FORM B – Amendments to Approved Applications for Human Embryonic Stem Cell Use In Vitro or In Vivo in Animals For Federally Approved Lines
Version 1.0 8/7/2007 / Office for the Protection of Research Subjects (OPRS)
Embryonic Stem Cell Research Oversight Committee (ESCRO)
1737 West Polk Street (MC 672)
203 Administrative Office Building
Chicago, IL 60612
Phone: 312.355.5288 Fax: 312.413.2929
www.research.uic.edu
In addition to a signed hard copy, please submit this form electronically to .
Page 4 of 4 /
/ Document # 0702
UIC Amendment Application for Human Embryonic Stem Cell Use In Vitro or In Vivo in Animals / Version 1.0 8/7/07
Office Use Only / Date Application Received: / ESCRO Application Number: E / ESCRO Amendment Number: E
This application is a resubmission; it is intended to replace: E
1. PROJECT TITLE:
2. PRINCIPAL INVESTIGATOR:
Name (Last, First):
/ Work Phone Number:
/ Fax Number:
Department Affiliation:
/ Mailing Address1 :
Choose one, if applicable:
New address – Change for all applications
Secondary address – Use for this application only
E-mail Address:
3. Nature of Amendment (check all that apply)
a. hES cell line used
/d. In vivo manipulations
/g. Project Title
b. In vitro manipulations
/e. Principal Investigator
/h. Funding Support
c. Animal species
/f. Project Personnel
/i. Other (e.g., COI, Performance sites, etc.)
Page 4 of 4 // Document # 0702
UIC Amendment Application for Human Embryonic Stem Cell Use In Vitro or In Vivo in Animals / Version 1.0 8/7/07
4. Summary of Requested Amendments
4a. New Cell Lines- List new cells lines, indicate if they will replace previously approved lines or will be used in addition to the approved lines, indicate if all manipulations of cells will be as previously approved or complete other appropriate sections of amendment form, and provide a justification for selection of the cell line.
Vendor / Vendor Number / NIH Registry
(if applicable) / UIC MTA Number / Number of Lines / Use of Cells
EX /
WiCell
/ H1 / WA 01 / 1999-00000 / 2 / In vitro onlyIn vivo in animals only
Both
a. / In vitro only
In vivo in animals only
Both
b. / In vitro only
In vivo in animals only
Both
4b. Significant Changes in In Vitro Manipulations (Attach copy of IBC Approval, if applicable, for this modification)
Describe significant changes in the processes used for characterizing, expanding, and maintaining the cells:
Describe any change as to whether cells will be banked or disposed of at completion of work and the process:
4c. Change in Animal Species (Attach copy of ACC Approval for this modification)
Identify the new species into which hES cells will be transplanted:
Describe the reason for the change and indicate whether or not this species will replace original species or will be used in addition to original species:
4d. Significant Changes in In Vivo Manipulations ((Attach copy of ACC Approval for this modification)
Describe significant changes in what will be transplanted, stage of development of animals at transplant, and in the contribution of the animal’s anatomy, physiology, and species-specific behavior:
4e. Change in Principal Investigator- New PI
Name (Last, First): / Degree:
Phone: / Fax: / Email:
Department Affiliation: / Mailing Address:
Funding Agency: / Has Funding Agency Been Notified? / Yes / No
Reason for the Request:
Specific procedures or techniques that PI will be performing for work covered by this research application:
Specific training and/or experience with stem cells and the scope of the work covered by this protocol:
4f. Addition of Project Personnel
Name (Last, First):
Degree: / Role in Research: / Co-Investigator
Other Project Staff
Phone: / Fax: / Email:
Department Affiliation: / Mailing Address:
Copy on Correspondence: Yes No
If the individual will be directly handling and using human embryonic stem cells in this study, please complete the responses below.
Specific procedures or techniques that the individual will be performing for work covered by this research application:
Specific training and/or experience with stem cells and the scope of work covered by this research application:
If not currently trained, list the person responsible for training along with the person’s expertise with the procedures/techniques used in the research:
4g. Change in Protocol Title
New Title: / Reason for Request:
4h. New or Additional Funding Support
Funding Agency (e.g., NIH, foundations, departmental, etc.):
Title of Funding Proposal:
PI on Funding Proposal:
Number Assigned by Funding Agency:
/ Proposal Approval Form (PAF) Number:
Funding Status: / Funded: / Pending: / Not Submitted Yet:
4i. Other Significant Changes
Describe any other significant changes to this protocol (e.g., changes in COI, performance site, etc.).
5. Assurance
The Principal Investigator assures that the above information is accurate and no changes described in this modification will be initiated until approval is granted by the ESCRO. The Principal Investigator also assures that all other aspects of the protocol that are not described in this modification will be conducted as in the approved protocol or a previously approved modification.
______/ ______
Principal Investigator Signature / Date
Page 4 of 4 /
/ Document # 0702
UIC Amendment Application for Human Embryonic Stem Cell Use In Vitro or In Vivo in Animals / Version 1.0 8/7/07
Page 4 of 4 /
/ Document # 0702