2009-07-07
The Obama Administration released final guidelines governing human embryonic stem cell (hESC) research to implement the President’s March 9, 2009, Executive Order
that will allow many of the approximately 700 existing cell lines to be
eligible for federal funding. The guidelines establish policy and
procedures under which the National Institutes of Health (NIH) will
fund extramural stem cell research. The previous policy implemented by
President George W. Bush had allowed federal dollars to pay for some
stem research, but only for the 21 cell lines that had existed prior to
August 2001. In the years since, scientists had learned to make better
stem lines, but those did not qualify for federal funds.
The final guidelines reflect several changes made in response to
criticism by the scientific community, including ASH, that the rules
the administration proposed in April – requiring that donors of
fertilized eggs sign extensive consent forms – would have made even
some of the stem cell lines approved by the Bush Administration
ineligible for further funding.
Dr. Raynard S. Kington, acting director of NIH, said during press
conference that older stem lines will be approved if they were created
under conditions that met the spirit of the new rules. The crucial test
will be whether the embryos used to create the stem cell lines were
created solely for reproductive purposes and whether donors freely
consented to their use in research.
The final guidelines stipulate that human stem cell lines created before July 7, 2009, may seek review by the Working
Group of the Advisory Committee to the Director (ACD). The ACD, which
is a chartered Federal Advisory Committee Act committee, will advise
NIH on whether the core ethical principles and procedures used in the
process for obtaining informed consent for the donation of the embryo
were such that the cell line should be eligible for NIH funding. The
guidelines specify that “this Working Group will not undertake a de novo
evaluation of ethical standards, but will consider the materials
submitted in light of the principles and points to consider in the
Guidelines, as well as 45 C.F.R. Part 46 Subpart A. Rather than
'grandfathering,' ACD Working Group review will enable pre-existing
hESCs derived in a responsible manner to be eligible for use in NIH
funded research.” In addition, Dr. Kington has indicated that
once the ACD established that the derivation procedure for any one stem
cell line was consistent with the Guidelines, all the lines that used
similar procedures could be eligible for expedited approval. He also
said the NIH will maintain a list of all the approved stem cell lines
on its Web site.
ASH applauds the NIH for issuing clear guidelines on research using
human stem cells that will advance the field of biomedical research and
provide more freedom for scientists to conduct research that could one
day lead to better treatments for disease and injuries. ASH is
particularly pleased that the final guidelines address the concerns
expressed in its comments
to the proposed rules earlier this year. The Society believes the new
rules establish a pathway by which research on existing stem cell lines
can finally advance with the full support of the federal government, as
well as maintaining and updating a registry of NIH-approved stem cell
lines. The Society plans on continuing to work with the NIH as it
periodically reviews and updates the guidelines as stem cell research
progresses, particularly in the areas of somatic cell nuclear transfer
and parthenogenesis.
ASH has long been active in supporting stem cell research
and is a member of the Coalition for the Advancement of Medical
Research, the nation’s most vocal proponent of the use of regenerative
medicine to cure disease and alleviate suffering. The Society was one
of the first physician organizations to support embryonic stem cell
research. ASH strongly supports federal funding for all avenues of stem
cell research under NIH federal research guidelines and with
appropriate public oversight.
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