New ESCRO Notification Form- hES and/or hPS Cells

This is the Notification and Request for Review by the Tri-SCI Embryonic Stem Cell Research Oversight Committee (ESCRO) of Proposed Research Involving Human Embryonic Stem (hES) Cells and/or Human Pluripotent Stem (hPS) Cells. 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 D3. How hES/hPS cells used (if applicable)

I D4. How info gained will advance understanding

I.E. Personnel and Training

List the Name, Role/Title, Institution, Department and date on which the mandatory training module "hESC and Covered hPS Research Operating Procedures" located at: https://www.trisci.org/exam/index.php?id=dbc43008aa749214890b8b1b2efa1735&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 more than 4 personnel will be involved in the research, 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.E. 1a. Name

I.E 1b. Role on Project*

I.E.1c. PI Department*

I.E.1d. Institution*

Select

I.E.1e. PI Research Operating Procedures Completion Date*

I.E.2a. Name

I.E.2b. Role on Project

I.E.2c. Department

I.E.2d. Institution

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I.E.2e. Research Operating Procedures Completion Date

I.E.3a. Name

I.E.3b. Role on Project

I.E.3c. Department

I.E.3d. Institution

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I.E.3e. Research Operation Procedures Completion Date

I.E.4a. Name

I.E.4b. Role on Project

I.E.4c. Institution

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I.E.4d. Department

I.E.4e. Training Completion Date

II.A. Proposed Use of Existing hES Cells

II.A1. Do you propose to use existing hES cells?

If No, skip to question IIIA.

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II.B. Do you propose to work with a non-Registry line that has not already been deemed acceptable for use in research by the ESCRO?

The Tri-SCI hES Cell Inventory is available at http://www.trisci.org/inventory.pdf

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If your answer is Yes: 1. Answer II B1-B5 below. 2. Complete the excel template, available on the Tri-SCI ESCRO website: http://www.trisci.org/ and attach the list of the non-registry cell lines under "File Attachments."

II.B1. Was written consent from all gamete donors secured?

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II.B2. Was written consent from the gamete donors obtained (or reconfirmed) at the time of donation?

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II.B3. Was written consent from all embryos donors secured?

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II.B4. Was written consent from the embryo donors obtained (or reconfirmed) at the time of donation?

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II.B5. Was cash or payments-in-kind provided to oocyte, sperm, embryo or somatic cell donors?

Select

If you answered YES to any question in Section II.B., please upload documentation and/or information under "File Attachments" located at the bottom of this form, describing the process for obtaining the cell lines in this application. If applicable, attach a copy of the consent form TEMPLATE (do not include any patient identifiable information) using the file attachment box at the bottom of this form. If you answered NO to questions in Section II.B., the proposed hES cell line does not meet minimum criteria established by the Tri-SCI ESCRO for approving use of the line for research. If you are not sure how to respond to any questions in Section II.B., please coordinate with the administrative contact at your institution to obtain the relevant information about the proposed hES cell line.

III.A. Do you propose to conduct research involving human embryos for purposes other than derivation of hES cells?

Select or enter value

If Yes, complete the separate application for "Research Involving Human Embryos."

III.B. Do you propose to conduct research designed or expected to generate human gametes?

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If you responded "Yes" to ANY of the questions in Section III, complete the Notification Form labeled - "Human Gametes."

IV. Do you propose to derive new hES cells?

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If Yes, complete Section IV below.

IV.A. Provide the scientific rationale for the need to generate new hES cell lines (as opposed to using existing lines):

IV.B1. Provide an estimate of the number of oocytes and/or embryos that will be used for the derivation.

IV.B2. Describe the basis for your estimate:

Provenance of Human Embryos Used to Derive new hESC

IV.C. At what stage of development are the human embryos with which you propose to initiate research?

IV.D. If you propose to culture human embryos past this initial stage of development, to what stage of development do you propose to culture human embryos?

IV.E. Do you propose to carry out genetic manipulations of human embryos of human gametes prior to fertilization?

Select or enter value

IV.F. Will the embryos or the gametes used to create the embryos be identifiable according to OHRP regulations?

For assistance in determining whether the materials are considered identifiable (for questions IV D1 and IV D2), see: http://www.grants.nih.gov/grants/policy/hs/PrivateInfoOrBioSpecimensDecisionChart.pdf http://www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf

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IV.G. If the proposed derivation is to proceed from donated embryos, were the embryos generated:

IV.G1. To treat infertility?

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IV. G2. For research purposes?

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IV. G3. For other purposes?

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IV. G4. If the embryos were generated for research or other purposes, please provide background information on the generation process:

V. Proposed Use of hPS (iPS Cells and other non-embryonic hPS) Cells

This section solicits information specifically about proposed use of hPS, not hES cells, to determine whether review of the proposed use of hPS cells is required. Note that proposed use of hES cells always requires review.

Does the proposed research include the use of hPS (iPS Cells and other non-embryonic hPS) Cells?

Select

If Yes, please complete questions V.A. - V.D.

V.A. Please list and identify the lines the PI proposes to use in an excel table.

Complete the excel template, available under the "Forms" tab on the Tri-SCI ESCRO website: http://www.trisci.org/ and attach the list of cell lines under "File Attachments."

V.B. Do you propose to transplant hPS cells into laboratory animals?

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V.B1. If Yes, at what stage of development?

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V.C. Do you propose to use hPS cells in in vitro experiments designed or expected to yield gametes (oocytes or sperm)?

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V.D. Do you propose to conduct in vitro research involving hPS cells for which the funding agency requires ESCRO review?

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V. D1. For each cell line listed:

V.D1a. Was written consent from all cell/tissue donors secured?

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V.D1b. Was cash or payment-in-kind provided to donors?

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If you answered Yes to any of the three questions above, please provide documentation supporting the statement or information describing the process. Attach this information under "File Attachments" located at the bottom of this form. If you answered No to either question 1 or 2 above, the proposed hPS cell line does not meet minimum criteria established by the Tri-SCI ESCRO for approving use of the line for research. If you answered “Unknown” to any of the three questions above, please coordinate with the administrative contact at your institution to obtain the relevant information about the proposed hPS cell line.

Scope of Proposed Research

VI.A1. Does the scope of the proposed research involve Basic Research?

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VI.A2. Does the scope of the proposed research involve Pre-clinical research?

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VI.A3. Does the scope of proposed research involve Clinical research?

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

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

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VI.B1b. Please provide additional details for the types of cells indicated in question VI.B1a.

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

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VI.B3. Into what species will you transplant human cells?

VI.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:

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

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VI.B5(a). If "Other Systems" please describe:

VI.B6. Do you anticipate that the human cells will contribute to the germ line of the animal?

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

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

VI.B9. At what stage/age the animals will 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):

VII. Other Required Reviews

VII.A. Institutional Review Board (IRB) review required?

Mark all that apply.

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VII.A1. IRB Protocol Number:

VII.A2. IRB Approval Date:

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

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VII.B1. IACUC Protocol Number:

VII.B2. IACUC Approval Date:

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

Select

VII.C1. IBC Registration or Protocol Number:

VII.C2. IBC Approval Date:

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

Select

VII.D1. If Yes, RSC Protocol Number

VII.D2. RSC Approval Date

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

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. If applicable - provenance documents (e.g., consent forms). 5. If you are using existing hES or hPS Cell Lines, complete the excel template (available on the Tri-SCI ESCRO website: http://www.trisci.org/) and attach the completed version here. 6. REQUIRED: Please attach a summary of the research in laymen's terms (free of acronyms) for the reviewers with non-scientific degrees 7.Attach 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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