Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

Abstract

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants’ sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants’ perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

A Qualitative Study on Experiences of HIV Vaccine Trial Participants in a Phase I/II Double Blinded, Randomized Placebo Controlled Clinical Trial in Tanzania: Lessons for COVID-19 Vaccine Testing

“…In the United States people of lower socioeconomic groups including those from Hispanic origin were more likely to volunteer to obtain better access to resources that they did not have (33). As a result, study investigators must ensure that such participants from low-income groups who volunteer are properly protected and understand the study aim, procedures and possible harm.…”

Informal professionalization of healthy participants in phase I clinical trials in Russia

“…An investigation of adverse events reporting found that rather than subverting trial results in an attempt to prevent the termination of trial participation and the associated loss of earnings, healthy trial participants were mostly willing to forgo their full compensation when believing that not reporting adverse events “jeopardizes their own safety or the validity of the research.” 19 In addition, another article reports on fairly common reflections among healthy trial participants on the importance of the possible societal benefits of their participation. 20 We can discern, then, the coexistence of a variety of attitudes and behaviors among healthy trial participants in different settings, whereas it is the subversive and rule-breaking practices that have received the most attention in scholarship on repeat trial participation to date. 21–24 Attention to specialized knowledge and skills, bound together by work ethic offered in this article, allows for a different way of defining what it means to be a professional trial participant.…”

“…19 In addition, another article reports on fairly common reflections among healthy trial participants on the importance of the possible societal benefits of their participation. 20 We can discern, then, the coexistence of a variety of attitudes and behaviors among healthy trial participants in different settings, whereas it is the subversive and rule-breaking practices that have received the most attention in scholarship on repeat trial participation to date. [21][22][23][24] Attention to specialized knowledge and skills, bound together by work ethic offered in this article, allows for a different way of defining what it means to be a professional trial participant.…”

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“…These mechanisms simplify the process by which the results of research can be shared with those who participated in the study, who are often motivated beyond monetary gain by interest in the topic or in a service to society. 54 Overall, by engaging in some or all of these practices before, during, and after a study, researchers can improve the diversity, equity, and generalizability of their work, but importantly, provide acknowledgment of the community as a key partner.…”