The purpose of "Social Construction of Benefit in Gene
Transfer Research" was 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. All studies were on a list of gene transfer
protocols
registered with the Recombinant
DNA Advisory Committee, Office of Biotechnology Activities of the
NIH. "Influence and Benefit in Gene Transfer Research" is a
competitive renewal of "Social Construction of Benefit in Gene Transfer
Research."
The study had three components (also see organizational
chart and project instruments):
- Interviews with investigators, study
coordinators,
and subjects
in 41 recent GTR studies
- Interviews with representatives of IRBs at 43
institutions
overseeing GTR
- Review of consent forms and protocol
information
for 321
GTR studies submitted to NIH OBA since 1990.
Products of this study are listed in Project Publications and Presentations.