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</ul></div> </div> </nav> <div class="engage-cta"> <div class="pull-right"> <a class="btn secondary-btn" href="/get-involved/">Get Involved</a> </div> </div> </div> </div> </header> <main id="primary" class="site-main"> <article id="post-1072" class="post-1072 policies type-policies status-publish hentry policy_areas-stem-cell-and-developmental-biology"> <div class="entry-content"> <div class="wp-block-group alignfull"><div class="wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow"><div id="hero-block_2c45e5a0c7ae5c1a441508b96eed96a9" class="hero alignfull" style="background-image: url('https://osp.od.nih.gov/wp-content/uploads/2022/02/Rectangle-22.jpg'); color: #ffffff"> <div class="inner-container"> <div class="container-hero"> <div class="hero-left"> <h1>Stem Cell and Developmental Biology Policy</h1> <p><p>Uses of certain biological materials and biotechnologies pose unique scientific, ethical, and social considerations in scientific research and clinical practice. OSP works with researchers to harness the power of scientific advances using biological materials such as human stem cells, and emerging technologies such as methods to study human cells in animal models, to provide a responsible path forward for conducting research.</p> </p> </div> </div> </div> </div> <div class="wp-block-group alignwide"><div class="wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow"><div class="yoast-breadcrumbs"><span><span><a href="https://osp.od.nih.gov/">Home</a></span> » <span><a href="https://osp.od.nih.gov/policies/">Policies</a></span> » <span class="breadcrumb_last" aria-current="page">Stem Cell and Developmental Biology Policy</span></span></div> <div id="custom-tabs-block_e6fea3ce7bbce19f896ae5dd6fbedd44" class="custom-tabs alignwide"> <div class="panel-group" id="accordion" role="tablist" aria-multiselectable="true"></div> <div class="container-tabs"> <div class="tab-navigation"> <ul id="tabs" class="nav nav-tabs"> <h5><span>Content</span></h5> <li><a class="active" data-toggle="tab" href="#tab0"><span>NIH Policy for Research with Human Stem Cells</span></a></li><li><a class="" data-toggle="tab" href="#tab1"><span>NIH Policy for Research with Certain Animals Containing Human Cells</span></a></li><li><a class="" data-toggle="tab" href="#tab2"><span>NIH Policy for Research Involving Human Embryos</span></a></li><li><a class="" data-toggle="tab" href="#tab3"><span>NIH Policy for Research with Human Fetal Tissue</span></a></li> </ul> <div class="container-ql"> <h5><span>Frequently Asked Questions</span></h5> <div><ul> <li><a href="https://stemcells.nih.gov/research-policy/stem-cells-faqs\" target="_blank" rel="noopener noreferrer">NIH Guidelines for Human Stem Cell Research</a></li> <li><a href="https://grants.nih.gov/faqs#/human-fetal-tissue-research.htm" target="_blank" rel="noopener">Human Fetal Tissue (Extramural)</a></li> <li><a href="https://stemcells.nih.gov/research-policy/stem-cells-faqs#other-5" target="_blank" rel="noopener">Embryos/Embryoids</a></li> </ul> </div> </div> </div> <div class="tab-content"> <div id="tab0" class="tab-pane fade active show"><h3>NIH Policy for Research with Human Stem Cells</h3> <p>OSP staff lead the ongoing implementation of the <a href="https://stemcells.nih.gov/research-policy/guidelines-for-human-stem-cell-research" target="_blank" rel="noopener">NIH Guidelines for Human Stem Cell Research</a>, which govern the conduct of NIH-funded human stem cell research.</p> <h5>Other information:</h5> <ul> <li><a href="https://stemcells.nih.gov/" target="_blank" rel="noopener noreferrer">NIH Stem Cell Website</a></li> <li><a href="https://grants.nih.gov/stem_cells/registry/current.htm" target="_blank" rel="noopener noreferrer">NIH Human Embryonic Stem Cell Registry</a></li> <li><a href="https://www.federalregister.gov/documents/2010/02/23/2010-3527/national-institutes-of-health-guidelines-for-human-stem-cell-research" target="_blank" rel="noopener noreferrer">FR Notice on Proposed Revision of Definition to Human Embryonic Stem Cells in the NIH Guidelines for Human Stem Cell Research</a> <ul> <li><a href="/wp-content/uploads/2022/09/Stem_Cell_Comments_201001-Sortable.xlsx">Public Comments on Proposed Revision</a></li> </ul> </li> </ul> </div><div id="tab1" class="tab-pane fade "><h3>NIH Policy for Research with Certain Animals Containing Human Cells</h3> <p>Animal models with human cells are used to study some human diseases and test investigational drugs. NIH funds such research subject to certain prohibitions, which are detailed in the <a href="https://stemcells.nih.gov/research-policy/guidelines-for-human-stem-cell-research" target="_blank" rel="noopener noreferrer">NIH Guidelines for Human Stem Cell Research</a> and in <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-158.html" target="_blank" rel="noopener noreferrer">NOT-OD-15-158</a>. NIH held a <a href="http://137.187.173.51/events/workshop-on-research-with-animals-containing-human-cells/">Workshop on Research with Animals Containing Human Cells</a> in 2015 on the state of the science and animal welfare issues.</p> <div>On August 4, 2016, NIH published notices in the Federal Register and the NIH Guide to Grants and Contracts requesting public comment on a proposal to amend Section IV and V of the <a href="https://stemcells.nih.gov/research-policy/guidelines-for-human-stem-cell-research" target="_blank" rel="noopener noreferrer">NIH Guidelines for Human Stem Cell Research</a>. The notices also requested comments on the proposed scope of certain human-animal chimera research to be considered by an NIH steering committee.</div> <ul> <li><a href="http://137.187.173.51/next-steps-on-research-using-animal-embryos-containing-human-cells/">“Under the Poliscope” blog</a></li> <li><a href="https://www.federalregister.gov/documents/2016/08/05/2016-18601/request-for-public-comment-on-the-proposed-changes-to-the-nih-guidelines-for-human-stem-cell" target="_blank" rel="noopener noreferrer">Federal Register Notice requesting public comment</a></li> <li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-128.html" target="_blank" rel="noopener noreferrer">NIH Guide Notice requesting public comment</a></li> <li><a href="https://grants.nih.gov/grants/rfi/responses_57.cfm" target="_blank" rel="noopener noreferrer">Public comments</a></li> </ul> </div><div id="tab2" class="tab-pane fade "><h3>NIH Policy for Research involving Human Embryos</h3> <p>Since FY1996, NIH has been prohibited from funding research involving the creation of human embryos for research purposes or research in which human embryos are destroyed (including for the derivation of human embryonic stem cells). That prohibition is incorporated into the <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section%204/4.2.4%20human%20embryo%20research%20and%20cloning%20ban.htm" target="_blank" rel="noopener noreferrer">NIH Grants Policy Statement at Section 4.2.4</a>. and the <a href="https://stemcells.nih.gov/research-policy/guidelines-for-human-stem-cell-research" target="_blank" rel="noopener noreferrer">NIH Guidelines for Human Stem Cell Research</a>. Furthermore, <a href="https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos" target="_blank" rel="noopener noreferrer">NIH does not fund any use of gene-editing technologies in human embryos</a>.</p> <p>OSP staff convene the NIH Human Embryo Research Steering Committee, which is charged with determining whether particular research involving human embryos would be fundable by NIH under the limitations of the <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section%204/4.2.4%20human%20embryo%20research%20and%20cloning%20ban.htm" target="_blank" rel="noopener noreferrer">NIH Grants Policy Statement Section 4.2.4</a>:</p> <p>“NIH funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) for research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and subsection 498(b) of the PHS Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism not protected as a human subject under 45 CFR 46, as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. Furthermore, per the <a href="https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos" target="_blank" rel="noopener noreferrer">NIH Director’s Statement of April 28, 2015</a>, NIH will not fund any use of gene-editing technologies in human embryos.</p> <p>In addition to the statutory restrictions on human fetal research under subsection 498((b) of the PHS Act, by Presidential memorandum of March 4, 1997, NIH is prohibited from using Federal funds for cloning of human beings.”</p> <p>NIH is not able to make an official determination of whether research may be supported by NIH until an application is submitted. If researchers have questions, they should contact their program officer. If they do not have an assigned program officer, they may utilize the <a href="https://projectreporter.nih.gov/reporter_matchmaker.cfm?new=1&source=aifn" target="_blank" rel="noopener noreferrer">NIH Matchmaker system</a>.</p> <div>Regarding research with models of human embryo development: NIH will not support research with a model that could be considered a human organism per the NIH Grants Policy Statement Section 4.2.4. While NIH continues to make decisions on a case-by-case basis, the research community should be aware that NIH has supported research with some human 2-dimensional micropattern cultures. NIH has also decided that the agency may not support research with some human blastula-stage models composed of epiblast and extra-embryonic cells in a relatively normal spatial orientation. Also see “Under the Poliscope” blogs:</div> <ul> <li><a href="http://137.187.173.51/human-embryo-development/">Sharing Our Current Thinking: Models Containing Aspects of Human Embryos</a> (March 11, 2021)</li> <li><a href="http://137.187.173.51/a-quick-word-about-human-embryo-model-systems/">A Quick Word About Human Embryo Model Systems</a> (October 10, 2019)</li> </ul> </div><div id="tab3" class="tab-pane fade "><h3>NIH Policy for Research with Human Fetal Tissue</h3> <p>All requirements at NIH Grants Policy Statement Section <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.14_human_fetal_tissue_research.htm?Highlight=fetal%20tissue" target="_blank" rel="noopener">4.1.14-4.1.14.2</a></p> <p>Of note, per Federal law (42 U.S.C. 289g-1 and 289g-2):</p> <ul> <li>It is unlawful to knowingly acquire, receive, or transfer human fetal tissue for valuable consideration</li> <li>For transplantation research involving human fetal tissue: <ul> <li>Consents/statements are required from the donor, the attending physician, the researcher, and the transplant recipient</li> <li>Other safeguards apply to the tissue procurement</li> </ul> </li> </ul> <p>Of note, per NIH policy:</p> <ul> <li>NIH expects informed consent to have been obtained from the tissue donor for any NIH- funded research using human fetal tissue <u>(</u><a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.14_human_fetal_tissue_research.htm?Highlight=fetal%20tissue" target="_blank" rel="noopener">NIH Grants Policy Statement 4.1.14</a><u>)</u></li> <li>Applicants/offerors need to provide detailed information addressing the use of human fetal tissue <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-111.html" target="_blank" rel="noopener">(</a><a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.1.14_human_fetal_tissue_research.htm?Highlight=4.1.14.2" target="_blank" rel="noopener"><span style="text-decoration: underline;">NIH Grants Policy Statement 4.1.14.2</span></a> and <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-111.html" target="_blank" rel="noopener">NOT-OD-21-111</a><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-111.html" target="_blank" rel="noopener">)</a></li> </ul> <p>More Information:</p> <ul> <li><a href="https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations/policies-procedures-use-human-fetal-tissue-hft-non-transplantation-research" target="_blank" rel="noopener">Policies and Procedures for the Use of Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH</a></li> <li><a href="https://grants.nih.gov/faqs#/human-fetal-tissue-research.htm" target="_blank" rel="noopener">FAQs (Extramural)</a></li> <li><a href="/wp-content/uploads/HFT_EAB_FY2020_Report_08182020.pdf">NIH Human Fetal Tissue Research Ethics Advisory Board–FY2020 Report</a></li> </ul> <ul> <li style="list-style-type: none;"> <ul> <li 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