Brief History Of Us Discussions And Policies Regarding Research Involving Human Embryos

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Public debates and deliberations about embryo research have extended over the last 30 years. In 1975, the Secretary of the Department of Health, Education, and Welfare (DHEW) announced that the department would fund no proposal for research on human embryos or on IVF unless it was reviewed and approved by a federal ethics advisory board. IVF was still an experimental technique: Louise Brown, the first IVF baby, was born in 1978 in the United Kingdom. The human subjects regulations that resulted from the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) required review of such work by an Ethics Advisory Board (EAB) to be appointed by the DHEW Secretary (National Commission, 1975). In 1977, NIH received an application from an academic researcher for support of a study involving IVF. After the application had undergone scientific review by NIH, it was forwarded to the EAB. At its May 1978 meeting, the EAB agreed to review the research proposal and later approved it for initiation.

With the increased public interest that followed the birth of Louise Brown that summer, the Secretary of DHEW asked the EAB to study the broader social, legal, and ethical issues raised by human IVF. On May 4, 1979, in its report to the Secretary, the EAB concluded that federal support for IVF research was "acceptable from an ethical standpoint," provided that some conditions were met, such as informed consent for the use of gametes, an important scientific goal that was "not reasonably attainable by other means" and not maintaining an embryo "in vitro beyond the stage normally associated with the completion of implantation (14 days after fertilization)" (DHEW EAB 1979, 106, 107). No action was ever taken by the Secretary with respect to the board's report; for other reasons, the department dissolved the EAB in 1980. Considerable opposition to the moral acceptability of IVF was expressed by some and contributed to paralysis regarding reconstitution of the EAB (Congregation, 1987).

Because it failed to appoint another EAB to consider additional research proposals, DHEW effectively forestalled any attempts to support IVF research with federal funds, and no experimentation involving human embryos was ever funded pursuant to the conditions set forth in the May 1979 report or through any further EAB review.

A 1988 report by the congressional Office of Technology Assessment about infertility forced a re-examination of the EAB (U.S. Congress, OTA, 1988), and a later House hearing focused on its absence. The DHEW Assistant Secretary promised to re-establish an EAB, and a new charter was published, but it was never signed after the election of President George H. W. Bush (Windom, 1988). The George H. W. Bush administration did not support re-establishing an EAB. The absence of a federal mechanism for the review of controversial research protocols continued until 1993, when the NIH Revitalization Act effectively ended the de facto moratorium on support of IVF and other types of research involving human embryos by nullifying the regulatory provision that mandated EAB review. In response, NIH Director Harold Varmus convened a Human Embryo Research Panel (HERP) to develop standards for determining which projects could be funded ethically and which should be considered "unacceptable for federal funding."

The HERP submitted its report to the Advisory Committee to the Director in September 1994.3 In addition to describing areas of research that were acceptable and unacceptable for federal funding, the panel recommended that under certain conditions federal funding should be made available to make embryos specifically for research purposes. Acting on this submission, the Advisory Committee to the Director formally approved the HERP recommendations (including provision for the deliberate creation of research embryos) and transmitted them to the NIH Director on December 1, 1994. On December 2, pre-empting any NIH response, President Clinton intervened to clarify an earlier endorsement of embryo research,

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stating that "I do not believe that Federal funds should be used to support the creation of human embryos for research purposes, and I have directed that NIH not allocate any resources for such requests" (Office of the White House Press Secretary, 1994).

The NIH Director proceeded to implement the HERP recommendations not proscribed by the President's clarification, concluding that NIH could begin to fund research activities involving "surplus" blastocysts. But before any funding decisions could be made, Congress took the opportunity afforded by the Department of Health and Human Services (DHHS) appropriations process (then under way) to stipulate that any activity involving the creation, destruction, or exposure to risk of injury or death of human embryos for research purposes may not be supported by federal funds under any circumstances. The same legislative rider has been inserted into later annual DHHS appropriating statutes, enacting identically worded provisions into law (the so-called Dickey-Wicker amendment, named after its congressional authors). Thus, to date, no federal funds have been used for research that requires the destruction of additional human embryos, whether generated originally for reproductive purposes or for research, although the current federal policy permits research on specific cell lines derived from blastocysts prior to August 2001.

When the reports of the successful isolation of hES cell lines were published in 1998, the question arose as to whether it was acceptable to provide federal funding for hES cell research that would use embryonic stem cells that were obtained from IVF blastocysts with private funding. The NIH Director sought the opinion of the DHHS General Counsel regarding the effect of the appropriations rider to the NIH Revitalization Act. The General Counsel reported that the legislation did not prevent NIH from supporting research that uses hES cells derived using private funding because the cells themselves do not meet the statutory, medical, or biological definition of a human embryo (NIH OD, 1999). Having concluded that NIH may fund both internal and external research that uses hES cells but does not create or actively destroy human embryos, NIH delayed funding until an ad hoc working group developed guidelines for the conduct of ethical research of this kind. These guidelines prescribed the documentation and assurances that had to accompany requests for NIH funding of research with human hES cells, and designated certain areas of hES cell research that were ineligible for NIH funding:

• the derivation of hES cells from human embryos,

• research in which hES cells are utilized to create or contribute to a human embryo,

• research utilizing hES cells that were derived from human embryos created for research purposes rather than for fertility treatment,

• research in which hES cells are derived using NT, that is, the transfer of a human somatic cell nucleus into a human or animal oocyte,

• research utilizing hES cells that were derived using NT,

• research in which hES cells are combined with an animal embryo, and

• research in which NT is used for the reproductive cloning of a human.

Before any grants could be funded, the 2000 election produced a new administration, and consequently the policies that exist today. As previously noted, on August 9, 2001, President Bush announced that NIH could fund research that uses hES cells but only if the cell lines had been derived prior to that date. The President maintained further that the guidelines for hES cell research developed during the Clinton presidency and the ethics advisory committee itself were no longer needed. Instead, an NIH Stem Cell Task Force composed entirely of NIH personnel was appointed to "focus solely on the science" of stem cell research. That might be explained by the fact that many of the remaining ethical guidelines that NIH had planned to put into effect were no longer needed, because they applied to issues surrounding federal funding of research on hES cell lines yet to be derived.

Meanwhile, other countries have been active in developing laws and regulations governing research in this area (see Chapter 4). In addition, in the United States a patchwork of state laws and programs ranges from a complete ban on all hES cell research to a new program recently enacted in California that funds the development of new lines derived from both IVF blastocysts and using NT.

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