Cell Line Provenance Policy
| Proposed Material | Information, Examples, etc. | Provenance Documents To Be Submitted By Investigators |
|---|---|---|
| Registered Pluripotent Cell Lines | • NIH Registered** • CIRM Registered • UK Stem Cell Bank • UK Human Fertilization & Embryology Authority • Canadian National Stem Cell Oversight Committee • Japanese Guidelines for Derivation & Utilization of Human Embryonic Stem Cells | Appropriate registry name and registry number for each line. Some lines may require approval documentation from the registry. **Per NOT-OD-26-031, NIH is pausing review and approval of applications for new human embryonic stem cell (hESC) lines to be added to the NIH Human Embryonic Stem Cell Registry (Registry). Previously approved hESC lines listed on the Registry may continue to be used in NIH-funded research. |
| Non-Registered Embryonic Pluripotent Cell Lines | Cell lines provided by a company, institution, or collaborator that do not appear on one of the above registration lists | 1. A sample Consent Document 2. IRB (or equivalent) Approval Letter appropriate to the Consent document |
| Induced Pluripotent Stem Cells (iPSC) | Source Material: • Fresh Somatic Cells: see guidance below • Archived Somatic Cells: see guidance below | Please provide the appropriate documentation based on the source material. |
| Fresh Somatic Cells for the purpose of generating a) induced or re- programmed pluripotent cells, or b) neural stem cells (NSC) that will be used for in vivo transplantation | Usually in the form of tissue (e.g., punch biopsy, foreskin, residual tissue from surgical procedure, etc.) | 1. A sample Consent Document 2. IRB (or equivalent) Approval Letter (at UCI, hSCRO approval precedes UCI IRB review and approval) 3. In some instances, a statement from the providing company or institution indicating specimens are de-identified, no access to the key code will be granted, and appropriate IRB (or equivalent) oversight was in place at the time of donation is acceptable. |
| Archived Somatic Cells for the purpose of generating a) induced or re- programmed pluripotent cells, or b) NSC that can be used for in vivo transplantation | Usually obtained from a tissue bank | Please provide written acknowledgement from provider (i.e., Tissue bank, Institution, etc.,) indicating specimens are de-identified, and researchers will not receive access to the key code under any circumstance. |
| Fetal Tissue-derived multipotent stem cells | Usually obtained from a tissue bank or academic institution | Please follow the guidance above for Fresh Somatic Cells |
| Fetal Tissue | Aborted pregnancy materials, pathology samples | Provide the following statements as outlined in Code of California Regulations title 17 § 100085: Use of Fetal Tissue. • Statement signed by woman donating the material (can be in the form of a sample Informed Consent document) • Statement signed by attending physician (can be in the form of a sample Informed Consent document) • Statement signed by Principal Investigator |
| Embryos/Oocytes | 1. Consent Document (either sample IRB-approved consent or consent document proposed for use) 2. In both instances (Embryos and Oocytes), IRB approval letter is required |