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Monitoring Stem Cell Research


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The President's Council on Bioethics
Washington, D.C.
January 2004
www.bioethics.gov



Appendix C

Bush Administration NIH Guidelines for Embryonic Stem Cell FundinG

Taken from the website of the National Institutes of Health on September 26, 2003

The text follows.

NOTICE OF CRITERIA FOR FEDERAL FUNDING OF RESEARCH ON EXISTING HUMAN EMBRYONIC STEM CELLS AND ESTABLISHMENT OF NIH HUMAN EMBRYONIC STEM CELL REGISTRY

Release Date:  November 7, 2001

NOTICE:  NOT-OD-02-005

Office of the Director, NIH

On August 9, 2001, at 9:00 p.m. EDT, the President announced his decision to allow Federal funds to be used for research on existing human embryonic stem cell lines as long as prior to his announcement (1) the derivation process (which commences with the removal of the inner cell mass from the blastocyst) had already been initiated and (2) the embryo from which the stem cell line was derived no longer had the possibility of development as a human being.

  • In addition, the President established the following criteria that must be met:
  • The stem cells must have been derived from an embryo that was created for reproductive purposes;
  • The embryo was no longer needed for these purposes;
  • Informed consent must have been obtained for the donation of the embryo;
  • No financial inducements were provided for donation of the embryo.

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 provide the cells listed on the Registry will have submitted to the NIH a signed assurance.  Each provider must retain for submission to the NIH, if necessary, written documentation to verify the statements in the signed assurance.

The Registry will be accessible to investigators on the NIH Home Page http://escr.nih.gov.  Requests for Federal funding must cite a human embryonic stem cell line that is listed on the NIH Registry.  Such requests will also need to meet existing scientific and technical merit criteria and be recommended for funding by the relevant National Advisory Council, as appropriate.  Further guidance is accessible at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html.

Inquiries should be directed to the Deputy Director for Extramural Research DDER@nih.gov.

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