Guidelines for Human Embryonic and Induced Pluripotent Stem Cells

The use of Human Embryonic Stem Cells (hESCs), which are subject to strict oversight, and Human Induced Pluripotent Stem Cell (iPSC) lines are considered major research tools by the Office of Intramural Research (OIR). There are no specific restrictions in the NIH Intramural Research Program (IRP) with regard to acquiring or sending out iPSC lines; however, there are relevant requirements in the new NIH Guidelines on hESCs that apply to potential uses of human iPSC lines. Please refer to the NIH Guidelines for iPS Cell Research for additional information.

Acquisition

Guidelines for acquisition of Human iPS and ES cell lines can be found at:

• Induced Pluripotent Stem (iPS) Cells
• Human Embryonic Stem (hES) Cells

If you are using, making or planning to acquire either hESCs or iPSCs please submit the following information

1. A completed and signed copy of the checklist/request form for the cell line(s) you will be using:
   • iPSC Checklist
   • hESC Checklist
2. Acquisition of iPSCs must be reviewed and approved for Human Subjects Research if the line has not been anonymized. Contact Office of Human Subjects Research Protection (OHSRP) for additional information (ohsr_nih_ddir@od.nih.gov or 301-402-3445). A copy of the review must be attached to the checklist.
3. If hESC or 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.
4. Derivation of iPSCs from patient, volunteer, or repository samples, either by an NIH investigator or by an outside entity/commercial source, must have IRB Approval. Provide an approved NIH IRB protocol number or exemption in addition to the other documents.
5. 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 Institutional Biosafety Officer, Richard Baumann (301-496-2960).

Melissa C. Colbert, Ph.D.
Assistant Director, Office of Intramural Research
NIH Agency Intramural Research Integrity Officer (AI RIO)
301-827-7745