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Policy & Guidelines Archive
The links below are some frequently requested policy statements and guidelines on NIH-funded stem cell research under prior policies. Notices that have been withdrawn or superceded are included for historical purposes.
Please note that the following documents are official publications of the U.S. Government. Although accurate when originally released, they may now contain out-of-date information, including broken hyperlinks.
- Human Embryonic Stem Cell Policy Under Former President Bush
(Aug. 9, 2001–Mar. 9, 2009)
- NIH Human Embryonic Stem Cell Registry Under Former President Bush
(Aug. 9, 2001–Mar. 9, 2009)
- Executive Order 13435: Expanding Approved Stem Cell Lines in Ethically Responsible Ways
June 22, 2007/Federal Register, Vol. 72, No. 120, p. 34589.
- Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles
April 10, 2002/NOT-OD-02-044/National Institutes of Health
- Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles (40K PDF file; requires Adobe Reader)
March 19, 2002/Office for Human Research Protections, DHHS
- Implementation Issues for Human Embryonic Stem Cell Research—Frequently Asked Questions
November 16, 2001/NOT-OD-02-014/National Institutes of Health
- Federal Government Clearances for Receipt of International Shipment of Human Embryonic Stem Cells
November 16, 2001/NOT-OD-02-013/National Institutes of Health
- Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Cell-Derived Test Articles (28K PDF file; requires Adobe Reader)
November 16, 2001/Office for Human Research Protections, DHHS
[Replaced by Guidance of March 19, 2002]
- Notice; withdrawal of NIH Guidelines for Research Using Pluripotent Stem Cells Derived from Human Embryos
November 14, 2001/Federal Register, Vol. 66, No. 220, p. 57107
- Notice of Withdrawal of NIH Guidelines for Research Using Pluripotent Stem Cells
November 7, 2001/NOT-OD-02-007/Office of the Director, NIH
- Notice of Extended Receipt Date and Supplemental Information Guidance for Applications Requesting Funding That Proposes Research with Human Embryonic Stem Cells
November 7, 2001/NOT-OD-02-006/Office of the Director, NIH
- Notice of Criteria for Federal Funding of Research on Existing Human Embryonic Stem Cells and Establishment of NIH Human Embryonic Stem Cell Registry
November 7, 2001/NOT-OD-02-005/Office of the Director, NIH
- NIH Funding of Research Using Specified Existing Human Embryonic Stem Cells
August 27, 2001/NOT-OD-01-059/National Institutes of Health
- Update on Existing Human Embryonic Stem Cells, August 27, 2001
- NIH Funding of Research Using Specified Existing Human Embryonic Stem Cells
August 23, 2001/NOT-OD-01-058/National Institutes of Health
[Superceded by NOT-OD-01-059]
- NIH Statement on the President's Stem Cell Address
August 9, 2001/Office of the Director, NIH
- President Bush's Address to the Nation, August 9, 2001
- Fact Sheet: Human Pluripotent Stem Cell Research Guidelines
January 23, 2001/National Institutes of Health
- Approval Process for the Documentation of Compliance with NIH Guidelines on the Use of Human Pluripotent Stem Cells in NIH Intramural Research
January 16, 2001/National Institutes of Health
[Withdrawn by Federal Register, Vol. 66, No. 220, p. 57107]
- Approval Process for the Documentation of Compliance with NIH Guidelines on the Use of Human Pluripotent Stem Cells in NIH Research Proposed for Support Under Grants and Cooperative Agreements
November 21, 2000/NOT-OD-01-003/National Institutes of Health
[Partially withdrawn by NOT-OD-02-007]
[Withdrawn by Federal Register, Vol. 66, No. 220, p. 57107]
- National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells; Correction
November 21, 2000/Federal Register, Vol. 65, No. 225, p. 69951
- Notification of Request for Emergency Clearance; Modification of OMB No. 0925-0001/Exp. 2/01, "PHS 398 Research and Research Training Grant Applications and Related Forms"
August 25, 2000/Federal Register, Vol. 65, No. 166, p. 51981
- National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells
August 25, 2000/Federal Register, Vol. 65, No. 166, p. 51975
[Corrected November 21, 2000]
[Withdrawn by Federal Register, Vol. 66, No. 220, p. 57107]
- Press Release: NIH Publishes Final Guidelines for Stem Cell Research
August 23, 2000/Office of the Director, NIH
- Approval Process for the Use of Human Pluripotent Stem Cells in NIH-Supported Research
August 23, 2000/NOT-OD-00-050/National Institutes of Health
[Partially withdrawn by NOT-OD-02-007]
- Draft National Institutes of Health Guidelines for Research Involving Human Pluripotent Stem Cells
December 2, 1999/Federal Register, Vol. 64, No. 231, p. 67576
- Press Release: NIH Publishes Draft Guidelines for Stem Cell Research
December 1, 1999/Office of the Director, NIH