title: Reflections on governance models for the clinical translation of stem cells.
abstract: Governance models for the oversight of human embryonic stem cell research have been proposed which mirror in large part familiar oversight mechanisms for research with human subjects and non-human animals. While such models are in principle readily endorsable, there are a set of concerns related to their implementation--such as ensuring that an elaborated informed consent process and conducting long-term monitoring of research subjects are tenable--which suggest areas where gathering data may facilitate more appropriate oversight. In addition, it is unclear whether a new governance model based at individual institutions are sufficient to address the ethical issues inherent to this research. Regardless, some of the concerns that have arisen in considering the appropriate governance of stem cell research, particularly the important translational pathway of innovation in contrast to staged research, transparency and publication, and social justice, may be useful in science and translational research more broadly.
authors.affiliation: Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D026683:Advisory Committees / Q000458:organization & administration; D054976:Clinical Governance; D003659:Decision Making, Organizational; D004059:Diffusion of Innovation; D033041:Embryo Research / Q000941:ethics / Q000331:legislation & jurisprudence; D053595:Embryonic Stem Cells; D035082:Federal Government; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D017146:Models, Organizational; D009307:National Academy of Sciences, U.S. / Q000458:organization & administration; D012586:Science / Q000941:ethics / Q000458:organization & administration; D012935:Social Justice / Q000941:ethics / Q000331:legislation & jurisprudence; D012958:Societies, Scientific / Q000458:organization & administration; D057170:Translational Research, Biomedical / Q000941:ethics / Q000458:organization & administration; D014342:Truth Disclosure / Q000941:ethics; D014481:United States