of risk in in varying and sometimes inconsistent ways. Social behavioral studies suggest that one’s understanding of study risk is thought to be influenced by personality attributes, level of education and literacy, as well as cultural background.

This session will:  a) provide an overview of risk communication, b) evaluate various approaches supported by IRBs and literacy experts for the articulation of study risk, and c) provide concrete suggestions for improving discussions of risk in consent forms.