APPROVAL PROCESS FOR THE USE OF HUMAN PLURIPOTENT STEM CELLS IN 
NIH-SUPPORTED RESEARCH

Release Date:  August 23, 2000

NOTICE:  OD-00-050 (See Notice OD-02-007 dated November 7, 2001)

National Institutes of Health

The purpose of this Notice is to outline procedures that the NIH is adopting 
for the approval of the use of human pluripotent stem cells in NIH-supported 
research.  The NIH published the National Institutes of Health Guidelines for 
Research Using Human Pluripotent Stem Cells (the Guidelines) in the Federal 
Register on August 25, 2000 
(see http://stemcells.nih.gov/news/newsArchives/fr25au00-136.asp and 
http://stemcells.nih.gov/news/newsArchives/fr21no00-104.asp).  

The Guidelines establish procedures for investigators/institutions requesting 
NIH funds for research using human pluripotent stem cells is conducted in an 
ethical and legal manner.  NIH will fund research using human pluripotent stem 
cell lines derived from embryos or fetal tissue only if that research is 
conducted in compliance with the Guidelines.  This Notice outlines the 
procedures NIH will use to implement oversight of this process.  Further 
details about this process will be published within weeks in the NIH Guide for 
Grants and Contracts.

The Guidelines outline the documentation that must be submitted by intramural 
investigators and by institutions on behalf of extramural investigators 
requesting the use of NIH funds to conduct research using human pluripotent 
stem cells derived from human embryos or human fetal tissue. This applies to 
investigators who want to use existing funds and who are requesting an 
administrative or competing supplement, and to those who are applying for new 
NIH funding.  This documentation will be reviewed for compliance with the 
Guidelines by a working group of the NIH Center for Scientific Review Advisory 
Committee (CSRAC), called the Human Pluripotent Stem Cell Review Group 
(HPSCRG).  Recommendations of the members of HPSCRG will be reviewed by CSRAC, 
and, if appropriate, approved in its public meetings. 

Details on the documentation required for HPSCRG review can be found in 
Section II.A.1 of the Guidelines for the utilization of human pluripotent stem 
cells derived from human embryos and in Section II.B.1 for the utilization of 
human pluripotent stem cells derived from fetal tissue.  For existing awards 
and administrative supplements, the applicant institution should reference the 
grant number under which the proposed research using human pluripotent stem 
cells derived from human embryos or human fetal tissue is to be conducted.   
If the proposed research constitutes a change in scope of the funded project, 
the principal investigator must obtain prior approval for the change in scope 
from NIH (see NIH Grants Policy Statement).  

In the case of intramural projects, investigators should send documentation 
materials to their Scientific Director, who should forward the materials to 
the Office of Science Policy (with a copy to the Deputy Director of Intramural 
Research).  Only after these materials have been reviewed by the HPSCRG and 
approved by the CSRAC will the research be allowed to proceed.  These 
submissions will be considered on the same schedule as outlined below for 
extramural requests.  The NIH Office of Science Policy will forward the 
CSRAC’s decision to the funding Institute or Center.

The originals and two copies of materials documenting compliance as described 
in the Guidelines, should be submitted (separate from any grant application) 
to the NIH Office of Science Policy at:

NIH Office of Science Policy
Attn: HPSCRG
Bldg. 1, Rm. 103
1 Center Drive
Bethesda, MD  20892

Applicants need to consider the meeting schedules of both the HPSCRG and the 
CSRAC in planning for potential start dates. The HPSCRG process does not 
change the receipt date, peer review date, or any other deadlines related to 
grant applications.  In no event will the NIH provide funds or allow existing 
funds to be used for research utilizing human pluripotent stem cells derived 
from human embryos or human fetal tissue until the documentation has been 
received and reviewed by the HPSCRG and approved by the CSRAC.  The NIH Office 
of Science Policy will forward the CSRAC decision to the funding Institute or 
Center.

Materials should be submitted according to the following schedule:

Materials received:  For review by HPSCRG in:   For consideration by CSRAC in:

March 15             April                      May
July 15              August                     September
November 15          December                   January

Investigators/institutions may be asked to provide additional supporting 
materials prior to determination of compliance. This could delay final 
approval.

At this time, the NIH is establishing these procedures for grant and 
cooperative agreement applications and intramural projects only.  More 
information about this process will be available in the forthcoming NIH Guide 
notice mentioned above.  Procedures for contract awards are being developed 
and will be published in the future.  In the meantime, questions and inquiries 
may be forwarded to: stemcell@mail.nih.gov. 


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