Human Enough? Organ Chips and their Ethical and Social Implications

Abstract: For over 80 years, the United States (US) Food, Drug, and Cosmetic Act of 1938 has required that new pharmaceuticals undergo safety and efficacy testing in non-human animals before being tested in humans. And yet, the translational failures of animal models have been well documented, and the reliance on them has long been the focal point of scrutiny from those within and outside the biomedical research community. Indeed, this issue has become a key site of interest, financial investment, and social action: so much so that in 2022, the US passed legislation that enables the use of alternatives to animal testing—such as novel computational and cell technologies—in order for new pharmaceuticals to receive US FDA approval to conduct human clinical trials. In this paper, I follow a set of these technologies called organ chips. Organ chips are microfluidic technologies that use human cells to model organs. They are typically a clear polymer about the size of a flash drive, with channels and reservoirs etched into the platform designed to model a particular organ. Chemical compounds can then be administered, offering insight to predicted human response. Examining the design and development of organ chips, I offer a sociological account that surfaces emergent ethical and social concerns in their development. I show how particular sets of actors and their values shape the design of organ chips and how making models “human enough” is socially negotiated. In doing so, I highlight ethical questions around cell sourcing, representation, and value tradeoffs.