How to Protect Healthy Volunteers from Exploitation in Biomedical Research?

Webinar Resources

UNC Empirical Bioethics Projects on Healthy Volunteer Clinical Trials (PIs: Jill A. Fisher & Rebecca L. Walker)

HealthyVOICES Project website:
https://healthyvoices.web.unc.edu

CMORE Project website:
https://cmore.web.unc.edu

Key Publications:

• Walker RL et al. (2022) Ethical Criteria for Improved Human Subject Protections in Phase I Healthy Volunteer Trials. Ethics & Human Research44 (5): 2-21.
• Fisher JA et al. (2021) Phase I Trial Compensation: How Much Do Healthy Volunteers Actually Earn from Clinical Trial Enrollment?Clinical Trials 18 (4): 477-487.
• Kalbaugh CA et al. (2021) Healthy Volunteers in US Phase I Clinical Trials: Sociodemographic Characteristics and Participation Over Time. PLoS ONE 16 (9): e0256994.
• Walker RL, Cottingham MD, Fisher JA (2018) Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research. Journal of Medicine and Philosophy 43 (1): 83-114.
• Fisher JA et al. (2018) Healthy Volunteers’ Perceptions of the Benefits of their Participation in Phase I Clinical Trials. Journal of Empirical Research on Human Research Ethics13 (5): 494-510.
• Fisher JA et al. (2018) Healthy Volunteers’ Perceptions of Risk in U.S. Phase I Clinical Trials: A Mixed-Methods Study. PLOS Medicine15 (11): e1002698.
• See also: Fisher JA (2020) Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals. New York University Press.

Exploitation of Healthy Volunteers (Trudo Lemmens, University of Toronto)

Key Publications:

• Lemmens T, Elliott C (2001) Justice for the Professional Guinea Pig. American Journal of Bioethics, 1(2):51-3.
• Lemmens T, Elliott C (1999) Guinea Pigs on the Payroll: The Ethics of Paying Research Subjects. Accountability in Research, 7(1):3-20.
• Lemmens T, Miller PB (2003) The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives. Journal of Law, Medicine, and Ethics, 31:398-418.

Ethics Projects on Controlled Human Infection studies (CHIs) (Seema K. Shah, Northwestern University)

Key Publications by Prof. Shah:

• Shah SK et al. Ethics of controlled human infection to address COVID-19. Science. 2020 May 22;368(6493):832-4.
• Shah SK, Rid A. Ethics of controlled human infection studies: past, present and future. Bioethics. 2020 Oct;34(8):745-8.
• Jamrozik E et al. Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group. Vaccine. 2021 Jan 22;39(4):633-40.
• Kraft SA et al. Exploring ethical concerns about human challenge studies: a qualitative study of controlled human malaria infection study participants’ motivations and attitudes. Journal of Empirical Research on Human Research Ethics. 2019 Feb;14(1):49-60.
• Marsh A et al. Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials. Forthcoming in PLoS One.

Other References Included in Prof. Shah’s Presentation:

• Miller FG, Grady C. (2001). The ethical challenge of infection-inducing challenge experiments. Clinical Infectious Diseases, 33, 1028-1033.
• Bambery B et al. (2016). Ethical criteria for human challenge studies in infectious diseases. Public Health Ethics, 9, 92-103.
• Selgelid MJ, Jamrozik E. (2018) Ethical challenges posed by human infection challenge studies in endemic settings. Indian journal of medical ethics, 3(4):263.
• Wertheimer A. (1999) Exploitation. Princeton: Princeton University Press.
• Stunkel L, Grady C. (2011) More than the money: a review of the literature examining healthy volunteer motivations. Contemporary clinical trials, 32(3):342-52.
• Fisher JA et al. (2018) Healthy Volunteers’ Perceptions of the Benefits of their Participation in Phase I Clinical Trials. Journal of Empirical Research on Human Research Ethics,13 (5), 494-510.
• Anomaly J, Savulescu J. (2019) Compensation for cures: Why we should pay a premium for participation in ‘challenge studies’. Bioethics, 7, 792-7.
• Roestenberg M, et al. (2018) Experimental infection of human volunteers. The Lancet Infectious Diseases, 18 (10), e312-22.
• Lenharo M (2021) What Do Researchers Owe Their Study Subjects? They let Zika scientists collect data from their kids. Then they heard nothing. Slate.
• Pike ER (2012) Recovering from research: A no-fault proposal to compensate injured research participants. American Journal of Law & Medicine, 38(1):7-62.
• Lederer SE (2015) Dying for Science: Historical Perspectives on Research Participants’ Deaths. AMA Journal of Ethics, 17(12):1166-71.

Professional Guinea Pigs (Roberto Abadie, University of Nebraska)

Key Publications:

• Abadie R (2010) The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. Durham, NC: Duke University Press.
• Elliott C, Abadie R. (2008) Exploiting a Research Underclass in Phase 1 Clinical Trials. New England Journal of Medicine, 358(22):2316-7.
• Abadie R (2019) The Exploitation of Professional “Guinea Pigs” in the Gig Economy: The Difficult Road From Consent to Justice. American Journal of Bioethics, 19 (9):37-9.