The project investigates medical research in the private sector to document how human subject volunteers obtain and understand information before enrolling in medical research and what factors influence their decisions to participate (or not participate) in research protocols. Specifically, this project will answer the following question: What are the effects of private sector recruitment, inducement, and consent practices on human subject volunteers' understanding of and decision-making about participation in medical research? Nested within this research question, this project will also query how do inducements for investigators' and research staff influence these research practices? The research mobilizes both qualitative and quantitative methods to collect and analyze data on research protocol for anxiety, depression, and insomnia. Observational studies and semi-structured interviewing will be carried out over 6 months in a core site in a national full-service contract research organization. The quantitative surveys, collected over 12 months, will provide additional breadth to the study by increasing the number of individuals in the analysis and the number of research protocols in which respondents are involved. The surveys will enable a generalization of the findings to guide future research on the effects of and ethics of the privatization of medical research on informed consent. Additionally, the results will begin to provide a basis for valid recommendations to address the ethical challenges raised by the privatization of medical research. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Predoctoral Individual National Research Service Award (F31)
Project #
5F31MH070222-02
Application #
6803563
Study Section
Special Emphasis Panel (ZRG1-EDC-3 (90))
Program Officer
Mayo, Donna J
Project Start
2003-09-17
Project End
2005-08-31
Budget Start
2004-09-17
Budget End
2005-08-31
Support Year
2
Fiscal Year
2004
Total Cost
$41,192
Indirect Cost
Name
Rensselaer Polytechnic Institute
Department
Miscellaneous
Type
Schools of Arts and Sciences
DUNS #
002430742
City
Troy
State
NY
Country
United States
Zip Code
12180