Informed Consent in Private Sector Mental Health Research

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DESCRIPTION: (provided by applicant) 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.