New ESCRO Notification Form - Human Embryos

This is the Notification and Request for Review by the Tri-SCI Embryonic Stem Cell Research Oversight Committee (ESCRO) of Proposed Research Involving Human Embryos for purposes other than derivation of hES cells. If you propose to use human embryos only to derive hES, please complete the ESCRO Notification Form for hES and/or 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 X. 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 Research Involving Human Embryos": https://www.trisci.org/exam/index.php?id=c85f8300801654cb00669210c2e25ece&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.E.1a. PI Name*

I.E.1b. Role on Project*

I.E.1c. PI Department*

I.E.1d. Institution*

Select

I.E.1e. "Tri-Institutional Research Operating Procedures for Research Involving Human Embryos" Training Completion Date*

I.E.2a. Name

I.E.2b. Role on Project

I.E.2c. Department

I.E.2d. Institution

Select

I.E.2e. "Tri-Institutional Research Operating Procedures for Research Involving Human Embryos" Training Completion Date

I.E.3a. Name

I.E.3b. Role on Project

I.E.3c. Department

I.E.3d. Institution

Select

I.E.3e. "Tri-Institutional Research Operating Procedures for Research Involving Human Embryos" Training Completion Date

I.E.4a. Name

I.E.4b. Role on Project

I.E.4c. Institution

Select or enter value

I.E.4d. Department

I.E.4e. "Tri-Institutional Research Operating Procedures for Research Involving Human Embryos" Training Completion Date

II. Proposed Use of Human Embryos

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

II.B. 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?

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

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II.D1. Will the embryos or the gametes used to create the embryos be identifiable or de-identified according to OHRP regulations?

For assistance in determining whether the materials are considered identifiable, please review: http://www.grants.nih.gov/grants/policy/hs/PrivateInfoOrBioSpecimensDecisionChart.pdf http://www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf

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III.E. If the proposed research is to involve the use of donated embryos, were the embryos generated:

III.E1. To treat infertility?

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III.E2. For research purposes?

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III.E3. For other purposes?

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III.E4. If the embryos were generated for research or other purposes, please provide background information on the generation process:

III.F. If the proposed research is to involve the use of embryos (either IVF or SCNT) generated from donated gametes:

III.F1. Were the gametes collected to treat infertility?

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III.F2. Were the gametes collected for research purposes?

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III.F3. Were the gametes collected for other purposes?

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III.F4. If the gametes were collected for purposes other than the treatment of infertility, please provide background information on the collection process:

III.G. If the gamete donor(s) and the embryo donor(s) are not the same individuals, did the gamete donor(s) consent to the donation of the resulting embryo(s) for the proposed research use?

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III.H. If the proposed work involves the use of donated gametes or embryos generated for or during fertility treatment, please describe at what stage in the donor(s)' clinical treatment, the consent for donation is occurring (e.g., post-treatment post-PGD testing, other):

If your answer is "other," please explain and define.

III.I1. Will cash or payments-in-kind be provided or have they been provided to oocyte, sperm, embryo or somatic cell donors?

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III.I2. If Yes, please describe the payments and justification for same:

III.J. Provide the name of the institution where the embryo(s) was generated and the name of the institution that provided the embryo(s):

III.K. If applicable, provide the name of the institution where you obtained or will obtain oocytes for use in generating SCNT embryos or generating IVF embryos specifically for research purposes:

III.L1. Are any individuals involved in the generation or provision of the embryos or in obtaining and providing donated gametes also listed as PIs or collaborators on the research?

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If No, skip to question II.1.b.

III.L1a. If Yes, do you have a blank copy of the approved consent form that was used to document that consent to use any gametes and/or the embryos for research was secured and that consent was secured from all gamete and/or embryo donors?

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If you answered Yes, please provide 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.

III.L1b. If No, do you have documentation that reflects that consent to use any gametes and/or the embryos for research was secured and that consent was secured from all gamete and embryo donors?

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

III.M1. Are any of the individuals who will conduct work on the proposed research involved in providing clinical care to any of the gamete or embryo donors?

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III.M1a. If Yes, describe what steps will be/were taken to ensure that the decision to donate gametes and/or embryos will be/was free of the influence of individuals who propose to use the embryos in research?

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

[If you responded Yes, complete IV. B1-B9]

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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 animal:

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IV.B3. What species will you use?

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

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

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

IV.B6. Do you anticipated that the human cells will 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?

Select

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. Upload any 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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