An Astute Guinea Pig in a First-in-Human Clinical Trial: Lessons for IRBs and the Disenfranchisement Social Science Literature

Abstract

Objective: This sociological article sits outside the dominant social science research paradigm of those researching subjects recruited into first-in-human clinical trials; they routinely characterise “guinea pigs” as powerless, exploited persons who present themselves both “ready to recruit and ready to consent”. This article highlights an exception to this paradigm documenting an instance where a first-in-human clinical subject deciphers a clinical trial regime and allows for a rational decision to maximise personal safety. Methods: This report of an ethically approved ethnographic study of clinical trialists (N=24) in either bioequivalency or first-in-human clinical trials focuses on one participant. Zach, a 25-year-old first-in-human trialist shared his secret and proudly agreed for its public airing. Results: Zach recounts a moment during the recruitment phase of a first-in-human clinical trial where he calculated the risk quotient of participating in the study during given trial dates. Zach was able to identify one trial date (of eight dates) that he saw was less risky than the other seven trial dates. The interactive article gives the reader sufficient information for them to also attempt to decipher what is essentially a cryptic crossword. Conclusion: If Zach’s claim is valid, and clinical trials safety or risk within a (sequential date) clinical trial is unequal, IRBs should insist this asymmetrical risk be made explicit in consent forms. Equally, future social science scholars researching clinical trial participants should be critically aware of human agency rather than blinded by their maximization of guinea pigs’ diminished autonomy.