Phase I Clinical Trials and the Informed Consent of Healthy Subjects

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DESCRIPTION (provided by applicant): This project will initiate exploratory research on the informed consent of healthy human subjects participating in Phase I pharmaceutical clinical trials. Private-sector, for-profit Phase I research clinics, specializing in the rapid recruitment of human subjects for in-patient studies, have proliferated in the last decade. These clinics tend to be located in economically depressed areas of the country and offer healthy volunteers large sums (e.g., $7,000) for their participation in studies. Although most scholars assume that healthy volunteers are motivated largely by financial inducements to participate in Phase I trials, there has been no assessment of the effects of financial inducements and informed consent upon subjects' decision-making. The proposed project will fill this empirical gap on informed consent of healthy volunteers in Phase I pharmaceutical research. Through a two-year exploratory study employing qualitative methods (observational studies and semi-structured interviews), this project will address three research questions: 1. what are the factors influencing healthy human subjects' decisions to participate in Phase I studies? 2. What procedures facilitate and/or impede informed consent in Phase I trials? 3. How do the interactions between healthy human subjects and research staff vary by subjects' gender, race, and class? Research will be conducted at 6 Phase I clinics (five commercial and one academic) in the United States. A minimum of 246 interviews will be conducted with human subject volunteers and research staff (i.e., physicians, nurses, administrators, and other research staff). Qualitative research is ideally suited to documenting more fully the context of and factors influencing human subjects' decision-making regarding participation in Phase I clinical trials. This research will provide important data on an area of informed consent that has received little scholarly attention to date. PUBLIC HEALTH RELEVANCE: Although many Phase I studies involve considerable risk and uncertainty, these early clinical trials are critical to the process of pharmaceutical research and development. Thus, it is necessary to optimize the informed consent process to protect subjects who participate in these trials. This research project will lead to policy recommendations detailing innovative interventions to improve informed consent in Phase I research clinics.