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/humansubjects/guidance/stemcell.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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