Federal concern with human embryo research began over 25 years ago with the advent of assisted reproduction technologies, i.e. in vitro fertilization (IVF) or "test tube babies."
Although the first report of laboratory studies of human fertilization appeared in Science in 1944, (the work was conducted in Brookline, Massachusetts), clinical IVF was successful first in Great Britain in 1978 for couples with infertility. IVF became standard of care in the United States in the early 1980's. As with all forms of clinical treatment, the medical community looked to basic science research to improve the safety and efficacy of IVF for mothers and babies.
In 1979, an Ethics Advisory Board for the National Institutes of Health issued guidelines for research on early human embryos, but no action was taken. The Federal Policy for the Protection of Human Subjects enacted in 1977 remained in place: 45CFR § 46.204(d), "No application or proposal involving human in vitro fertilization may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered advice as to its acceptability from an ethicalstandpoint." Since there was no Ethics Advisory Board, federally funded research was not possible.
Throughout the 1980's, public debate about conducting research on early human embryos took place in Great Britain. Many were in favor, many were opposed. The debate ultimately led to the formation of a regulatory body to oversee research on human fertilization. That regulatory body remains active today, which is why embryonic stem cell research was first possible in England.
In 1993, former President Bill Clinton initiated the National Institutes of Health Revitalization Act(Pub. L. No. 103-43), section 121(c) which simply eliminated 45CFR § 46.204(d), paving the way for Federal funding of grant applications to study human fertilization without the need for additional review by an Ethical Advisory Board.
When this possibility became known to the U.S. Congress in 1996, Representatives Jay Dickey and Roger Wicker authored a rider for the budget of the National Institutes of Health: Balanced Budget Downpayment Act, I, Public Law No 104-99, § 128, 110 Stat. 26, 34 "...none of the funds appropriated shall be used to support any activity involving: 1) the creation of a human embryo or embryos for research purposes; or 2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R 46.208(a)(2) and section498(b) of the Public Health Service Act (42 USC 289g(b)." Further, "For purposes of this section, the term 'human embryo or embryos' includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this ACT, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells."
The Dickey-Wicker amendment to the budget of the National Institutes of Health has been renewed each year since 1996. Both men are currently active in the U.S. congress. Jay Dickey is a Congressman from Arkansas and Roger Wicker is a Senator from Mississippi. Neither President Bush's nor President Obama's Executive Order changed this Federal moratorium. (see August 24, 2010: Preliminary Injunction)
Given the wide-spread support among U. S. citizens for human embryonic stem cell research, it seems highly likely that broad public debate could convince congress that the will of the people is to allow taxpayer dollars to conduct research on the use of embryonic stem cells for regenerative medicine.
Until that time, private and state funding seems imperative to move this promising field forward. Increasing tax benefits for philanthropists who donate to stem cell research would help bridge the current gap in funding between the number of U.S. scientists capable and eager to conduct the necessary research, and the funding currently available.