Embryonic Stem Cell Research

[I thought that this would be of interest to MOJ readers.   I've reprinted the whole piece--from today's online Chronicle of Higher Education--because one has to be a subscriber to access the item.]

National Academies Report Recommends New Oversight Boards and Tighter Rules for Stem-Cell Research

By JEFFREY BRAINARD

Universities and research institutions should set up a new kind of in-house oversight committee to approve and manage studies using human embryonic stem cells, a National Academies panel recommended on Tuesday. In a report, the panel also suggested guidelines for the ethical conduct of the research that are stricter than existing government rules.

The report, "Guidelines for Human Embryonic Stem Cell Research," says the new oversight committees would provide an additional level of review beyond the monitoring done by other university committees, like institutional review boards. The panel said that the new committees would ensure that the controversial studies were conducted in a uniform and transparent way, and thus would help build public confidence in them.

For example, the panel assumed that university researchers would continue to create new colonies, or lines, of human embryonic stem cells. The practice remains controversial because scientists must destroy early-stage embryos to obtain the cells, and some people consider the embryos to be human lives. The panel said that out of respect for those ethical concerns, the new oversight committees should not allow researchers to destroy embryos that are older than 14 days. The proposed guidelines would require that researchers obtain informed consent from all donors of eggs and sperm used to make embryos used in studies -- including from anonymous sperm donors, which is not now required.

"While we were hesitant to recommend another bureaucratic oversight entity, the burden in this case is justified, given the novel and controversial nature of embryonic-stem-cell research," Jonathan D. Moreno, a professor of biomedical ethics at the University of Virginia and co-chairman of the academies' panel, said in a written statement.

The panel prescribed the changes in response to a "perception" that the research "is unregulated," the report says. Scientists now face a patchwork of federal and state regulations covering stem-cell studies, and many of the rules "were not designed with this research specifically in mind, and there are gaps in how well they cover" the research.

What's more, President Bush decided in 2001 that scientists could receive federal research funds for such studies only if they used stem-cell lines that existed at the time. As a result, a growing number of universities are moving toward using private or state funds to study newer lines of stem cells that, researchers say, appear to be more scientifically promising. Some observers have worried that the trend will reinforce the variation across states.

Supporters of stem-cell research hope that the panel's report will play a role in helping to relax Mr. Bush's limits, although the panel itself did not recommend such a step. Even with private and state money flowing into the field, advocates say, the research will move forward more rapidly with federal funds.

"Leading institutions engaged in stem-cell research have many of the protections recommended ... already in place," said Daniel P. Perry, president of the Coalition for the Advancement of Medical Research, a consortium of universities and other groups that supports the studies. "They need only a more supportive and positive federal environment to make the research flourish. The strong ethical standards in this timely report should give Congressional champions of research even more support to expand the current federal stem-cell policy, and should give those who are still waiting on the sidelines a reason to get in the game."

While the report urges universities to adopt the guidelines voluntarily, it also suggests that agencies providing research funds and academic publishers push universities to observe them as a condition of receiving the funds and getting papers published.

The new review boards would consider a variety of issues. They would oversee steps to protect the privacy of parents who donated embryos, sperm, or eggs used in the research. Most stem-cell lines have been created from excess embryos left over from fertility clinics.

In addition, the proposed guidelines would prohibit researchers from paying donors of sperm and eggs used to create embryos. Women who donate eggs for reproductive purposes usually are paid, to reflect the heightened risks associated with the medical procedure to harvest the eggs. But some people view payments as an inappropriate inducement, the panel said.

"The sensitivities surrounding this research are significant, and we thought it was better to err on the side of caution," Richard O. Hynes, a professor of biology and co-chairman of the academies' panel, said at a news conference on Tuesday.

The stem-cell committees would also review all work to create new lines of stem cells and would require scientists to explain why doing so would advance the research.

The committees would also approve any proposal to transplant human embryonic stem cells into animals. Scientists use the technique to study how the human cells grow and function in living systems, and they hope to learn how to use the cells to develop new medical treatments for diseased and ailing organs in human beings. Stem cells are undifferentiated building blocks capable of developing into any specialized cell in the adult body.

In addition, the panel recommended that the university oversight committees bar research to implant human stem cells into early-stage embryos of monkeys. The report said this would avoid the unwanted, but unlikely, result that the human cells would endow the animals with human-like mental capacities. The boards should carefully monitor transplants of the cells into animals of other species, the panel said.
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Michael P.