Date of Conferral

2023

Degree

Ph.D.

School

Public Health

Advisor

Raymond Panas

Abstract

Clinical trials are the standard for approving medicines for public use. To conduct trials, researchers depend on a declining number of volunteers. The healthy volunteer effect, a phenomenon in which participants demonstrate better outcomes than their peers, limits the generalizability of trial outcomes. The healthy volunteer effect does not fully explain the outcome difference between volunteers and nonvolunteers. The purpose of this cross-sectional quantitative study was to examine personal hardiness as an unexplored component of the healthy volunteer effect and determine whether personal hardiness is associated with willingness to participate. Hardiness was a personality construct that represented resilience to stress. The hardiness model for performance and health enhancement served as the theoretical framework for this study. Data were collected through a single-administration electronic questionnaire with 208 U.S.-based adults. Ordinal regression was used to assess the relationship between hardiness and willingness. A statistically significant association was found between high hardiness and willingness (p < .001), and high hardiness increased the odds of being more willing to participate by four times. An association between hardiness and willingness may provide participants with more accurate risk/benefit assessments and allow researchers to quantify and adjust for bias due to hardiness. Results could influence future study designs, result in more careful participant considerations, and impact how trial outcomes are interpreted and applied to the public. Implications for positive social change include quantifying and adjusting for hardiness as a standard practice in clinical trials, which could maximize the effectiveness of new treatments and provide insight into real-world efficacy.

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