Stem Cell and Developmental Biology Policy

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.

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Frequently Asked Questions

NIH Policy for Research with Human Stem Cells

The NIH Guidelines for Human Stem Cell Research govern the conduct of NIH-funded human stem cell research.

Per NOT-OD-26-031, NIH is assessing the robustness of emerging biotechnologies to reduce or potentially replace reliance on human embryonic stem cells (hESCs) for research. During this review, NIH is pausing review and approval of applications for new hESC lines to be added to the NIH Human Embryonic Stem Cell Registry.

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NIH Policy for Research with Certain Animals Containing Human Cells

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 NIH Guidelines for Human Stem Cell Research and in NOT-OD-15-158. NIH held a Workshop on Research with Animals Containing Human Cells in 2015 on the state of the science and animal welfare issues.

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 NIH Guidelines for Human Stem Cell Research. The notices also requested comments on the proposed scope of certain human-animal chimera research to be considered by an NIH steering committee.

NIH Policy for Research involving Human Embryos

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 NIH Grants Policy Statement at Section 4.2.4. and the NIH Guidelines for Human Stem Cell Research. Furthermore, NIH does not fund any use of gene-editing technologies in human embryos.

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 NIH Grants Policy Statement Section 4.2.4:

“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 NIH Director’s Statement of April 28, 2015, NIH will not fund any use of gene-editing technologies in human embryos.

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.”

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 NIH Matchmaker system.

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:

NIH Policy for Research with Human Fetal Tissue

Per NOT-OD-26-028, effective January 22nd, 2026, NIH funds are not permitted to be used for research using human fetal tissue (HFT) from elective abortions.

NIH funds are permitted for use of research involving HFT obtained from miscarriage or stillbirth, which are subject to requirements outlined in NOT-OD-15-143 and NOT-OD-16-033.

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