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.
| Henderson, Gail E (2011) Is informed consent broken? Am J Med Sci 342:267-72 |
| Schaffer, Rebecca; Henderson, Gail E; Churchill, Larry R et al. (2009) Parents' online portrayals of pediatric treatment and research options. J Empir Res Hum Res Ethics 4:73-87 |
| Henderson, Gail E; Churchill, Larry R; Davis, Arlene M et al. (2007) Clinical trials and medical care: defining the therapeutic misconception. PLoS Med 4:e324 |
| Easter, Michele M; Henderson, Gail E; Davis, Arlene M et al. (2006) The many meanings of care in clinical research. Sociol Health Illn 28:695-712 |
| Henderson, Gail E; Easter, Michele M; Zimmer, Catherine et al. (2006) Therapeutic misconception in early phase gene transfer trials. Soc Sci Med 62:239-53 |
| King, Nancy M P; Henderson, Gail E; Churchill, Larry R et al. (2005) Consent forms and the therapeutic misconception: the example of gene transfer research. IRB 27:1-8 |
| Churchill, Larry R; Nelson, Daniel K; Henderson, Gail E et al. (2003) Assessing benefits in clinical research: why diversity in benefit assessment can be risky. IRB 25:1-8 |
| Davis, Arlene M; Hull, Sara Chandros; Grady, Christine et al. (2002) The invisible hand in clinical research: the study coordinator's critical role in human subjects protection. J Law Med Ethics 30:411-9 |
