PROCEDURES FOR SUBMISSION OF COMPLIANCE DOCUMENTS TO THE HUMAN PLURIPOTENT STEM 
CELL REVIEW GROUP FOR THE RESEARCH USE OF HUMAN EMBRYONIC GERM CELLS

Release Date:  May 3, 2002

NOTICE:  NOT-OD-02-049

National Institutes of Health

Research use of human embryonic germ cells derived from fetal tissue with 
Federal funds requires review of compliance with the NIH Guidelines for Research
Using Human Pluripotent Stem Cells 
http://stemcells.nih.gov/news/newsArchives/fr25au00-136.asp.  Embryonic germ cells 
are pluripotent stem cells derived from fetal tissue and are distinct from 
human embryonic stem cells that are derived from human embryos.  This notice 
does not pertain to human embryonic stem cells.  The Guidelines require that 
certain documents be submitted to and reviewed by the Human Pluripotent Stem 
Cell Review Group (HPSCRG).  In accordance with the NIH Guidelines, the HPSCRG 
review will be conducted in a public meeting.  This notice describes the 
documents investigators are required to submit and the submission process for 
HPSCRG review.  

Investigators who intend to use existing funds, request an administrative
supplement, or apply for new Department of Health and Human Services (DHHS) 
funds for research using human embryonic germ cells derived from fetal tissue 
are required to submit the following for HPSCRG review: 

1. An assurance signed by the responsible institutional official that the 
embryonic germ cells were derived from human fetal tissue in accordance with 
the conditions set forth in Section II.B.2 of the NIH Guidelines and that the 
institution will maintain documentation in support of the assurance, 
2. A sample informed consent document (with patient identifier information 
removed) and a description of the informed consent process that meet the 
criteria for informed consent set forth in Section II.B.2.b of the NIH 
Guidelines, 
3. An abstract of the scientific protocol used to derive human embryonic germ 
cells from fetal tissue, 
4. Documentation of institutional review board approval of the derivation 
protocol, 
5. An assurance that the stem cells to be used in the research were or will be 
obtained through a donation or through a payment that does not exceed the 
reasonable costs associated with the transportation, processing, preservation, 
quality control and storage of the stem cells, 
6. The title of the research proposal or specific subproject that proposes the 
use of human embryonic germ cells, 
7. An assurance that the proposed research using human embryonic germ cells is 
not a class of research that is ineligible for NIH funding as set forth in the 
NIH Guidelines (Section III) and, 
8. The Principal Investigator"s written consent to the disclosure of all 
material submitted as necessary to carry out the public review and other 
oversight procedures set forth in the NIH Guidelines.

DHHS funds may be used to support research to derive human embryonic germ cells 
from fetal tissue, as well as for research utilizing such cells. Such research 
is governed by Federal statutory restrictions regarding fetal tissue research at 
42 U.S.C. § 289g-2(a) and the Federal regulations at 45 CFR § 46.210. All 
DHHS-funded research involving the derivation or utilization of embryonic germ 
cells from human fetal tissue must comply with the fetal tissue transplantation 
research statute at 42 U.S.C. § 289g-1 and with 42 U.S.C. § 289g-2(b).  
Applicants to the HPSCRG review process are advised to review issues pertaining 
to informed consent processes described in Section II.B.2.b. of the NIH 
Guidelines.  Applicants should also review the Guidance for Investigators and 
Institutional Review Boards Regarding Research Involving Human Embryonic Stem 
Cells, Germ Cells, and Stem Cell Derived Test Articles issued on March 19, 2002 
by the Office of Human Research Protections, DHHS. 
http://www.hhs.gov/ohrp/references/HESCGuidance.pdf 

Applications for HPSCRG review may be submitted prior to, at the time of, or 
after the scientific review of a research proposal.  Federal funds may not be 
used or awarded prior to the approval by HPSCRG.  All documents described above 
should be accompanied with a cover letter describing the grant application or 
research grant under which the proposed research will be conducted.  These 
materials should be submitted by mail to:

Dr. Della Hann
Office of Extramural Research
Office of the Director, NIH, Bldg 1, Rm 144
One Center Drive, Bethesda, MD  20892.  
Inquires about the HPSCRG review process can be made to DDER@nih.gov or 
by phone (301) 496-1096.


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H H S Department of Health
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