Human Embryonic Stem Cell (hESCs) Use in the Intramural Research Program

Development

• Derivation of hESCs from human embryos is prohibited by the annual appropriations restriction on funding of human embryo research, also known as the Dickey-Wicker Amendment.

Acquisition

• If you are using or planning to acquire hESCs, please submit the following information:A completed and signed copy of the checklist for the cell line(s) you will be using:
  • hESC Checklist
• If hESC lines are purchased from or made by a commercial source or obtained from an outside collaborator, contact the Technology Transfer Office or your Technology Development Coordinator. A copy of the Material Transfer Agreement (MTA) should also be included.
• All hESCs that have been reviewed and deemed eligible by NIH in accordance with the NIH Guideline for Human Stem Cell Research are posted on the NIH Human Stem Cell Registry.
• The “see details” link on the NIH Human Embryonic Stem Cell Registry includes information on two categories of possible use restrictions of lines on the NIH Human Embryonic Stem Cell Registry: Provider Restrictions and NIH Restrictions.
  • Provider Restrictions include things such as experiments that are prohibited with the cell line, or requirements that proposed research be approved by an ESCRO or other type of ethical review committee.
  • NIH Restrictions are imposed on the use of a line based on the usage of the cells as agreed to by the donors in their informed consent process. Furthermore, other cell lines derived from a restricted hESC line are subject to the same restriction.

Use Restrictions

• IRP researchers must not introduce hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells into non-human primate blastocysts. See the NIH Guidelines for Human Stem Cell Research.
• IRP researchers must not breed animals where the introduction of hESCs or human induced pluripotent stem cells may have contributed to the germ line. See the NIH Guidelines for Human Stem Cell Research.
• IRP researchers must not introduce human pluripotent stem cells into non-human vertebrate animal pre-gastrulation stage embryos. See NOT-OD-15-158.