ESCRO Office use only:
ESCRO record #:
ESCRO received:
____/___/____
Embryonic Stem Cell Research Oversight ESCRO
University of Washington
University of Washington, Office of Research, Gerberding Hall G80, Box 351202
Seattle, WA 98195-1202 Phone: (206) 685-7010 Fax: (206) 685-9210 email:
escro@u.washington.edu
New Application Form
(General application FAQs)
(General questions about appendices
General Instructions: For instructions on how to submit this form, please go to How to submit
ESCRO forms
Please note: Your proposal may require other institutional compliance reviews. The ESCRO office
will work with applicable Compliance Offices (e.g., EH&S, IACUC, HSD, OTT) to facilitate
concurrent reviews and will notify these Offices promptly of ESCRO approval. Please note that the
main responsibility for obtaining required compliance approvals rests on the Principal Investigator.
I. Investigator Information
Submission Date
of Application:
Study Title:
Name
Email:
Phone
Fax
Name
Email:
Phone
Fax
Principal
Investigator:
Faculty position:
Department:
*Contact Person:
Staff position:
Department:
* Contact Person is required if different than PI.
*Mailing Address:
*This address is the location where you would like signed materials delivered.
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1.




II. Project (FAQs)
Abstract: Describe in 250 words or less, in layman’s terms the following:
the goals of the research,
rationale for using hESC lines and/or iHPSCs (or other hESC-like lines),
brief description of the approach, and
benefits to society.
2. Please send an electronic copy of the scientific portion of the grant and/or gift application(s)
supporting this hESC proposal (if available*) to escro@u.washington.edu.
Grant/gift application attached: Please list the specific aims and page numbers that
describe the proposed hESC research (e.g. specific aim 3, pages 33-36):
If no grant or gift application is available, please provide a brief summary of how this research is
being supported. Include in your explanation whether this support money entails any restrictions as
to its use (e.g., gift from Mr. and Mrs. O. Smith; money must be used to study non-federal hESC
lines).
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III. Source of Cells (FAQs)
1. Check all that apply and provide additional information below.
human embryonic stem cell (hESC) lines listed on the NIH Human Embryonic Stem Cell
Registry currently eligible for federal funding.
hESC line(s) derived from human embryos/oocytes, including SCNT. Please complete the
“Financial Supplement for hESC research that is not currently eligible for federal funding.”
iHPSCs (or other hESC-like line(s)) derived exclusively from somatic cells (for example,
using induced pluripotent cells).
2. Name(s) of the cell line(s) and source information. Source information consists of the
collaborator from whom you received the cell lines. Please include the collaborator’s name and
institution.
Name of cell line(s)
Source Information
Currently listed on NIH hESC
Registry (i.e. Yes or No)
3. Location(s) of storage and research (include building number, room and lab numbers, and full
physical address of any off-site locations): If using ineligible hESC lines, please also complete
the “Financial Supplement for hESC research that is not currently eligible for federal
funding.”
Building Name
Room & Lab
Number(s)
Room Function (e.g. cell
culture, freezer farm,
microscopy, wet bench)
4. Unless your research is restricted to use of hESC lines listed on the NIH Human Embryonic Stem
Cell Registry, documentation of provenance is likely required. Please append IRB approval and
approved consent-of-origin form, or describe why provenance is not available.
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IV. Intended Research (FAQs)
Check all that apply and provide additional information where requested.
Studies involving the ex vivo passage or terminal differentiation of hESC line(s).
Generation of hESCs, iHPSCs (or other hESC-like lines) using oocytes, embryos, or fetal
tissue. Complete Appendix A.
Transplantation of hESC line(s), iHPSCs (or other hESC-like lines), or the differentiated cells
from either, into research animals. Complete Appendix B.
Transplantation of hESC line(s), iHPSCs (or other hESC-like lines), or the differentiated cells
from either, into humans. Complete Appendix C.
Generation of embryos from hESC, iHPSCs (or other hESC-like lines). Complete Appendix
D.
V. Additional Oversight (FAQs)
Check all that apply to the use of hESC described in this ESCRO application. Provide additional
information where requested.
Other Committees/Offices
(Check all that apply)
Oversight Office # assigned
to protocol , if available
(SC = significant change to
existing oversight file)
Approval date
(office use
only)
___/___/___
Environmental Health & Safety #
(EH&S)
new
SC
Institutional Animal Care and Use #
Committee (IACUC)
new
SC
___/___/___
___/___/___
*Institutional Review Board
#
new
SC
Office of Technology Transfer
#
new
SC
___/___/___
*IRB approval is required for donation of human gametes, embryos, and human biological
materials for which the donor can be identified.
**Please report whether you have submitted a new application to the Oversight Office or
submitted a significant change or amendment to an existing file residing in the Oversight
Office.
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VI. Conflict of Interest
Does the Principal Investigator, any co-investigator, or research coordinator involved with this study
(or in aggregate with his/her spouse, dependents, or member of his/her household) have a financial
relationship with the source of funding that requires filing a University of Washington Significant
Financial Interest Disclosure (SFID) Form (see GIM 10 for more information on SFID) with the
Office of Sponsored Programs (OSP) or the Office of Research (OR).
*Yes
No
* If Yes, ESCRO will not approve the protocol until the relevant conflict-of-interest approvals have
occurred.
VII. Investigator Certification (FAQs)
The following are the minimum responsibilities of Principal Investigators as stated in this formal
agreement with the University of Washington’s ESCRO Committee. Check off each item to indicate
that you have carefully read and understand your responsibilities.
I, the Principal Investigator, certify that I have answered all questions on this document and its
attachments truthfully.
I, the Principal Investigator, am responsible for assuring that all personnel (researchers and staff)
involved with this human embryonic stem cell research proposal complies with governing regulations
as described in GIM-36.
I, the Principal Investigator, certify that by signing this form, I certify that I will not spend any
federal dollars to support research ineligible for federal funding..
I, the Principal Investigator, will participate in an annual survey documenting the hESC lines in my
possession.
I, the Principal Investigator, agree that I will adhere to all University Oversight Office requirements
that are applicable to my proposal.
I, the Principal Investigator, will ensure that associated investigators do not perform experiments
for human reproductive cloning.
I, the Principal Investigator, will ensure that no person working on this project will allow an animal
into which hESCs have been introduced to breed without prior ESCRO approval.
I, the Principal Investigator, will ensure that no investigators will allow any human embryo to
develop past day 12 or the point of primitive streak development, whichever comes first.
I, the Principal Investigator, have reviewed and understand UW Policy GIM 36 including the
prohibited research activities as outlined in section V.C. I verify that I and all staff who are performing
work related to this hESC proposal will follow this policy.
VIII. Principal Investigator Signature
Date:
Print Name:
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Signature:
I am responsible for ensuring this research complies with the policies listed in the
Investigator Certification and any other relevant guidelines from the University of
Washington and Federal and State agencies.
Date:
Signature:
Date:
Signature:
IX. Department Head approval required
Print Name:
X. Dean of School/College approval required (FAQs)
Print Name:
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Embryonic Stem Cell Research Oversight ESCRO
University of Washington
ESCRO Office Use Only - New application
ESCRO record #: ______________
ESCRO review/approval type:
Full
Expedited
ESCRO agenda date _____/_____/_____
_______________________________________
ESCRO Committee Chair signature or designee
ESCRO approval from date:
Copy sent to:
IACUC
EH&S
HSD
Date sent: ___/____/____
ESCRO staff initials: ________
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_____/_____/_____
ESCRO Chair release date
approval to date:
C4C
UW Medicine Compliance
Appendix A. Research involving the generation of hESC line(s), iHPSCs (or other hESC-like
lines) using oocytes, embryonic, or fetal tissues. (FAQs)
Please provide the following information:
1. Origin of starting cells:
2. Brief description of process including:

number of embryos that will be destroyed;

method for evaluating quality of derived lines;

process for disposal of human tissues;

other significant aspects of the methods:
3. Scientific justification, including:

logic for using the specific method or for developing a new method;

where applicable, rationale for using particular genotypes:
Please note: IRB approval is required.
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Appendix B. Research involving the transplantation of hESC line(s), iHPSCs (or other hESClike lines), or the progeny from either, into research animals. (FAQs)
Please provide the following information:
1. Origin of starting cells:
2. Brief description of process, including:

information about the number of transplanted cells;

the length of time after transplantation of cells that host animals will be kept alive;

any use of live cells recovered from host animal after transplantation (e.g., transplantation
into another animals or culture);

where applicable, the method to prevent breeding of animals, unless a specific exemption
has been granted;

other significant aspects of the methods:
3. Scientific justification, including:

logic for using a specific method or for developing a new method;

when using hESCs, the rationale for using hESCs;

the rationale for choosing specific research animals:
Please note: IACUC approval is required.
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Appendix C. Research involving the transplantation of hESC line(s), iHPSCs (or other hESClike lines), or the progeny from either, into humans. (FAQs)
Please provide the following information:
1. Origin of starting cells:
2. Brief description of process, including:

methods for the transplantation;

methods for tracking the transplanted cells;

other significant aspects of the methods:
3. Scientific justification, including:

logic for using a specific method or for developing a new method;

when using embryos, the rationale for using human embryos;

the rationale for choosing specific human research subjects:
Please note:

IRB approval is required.

Provide Investigator Brochure, if available.
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Appendix D. Research involving the generation of embryos from hESC or iHPSCs (or other
hESC-like lines). (FAQ)
Please provide the following information:
1. Origin of starting cells:
2. Brief description of process, including:

methods for evaluating the quality of embryos;

methods for destroying unwanted embryos;

methods for terminating development by day 12 or by primitive-streak formation, whichever
comes first);

other significant aspects of the methods:
3. Scientific justification including the rationale for creating a human embryo for research purposes:
Please note: IRB approval may be required.
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