Chapter 1 - Regulatory and policy considerations in iPSC research

Abstract

Enthusiasm for scientific discovery involving the derivation of induced pluripotent stem cells (iPSCs) may cause researchers to overlook regulatory and policy considerations particularly in early-stage discovery research. However, as the global regulatory policy landscape becomes more complex, researchers should strive to ensure their protocols conform to foreseeable international standards. Programs that are not aligned with this policy landscape may encounter regulatory bottlenecks as they advance—particularly preclinical research. In the context of iPSC research, there are a set of regulatory norms that should guide basic and clinical programs. These norms are applicable into three general areas—(1) materials (biospecimen) acquisition, (2) iPSC derivation and differentiation, and (3) product (cell line) and data stewardship. This chapter draws on experience with the administration of research grant awards and investment opportunities to suggest strategies for anticipating and addressing regulatory policy considerations in early-stage research programs.