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The Center for Genetics and Society welcomes the National Academies committee's recognition of the ethical and social issues that are raised by human embryonic stem cell research and somatic cell nuclear transfer. We welcome too its acknowledgment that additional oversight of this research must be put in place before further research is undertaken.

But though the new National Academies guidelines raise many of the significant issues, its recommendations fail to fully address them.

"Although the National Academies committee is asking the right questions, some of its answers fall short," commented Marcy Darnovsky, CGS Associate Director. "The scale of the research, including what's about to be launched in California and other states, makes it urgent that we put in place tougher oversight and regulation, of the sort that countries such as Canada and the United Kingdom have already adopted."

Examples of further recommendations which address significant issues raised by the National Academies include:

1) A federal licensing and oversight agency should be established to regulate all research involving human embryos and embryonic stem cells. Models for such an agency exist in a number of countries.

The local "Embryonic Stem Cell Research Oversight" (ESCRO) committees that the National Academies recommends are an inadequate substitute for a national-level oversight and regulatory mechanism for this research similar to the Human Fertilization and Embryology Authority (HFEA) in the UK. Though the National Academies guidelines recommend that the ESCRO committees have public members, the committees as they are envisioned in the guidelines, like local Institutional Review Boards, will almost certainly be dominated by members close to the institutions-public, private, and for-profit-that will be doing the research. For that reason, the local committee members are likely to find it difficult to inconvenience their colleagues who wish to proceed with their projects. Stricter protection against conflict of interest is necessary.

In addition, the ESCROs, unlike bodies such as the UK's HFEA, which is required to have a majority of non-scientists on its decision-making committee, will have no oversight or enforcement capabilities.

2) Any woman providing eggs for research, whether she is undergoing IVF procedures or has volunteered or been recruited specifically for research purposes, should be cared for by an independent physician responsible for her safety and health, and not connected with the research project. Volunteers and recruits who provide eggs for research should receive no-cost medical treatment for any condition arising out of the egg extraction process.

We welcome the National Academies' recommendations that women providing eggs for stem cell research not be paid nor reimbursed beyond direct expenses. This is necessary in order to avoid economic inducement for the provision of eggs.

However, though the National Academies guidelines acknowledge the serious risks of the hormones used in conjunction with the extraction of eggs, they do not require that women providing eggs be cared for by a physician who is not involved with the research, placing women at risk in situations ripe for conflict of interest. (The guidelines state, "Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person.")

In addition, the costs of any injuries sustained by women providing eggs should be covered by the researchers. (The guidelines state that women providing eggs should be informed as to whether or not such coverage is provided, and state that "in general, compensation is not assured.)

3) Procedures should be put in place for tracking and monitoring the derivation, use, and disposal of clonal embryos produced by SCNT, in order to prevent their misappropriation and misuse in efforts to produce cloned or genetically modified human children. This is especially important since the majority of U.S. states, and the federal government, have not yet enacted laws prohibiting reproductive cloning.

The National Academies guidelines include detailed recommendations about procedures for tracking and monitoring the derivation, use, and disposal of cell lines, and these procedures should be extended to clonal embryos.

Contact: 
Marcy Darnovsky
510-625-0819 x305