Reexamining equipoise through the lens of potential research participants

Abstract: The concept of equipoise has long been debated among the research ethics community, but its perception among potential research participants has received relatively little attention. This panel will refocus the debate about equipoise through the lens of patient and family experiences. Using a combination of conceptual and empirical analyses, the panelists will reexamine equipoise and explore appropriate paths forward for clinical trial design and regulation.

The moderator will introduce the concept of equipoise, discuss its implications for clinical research, and highlight ongoing ethical debates. Panelist 1 will then share empirical data from parents of infants in the neonatal intensive care unit (n=38) about how they assess equipoise in comparative effectiveness research, exploring how parents perceive a trial’s ethical acceptability, their preferences for informed consent, and the nuanced relationship between clinical communication, trust in the knowledge of one’s clinician, and trust in research. Panelist 2 will further examine communication with participants, drawing on an empirical analysis of interviews with key stakeholders about notification of pragmatic clinical trials (n=23), as well as a historical and normative examination of how regulatory criteria for communication to participants are applied in practice. Finally, Panelist 3 will present a conceptual analysis via a novel taxonomy of the nature of patient and family concerns related to randomization in clinical trials, highlighting the interplay between views on randomization and perceptions of equipoise. Together, the panelists will explore how a nuanced consideration of these concepts can facilitate more targeted regulatory responses and a path forward for clinical research.

Keywords: Randomization, Informed consent, Pragmatic clinical trials