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.
NIH Policy for Research with Human Stem Cells
OSP staff lead the ongoing implementation of the NIH Guidelines for Human Stem Cell Research, which govern the conduct of NIH-funded human stem cell research.
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.
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 4.2.5. 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 4.2.5:
“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.
- Sharing Our Current Thinking: Models Containing Aspects of Human Embryos (March 11, 2021)
- A Quick Word About Human Embryo Model Systems (October 10, 2019)
NIH Policy for Research with Human Fetal Tissue
All requirements at NIH Grants Policy Statement Section 4.1.14-22.214.171.124
Of note, per Federal law (42 U.S.C. 289g-1 and 289g-2):
- It is unlawful to knowingly acquire, receive, or transfer human fetal tissue for valuable consideration
- For transplantation research involving human fetal tissue:
- Consents/statements are required from the donor, the attending physician, the researcher, and the transplant recipient
- Other safeguards apply to the tissue procurement
Of note, per NIH policy:
- NIH expects informed consent to have been obtained from the tissue donor for any NIH- funded research using human fetal tissue (NIH Grants Policy Statement 4.1.14)
- Applicants/offerors need to provide detailed information addressing the use of human fetal tissue (NIH Grants Policy Statement 126.96.36.199 and NOT-OD-21-111)
- Policies and Procedures for the Use of Human Fetal Tissue (HFT) for Research Purposes in the Intramural Research Program at NIH
- NIH Human Fetal Tissue Research Ethics Advisory Board–FY2020 Report