2009-04-17
The National Institutes of Health (NIH) has released draft guidelines
that will govern the circumstances under which it will fund human stem
cell research. These draft guidelines have been issued in response to
the March 9 Executive Order issued by President Obama that lifted previous restrictions on federally funded human embryonic stem cell research.
The new draft guidelines permit NIH funding of research using human
embryonic stem cells derived from embryos that were created by in vitro
fertilization (IVF) for reproductive purposes and are no longer needed.
The guidelines also list the derivation and documentation requirements
that must be met for all cell lines to be considered eligible for
research funding from the NIH. The NIH will continue to be prohibited
from funding the derivation of new stem cell lines from human embryos
(sometimes referred to as the “Dickey-Wicker Amendment”). The draft
guidelines also outline circumstances under which human stem cells from
allowable sources would nevertheless be ineligible for funding, such as
research involving the use of human embryonic stem cells and adult iPS
cells in animal breeding, and human embryonic stem cells derived from
other sources, including somatic cell nuclear transfer,
parthenogenesis, and/or IVF embryos created for research purposes.
The NIH draft guidelines are available on the NIH Web site
and will be open for public comment through May 26, 2009. ASH will be
submitting comments in response to the draft NIH guidelines addressing
a number of specific recommendations and concerns about the guidelines
as they are currently drafted, including:
The final guidelines should clarify the NIH’s
expectation that other federal agencies that fund human embryonic stem
cell research will adopt the same principles.
Federal
funds should be allowed for research using all existing human stem cell
lines created by following ethical practices at the time they were
derived. The derivation and documentation requirements outlined in the
final NIH guidelines should be applied only to hES cell lines generated
henceforth.
Federal funds should be
allowed for research using human stem cell lines derived from sources
other than excess IVF embryos, such as somatic cell nuclear transfer
(SCNT), parthenogenesis, and embryos created for research purposes.
The
NIH should clarify definitions of “donor(s) and individual(s) seeking
reproductive services” and their informed consent requirements and
protections in Section II.B.
The final
guidelines should include a continuation of the NIH-funded registry
that will list the human stem cell lines eligible for research using
NIH funds.
The NIH should monitor
developments in the area of stem cell research, and review and update
its guidelines periodically as the research in this area progresses.
A copy of the Society’s comment to NIH on the draft will be available on the ASH Web site no later than May 26, 2009.
The American Society of Hematology 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. One of the first of the few physician organizations to take
a public position on the issue,
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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