GUIDANCE FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS REGARDING 
RESEARCH INVOLVING HUMAN EMBRYONIC STEM CELLS, GERM CELLS AND STEM 
CELL-DERIVED TEST ARTICLES   

Release Date:  April 10, 2002

NOTICE:  NOT-OD-02-044
 
National Institutes of Health

On March 19, 2002, the Office for Human Research Protections (OHRP), 
Department of Health and Human Services updated and replaced its 
November 16, 2001 guidance entitled, "Guidance for Investigators and 
Institutional Review Boards Regarding Research Involving Human 
Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles."

OHRP's March 19, 2002 guidance can be found at 
http://www.hhs.gov/ohrp/references/HESCGuidance.pdf [PDF
document, requires free Adobe Acrobat Reader].
The OHRP document describes when research activities involving human 
embryonic stem cells (hESCs), human embryonic germ cells derived from 
fetal tissue, or hESC- or germ cell-derived test articles are 
considered human subjects research and what regulatory controls apply
to that research.

The National Institutes of Health maintains two websites to assist 
investigators:

"Implementation Issues for Human Embryonic Stem Cell Research" contains 
additional information related to NIH activities and procedures, 
including Frequently Asked Questions, at 
http://grants.nih.gov/grants/stem_cells.htm.

"NIH Stem Cell Information" provides additional background documents 
and information at http://stemcells.nih.gov/index.asp

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