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

Update: The following update relating to this announcement has been issued: 

July 6, 2009 - This Notice has been Superseded by: NOT-OD-09-116.

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:

o The stem cells must have been derived from an embryo that was created for 
reproductive purposes;
o The embryo was no longer needed for these purposes;
o Informed consent must have been obtained for the donation of the embryo;
o 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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