This paper examines potential ethical and legal issues arising during the research, development and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological samples; data; health; vulnerable populations; neural organoids; and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detrimental to best personalizing treatment decisions in the clinic.

Item Type:	Refereed Article
Keywords:	personalised medicine, health, bioethics, patents
Research Division:	Philosophy and Religious Studies
Research Group:	Applied ethics
Research Field:	Bioethics
Objective Division:	Culture and Society
Objective Group:	Ethics
Objective Field:	Bioethics
UTAS Author:	Nielsen, J (Associate Professor Jane Nielsen)
ID Code:	145689
Year Published:	2022 (online first 2021)
Funding Support:	Australian Research Council (DP180101262)
Deposited By:	Law
Deposited On:	2021-08-02
Last Modified:	2022-07-22
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