What is HealthyVOICES?
HealthyVOICES is a five-year qualitative study designed to explore the participation of healthy volunteers in Phase I clinical trials. The full project name is “Healthy Volunteers On their Involvement and Clinical Experiences in Studies.” We use the acronym HealthyVOICES to emphasize the importance of our participants’ perceptions of and experiences in clinical trials.
Research to date focuses on why healthy people decide to participate in clinical trials, but does not examine how they participate. This project will examine how these individuals participate by addressing the following questions:
- How do healthy people view and assess the risks of participating in Phase I studies?
- How do they decide which studies to enroll in and which ones to avoid?
- How does their identification as “serial participants,” professional “guinea pigs,” or “lab rats” influence their behavior, including how they take care of their bodies?
We have enrolled into the HealthyVOICES project 180 healthy volunteers with different levels of experience participating in Phase I studies. Over the course of a three-year period, they participate in five interviews and maintain “clinical trial diaries,” surveys recording their ongoing participation in Phase I studies. These two sources of data allows us to compare how they talk about their clinical trial activity in their semi-structured interviews with their actual behavior as represented by their CTDs.
HealthyVOICES is funded by a grant from the National Institute of General Medical Sciences of the National Institutes of Health.