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Northwestern University Feinberg School of Medicine
Office for Regulatory Affairs

Registration

Registration is required for any covered cell types.  The registry will maintain a record of all hESC lines including newly created hESC lines, kept at or under the auspices of NU. The registry will contain information on the source and provenance of the hESC lines, the location of the hESC lines, the name of the investigators responsible for the safekeeping of the hESC lines, the disposition of the hESC lines, and such other information the NUCHSR deems appropriate. The information provided to and listed in the registry are strictly for monitoring purposes and are not available to the public.

Investigators should complete the registration form to register their hESC. Registration excludes adult multipotent and induced pluripotent human stem cells (iPSC), unless they are being used for the purpose of creating totipotent stem cells or gametes.

The following categories of Human Stem Cell Research are subject to NUCHSR Registration only:

  1. In vitro research using hESC lines that are listed on the NIH hESC Registry.
  2. In vitro research using hESC lines that have been pre-approved for such use by the NUCHSR; 
  3. In vitro research using Human Stem Cells, if
  4. Institutional Review Board (IRB) review approval has been received (i.e., the cells were obtained by a process approved by an IRB to ensure that donor(s) provided voluntary informed consent in accordance with then current federal and state law, regulations, and guidelines), and
  5. The cell lines have been de-identified (i.e., the cell lines and any corresponding information are anonymous or are coded in such a manner that the donor(s) cannot be identified (by the investigators or others) directly or indirectly through identifiers linked to the donor(s), pursuant to a written agreement obtained from the source of the cell lines stating that the identity of the donor(s) will not be released to the investigator under any circumstances);
  6. Research involving the transplantation of non-totipotent and non-pluripotent Human Stem Cells or cells derived from non-totipotent and non-pluripotent Human Stem Cells into human subjects; and
  7. Other types of Human Stem Cell Research that the Vice Dean for Research or Regulatory Affairs has made a written determination, after due consideration of the likely risks and benefits of such research, that such categories are permissible without the additional review of the NUCHSR.