Commonly Asked Questions
If you didn't find an answer to your question on this page, please contact the Office for Regulatory Affairs at ora@northwestern.edu
What is the effective date of the policy?
All existing lines must be registered by December 31, 2020. All new lines should be registered within one month of acquisition.
What is considered a “covered cell type”?
- Human embryonic stem cells (hESC)
- Human totipotent stem cells
- Human gametes
- Human zygotes
- Human embryo ex vivos
Under what circumstances is registration not required?
Unless otherwise provided in the terms of the grant, contract, agreement, or other funding supporting the research and/or other activities, the following research and/or other activities are not subject to this Policy:
- Use of non-Human Stem Cells;
- Use of fetal tissue or stem cells derived from human adults or umbilical cord blood, placentas, or fetuses, or research involving any other type of human cells, unless the experiments are designed or expected to yield gametes;
- Transplantation of stem cells as part of a standard of care or other recognized and accepted medical treatment for a disease or condition; Transplantation of Human Stem Cells as part of a Human Subjects Research project subject to IRB review or as part of innovative care that departs in a significant way from standard or accepted practice may require ESCRO Registration, NUCHSR review, or be prohibited;
- The creation and ex vivo passage of iPSCs. NUCHSR Registration and NUCHSR review and approval are required if the iPSCs are pluripotent stem cells and are transferred into an animal or human, or are used to make an embryo; and
- Other categories of Human Stem Cell Research or activities that the Vice Dean for Research or Regulatory Affairs has made a written determination, after due consideration of relevant legal and ethical requirements, that such research or activities are appropriate for exemption from NUCHSR Registration.
- Derivation of human iPSCs for research purposes
What is the turnaround time for the review and approval process?
2 weeks. The Office for Regulatory Affairs will contact you regarding your application.
Who are the members of the NUCHSR Committee?
Dr. John Kessler, Dr. Evangelos Kiskinis, Dr. Monica Laronda and Dr. Guillermo Oliver
What is the deadline for submitting cell types for the registry?
Does this policy include iPSCs?
No, except research in which animal chimeras incorporating Human Stem Cells, including but not limited to hESCs and iPSCs, with the potential to form gametes are bred to each other.