The Future of Stem Cell Research and its Clinical Translation in Canada: Exploring Questions of Governance and Policy Options.

ABSTRACT

Stem cell research is a promising area of biomedical research with tremendous potential for increasing our understanding of human development and for improving clinical treatment options across a range of serious conditions. However, it has historically also been a complex field, both scientifically and ethically. It raises numerous policy tensions including those related to the acceptability of different forms of research in the field and, more recently, regarding how to respond to the rapidly growing private market for clinical applications that lack broadly accepted forms of evidence of safety and efficacy. Using the Canadian market for unproven stem cell interventions as a case study, this review paper identifies questions of governance and policy options as they relate to the future of stem cell research and its clinical translation in Canada. Key areas of inquiry include the roles and influence of evidence, scientific and clinical imperatives, and public pressure on policy decisions, as well as the role of regulation in managing risks and uncertainty in fast moving fields of biomedicine. Examining these questions in a Canadian context is particularly timely at present given the emerging domestic private market for stem cell-based interventions coupled with scientific developments in the field that are highlighting ambiguities and other challenges with our current regulatory framework.