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

Abstract

During the George W. Bush Administration, federally fundable human embryonic stem cell (hESC) research was limited to certain kinds of research on, at most, 21 existing stem cell lines of dubious quality. Many assumed that the Obama administration would usher in a sea change by expanding NIH support for hESC research and reducing the patchwork of state and federal regulations that governed it under the prior administration. As expected, President Obama signed an executive order revoking the Bush policy, and NIH issued implementing Guidelines for Human Stem Cell Research. In this article, we analyze the extent to which the Guidelines are likely to achieve two of their stated goals: “expand[ing] NIH support” for stem cell research and “ameliorat[ing]” the “patch- work” of standards that now govern it.

With respect to the goal of expanding federal hESC research, the Guidelines effect only incremental change in the scope of eligible research, preserving all of 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 U.S., much less in the world. Multiple funders and regulators, and so multiple sets of rules, will continue to exist, with none clearly dominant.

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.

Keywords: Stem cells, embryo, NIH, Bush, Obama, Dickey-Wicker Amendment, federal funding, regulation