Induced Pluripotent Stem Cells (iPSCs) Use in the Intramural Research Program

Development

• Derivation of iPSCs from identifiable patient, volunteer, or repository samples, either by an NIH investigator or by an outside entity/commercial source, must have prospective IRB Approval. Provide an approved IRB protocol number in addition to the other documents.
• All iPSCs that are generated within the IRP or under contract to be used for in vitro experiments or in animals using recombinant DNA technology must also be reviewed and approved by the Institutional Biosafety Committee. The cells you will get back may be considered recombinant materials and need to be registered. Include the IBC number and approval/registration date. If you have any questions contact the NIH Institutional Biosafety Officer, Richard Baumann (301-496-2960).

Acquisition

• If you are using, making or planning to acquire iPSCs please submit the following information:
  • A completed and signed copy of the checklist/request form for the cell line(s) you will be using:
    • iPSC Registration (PDF File)
  • Acquisition of iPSCs must be reviewed and approved by an IRB if the line has not been anonymized. A copy of the approval must be attached to the checklist.
  • If iPSC 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 MTA agreement should also be included.
  • iPSCs made by a NIH Core facility (e.g., NHLBI) may also require an MTA for transfer of cells to you. This is for tracking purposes.

Use Restrictions

• IRP researchers must not introduce hESCs (even if derived from embryos donated in accordance with these Guidelines) or human iPSCs 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 iPSCs 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.