This project examines how the """"""""benefits"""""""" of gene transfer research are described and understood by principal investigators, study coordinators, subjects, IRB chair and consent forms. One phase of this study involve telephone interviews with the principal investigator, study coordinator, 10 subjects and IRB chair in 40 studies . Currently approximately 10 sites have been enrolled. Another part of this projects involves the analysis of approximately 300 consent forms that describe gene transfer research. Approximately 35 consent forms have been coded.
| 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 |
