title: Overseeing innovative therapy without mistaking it for research: a function-based model based on old truths, new capacities, and lessons from stem cells.
abstract: Should innovative therapy occur only within a research paradigm and under institutional review board oversight? The health risks from current human embryonic stem cell clinical applications have raised again a fundamental question addressed first in papers submitted to inform the writing of the Belmont Report. Revisiting the thinking underlying the Belmont Report, together with examining changed circumstances since then, leads to a new model for overseeing innovative therapy based on its unique risks and context, important changes since the Belmont Report, and new opportunities for addressing risks through safety and quality systems in health care.
authors.affiliation: Children's Hospital Boston, USA.
authors.forename: Patrick L
authors.initials: PL
authors.lastname: Taylor
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D057176:Compassionate Use Trials / Q000941:ethics / Q000331:legislation & jurisprudence; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D004059:Diffusion of Innovation; D028744:Ethics Committees, Research / Q000941:ethics / Q000458:organization & administration; D033161:Government Regulation; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D017146:Models, Organizational; D056687:Off-Label Use / Q000941:ethics / Q000331:legislation & jurisprudence; D009937:Organizational Objectives; D012449:Safety / Q000331:legislation & jurisprudence; D033581:Stem Cell Transplantation / Q000941:ethics* / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration