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

Abstract

Background: Previous social science research has shown how some healthy phase I trial participants identify themselves as workers and rely on trials as a major source of income. The term “professionalization” has been used to denote this phenomenon. Purpose: We aim to examine a component of healthy trial participants’ professionalization that has not yet been systematically studied: how repeat phase I trial participants develop and claim expertise that distinguishes them from others and makes them uniquely positioned to perform high-quality clinical trial labor. We also aim to explain the significance of these research results for protection of healthy participants in phase I trials. Methods: This qualitative exploratory study was conducted in Russia, in two phase I trial units. It involved semi-structured interviews with 28 healthy trial participants with varying lengths of experience in trials, observations of work done in trial units, and interpretive conversations with investigative staff. Results: Interviewed healthy individuals who repeatedly participate in phase I trials describe developing knowledge and skills that involve appreciating the meaning of trial procedures, coming up with techniques to efficiently follow them, organizing themselves and others in the course of a trial, and sharing tacit ways of doing trial work well with other less experienced participants. Our results suggest that a prerequisite for such expertise-centered professionalization is the emergence of a positive identity linked to seeing value in trial participation work. A crucial component of professionalization thus understood is the development of a work ethic that entails caring about results and being reliable partners for investigators. Limitations: The attitudes and behaviors presented in this article are not suggested to be universally shared among healthy trial participants, but rather represent a particular instance of professionalization that coexists with other views and tactics. Conclusions: A way of better protecting healthy trial participants begins with recognizing their skills, knowledge, and the centrality of the contribution they are making to pharmaceutical research. Currently, the expertise of experienced trial participants is recognized on the work floor only; therefore, the professionalization we described is informal. Yet, the informal professionalization process is inherently risky as it does not involve any change in the formal conditions of trial participants’ work. Instituting formal measures for protecting healthy trial participants as skilled workers combined with recognition of their expertise is essential.

Controlled human infection with SARS-CoV-2 to study COVID-19 vaccines and treatments: bioethics in Utopia

“…There is ample evidence from both LMICs and from highincome countries that recruitment to phase 1 pharmaceutical trials in some instances involves the exploitation of the socioeconomically disadvantaged, and that recruitment to phase 1 trials is not consistent with any principle of fair selection of participants. [21][22][23][24][25] Unless the exclusion argued for by the WHO working group is observed in relation to CHIs we should expect the phase 1 pattern of exploitative recruitment to be replicated in CHIs. This would make the projects prima facie unethical.…”

Ethics and etiquette in an emergency vaccine trial. The orchestration of compliance

“…During my research, I encountered a situation that many critical bioethicists and anthropologists have expressed concerns about: "healthy" clinical trial participants often approach their participation in research as a kind of precarious employment, beyond altruistic volunteerism, something that highlights the awkwardness of the cheerful formal bioethical discourse of "gifts" and "compensation" (Abadie, 2015;Bernstein, 2003;Fisher, 2013;Lemmens & Elliott, 2001;Zvonareva et al, 2019). Others have proposed the notion of clinical labour to conceptualize the participation of healthy volunteers in trials (Cooper & Waldby, 2014).…”

Commentary on Zvonareva et al.: Exploring the many meanings of “professional” in research participation

“…As highlighted by Roberto Abadie's book The Professional Guinea Pig, 2 the focus is largely on those participants, particularly healthy volunteers, who enroll in clinical trials as though it were their full-time job. In contrast, the excellent article by Zvonareva et al 3 illustrates that the term ''professional'' can be interpreted in multiple ways that differentially attend to who enrolls in clinical trials and how they perceive their role as research participants. Drawing upon the sociology of professions, 4,5 Zvonareva et al are particularly interested in the specialized knowledge and skills that healthy volunteers acquire through their clinical trial involvement, making them highly reliable-and thus valuable-participants.…”

“…One participant described his preference for the term: ''A veteran means like old-school ... We just call 'em 'veterans'' cause they've been through it and they know all the routines and so when they go through it [a study], they know it's a cinch.'' One participant rejected the term ''professional'' because of the unwarranted prestige he thought it conveyed to research participation: Returning to Zvonareva et al's 3 article, attention to the positive work ethic that research participants might bring to their clinical trial involvement is much needed.…”