Oversight and Evidence in Stem Cell Innovation: An Examination of International Guidelines and Emerging Trends in Regulation

• In Event: Concepts and Practices of ELSI: 1. ELSI as a Political Terrain

Abstract

Disputes have recently emerged in the public, bioethical and professional discourses over whether certain types of stem cells may be administered to patients as innovative therapies before evidence of safety and efficacy has been demonstrated in clinical trials. Two professional organisations have issued guidelines that offer different perspectives on when it may be ethically justifiable to innovate with stem cells in clinical settings. In this paper, I examine the guidelines of both organisations with respect to how they each attempt to frame innovation with stem cells as either research or practice and define what ought to constitute as oversight for such innovation. I argue that, through these guidelines, both organisations are attempting to establish legitimacy for their version of an evidence-base and assert epistemic authority over the emergent field of regenerative medicine. I also discuss international trends in regulation that are aimed as accelerating the market approval process for innovative stem cell-based products. Implications for establishing standards of evidence and oversight frameworks for stem cell innovation are discussed.

Author

• Tamra Lysaght, National University of Singapore