Future Directions for Oversight of Stem Cell Research in the United States: An Update

On 9 March 2009, President Barack Obama (2009a) signed an executive order revoking the statement issued by President George W. Bush during a televised speech in August 2001, in which the latter had sharply restricted the scope of federally funded human embryonic stem cell (hESC) research to cell lines derived (without federal funding) prior to 9:00 P.M. EDT on 9 August 2001. Action by President Obama to remove the cut-off date had been expected. It came as a surprise, however, that he gave authority to determine the scope of eligible research to the Director of the National Institutes of Health (NIH), referencing only general concerns of responsibility, scientific worth, and legality.¹ This contrasted not only with the approach of former President Bush, but also with that of former President Clinton, who had expressed personal opposition to the creation of embryos for research and had a distinction between hESCs derived from embryos created for research and those derived from spare embryos enshrined in NIH policy.

President Obama’s remarks upon signing the executive order give some insight into the thinking behind his approach. Implicit in them are the views that earlystage human embryos outside the womb do not have full moral status and that the destruction of human embryos in the effort to care for and ease the suffering of human beings who do have full moral status does not devalue human life. The President also stressed that the decision to pursue hESC research reflected not only his opinion, but also a broad social consensus. He concluded with strong ethical commitments on two fronts:

We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society.

(Obama 2009b)

The specific guarantee that President Obama gave against government support for the development of cloning techniques for human reproductive purposes made his silence on the use of cloning for research seem significant. Comments he had made in the course of the campaign (Obama 2008) suggested that he would affirm the Clinton-era policy of limiting federal funding to hESCs derived from spare embryos. Did this silence mean that President Obama was opening the door to federal funding of research cloning when and if scientists might manage that feat?

2009 NIH Guidelines

The answer to this question and several others came on 17 April, when Raynard Kington, the acting director of NIH, released Draft NIH Guidelines for Human Stem Cell Research (NIH 2009), developed by an NIH Stem Cell Task Force, along with a request for public comment within 30 days of their publication in the Federal Register.² The 2009 Draft Guidelines exclude from federal funding the derivation of hESCs, a restriction mandated by the reenactment of the Dickey-Wicker Amendment as part of the 2009 Omnibus Appropriations Act (Public Law 111-8, Division F, Title V, § 509). The 2009 Draft Guidelines also exclude the use of hESCs derived from embryos created for research purposes, and so represent a refusal to open the funding door as broadly as the NIH interpretation of the Dickey-Wicker Amendment might allow, at least for the time being.

It appears that the drafters used as their starting point the 2000 NIH Guidelines for Research Using Human Pluripotent Stem Cells (NIH 2000) dating from the Clinton Administration, rather than more recent guidelines from the National Academy of Sciences (National Research Council 2005; 2007; 2008) and other private bodies. Both the format and content of the 2000 and 2009 NIH efforts are similar, making the departures in the latter stand out in high relief. We highlight departures related to informed consent to embryo donation, creation of human-nonhuman chimeras, and the role of an NIH task force, updating our original comment (Cohen and Majumder 2009).

Informed Consent to Embryo Donation

The 2009 NIH Draft Guidelines require that certain statements...