The idea for the HealthyVOICES project came about when Dr. Jill Fisher was conducting a previous study on healthy volunteers who participate in Phase I research. In that earlier study, Dr. Fisher investigated healthy volunteers’ motivations for enrolling in Phase I studies and assessed how well informed they were about the trials.* To collect data for that project, Dr. Fisher visited 6 Phase I clinics in the U.S. to observe the informed consent process and study procedures like blood draws, lumbar punctures (spinal taps), and drug dosing. She also interviewed 33 research staff members and 235 healthy volunteers who screened for or participated in studies while she was visiting those clinics. The results of that project are published in her award-winning book Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals. Those findings also led to the HealthyVOICES project. Here’s a snapshot of what Dr. Fisher found from her first study on healthy volunteers and what HealthyVOICES is designed to learn:
- Serial participation in Phase I studies is the norm. The current study will examine what catalyzes individuals to begin or discontinue serial participation.
- Participants report that their perceptions of risk change as they gain experience in studies. We will track how perceptions of risk change over time and what effect these perceptions have on healthy volunteers’ participation.
- Volunteers have their own criteria for studies in which they enroll. We will measure how important these criteria are to healthy volunteers and when, if ever, they would alter these criteria.
- Many serial participants said that they had changed their health behaviors as a result of trying to qualify for clinical trials. We will explore how prevalent these types of behavior change might be and what benefits participants might experience for their health more broadly.
HealthyVOICES has also built upon Dr. Fisher’s earlier work by incorporating an interdisciplinary team-based approach to the research. The project team includes faculty and trainee investigators who have expertise in the fields of science and technologies studies (STS), communication studies, sociology, psychology, law, public health, and bioethics. Thus, we approach the analysis of data from multiple viewpoints to interpret the findings.
* Dr. Fisher’s earlier research study was supported by a grant from the National Cancer Institute of the National Institutes of Health.