Social Construction of Benefit in Gene Transfer Research

The purpose of this study is to determine how the prospect of direct benefit to research subjects in gene transfer research (GTR) (usually called 'gene therapy') is understood and discussed by research subjects, investigators, study coordinators, and IRBs, and explained in consent forms. The research team expects to find that the prospect of benefit from receiving the investigational intervention is often exaggerated and that this exaggeration of benefit is accompanied by language confusion in consent forms, blending of the roles of physician and researcher, and other aspects of the review of research and the consent process. To investigate these issues, the researchers will interview investigators, study coordinators, and subjects in up to 40 recent GTR studies, to analyze consent forms and protocols for all GTR studies approved since 1990 (N=about 275), and to interview IRBs at institutions overseeing the 40 studies. They will develop a model that explains the variation in participants' understanding and discussion of benefit from GTR interventions, controlling for contextual factors, within and between these studies. They will separately assess variation in understanding and discussion of benefit in consent forms and by IRBs. The researchers hope to discover some ways of reducing the tendency toward exaggeration of benefit by careful attention to language in the consent form process, by education of investigators and IRB members, and by consideration of research. Based on these findings, the researchers hope to develop an improved policy standard for the presentation of benefit in GTR specifically and clinical research generally.