Informed consent in gene transfer research

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While there has been much attention given to understanding the risks of research there has been much less attention given to the benefits of research. The purpose of this study is to understand how the participants (Principle Investigators (PIs), Study Coordinators (SC), Subjects, and IRBS) understand the benefits of gene transfer research. The study focuses on the relationship between research and treatment, the dual roles of researcher and clinicians, and the expectations of benefit by the participants. The study includes interviews with PIs, SCs, Subjects, and IRB Chairs. It also includes a content analysis of gene transfer consent forms. The interviews have been completed and the consent forms have been coded. We have completed the initial analysis of the data from the 41 IRB interviews and found that there is a wide range of approaches to evaluating the benefits of research. While most IRBs consider benefits to subjects and benefits to society, there are a few IRBs that exclude one or the other. This variability is concerning since one of the primary objectives of IRBs is to conduct an assessment of the balance of risks and benefits. Further clarity about how benefits should be considered by IRBs may improve their ability to assess research.