[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.
_________________________
Michael P.