April 8, 1999
Rules Proposed for Cell Research
By PAUL RECER AP Science Writer
BETHESDA, Md. (AP) - Government advisers drew up proposed rules Thursday
to control federal financing of research on ``master cells'' obtained
from human embryos - a promising area of science that has raised serious
ethical questions.
A 13-member committee drafted a proposal that would permit the National
Institutes of Health to pay for master cell studies only if researchers
adhered to strict guidelines that would control how the cells were
obtained.
The cells, called pluripotent stem cells, are the building blocks for
nearly all of the tissues in the body. They are capable of growing
virtually any human tissue. Researchers believe they can learn how to
use the cells to make body parts or to correct some disorders, such as
Parkinson's disease or diabetes.
But the cells only can be obtained from human embryos or from very early
fetuses. A federal law bans government funding of embryo research and
severely restricts fetal research. At least 75 members of Congress have
said stem cells taken from human embryos are covered by the ban. Some
religious organization also are opposed to the research.
Two privately funded researchers recently isolated pluripotent stem
cells. NIH director Harold Varmus has proposed that these existing stem
cell cultures are not covered by the ban because federal funds were not
used to create them.
Varmus selected the committee of advisors to draw up rules to guide NIH
should the agency decide to fund pluripotent stem cell research.
Under the proposed guidelines, federal grants would be forbidden to
researchers who propose, as part of their research, to create or destroy
a human embryo. Because removing stem cells kills an embryo, this would
prohibit federal funding for creating new cultures of embryonic stem
cells.
The proposed rules also would forbid federal funding of research into
the cloning of humans, or research that would create an embryo using
stem cells.
The rules, however, would permit federal support of research using
existing stem cell cultures created by privately-funded scientists, such
as the two stem cell lines created recently.
New embryonic stem cell cultures could be used in federal research, the
rules state, only if privately-funded scientists obtained the cells from
embryos that had been created for infertility treatment and were ``in
excess of clinical need.''
Use of pluripotent stem cells from embryos created for research purposes
also are forbidden.
Stem cells from fetuses can be used, the rules say, if they are obtained
``after a spontaneous abortion or induced abortion or after a
stillbirth.''
The committee of advisors also recommended a strict process of informed
consent requiring that donors of fetal tissue or embryos be told about
the potential use of the specimens.
Under the proposed system, a stem cell research grant application would
be considered first by an NIH science committee. If that group approves,
then an oversight committee would determine if the proposal complies
with the guidelines. Only then could the grant be considered for final
approval.
Dr. Shirley M. Tilghman of Princeton University, co-chair of the
advisory committee, said the proposed guidelines will put into final
form and reconsidered by committee members.
The rules then will be published in the Federal Register for 60 days of
public comment. Another advisory committee will evaluate the guidelines
and make a recommendation to Varmus, who will make the final decision
about funding of stem cell research.
Tilghman said the proposed rules should be published ``in late spring.''
Copyright © 1999 The Associated Press.
--
Judith Richards, London, Ontario, Canada
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