Final Word: The National Academies' Guidelines for Human Embryonic Stem-Cell Research

On April 26 the National Academies of Sciences and the Institute of Medicine released guidelines for human embryonic stem (hES) cell research, the result of eight months of deliberations by a human research ethics committee I co-chaired with MIT's Richard O. Hynes. Composed of scientists, physicians, lawyers, ethicists, a social scientist, and a private citizen, the committee held a two-day public workshop and numerous meetings. We also reviewed international guidelines, policies, and procedures in this field.

Jonathan D. Moreno, Ph.D.

The guidelines are not legally binding, but it is hoped that all parties — the scientific community, research institutions, private companies, scientific journals, and all other stakeholders — will voluntarily adhere to them and impose sanctions if they are violated. Although the American public expects all research to be conducted according to the highest ethical standards, clearly this is an area that is particularly sensitive. Therefore, uniformity of good conduct is especially important for this work to progress.

A key recommendation calls for all hES cell research protocols to be reviewed by an embryonic stem-cell oversight (ESCRO) committee. We were hesitant to recommend another bureaucratic oversight entity, but the burden in this case is justified given the novel and controversial nature of hES cell research. Oversight is especially important considering the vacuum left by current federal policy that places severe constraints on public funding. ESCRO committees should include experts in biology, stem-cell research, law, and ethics as well as public representatives.

One important source of stem cells is unused blastocysts from in vitro fertilization clinics. Another is blastocysts created by nuclear transfer (often called "therapeutic cloning"). The guidelines recommend that ESCRO committees review research proposals involving stem cells from both sources. Incorporating a recommendation from a previous National Academies report, the guidelines also reflect that nuclear transfer must not be used in an attempt to reproduce a human being; ESCRO committees should review research on new hES cell lines; and no human embryos should be grown in culture for longer than 14 days or indicate the formation of the primitive streak (the structure that becomes the brain and nervous system).

Additional recommendations established by the guidelines include the following points. Internal review boards should continue to review aspects of the research involving human subjects such as patients who are to receive stem-cell therapy, or gamete or blastocyst donors. A rigorous donor consent process must be established, and to avoid financial conflicts of interest, no payments should be made for gametes or blastocysts. Researchers may not propose that more blastocysts be created by in vitro fertilization clinics than are intended for reproductive purposes. Only after reproductive efforts have ceased may potential donors be asked to consent to the research use of surplus blastocysts. Many other protections for donors are necessary, including confidentiality. Institutions must establish a registry for stem-cell lines banked there, complete with full scientific and consent documentation for the source of each line.

Under the guidelines, chimeras should not be created if there are other alternatives. No animal embryonic stem cells should be transplanted into a human blastocyst, and an ESCRO committee must review proposals to place hES cells into an animal. No hES cells should be put into nonhuman primates, and no animal into which human embryonic stem cells have been introduced should be allowed to breed.

The guidelines include many more details. It is of critical importance for all involved in this exciting area of science to familiarize themselves with the guidelines (www.nap.edu) and to commit themselves to stringent ethical conduct.

Jonathan D. Moreno, Ph.D., is the director of the Center for Biomedical Ethics at the University of Virginia, PO Box 800758, UVa Health System, Charlottesville, VA 22908, 434.924.8274.