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ESCRO Application

Submission Date

M-D-Y

What would you like to do? (Select One)

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Submit an amendment to an existing application.

Submit a new ESCRO application.

ESCRO Record #

Change in PI?

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New PI Info:

New PI First Name:
New PI Last Name
Email:
Reason for Change in PI:

Study Title:

Department

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Current PI Info:

First Name:		Last Name
Email:		Department:

Study Title:
Faculty Position:

ESCRO Changes

Changes to Abstract (check all that apply)
Description of changes

NEW ESCRO APPLICATION

Primary PI Contact Info:

PI First Name:		PI Last Name:
Email:		Phone:

Study Title:
Faculty Position:
Department:

Secondary Contact Person
(If different from PI)

First Name		Last Name
Department		Staff Position
Email		Phone

Mailing Address

Department

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Department

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Proposed Study - Abstract

Describe the following in detail:

Goals of the research
Brief description of the approach
Rationale for using human embryos, hESC or hiPSCs, complex embryo models, or brain or gonadal organoids
Significance of the research for human health

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Intended Research

*Check with ESCRO if your intended research is not captured in the listed categories. (If you are submitting an amendment, select all that apply to the changes.)

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Studies involving in-vitro passage or differentiation of hESC lines. Complete Appendix A

Studies that involve the destruction of human embryos in your lab or in another lab that is sharing cells or embryos with your lab for analysis. Complete Appendix B

Transplantation of hESCs, hiPSCs, or cells derived from either, into non-human research animals. Complete Appendix C

Generation of embryos, complex embryo models (e.g., blastoids, gastruloids, assembloids), brain organoids, or gametes from either hESCs or hiPSCs. Complete Appendix D

Appendix A

Studies involving in vitro passage or differentiation of hESC lines

Please send an email to "ESCRO@uw.edu" with the following information: Name(s) of the cell line(s) and source information (name of investigator and institution from which you received the cell lines). If you have derived the cell line(s) directly from specimens donated by a human donor, please write "donor" and the IRB protocol number.*

Name of Cell Lines

Source of Cell Lines

NIH hESC Registry #

*For hESC research that is not currently eligible for federal funding:

a). Append the approved consent-of-origin form if using hESCs not listed on the NIH Human Embryonic Stem Cell Registry. If the consent form is not available, please explain.

b). Complete the Financial Supplement Form. (Email ESCRO@uw.edu to request the form)

(If your research is ineligible for federal funding - the Financial Supplement Form must be completed). See GIM 36

Appendix B

Studies involving destruction of human embroys

Describe:

Source and number of embryos that will be used.
Significant aspects of the methods, including how cells will be derived (if applicable).
Process for disposal of human tissues.

2. Scientific justification, including:

Reason for destroying embros.
Where applicable, rationamle for using particualr genotypes.

Applicants must:

a). Append the approved original donor consent-of-origin form and consent for use of embryos for research.

b). Complete the Financial Supplement Form. (Email ESCRO@uw.edu to request the form)

***Please note: IRB approval is required***

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Appendix C

Transplantation of hESCs, hiPSCs, or cells derived from either, into non-human research animals.

Name(s) of the cell line(s) and source information (name of investigator and institution from which you received the cell lines).

*For hESC research that is not currently eligible for federal funding and if applicable, for hIPSCs you are proposing to use:

a). Append the approved consent-of-origin form if using hESCs not listed on the NIH Human Embryonic Stem Cell Registry as well as for hIPSCs you are proposing to use. If the consent form is not available, please explain.

b). Complete the Financial Supplement Form. (Email ESCRO@uw.edu to request the form)

***Please note: IACUC approval is required.

Have you have derived the cell line(s) directly from specimens donated by a human donor?

Yes

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If you have derived the cell line(s) directly from specimens donated by a human donor, please provide the IRB protocol number.

Species of research animal(s) used as recipient

Specific aims of research, brief description of methods, and endpoints of transplant studies.

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Scientific justification for transplanting hESCs or hiPSCs into research animals.

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Address any ethical issues that these experiments might raise.

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Appendix D

Generation of embryos, complex embryo models (e.g., blastoids, gastruloids, assembloids), brain organoids, or gametes from either hESCs or hiPSCs.

Please describe:

1. Overall research goals.

2. Source of hESCs or hiPSCs that will be used.*

3. Specific aims and brief description of methods.

4. Scientific justification (for example, if generating an organoid model, briefly state what will be learned from an organoid model compared to a standard two-dimensional cell culture model). Explain any ways you will control or limit culture of embryos or gametes (i.e., prevention of allowing development to extend past legal or ethical limits; prevention of fertilization occurring between sperm and eggs).

5. Address any ethical issues that these experiments might raise.

*For hESC research that is not currently eligible for federal funding and if applicable, for hIPSCs you are proposing to use:

a). Append the approved consent-of-origin form if using hESCs not listed on the NIH Human Embryonic Stem Cell Registry as well as for hIPSCs you are proposing to use. If the consent form is not available, please explain.

b). Complete the Financial Supplement Form. (Email ESCRO@uw.edu to request the form)

Please note: Other Oversight Office approval, such as IRB, IACUC, may be required.

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Which other office(s) who may provide oversight into your research?

Environmental Health & Safety (EH&S)

Institutional Animal Care and Use Committee (IACUC)

Institutional Review Board (IRB)

CoMotion

Financial Conflict of Interest (FCOI)

EH&S - Biological Use Authorization #

IACUC - Biological Use Authorization #

IRB - Biological Use Authorization #

Approval Date

M-D-Y

Approval Date

M-D-Y

Approval Date

M-D-Y

CoMotion - Material Transfer Agreement

FCOI - Material Transfer Agreement

Approval Date

M-D-Y

Approval Date

M-D-Y

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)?

**If Yes, ESCRO will not approve the protocol until the relevant conflict- of- interest approvals have occured.

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Yes No

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Investigator Certification

I, the Principal Investigator:

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am responsible for assuring that all personnel (researchers and staff) involved with this proposal understand and comply with UW Policy GIM 36.

will participate in an annual update describing any significant changes in specific aims for this research.

will adhere to all University Oversight Office requirements that are applicable to this proposal.

certify that I have answered all questions on this document and its attachments truthfully.

Additional Documents (Please upload any attachments you would like to share with the ESCRO team)

Upload file

Principal Investigator Signature

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Today's Date

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M-D-Y

This application requires review by the following:

Administrative Review Committee Review

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This ESCRO application has been approved by the Chair.

Yes No

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Chair Signature

Add signature

ESCRO Approval Date

M-D-Y

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ESCRO Application

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