Stem Cell Research Oversight Committee
(SCRO) University of Connecticut
SCRO form AC-2
(last revised 6-2-2015)
438 Whitney Road, Ext., U-1246, University of Connecticut, Storrs, CT 06269
Phone: (860) 486-1725 Fax: (860) 486-1044, email: Dana.wine@uconn.edu
SCRO Office Date Received:
SCRO Annual Continuation Form
SCRO Protocol #:
Date of Initial SCRO Approval:
Expedited (not injecting cells into animals)
Full Review (injecting cells into animals)
Section I: General Information
Note: All Text boxes are expandable
Date of this Continuation
Application:
Department:
SCRO Protocol number:
Project Title:
Expected date for
Completion of Project:
Contact
Email:
Information:
*Mailing address:
Principal Investigator:
Phone:
Fax:
*This is the address where you would like signed materials delivered.
Source of Funding:______________________________________________
Do you plan to continue this project past the protocol expiration date?
Yes I intend to continue the project
No I do not plan to continue the project
A. Amendments & Other Approvals:
The SCRO requires prior notification and/or approval of the following types of modifications:
1) Changes in experimental protocols in the use of hESC or derivatives, human gametes, or embryos;
iPS cells;
2) Additions/deletions of research personnel (including post-docs and graduate students;
3) Requests for additional types or sources of hESC lines;
4) Changes in procurement of human embryos or gametes;
5) Changes in lab location or addition of equipment used for hESC lines not approved by NIH;
6) Injection of cells into animals or iPSCs into neural system or into fetal animals;
7) Changes in the source of funding or the addition of new funding.
For the SCRO amendment form and instructions go to http://www.scro.uconn.edu/ and click on
“forms.”
Revised 11-18-2013
Annual Continuation Form
Have you made any changes to your experimental protocols using hESC or derivatives?
Yes
No
If Yes, briefly describe those changes.
Section II: Use of Human Cell Lines
1. Have you received hESC lines, or modified hESC lines, within the past 12 months in
connection with this project (e.g. WiCell H9; neural progenitors obtained from WiCell H9;
Mesenchymal cells obtained from H7;
YES
NO.
If NO go to question 2. If YES, complete this section (check and complete appropriate
choices- additional space is provided at the end of the document).
Cells were obtained from the UConn-Wesleyan Core
Cell Type
Qty
Cell Type
Cells were obtained from another source
Cell Type
Qty
Investigator
Qty
Source (University)
2. Do you anticipate using any other hESC lines, or modified hESC lines, within the next 12
months?
YES
NO Indicate their source(s).
UCONN-Wesleyan Core, quantity
Other source (provide source)
Revised 6-2-2015
.
, quantity
2
.
Annual Continuation Form
3. Was an IRB protocol (not involving human embryos and gametes) associated with this
project submitted, modified, or renewed within the past twelve months?
YES
NO.
If no go to section III.
If yes, indicate which experiments in your approved protocol you plan to conduct, and the
results and any unexpected outcomes. Please provide the IRB Approval.
File a SCRO Amendment form for any materials not already listed on your approved SCRO
protocol.
Section III: Use of Animal Models and Status of Animal Use Approvals
1. Does your stem cell project (now or in the future) involve experiments that implant hESC
or hESC derivatives into animals?
YES
NO
If no, go to Section IV.
If yes, complete this section.
If yes, indicate which experiments in your approved protocol you conducted. Describe any
unexpected outcomes. (This information will be used by SCRO).
2. Did you implant hESC/hESC derivatives into animals within the past 12 months?
YES
NO IACUC protocol number
If yes, indicate the type(s) of human cells implanted, the type of animal models, and any
known properties of these implanted cells. Also describe any unexpected outcomes. (This
information will help the SCRO in its future assessment of ethical issues associated with
the creation of chimeras in stem cell research.)
3. Do you plan to implant hESC/hESC derivatives into animals within the next 12 months?
YES
NO
If yes, indicate which experiments in your approved you conducted. Describe your expected
results and what you plan to monitor, along with your monitoring plan:
(What will be monitored, by whom, and how frequently). Describe any unexpected
outcomes.
If yes do you have IACUC approval
YES
NO Protocol number
A continuation of SCRO approval will be provided only for those activities and time periods
for which it has all required ACC/IACUC documentation.
Revised 6-2-2015
3
Annual Continuation Form
4. Were any of these ACC/IACUC protocol(s) modified or renewed within the past 12
months?
YES modified
YES renewed
NO
If yes to modified, please attach a signed copy of the ACC/IACUC approval letter for any
modifications within the past 12 months not previously sent to the SCRO and briefly
describe the nature of any modifications.
If yes to renewed: Please provide us a signed copy of the ACC/IACUC renewal letter.
Section IV: Use of Human Embryos & Gametes in Stem Cell Research
and IRB Approvals
1. Does your stem cell project (now or in the future) involve the use of human embryos or
gametes?
YES
NO
If no, go to Section V.
2.a. Please provide the IRB protocol numbers associated with this project.
2.b. Were any of these IRB-approved protocol(s) modified or renewed within the past 12
months?
YES modified
YES renewed
NO
If yes to modifications, please attach a signed copy of the IRB approval letter for any
modifications within the past 12 months not previously sent to the SCRO and briefly
describe the nature of any modifications.
If yes to renewal, please attach a signed copy of the IRB renewal letter.
3. Do you anticipate modifying your informed consent or procurement protocols associated
with this project within the next 12 months?
YES
NO
If yes, please describe the anticipated date of implementation and nature of the
modifications. SCRO approval will not include these modifications without an appropriate
IRB approval and SCRO amendment form.
4. Use of Human Embryos
(
Not applicable)
4.a. State the number of donated embryos received within the past 12 months and the
clinical source of these donations.
Revised 6-2-2015
4
Annual Continuation Form
4.b. Describe the status of the embryos received in terms of numbers currently in storage,
numbers used within the past 12 months for research, and numbers of stem cell lines
derived. Provide information on date received, date thawed, and date of disposal or stem
cell derivation for each individual vial. Attach a separate record sheet if convenient.
4.c. Briefly describe any unexpected results of this research.
5. Use of Human Gametes
(
Not applicable)
5.a. State the number of donated oocytes or quantity of donated sperm received within the
past 12 months and the clinical source of these donations.
5.b. Describe the status of the gametes received in terms of numbers currently in storage,
numbers used within the past 12 months for research, numbers of embryos generated and
number of stem cell lines derived. Provide information on date received, date thawed or
used, and date of disposal or stem cell derivation for the materials. Attach a separate
record sheet if convenient.
5.c. Briefly describe any unexpected results of this research.
Section V: Investigator Certification
I certify that this protocol is being conducted in adherence to the University of Connecticut
policies for the conduct of hESC research and in compliance with all relevant State of
Connecticut and federal laws and regulations.
Principal Investigator’s Name (print)
Date
Principal Investigator’s Signature (stamped/electronic signatures are not accepted)
Date
ADDITIONAL CELL LINES
Cells were obtained from the UConn-Wesleyan Core
Cell Type
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Qty
Cell Type
5
Qty
Annual Continuation Form
Cells were obtained from another source
Cell Type
Qty
Investigator
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6
Source (University)