Policy & Guidelines

The links below are some frequently requested policy statements and guidelines on NIH-funded stem cell research. Notices that have been withdrawn or superceded are included for historical purposes.

The Stem Cells FAQs: Funding Questions can help answer questions about NIH funding for stem cell research.

The NIH Office of Extramural Research Grants Policy and Guidance page offers a complete list of NIH policy notices and statements.

NIH Guidelines

The National Institutes of Health released the Guidelines for Human Stem Cell Research on July 6, 2009. The Guidelines are effective beginning July 7, 2009.

• Read the NIH Guidelines for Human Stem Cell Research

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 Although accurate when originally released, they may now contain out-of-date information, including broken hyperlinks.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)
  March 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.
  • HHS/NIH Plan for Implementation of Executive Order 13435
    September 18, 2007/National Institutes of Health
  • Criteria for Determining Pluripotency in Human Cells
• 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
• 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
• 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