SOCIAL CONSTRUCTION OF BENEFIT IN GENE TRANSFER RESEARCH

University Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Linked publications & trials

Abstract

DESCRIPTION (Adapted from the Investigator's Abstract): 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 investigators expect to find that the prospect of benefit from receiving the investigational intervention is often exaggerated; they expect to find 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, they propose to 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. The investigators 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. They hope to discover some ways of reducing the tendency toward exaggeration of benefit by careful attention to language in the consent form and process, by education of investigators and IRB members, and by consideration of how the context in which GTR takes place can affect the understanding of the parties to this research. Based on their findings, they hope to develop an improved policy standard for the presentation of benefit in GTR specifically and clinical research generally.