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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.

Once NIH approves a cell line, it will appear on the NIH Human Embryonic Stem Cell Registry. To submit a request to the Advisory Committee to the Director (ACD) for approval of a new cell line, fill out NIH Form 2890.

Read the National Institutes of Health Guidelines on Human Stem Cell Research. To seek NIH approval, applicants take one of three paths.

  1. Embryos donated in the U.S. on or after July 7, 2009
    • Meet requirements of Section II A in the National Institutes of Health 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
  3. Embryos donated outside the U.S. on or after July 7, 2009

For grant application information, read our December 23, 2009, article "Wait's Over for Human Stem Cell Lines," and see the December 2, 2009, Guide notice. For additional information, read Stem Cell Information. Send questions to stemcells@mail.nih.gov.

Last Updated February 13, 2013

Last Reviewed February 13, 2013