February 10, 2017
Complete the ESCRO Amendment (DOC) and email to ORIE@wustl.edu.
ESCRO approval covers only the research and specific use of hESC/hPSC/hiPSC lines described in your approved ESCRO application.
Any change in the research or hES cell lines approved by ESCRO must be submitted as an Amendment and approved by ESCRO before making the change.
Examples include but are not limited to:
- adding new research team members
- adding a sponsored research award
- adding additional hESC line(s)
- change in the specific aims initially approved by ESCRO
- change in experimental procedures using hESC/hiPSC
- For example: adding experiments in animals using hESC/hiPSC when ESCRO approval is for in vitro work only
- shifting the research emphasis from one disease to another
- substituting one animal model for another
- using different hESC line(s) than previously approved by ESCRO, including subclones/ mutations of the parent line
How long does it take for an Amendment to be approved?
- Minor changes are approved by the ESCRO Chair, generally within 1-2 days
- More than minor changes must be approved by the convened ESCRO and may take 1-2 months, depending on committee members’ availability
What are examples of minor and more than minor changes?
Minor changes:
- adding new research team members
- change in funding (adding a sponsored research award)
- adding hESC lines or using different hESC line(s) than previously approved (if the hESC lines are on the NIH registry)
- change in research performance site
- changes to improve clarity in statements or to correct typographical errors
More than minor changes:
- adding hESC lines not on the NIH registry
- change in specific aims
- change in use of animals (i.e., adding animals, changing type of animal used, or increasing the number of animals)
- shift in research emphasis from one disease to another