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Update: July 7, 2009 – This Notice is superseded by NIH-OD-09-116 NIH Guidelines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, (, 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 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 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 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 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

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NIH Funding Opportunities and Notices

H H S Department of Health
and Human Services

  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892