The purpose of this study to is to understand how the participants (Principle Investigators (PIs), Study Coordinators (SC), Subjects, IRBS) understand the benefits of gene transfer research. The study will focus on the the relationship between research and treatment, the dual roles of researcher and clinicain, and the expectations of benefit by the participants. The study includes intervews with PIs, SCs, Subjects, and IRB Chairs. It also includes an analysis of gene transfer consent forms. Over 250 consent forms have been obtained and coding is almost complete. The interviews with IRB chairs is almost complete. The remaining interview are ongoing.
| 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 |
| Henderson, Gail E; Davis, Arlene M; King, Nancy M P et al. (2004) Uncertain benefit: investigators' views and communications in early phase gene transfer trials. Mol Ther 10:225-31 |
| 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 |
