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Draft National Institutes of Health Guidelines for Human Stem Cell Research Notice -- published in Federal Register.[Federal Register: April 23, 2009 (Volume 74, Number 77)][Notices]             [Page 18578-18580]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr23ap09-42]   For full text see:


http://edocket.access.gpo.gov/2009/E9-9313.htmURL for the comments form:http://nihoerextra.nih.gov/stem_cells/add.htmSummary:Draft National Institutes of Health Guidelines for Human Stem Cell Research NoticeSUMMARY: The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines).    The purpose of these draft Guidelines is to implement Executive Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-funded research, to establish policy and procedures under which NIH will fund research in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH research involving human stem cells.    These draft Guidelines would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose. Funding will continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells. Specifically, these Guidelines describe the conditions and informed consent procedures that would have been required during the derivation of human embryonic stem cells for research using these cells to be funded by the NIH. NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these Guidelines.    NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding of human embryo research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/09), otherwise known as the Dickey-Wicker Amendment.    According to these Guidelines, there are some uses of human embryonic stem cells and human induced pluripotent stem cells that, although those cells may come from allowable sources, are nevertheless ineligible for NIH funding.    For questions regarding ongoing NIH-funded research involving human embryonic stem cells, as well as pending applications and those submitted prior to the issuance of Final Guidelines, see the NIH Guide http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-085.html.DATES: Written comments must be received by NIH on or before May 26, 2009.ADDRESSES: The NIH welcomes public comment on the draft Guidelines set forth below. Comments may be entered at: http://nihoerextra.nih.gov/stem_cells/add.htm. Comments may also be mailed to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland 20892-7997. Comments will be made publicly available, including any personally identifiable or confidential business information they contain.                       

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