New ESCRO Notification Form- Human Gametes

This is the Notification and Request for Review by the Tri-SCI Embryonic Stem Cell Research Oversight Committee (ESCRO) of Proposed Research Designed or Expected to Generate Human Gametes. Carefully complete this form so that it accurately reflects your proposed research plan. PLEASE BE ADVISED: The system does NOT save your progress unless the application is submitted. If you wish to save your application, but not submit it for review, please select: “This submission is NOT complete” in question VIII. Incomplete applications will be returned for revision. If you have any questions, please contact the ESCRO Administrator at your institution.

I.A. Project Title*

I.B1. Principal Investigator (PI) Name*

I.B2. Institution*

Select

I.C. Funding Source for proposed research*

Please list any awarded grants (must be officially awarded) or internal funding sources that will be supporting this research.

I.D. Narrative Description

Please respond to the following questions for the proposed research in LAY terms (e.g., in a way that would be useful for a public announcement or public relations purposes). Avoid jargon, acronyms, and technical terms, or using an abstract from your grant application. This description will be used by the ESCRO Committee, which includes non-scientists, in its evaluation of the ethical appropriateness of your proposal. If lay language is not used, please note that this form will be returned to the PI for revision.

I.D1. What is the goal of the proposed research? (300 word limit)*

I.D2. Please provide a general background, method and context for this study:*

I.E. Personnel and Training

List the Name, Role/Title, Institution, Department and date on which the mandatory training module: "Tri-Institutional Research Operating Procedures for Gamete Generating Research": https://www.trisci.org/exam/index.php?id=6997118651f8c54f7ef71fb824a12956&start=1 for each person (starting with the PI) who will conduct work on the proposed research. For Fellowships, the Fellow – not the mentor – should be listed as PI. If the proposed work involves more than 4 personnel, please complete the excel template, available under the "Forms" tab on the Tri-SCI ESCRO website: http://www.trisci.org/ and attach the completed version under "File Attachments."

I.E1a. PI Name*

I. E1b. Role on Project*

I.E1c. PI Department*

I.E1d. Institution*

Select

I.E1e. "Tri-Institutional Research Operating Procedures for Gamete Generating Research" Training Completion Date*

I.E2a. Name

I.E.2b. Role on Project

I.E2c. Department

I.E2d. Institution

Select

I.E2e. "Tri-Institutional Research Operating Procedures for Gamete Generating Research" Training Completion Date

I.E3a. Name

I.E3b. Role on Project

E.3c. Department

I.E3d. Institution

Select

I.E3e. "Tri-Institutional Research Operating Procedures for Gamete Generating Research" Training Completion Date

I.E4a. Name

I.E4b. Role on Project

I.E4c. Institution

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I.E4d. Department

I.E4e. "Tri-Institutional Research Operating Procedures for Gamete Generating Research" Training Completion Date

II. Proposed use and/or Generation of Human Gametes

II.A. Do you propose to conduct research designed or expected to generate human gametes?

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II.B. Specify if gametes will be generate from:

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II.B1. If you answered "Other" to the question above, please provide additional details here:

II.C. Will the cells used to generate the human gametes be identifiable or de-identified according to OHRP regulations?

For assistance in determining whether the materials are considered identifiable or de-identified, please review: http://www.grants.nih.gov/grants/policy/hs/PrivateInfoOrBioSpecimensDecisionChart.pdf

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II.D. Did the donor(s) of the cells consent to the proposed research use to generate human gametes?

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II.D1. If Yes, do you have a blank copy of the consent form reflecting such consent?

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If you answered Yes, please provide a copy of the consent form template (do not include any protected health information) using the file attachment box at the bottom of this form.

II.D2. If No, do you have documentation that reflects that consent to use the cells for the proposed research was secured?

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If you answered Yes, please provide a copy of the documentation. You may upload as an attachment at the bottom of this form.

II.E. Are any of the listed PIs or collaborators on the research involved in obtaining and providing the cells that will be used to generate human gametes?

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III. Experimental Procedures

III.A. Does the scope involve basic research?

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III.B. Does the scope involve pre-clinical research?

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III.C. Does the scope of proposed research involve clinical research?

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IV.B1. Do you propose to transplant human cells into laboratory animals?

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IV.B1a. Which type(s) of human cells do you propose to transplant?

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IV.B2. At what stage of development of the laboratory animal:

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IV.B3. Into what species will the cells be transplanted?

IV B4. If human cells are to be introduced at embryonic or fetal states of development, what scientific or temporal limitations will be placed on embryonic or fetal development:

IV.B5. Whether you anticipate that a possible effect will be migration/function of the human cells in:

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IV.B5a. If "Other Systems" please describe:

IV.B6. Do you anticipate the human cells to contribute to the germ line of the animal?

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IV.B7. Will animals into which human cells have been introduced be bred to produce offspring?

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IV.B8. If breeding of animals into which human cells have been introduced is not to occur, what steps will be taken to prevent breeding:

IV.B9. At what stage/age will the animals be sacrificed (if there is a range of stages/ages, state the range but also state the maximum age the animal will be allowed to achieve prior to sacrifice):

V.A. Other Required Reviews: Institutional Review Board (IRB) review required?

Mark all that apply.

Select

V.A1. IRB Protocol Number:

V.A2. IRB Approval Date:

V.B. Institutional Animal Care & Use Committee (IACUC) review required?

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V.B1. IACUC Protocol Number:

V.B2. IACUC Approval Date:

V.C. Institutional Biosafety Committee (IBC) review required?

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V.C1. IBC Registration or Protocol Number:

V.C2. IBC Approval Date:

V.D. Radiation Safety Committee (RSC) review required?

Select

V.D1. If Yes, RSC Protocol Number:

V.D2. RSC Approval Date:

VI. Financial Conflict of Interest (COI) Certification- Current Filing Date

VII. File Attachments*

The following documents must be attached to this submission: 1. The curriculum vitae (CV) for the PI and Co-PI. 2. The research/grant proposal (including Specific Aims/Rationale/References) as submitted to the funding agency. 3. The scientific critique from the funding agency (the "pink sheet"), if available. 4. Attach any supplemental documents pertaining to this form. Examples include provenance documents (e.g., consent forms) or any other relevant information.

Drag and drop files here or

VIII. ESCRO Submission*

This submission is complete.

This submission is NOT complete (A link for this application will be returned to you)

IX. Principal Investigator Certification*

I certify that I will abide by the Tri-Institutional Research Operating Procedures for ESCRO Reviewed Research, and will comply with relevant institutional policies and restrictions related to the prohibition of use of federal funds for work involving non-Registry hES cells and their derivatives. I certify that the information provided above is true and correct to the best of my knowledge and accurately represents the proposed research plan. I understand that the Tri-SCI ESCRO’s decision with respect to my application is based on the information provided in this form. If the proposed work is approved by the ESCRO Committee, I agree to inform the Tri-SCI ESCRO in writing of any material changes or modifications to the information provided above as soon as possible, and in any event, no later than 30 days after I become aware of the need for such change or modification. I also agree to submit an Annual Progress Report to the ESCRO Committee on or before the anniversary date of the ESCRO approval. PLEASE TYPE YOUR NAME BELOW TO CERTIFY:

IX.A. Principal Investigator Certification Date*

Send me a copy of my responses

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