Frequently Asked Questions - Source of Cells
- What type of information do I need to provide to describe the “name of cell lines” and “source information”?
- Under “Source information," do I need to include commercial sources from which I obtain somatic cells?
- What type of information do I need to provide to describe "location of storage and research"?
- What if I want to use derivatives from hESC lines or create genetically different cells from hESC lines (e.g. cardiomyocytes)?
- Why do I need to provide the blank consent of origin and IRB approval for lines that are not listed on the NIH hESC Registry?
- What is meant by “provenance is likely required”? What rationale is acceptable to ESCRO for requesting to waive provenance?
The source is the collaborator. If you received a line from a colleague at UCSF, identify that contact person by providing his/her name and institution. If you received the line from an investigator within the Institute of Stem Cell and Regenerative Medicine (ISCRM) community, reference the UW colleague as a source.
For cell lines that are listed on the NIH Human Embryonic Stem Cell Registry, an example of name of cell lines and source information would be:
H7, National Stem Cell Bank, or
UC06 (HSF6), University of California, San Francisco via Susan L. Fisher.
For lines not listed on the NIH Human Embryonic Stem Cell Registry, an example of name of cell lines and source information would be:
HUES-2 Harvard University via Elena Kfoury
ESCRO does not review the use of somatic cells unless the investigator plans to induce pluripotency and manipulate the hESC-like line further in vivo, in which case provenance documentation is needed. Therefore, with this one exception, the ESCRO application does not require you to list sources of somatic cells.
Give the UW building name and room number. For each room, explain whether you plan to conduct tissue-culture work, wet-bench work, surgery, microscopy, etc. This information will help other oversight offices, such as IACUC or EH&S, evaluate your application as well.
Examples of research and storage information would be:
HSB J229 -80oC freezer storage
HSB J229C microscopy
HSB J229A tissue culture
HSB J234 wet-bench work
For work conducted off-site, give the complete address, for example:
960 Republican Street
Seattle, WA 98109
as well as room and use information.
Yes, if the hESC-derived cell line still retains the ability to create all three embryonic germ layers. According to section V.D. of GIM 36, “Except as provided in section V. E. below, all hESC research, including research involving the use or creation of a hESC-derived cell line, must be reviewed and approved by the ESCRO Committee prior to the commencement of the research.” An hESC-derived line means, “one or more cells or cell line, including a hESC line created from the destruction of a human embryo, but does not include a hESC line created by SCNT without destruction of a human embryo.”
For example, modifying the H7 cell line by addition of a GFP-reporter would create a genetically distinct hESC-derived cell line that still retains the characteristics of an embryonic stem cell; use of this new cell line would require ESCRO approval.
No, if the hESC derivative no longer retains the ability to generate all three embryonic germ layers. A hESC derivative is defined as “any DNA, RNA, protein, or other biological products secreted by or extracted from a hESC, including an adult stem cell, but does not include any HESC line, HESC-derived cell line, data, or intellectual property.”
Consent and IRB documents should ensure that individual decisions about donation will not affect the quality of care the donor receives and should ensure that donations are made free from undue influence. Please include original donor consent forms in original language as well as English translation for:
- egg donations made in context of research;
- egg donations made in the context of fertility treatment;
- sperm donor consent form for research;
- sperm donor consent form made in context of fertility treatment, consent form from donor of blastocyst if different from above;
- somatic cell donor consent form.
GIM 36 prohibits payment to a donor solely for the purpose of creating a human embryo to be used in hESC research.
In general, provenance documentation is required for any non-federally approved hESC-line(s). An exception to this requirement may include when induced pluripotent stem cell lines are created from anonymized somatic cell sources where the PI cannot ascertain the identity of the individual who donated the somatic cell. In such cases, the PI should briefly explain the history of the cell line and cite relevant literature supporting the origin of the cell line.