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Thursday, September 16, 2010

Stem Cell Research: Ethical and Legal Issues

Erin D. Williams
Specialist in Public Health and Bioethics

Edward C. Liu
Legislative Attorney

Judith A. Johnson
Specialist in Biomedical Policy

In August 2010, a federal district court ruling in the case of Sherley v. Sebelius preliminarily enjoined the award of federal funding for all embryonic stem cell research (ESR). As explained in the next paragraph, prior to the ruling, federal funding had been available for research using established embryonic stem cell (ES) lines, but not for the establishment of ES lines. Neither the Sherley case nor the affected federal policy restricts or regulates ESR conducted solely with private, local, and/or state government funding, or with funding from other non-federal sources. 

Since 1996, federal funding for research that involves the creation or destruction of human embryos has been prohibited. This prohibition is due to the Dickey Amendment, a rider placed on Health and Human Services (HHS) annual appropriation each year since FY1997. Federal policy allowing research on established ES lines was based on an HHS interpretation of Dickey, issued in 1999 by then HHS General Counsel, Harriet Rabb (HHS 1999 Opinion). The HHS 1999 Opinion concluded that Dickey prohibited the use of HHS funds to establish ES lines (which involves embryo destruction), but not to conduct research using ES from established lines (on the theory that ES themselves are not embryos). In the context of the HHS 1999 Opinion, the Obama administration created its ES policy, which permits federal funding for research using established ES lines that meet certain ethical requirements. The Obama ES policy is articulated in two 2009 documents: Executive Order 13505 (Obama EO), and National Institutes of Health guidelines issued pursuant to the EO (NIH 2009 Guidelines). In Sherley, the court issued a preliminary injunction, enjoining HHS from "implementing, applying, or taking any action whatsoever pursuant to" the NIH 2009 Guidelines "or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines," on the theory that they violate Dickey—effectively prohibiting the award of federal ESR funding. In response, on August 31, 2010, HHS filed a notice of appeal, and an emergency motion to stay the injunction. 

In light of Sherley, Congress has four policy options. First, it could reinstate or expand federal funding for ESR by eliminating or modifying the Dickey Amendment, or by passing other legislation (H.R. 872, H.R. 873, S. 487, and H.R. 4808). (Note that the effect of such legislation could be questioned if Dickey and the Sherley holding persist.) Second, Congress could encourage possible alternatives to ESR through research funding or tax incentives for activities that that do not involve the destruction of human embryos (S. 99, S. 3751, H.R. 877, H.R. 1230, H.R. 1654, H.R. 2107, H.R. 6081, and H.R. 6083). Third, it could restrict or eliminate ESR by prohibiting federal research funding, banning certain cloning techniques, or giving embryos a constitutional right to life (H.R. 110, H.R. 227, S. 346, H.R. 881, and H.R. 1050). (Enactment of a law banning federal ESR funding would preclude such funding even if Sherley were overturned or Dickey were eliminated.) Fourth, it could take no action, which would preclude federal ESR funding unless or until the Sherley case were reversed. 

Many opinions about the ethics of ESR have been published. The positions could be broadly categorized as for or against ESR; however, there is an array of finer distinctions that reveal more subtle variation in ethical, moral, and factual beliefs. Breaking down ESR arguments according to these finer distinctions demonstrates both the complexity of the issues and the points of resonance among the opinions. The broadest discussion involves the balance of embryo destruction and relief of human suffering. More subtle issues focus on the relative importance of embryo viability, the purpose of embryo creation, new versus existing ES lines, donor consent, egg procurement, possible alternatives, and federal funding. This report presents background concepts, outlines legal arguments related to Sherley, and details the ethical arguments that surround ESR.

Date of Report: September 1, 2010
Number of Pages: 24
Order Number: RL33554
Price: $29.95

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