How to Get a Human Embryonic Stem Cell Line Approved

Applicant institutions seeking funding must go through an NIH administrative review process to gain approval for a human embryonic stem cell (hESC) line.

To seek NIH approval, applicants take one of three paths. The full process is not yet final, and we will post more information after NIH publishes it.

Once NIH approves a cell line, it will appear on the future NIH Human Embryonic Stem Cell Registry. 

1. Embryos donated in the U.S. on or after July 7, 2009
   • Meet requirements of Section II A in the NIH Guidelines on Human Stem Cell Research. Here are the highlights, but read the full document:
     • Show that the embryos used to derive hESCs were created using IVF for reproduction but are no longer needed for that purpose.
     • Show that donors were informed that the embryos will be used for stem cell research and have been made fully aware of all choices, including donating the embryos to others.
     • State that no donors were paid for embryos nor were any threats or inducements made that could have pushed donors toward making a donation.
     • Inform donors that there are no stipulations on who may receive medical benefits (e.g., transplant recipients).
     • Ensure donors understand this research is not intended to benefit them medically.
2. Embryos donated either in or outside the U.S. before July 7, 2009
   • Meet requirements of Section II A in the NIH Guidelines on Human Stem Cell Research.
   • Or if you cannot, submit a request to a new Working Group of the Advisory Committee to the Director (ACD).
     • ACD Working Group takes into account principles in Section II A and 45 CFR 46 Subpart A (Common Rule).
     • NIH Director makes the final decision.
3. Embryos donated outside the U.S. on or after July 7, 2009
   • Meet requirements of Section II A in the NIH Guidelines on Human Stem Cell Research.
   • Or if you cannot, submit information to the ACD Working Group, which assesses whether the foreign standards protections are equivalent to the Section II A requirements.
   • NIH Director makes the final decision.

For grant application information, read our August 5, 2009, article "Human Embryonic Stem Cell Research Gets the Green Light," and see the July 15, 2009, Guide notice. Send questions to stemcells@mail.nih.gov.