IN PRINT: The More Things Change: The New NIH Guidelines on Human Stem Cell Research Fall 2009

The More Things Change: The New NIH Guidelines on
Human Stem Cell Research

Published in the Kennedy Institute of Ethics Journal (see link in gray box below).

By Michelle N. Meyer and James W. Fossett

James W. Fossett and Michelle N. Meyer

ABSTRACT: Many assumed that the Obama administration would usher in a sea change from the previous administration by expanding support from the National Institutes of Health (NIH) for human embryonic stem cell (hESC) research and reducing the patchwork of state and federal regulations that currently governs it. In this article, we conclude that changes in hESC research from the Bush era are likely to be limited in scope.

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The full article is available in the Kennedy Institute of Ethics Journal, Vol. 19, No. 3, 289–307 © 2009 by The Johns Hopkins University Press.

Kennedy Institute of Ethics Journal

NIH issued new “Guidelines for Stem Cell Research” in July. With respect to the goal of expanding federal hESC research, the guidelines effect only incremental change in the scope of eligible research, preserving all the Bush restrictions except the prohibition on funding research on new lines. Although that amendment expands — in theory, infinitely — the number of new eligible lines, much research is based on existing lines, and the number of those that will become eligible depends on how strictly NIH applies its detailed informed consent requirements. Finally, the significance of expansions in the fundability of hESC research is meaningful largely to the extent that such research is funded, and we predict that, compared to other funders, NIH’s funding will only modestly increase.

With respect to the goal of ameliorating the “patchwork” of standards governing U.S. stem cell research, although the guidelines centralize crucial aspects of federal policy, and may exert influence even over non-NIH-supported researchers and other research funders and regulators, they almost certainly will not substantially reduce the multiple standards for conducting hESC research that exist in the United States, much less in the world.

Although there are significant uncertainties around the ultimate impact of the guidelines, there can be little doubt that their intent was to produce incremental, rather than sweeping, change in federal hESC policy. Our best guess for the short-term future of U.S. stem cell policy in the aftermath of the guidelines, then, is that — for better or worse — it will look very much like the recent past.


The Nelson A. Rockefeller Institute of Government, the public policy research arm of the State University of New York, conducts fiscal and programmatic research on American state and local governments. It works closely with federal, state, and local government agencies nationally and in New York, and draws on the State University’s rich intellectual resources and on networks of public policy academic experts throughout the country.