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NHLBI Investigator's Guide to Human Embryonic Stem Cell Research



NHLBI Guidance

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NHLBI Investigator's Guide to Human Embryonic Stem Cell Research Contact(s): Dr. John Thomas
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GUIDANCE:

Background

On March 9, 2009, President Barack Obama issued Executive Order 13505, "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells." On July 7, 2009 the NIH issued Guidelines for Human Stem Cell Research that provided NIH-funded researchers with access to human embryonic stem cell (hESC) lines by establishing an NIH Human Embryonic Stem Cell Registry. The Guidelines also establish the eligibility criteria for hESC line to be posted on the Registry.

Cell Lines Permitted for hESC Research

If your research project grant was funded before April 17, 2009

  • You may continue ongoing research using the same hESC lines from the former NIH Registry until your grant ends, but
  • You may not begin new research that uses additional hESC lines from the former NIH Registry, however,
  • You may begin new research with hESC lines from the current NIH Registry

If your research project grant was funded on or after April 17, 2009

You may use only hESC lines from the current NIH Registry. For more details, please refer to the NIH Guide Notice NOT-OD-09-123 (July 15, 2009): "Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research."

As you are identifying cell lines on the NIH Registry, note that selected lines may be:

  • On Hold - A line On Hold is not available for current use in NIH-supported research; Example - 0001[CHB-1]
    • For more details about "On Hold" status, please refer to NOT-OD-10-063 (February 19, 2010) "Status of Certain Embryonic Stem Cell Lines."
  • Have Provider or NIH Restrictions - Lines may be available but limited to specific use by the Provider or by NIH.
    • Examples - NIH Registration Nos. 0012[RUES1] - Provider Restriction or 0014[HUES-1] - NIH Restriction
    • You can view any restrictions by going to the current NIH Registry and clicking on the "details" link for a particular line.
    • For more details about restrictions, please refer to these NIH Guide Notices:
      1. NOT-OD-10-029 (December 14, 2009) "Clarification of Terms and Conditions of Awards using Human Embryonic Stem Cells."
      2. NOT-OD-10-056 (February 19, 2010) "Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research."

Information for hESC Research

Investigators with questions about NIH-supported hESC research may contact Dr. John Thomas for current information on this research area.

  • Current NIH hESC research policies,
  • NIH funding mechansims for hESC research, and
  • Issues related to training and collaborative projects.

NIH Human Embryonic Stem Cell Registry

The NIH has developed its current NIH Human Embryonic Stem Cell Registry comprised of lines that have been submitted, reviewed and judged eligible for use in NIH-funded research per the 2009 NIH Guidelines on Human Stem Cell Research. For more information on this process, please refer to NOT-OD-10-020 (December 2, 2009) "First Human Embryonic Stem Cells Approved for use under the NIH Guidelines for Human Stem Cell Research."

Stem Cell Information

The NIH Stem Cell Information web site contains numberous links that may be useful to experienced researchers as well as to those planning their first research project that involves stem cells. Resources include information on submitting hESC lines to the NIH Registry to basic information on stem cells plus links to current research as well as information to upcoming hESC training courses.

 

REFERENCES:

First Human Embryonic Stem Cell Lines Approved for Use under New NIH Guidelines - December 2, 2009

Guidance on the Review and Award of Human Embryonic Stem Cell Research - STAFF ONLY

 

VERSION RECORD:

Preceding Policies

Date of Issue

NHLBI Investigator's Guide to Human Embryonic Stem Cell Research

February, 2002

 

CONTACT(S):

Dr. John W. Thomas
Division of Blood Diseases and Resources
ational Heart, Lung, and Blood Institute
Phone: (301) 435-0065
email: ThomasJ@nhlbi.nih.gov

 

Last Updated: April 21, 2010

 

For questions and/or concerns regarding the content of this page, please contact the
Clinical Research Policy Manager


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