The National Academies' Guidelines for Human Embryonic Stem Cell Research are not the first document to speak to the conduct of human embryonic stem cell research in the United States. The Clinton administration issued detailed guidelines for federal funding of embryonic stem cell research in 1999, President Bush issued his now famous version in 2001, and both the National Bioethics Advisory Council and the President's Council on Bioethics have weighed in on the issue. Yet the previous guidance was of limited use. Some of it was formulated only for federally funded research, some of it could be considered out of date, and some of it was probably just too restrictive to meaningfully guide institutions and researchers who have already decided to move forward with the research. Thus the National Academies' guidelines were received as filling a policy vacuum.
The guidelines do not address any new issues. Much of what they cover mirrors the legislation, regulations, and guidelines of other nations. Nor does the committee that drafted them provide any remarkable insights in its accompanying commentary. Yet in a country without any real national oversight of stem cell research, guidelines issued by such an important body carry significant weight. The issues they cover and the steps they recommend should give institutions, researchers, and potential funders a place to start when considering embryonic stem cell research proposals.
The committee clearly wanted guidelines that permit most research, including the generation of new cell lines by nuclear transfer (cloning) and the creation of animal-human chimeras--both of which are banned in some countries. But it also wanted "to reassure the public and Congress that the scientific community is attentive to ethical concerns and capable of self regulation." It therefore needed to suggest ways of responding to concerns about the conduct of embryonic stem cell research without preventing the research from taking place. Such concerns, it noted, include a lack of standard protections and a lack of uniformity in their implementation. In the end, then, the majority of its recommendations are not for bans but for procedures.
Two recommendations are particularly significant. First, the committee recommends that much embryonic stem cell research be subject to stronger oversight at both local and national levels. Under these proposals, each institution engaged in embryonic stem cell research would establish an Embryonic Stem Cell Research Oversight (ESCRO) committee to oversee all issues related to the derivation and use of embryonic stem cells, review all proposals for scientific merit, maintain records of research that takes place at the institution, and educate investigators. Local institutional review boards (IRBs) would provide additional oversight, even though much embryonic stem cell research will not, strictly speaking, need to go before an IRB. The guidelines recommend that the procurement of egg, sperm, and embryos always be reviewed by an IRB, regardless of whether federal regulations require it, and that IRBs never waive the requirement for informed consent from a person donating cells, eggs, sperm, or embryos to research, even if the regulations for human subject research provide for such waiver. …