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<TITLE>NOT-OD-01-059: NIH FUNDING OF RESEARCH USING SPECIFIED EXISTING HUMAN EMBRYONIC STEM CELLS</TITLE>
<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: NIH FUNDING OF RESEARCH USING SPECIFIED EXISTING HUMAN EMBRYONIC STEM CELLS NOT-OD-01-059. NIH">
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NIH FUNDING OF RESEARCH USING SPECIFIED EXISTING HUMAN EMBRYONIC STEM CELLS
Release Date: August 27, 2001 (Supercedes <a href="/grants/guide/notice-files/NOT-OD-01-058.html">NOT-OD-01-058</a> dated August 23, 2001)
NOTICE: NOT-OD-01-058
<p style="color: #FF0000;"><b>Update: July 7, 2009 This Notice is superseded by <a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html">NIH-OD-09-116</a> NIH Guidelines<br>for Human Stem Cell Research</b></p>
National Institutes of Health
In accordance with the President"s announcement of August 9, 2001,
(<a href="http://www.nih.gov/news/pr/aug2001/od-09.htm">http://www.nih.gov/news/pr/aug2001/od-09.htm</a>), the National Institutes of
Health is initiating a process to enable researchers to use Federal funds to
conduct research using human embryonic stem cells as long as the derivation
process (which begins with the destruction of the embryo) was initiated prior
to 9:00 p.m. EDT on August 9, and the following criteria are met: the stem
cells must have been derived from an embryo that was created for reproductive
purposes and was no longer needed, informed consent must have been obtained
for donation of the embryo, and that donation must not have involved
financial inducements. The President"s complete remarks and related
information are available at
<a href="https://www.whitehouse.gov/news/releases/2001/08/20010809-2.html">http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html</a>.
Investigators may not conduct research on any human embryonic stem cells
until the NIH issues the policies and the procedures that will enable
researchers and their institutions to document adherence to the criteria
established by the President for use of these cells with Federal funds
(direct and F&A). NIH has issued an update on existing human embryonic stem
cells that can be found at <a href="http://stemcells.nih.gov/policy/statements/082701list.asp">http://stemcells.nih.gov/policy/statements/
082701list.asp</a>.
In order to facilitate research using human embryonic stem cells, the NIH is
creating a Human Embryonic Stem Cell Registry that will list the human
embryonic stem cells that meet the eligibility criteria. Specifically, the
laboratories or companies that derived the cells listed on the Registry will
have provided a signed assurance that the derivation process was initiated
prior to 9:00 p.m. EDT on August 9, 2001, the stem cells were derived from an
embryo that was created for reproductive purposes and was no longer needed,
informed consent was obtained for donation of the embryo, and that donation
did not involve financial inducements. The Registry will be accessible to
investigators on the NIH Home Page <a href="http://www.nih.gov">http://www.nih.gov</a>.
Initially, the Registry will contain basic information about the cells. This
information will include a unique identifier, the name of the company or
laboratory that derived the cells, contact information for the
company/laboratory, and an assurance that the cells meet the President"s
criteria. In the future, to further assist researchers, additional
information may also be included in the Registry, such as details about the
derivation of the cells, the number of passages, culture conditions, and
growth characteristics, a description of efforts to characterize the cells,
including molecular markers and evidence of pluripotency, relevant
publications, DNA fingerprinting data, and quality assurance data, such as
the results of tests for Mycoplasma and standard human pathogens.
The NIH is working expeditiously to ensure that the Registry will be
operational as soon as possible. General questions or comments about the
Registry should be addressed to <a href="/cdn-cgi/l/email-protection#9eedeafbf3fdfbf2f2ecfbf9f7edeaece7def1fab0f0f7f6b0f9f1e8"><span class="__cf_email__" data-cfemail="ec9f9889818f8980809e898b859f989e95ac8388c2828584c28b839a">[email&#160;protected]</span></a>. Researchers who
are interested in studying or using particular human embryonic stem cells in
their research will be expected to contact the company/laboratory directly to
arrange for access to these cells. Investigators should be aware that, in
some cases, existing cells need to be expanded in culture to reach larger
numbers for the purposes of distribution, and that, in other cases, the
derivations are still in the early stages of characterization and, thus, may
not be immediately available.
With regard to the funding of research on both embryonic stem cells and adult
stem cells in humans and animals, the NIH welcomes investigator-initiated
grant applications proposing research using such stem cells, including
requests to use existing funds or for supplements to existing grants to
conduct such research. The NIH is also exploring a number of initiatives to
facilitate research on all forms of stem cells. To hasten the development of
a program of research and to stimulate submission of grant applications in
this arena, some Institutes and Centers will be issuing Program Announcements
to describe new, continuing, or expanded interests relevant to stem cell
research, such as new approaches to the characterization of stem cells or the
development of methods to differentiate cells into specific somatic cells for
study. Other Institutes and Centers may issue specific Requests for
Applications, which invite grant applications, include a special receipt
date, and a set-aside of funds. Another possibility may be provision of
resources (using contract or other mechanisms), in order to ensure adequate
production of cells, means for their distribution, and adequate training of
researchers as to how to maintain the cells. As usual, further updates and
all solicitations will appear in the NIH Guide for Grants and Contracts that
is available online at <a href="//grants.nih.gov/grants/guide/index.html">http://grants.nih.gov/grants/guide/index.html</a>.
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<A HREF="/grants/guide/WeeklyIndex.cfm?WeekEnding=08-31-01">Weekly TOC for this Announcement</A><br>
<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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