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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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.

Other information:

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 4.2.5. 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.

Regarding research with models of human embryo development: see “Under the Poliscope” blogs.

NIH Policy for Research with Human Fetal Tissue

All requirements at NIH Grants Policy Statement Section 4.1.14-4.1.14.2

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:

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