United States Regulation of Stem Cell Research: Recasting Government’s Role and Questions to Be Resolved

Humans, like many other animals with central nervous systems, run under the control of biological clocks distributed among the various organs of their bodies and synchronized by a master clock located in their brains. Like an organism in which these clocks have been disconnected from their master, the many arms of United States federal and state law governing stem cell research and medicine exhibit a profound lack of synchronicity and varying degrees of “soft” and “hard” touch. This situation, we believe, results largely from the United States National Institutes of Health (“NIH”) having been stymied since the late 1970s from becoming a fully formed “master clock” for a nationwide, perhaps worldwide, human embryology research program—one that includes the study of human embryonic stem cells (“hESCs”) and regenerative medicine. This is a role that the NIH has successfully achieved in many other areas of health science. A solution to this problem may be the invention in 2007 of induced pluripotent stem cells (“iPSCs”). Beyond iPSCs, the tantalizing potential looms for reprogramming adult somatic cells directly into other types of adult somatic cells without having to revert to pluripotent status. But even if these innovations may help resolve decades of ethical and religion-based debates over hESCs, a larger problem not specific to any technology remains: addressing the conflicts that now exist among federal and state governments over how best to regulate stem cell research and medicine—conflicts that arose in an environment without the NIH being able to play its historic lead role in shaping ethical, legal, and socially acceptable practices for this emerging area of health science.

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