On March 9, 2009, President Obama issued Executive Order 13505, rescinding the restrictive policy of the Bush administration on federal funding of human embryonic stem cell (hESC) research. President Bush’s policy, announced in August 2001, allowed federal funding of hESC research only with respect to a limited number of specified hESC lines already in existence. Among scientists involved in hESC research, there has been a strong consensus that the limited number, quality, and scientific characteristics of these existing hESC lines makes them an inadequate foundation for a robust program of stem cell research.
Executive Order 13505 lifts the Bush administration’s funding restriction, and announces that it will be the policy of the Obama administration to “expand NIH support for the exploration of human stem cell research.” The order states that NIH may support and conduct “responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” The order further directs the Secretary of the Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), to issue new guidance on human stem cell research, based on “other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards.” The NIH guidance is to be issued within 120 days from the date of the order, or by July 7, 2009.
Obama’s action came as no surprise – he had repeatedly promised during the presidential election campaign to overturn the Bush administration’s restrictive policy on federal funding of hESC research. There has been some comment, however, on the fact that the executive order leaves it to NIH to specify the criteria, guidelines, and safeguards that will govern federal hESC research funding. While this approach is broadly consistent with the new administration’s policy of leaving scientific decisions to scientists, rather than to politicians, some have pointed out that the new guidelines will have to take into account not only scientific considerations, but also significant ethical concerns.
Although there is no settled consensus on these ethical issues, there are existing guidelines to which NIH may refer as it develops its guidance over the next several months. The Institute of Medicine of the National Academies, for example, has published extensive guidelines on the conduct of hESC research, as has the International Society for Stem Cell Research. It is expected that NIH will carefully study and be influenced by these and other sets of existing guidelines. Indeed, the order itself, as noted above, states that NIH’s new guidance should be based in part on “other widely recognized guidelines on human stem cell research.”
The new executive order will have two major consequences for institutions that are involved in hESC research. The first, most obvious, and most important consequence is that NIH will soon, for the first time, be a major source of funding for hESC research. It may be assumed that this funding will not actually become available until the NIH guidance on human stem cell research has been issued this summer, and if grant applications for hESC research are not even invited or accepted until after that guidance is in place, the release of NIH hESC research funding may not occur until the end of 2009 or later.
It is uncertain how much of the new NIH research funding made available under the federal government’s stimulus legislation will be used to support hESC research, because NIH has announced that it intends to use that funding primarily to fund research proposals that were previously submitted to NIH but not funded. Few, if any of these proposals, of course, would have involved hESC research, since NIH has been banned from funding most hESC research until now. The NIH’s acting deputy director, however, has publicly stated that he anticipates that some of the new $10 billion in NIH grant funding included in the stimulus legislation will be available for use under the new NIH hESC guidelines. In any case, there is little question that the president’s executive order will in fairly short order result in very significant NIH support for hESC research. NIH is highly motivated to make that happen, as is the Obama administration.
The second consequence is less significant in the long run, but it will be immediately felt and will be warmly welcomed by research institutions engaged in hESC research. Since Bush’s stem cell policy was first announced almost eight years ago, many research institutions have gone to enormous trouble and expense to segregate their hESC research activities (funded by non-federal sources) from their federally funded research activities. They have done so out of a concern that any intermingling of federally funded research activity with their (non-federally funded) hESC research might be viewed as a form of partial federal funding of hESC research, in violation of the Bush administration’s policy. With the lifting of the Bush administration funding restriction, these complicated and burdensome segregation measures will no longer be necessary.
At some institutions, equipment purchased under federal grants has been specially marked to ensure that it is never used in hESC research, even though, in general, federal rules would clearly permit the institutions to use the equipment on non-federal projects. Completely separate supply rooms have been set up at some institutions to keep “hESC supplies” and “federal supplies” segregated from each other. In some instances institutions have taken pains to avoid conducting hESC research in buildings that were constructed or renovated in whole or in part with federal funds. A few institutions have gone so far as to create virtual hESC research institutes, walled off physically, administratively, and financially from other institutional research activity. Needless to say, these “firewalls” have resulted in a great amount of needless expense and inconvenience, and have adversely affected the quality of both the federal research and the hESC research. There appears to be no good reason now not to dismantle the firewalls that the Bush administration policy caused so many institutions to set up.
It is important to keep in mind, however, that the executive order authorizes federal support of hESC research only “to the extent permitted by law.” The so-called Dickey-Wicker amendment1, an annually enacted appropriations rider that prohibits HHS funding of research in which human embryos are created or destroyed, is still law. Most hESC research is performed using existing hESC lines, and does not involve the creation or destruction of human embryos. For hESC research that is covered by the Dickey-Wicker amendment, however, some of the kinds of firewalls described above might still be necessary. This may be a short-term issue, because there appears to be considerable support in Congress for enacting legislation that would do away with the Dickey- Wicker limitation.
In summary, Executive Order 13505 holds the promise of very significant new federal funding for hESC research in the near future, if not the immediate future. Although the guidelines and safeguards that will apply to such federal research are not yet precisely known, the next several months should remove most of that uncertainty. In the meantime, institutions that have felt compelled over the last eight years to wall off their federal research from their hESC research using special physical, administrative, and financial procedures may now begin to take those walls down.