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Embryonic Stem Cell Research Oversight
Q: When do you have to apply?
A: You must secure ESCRO approval to obtain hES cell lines or to perform an independent research project with hES cell lines. (You must also obtain an Materials Transfer Agreement for cell lines, so beginning the MTA process and the ESCRO application process go hand-in-hand.)
Q: How long is the approval from the ESCRO Committee valid?
A: ESCRO approvals are valid for three years, with annual reporting in the meantime. The committee staff will contact the investigator to trigger the annual review.
Last reviewed: May 26, 2007.
Copyright © 2007-2008 The Regents of the University of Michigan
Embryonic Stem Cell Research Oversight
FREQUENTLY ASKED QUESTIONS
- Q: How do you apply to the ESCRO Committee?
- A: Contact us at ESCROquestions@umich.edu or 615-8936 to obtain the application form. Ultimately our website will include the application form for download.
- You can email us back the form once it is completed. It then goes to the committee for review. The ESCRO Committee is scheduled to meet monthly.
- Currently, every application is seen by the whole committee, however, as reviewing experience increases we will begin to use an expedited process without a convened meeting for certain types of research, such as purely in vitro work with NIH Registry lines.
- Q: How does the ESCRO Committee coordinate with the IRB and UCUCA?
- A: An investigator may apply to the ESCRO simultaneous with a related IRB or UCUCA application. The ESCRO application requests tracking information about related IRB and UCUCA applications, and the ESCRO Committee will request information from these committees where appropriate.
- Q: What does the ESCRO Committee consider during its review?
- A: The NAS report (the Guidelines) provides a list of questions which the Committee uses as points to consider in reviewing hES cell applications, and these are below. The ESCRO application is designed to elicit responses that address these areas:
- What is the scientific question being asked by the proposed research involving human embryonic stem cells? Does the underlying hypothesis address an important scientific question? Could the question reasonably be addressed in any other way?
- Does the research team have the appropriate expertise and training in deriving or culturing either human or nonhuman stem cells? If training is the primary purpose of the proposal, is the training being conducted under the supervision of appropriate experts?
- Has the investigator articulated a compelling rationale for using human stem cells instead of non-human stem cells?
- Has the investigator articulated a compelling rationale for using human embryonic stem cells instead of other types of stem cells?
- Has the investigator justified the selection of the stem cell line(s) to be used?
- Has the investigator articulated a rationale for creating a new stem cell line or could the proposed research be conducted with existing cell lines? If more than one cell line is to be derived, has the investigator justified the number he/she proposes to make?
- Q: What does the ESCRO Committee consider in its review of animal work with hES cells?
- A: The following points to consider with regard to implantation to nonhuman animals also come from the NAS report:
- Are hES cells required, or can cells from other primates or animals be used?
- Has sufficient animal work preceded the proposed work involving hES cells?
- Might the cell transfer result in the animal's acquiring characteristics that are valued as distinctly human?
- If hES cells are to be transferred into an animal embryo or fetus, have studies (for example, with ES cells from other species or interspecies chimeras) suggested that the resulting creature would exhibit human characteristics that would be ethically unacceptable to find in an animal?
- If visible human-like characteristics might arise, have all those involved in these experiments, including animal care staff, been informed and educated about this?
Other questions?
Contact the ESCRO Committee at 734-615-8936, or ESCROquestions@umich.edu
Last reviewed: May 26, 2007.