Law, Public Policy and Social License for Next-Generation Regenerative Medicine
PI: Pr. Amy ZARZECZNY, University of Regina, Canada
Funder: Canadian Stem Cell Network
We are at a critical time for clinical translation of regenerative medicine, which offers potential life-changing improvements to treatment options for many conditions. Successful clinical translation will require regulation and governance frameworks (tools, institutions and processes) that support development of safe, effective and globally accessible treatments, and which prevent illegitimate, premature, and unethical translation. It is important these frameworks operate in a context that promotes public trust, inclusive innovation and technology uptake, and global health justice. This context is necessary to maintain regenerative medicine’s social license to operate. The objective of this project is to support development of an inclusive regulatory and governance framework that will strengthen the social license for the clinical translation of regenerative medicine. We will do so by advancing knowledge in three key areas: (1) Design and updating of regulatory systems that support sustainable and equitable innovation and technology translation; (2) Understanding misinformation about regenerative medicine and its relationship with public trust; (3) Strengthening professional regulation as a governance mechanism for clinical applications of regenerative medicine. We will take an innovative approach, adopting a global justice lens for our work. Notable deliverables will include recommendations for policy and regulatory reform, academic publications and presentations, writings for the popular press, high-impact Policy Briefs, and training for Highly Qualified Personnel (HQP). We have assembled a strong and diverse team, many of whom have a history of successful collaboration in stem cell and regenerative medicine research. Our multidisciplinary team brings expertise in law, policy, ethics, stem cell science, regulation, governance, media studies, global health, public engagement and knowledge translation, among other areas, as well as international perspectives (including the US, Australia, Europe, and South Africa). We will leverage key partnerships, including #ScienceUpFirst, EuroGCT and the Centre for the Study of Science and Innovation Policy, to enhance the reach and impact of our work. HQP will have a central role in all aspects of the project, building on the Health Law Institute’s successful training model.