Michelle N. Meyer and James W. Fossett

Many assumed that the Obama administration would usher in a sea change from the previous administration by expanding NIH support for human embryonic stem cell (hESC) research and reducing the patchwork of state and federal regulations that currently governs it. This article examines the extent to which NIH’s new Guidelines are likely to accomplish these goals.

During the 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 (Baker 2008). With the election of Barack Obama, hESC advocates hoped that the National Institutes of Health (NIH) would become the “central source of funding” of hESC research, leading to less duplication of effort, more collaboration, quicker progress toward clinical trials, and “federal rules and procedures to clear up the ethical derivation of new embryonic stem cell lines” (Wong 2009). As expected, President Obama signed an executive order revoking the Bush policy (2009a). Most researchers hailed it as “signal[ing] a sea change from the last Administration” (Holden 2009). NIH (2009c) then issued implementing Guidelines for Human Stem Cell Research.

 

Throughout the process, the administration announced several goals, including to support and conduct legal, “scientifically worthy” research based on sound, depoliticized science and “open inquiry.” It also sought to “expand NIH support” for stem cell research, “ameliorate” the “patchwork” of standards that now govern it, and ensure America’s “economic prosperity” and “global leadership in scientific discoveries” by preventing its “best scientists” from leaving for other countries. Finally, it sought to support “responsible” research on lines derived with the informed consent [End Page 289] of the embryo donors, for which there is broad public support (NIH 2009a & c; Obama 2009a & b).

 

Each goal raises questions that have received considerable attention. There are continuing debates, for example, about whether the Dickey-Wicker Amendment (Consolidated Appropriations Act, 2009), which prohibits federal funding from being used to support research that involves creating or destroying human embryos, should be repealed and whether it permits federal funding of research on hESC lines derived using nonfederal funds. Scientists and others debate the relative merits of adult stem cells, induced pluripotent stem cells, and hESCs, as well as lines derived from spare IVF embryos versus embryos created via somatic cell nuclear transfer (SCNT) or parthenogenesis. There is considerable debate over standards of informed consent; what to do when existing lines fail to meet those standards; whether hESC research is morally exceptional or should be treated like all other human subject research; and whether the scope of federally-funded research should hew closely to broad consensus, reflect the views of the party in office, or be driven solely by scientific considerations.

 

In this article, we place these complex issues to one side in order to focus on two less contentious questions: the extent to which the Guidelines are in fact likely to achieve two of their stated goals: expanding federal support for hESC research and ameliorating the current patchwork of standards. As President Obama (2009b) has recognized, federal stem cell policy involves a “difficult and delicate balance” of values and goals. Not surprisingly, many of the administration’s goals stand in tension with one another, and the Guidelines reflect a series of tradeoffs. At least if one is a consequentialist, whether the Guidelines strike an ethically satisfactory balance depends in part on the extent to which they succeed in achieving some objectives at the expense of others. Thus, although we do not resolve these normative questions here, we think that our analysis will prove useful to those who seek to do so.