NIH FUNDING OF RESEARCH USING SPECIFIED EXISTING HUMAN EMBRYONIC STEM CELLS

Release Date:  August 27, 2001 (Supercedes NOT-OD-01-058 dated August 23, 2001)

NOTICE:  NOT-OD-01-058

Update: July 7, 2009   This Notice is superseded by NIH-OD-09-116 NIH Guidelines
for Human Stem Cell Research
National Institutes of Health

In accordance with the President"s announcement of August 9, 2001, 
(http://www.nih.gov/news/pr/aug2001/od-09.htm), 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 
http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html.

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 http://stemcells.nih.gov/policy/statements/
082701list.asp.

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 http://www.nih.gov.

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 [email protected].  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 http://grants.nih.gov/grants/guide/index.html.

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