Congressional Activity on hESC Research, as appeared in BNA Medical Research Law & Policy Report

Despite the executive order lifting federal restrictions on hESC research, it is still unclear whether any federal funds can be appropriated to support that research.

The problem lies in the language of the Dickey-Wicker Amendment, which has been a part of all federal appropriations bills since 1996, and most recently was incorporated into the Omnibus Appropriations Act of 2009, which was signed into law just three days after the executive order was signed by President Obama.

This amendment prohibits the use of federal funds to either create a human embryo for research purposes or to conduct research in which a human embryo is "destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero." A human embryo is defined broadly as "any organism not protected as a human subject under 45 CFR 46 [the Common Rule] . . . that is derived by fertilization, parthenogenesis, cloning, or other means from one or more human gametes or human diploid cells."1

A question left unresolved by the language of the Dickey-Wicker Amendment is whether federal funds can be used to fund research using stem cell lines derived from research using private funds. Although toward the end of the Clinton administration the HHS general counsel informed the director of NIH that federal funds could be used for this research, no funds were ever allocated or awarded based on this interpretation before the 2001 executive order took effect.

The Obama administration has not yet taken a position on the Dickey-Wicker ban, and has indicated that only Congress can reverse it. Two versions of a bill that would accomplish this recently were reintroduced in the House by Reps. Diana DeGette (D-Colo.) and Michael N. Castle (R-Del.).2 A companion bill was introduced in the Senate by Sen. Tom Harkin (D-Iowa).3 Previous versions of the bills were vetoed twice during the Bush administration. The bills would authorize federal support of research using hESC, subject to the following guidelines:

  • the stem cells must have been derived from embryos donated from in vitro fertilization clinics, and must be in excess of the clinical needs for any fertility treatment;
  • there must be a determination in consultation with the individuals seeking fertility treatment that the embryos would never be implanted; and
  • the individuals donating the embryos must give their informed consent without any inducements to make the donation.

In addition, both versions of the bill would obligate the director of NIH to publish guidelines on research involving hESCs. Both H.R. 872 and the Senate bill would mandate that all research conducted or supported by NIH comply with the published guidelines, although NIH could determine the extent to which any guidelines apply to research using hESCs derived before the effective date of the guidelines.

1 Pub. L. No. 111-8, Title 5, § 509.

2 H.R. 872 and 873, 111th Cong., 1st Sess.

3 S. 487, 111th Cong., 1st Sess.