NIH Guidelines for Human Stem Cell Research

Notice Number: NOT-OD-09-116

Key Dates
Release Date: July 6, 2009
Effective Date: July 7, 2009

Other Relevant Notices  

  • September 10, 2010 – See NOT-OD-10-136 Amended Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration
  • August 30, 2010 - See NOT-OD-10-126 Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration.
  • February 19, 2010 - See Notice NOT-OD-10-063 Status of Certain Human Embryonic Stem Cell Lines.
  • February 19, 2010 - See Notice NOT-OD-10-056 Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research.
  • December 14, 2009 - See Notice NOT-OD-10-029 Clarification of Terms and Conditions of Awards using Human Embryonic Stem Cells.
  • December 2, 2009 - See Notice NOT-OD-10-020 First Human Embryonic Stem Cells Approved for use under the NIH Guidelines for Human Stem Cell Research.
  • July 15, 2009 - See Notice NOT-OD-09-123 Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research.
  • April 17, 2009 - See NOT-OD-09-085 Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells
  • April 24, 2009 - See NOT-OD-09-086 Public Comment Period Open for Draft Stem Cell Guidelines through May 26, 2009

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

On March 9, 2009, President Barack H. Obama issued Executive Order (EO)13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.  The EO states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.  NIH published draft Guidelines for research involving hESCs in the Federal Register for public comment, 74 Fed. Reg. 18578 on April 23, 2009. The comment period ended on May 26, 2009.  Approximately 49,000 comments on the draft Guidelines were submitted to NIH by patient advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, private citizens, and members of Congress.

The final NIH Guidelines for Human Stem Cell Research implementing the EO and establishing policy and procedures under which the NIH will fund such research, were released today and are available at http://stemcells.nih.gov/policy/pages/2009guidelines.aspx.  They will be effective on July 7, 2009. Public comments on the draft Guidelines were also released today and are available at http://hescregapp.od.nih.gov/comments/web_listing_2.htmp.

The Guidelines will ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.  Internal NIH policies and procedures, consistent with the EO and these Guidelines, will govern the conduct of intramural NIH stem cell research.

The Guidelines prescribe the assurances and supporting documentation that must accompany requests for NIH funding for research using hESCs, and describe research that is not eligible for NIH funding.  NIH will provide additional guidance concerning the implementation of the Guidelines and the status of pending applications in future Guide Notices.
Ongoing NIH-supported research involving previously approved hESC lines may continue.  No new uses of hESC may be initiated in ongoing funded studies unless reviewed and approved by the NIH. 

Inquiries

Inquiries should be directed to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD 20892
Email: GrantsPolicy@od.nih.gov

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