HealthyVOICES & CMORE
With funding from the National Institutes of Health, I conducted a five-year qualitative study designed to explore the participation of healthy volunteers in Phase I clinical trials. We called the project HealthyVOICES or “Healthy Volunteers On their Involvement and Clinical Experiences in Studies.” Rather than simply focus on why healthy people decide to participate in clinical trials, this project examined how these individuals participate in Phase I trials. Our primary questions were:
How do healthy people view and assess the risks and benefits 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 enrolled 180 healthy volunteers with different levels of experience participating in Phase I studies. Over the course of a three-year period, they participated in five interviews and maintained “clinical trial diaries” (CTDs), surveys recording their ongoing participation in Phase I studies. These two sources of data allowed 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. More details about the design of this research study can be found here.
For more information, please visit the HealthyVOICES Project website.
Continuing this line of research, we have begun the Comparative Model Organism Research Ethics (CMORE) for Healthy Volunteers project to address the need for a novel evidence-based approach to the protection of Phase I healthy volunteers. The project has the following aims:
Describe and normatively evaluate the limitations of current research oversight in Phase I trials by analyzing data on healthy volunteers’ perceptions of clinical trials, including through a non-human animal research “model organism” lens;
Compare the ways in which Phase I researchers, non-human animal researchers, bioethicists and policymakers, regulatory and research oversight staff, and healthy volunteers conceptualize: a.) similarities and differences between healthy volunteer and non-human animal research and b.) ethical, policy, and translational science problems particular to each arena; and
Develop ethics and policy guidance for Phase I healthy volunteer research that a.) extrapolates from the model organism framework, b.) is attentive to the structural features of Phase I research, and c.) is vetted by expert stakeholders.
For more information, please visit the CMORE Project website.