Tri-Institutional ESCRO Amendment Form

This is the Tri-Institutional Amendment Form for Research Involving HUMAN EMBRYOS, hES CELLS, COVERED hPS CELLS and/or HUMAN GAMETE GENERATION. * You must complete this form in one sitting. Be sure to complete the checkbox at the end of the form with either "The submission is complete" or "Submission is NOT complete - please return the form to me." You may "Submit" the form at any point and the ESCRO Administrative staff will return the form to you for completion and/or revision. * Mark the checkbox at the end of the form: "Send me a copy of my responses" for your records. This form may be used to seek approval for: • Alternative methods to derive hES cells, to generate hPS cells and/or generate human gametes. • Use of hES cells in a protocol that previously did not involve use of hES cells. • Generation of/use of hPS cells in a protocol that previously did not involve generation or use of hPS cells. • Add in vivo methods to a protocol that previously did not involve in vivo methods. • Addition of specific hES and/or hPS cell lines to a protocol for which there is already approval for use of other hES and/or hPS cells. This form MAY NOT be used to seek approval for: • Derivation of new hES cells if the original protocol did not include approval for derivation of new hES cells. • Research designed or expected to generate human gametes if the original protocol did not include approval for such. • Research involving human embryos for purposes other than derivation of hES cells if the original protocol did not include approval for such.

Today's Date*

Protocol Title*

Principal Investigator (PI)*

Protocol Approval Date*

Provide the original approval date (i.e., initial approval date) of the protocol.

Nature of the Amendment*

(Select Applicable):

Alternate methods to derive hES cells, generate hPS cells, or generate human gametes (Complete Sections I, II, V, VI);

Use of hES cells on a protocol that previously did not include hES cell research (Complete Sections I, II, III, V, VI);

Generation/Use of hPS cells on a protocol that previously did not include hPS cell research (Complete Sections I, II, III, V, VI);

Add in vivo methods to a protocol that previously only contained in vitro methods (Complete Sections I, II, IV, V, VI);

Addition of specific hES and/or hPS cell lines to a protocol for which there is already approval for use of other hES and/or hPS cells;

Continuation of the same research protocol under the same terms with use of funds from an additional source/agency.

I. Narrative Description:

Describe the proposed modification to the scope, methods and/or materials for which you are seeking approval 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.

II. Justification for amendment:

Describe the scientific need for the proposed amendment and how it will advance the overall aims of the approved protocol. Please use LAY terms.

III. Cell lines to be added:

Does this amendment request the addition of hES or hPS cell lines not included on the originally approved ESCRO protocol, complete this table and the following questions regarding cell line provenance? If this amendment does not request any additional cell lines, skip to Section IV. *[OPTION for ESCRO ADMIN discussion: If answer is YES, attach a table rather than entering cell line information into Smartsheet]

Select

III A. Cell line ID/code

IIIB. Is this an hES cell?

Select

IIIC. Is this an hPS cell?

Select

III D. Is this listed on the NIH Registry?

The NIH Registry is available at: https://grants.nih.gov/stem_cells/registry/current.htm

Select

III E. Is it listed in the Tri-SCI Inventory?

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

Select

III F1. Was written consent from all gamete donors secured?

(For questions III F1-III F5): For each non-Registry hES cell line listed below that has not already been deemed acceptable for use in research by the ESCRO (see the Tri-I hES Cell Inventory available at http://www.trisci.org/inventory.pdf)

Select

III F2. Was written consent from the gamete donors obtained (or reconfirmed) at the time of donation?

Select

III F3. Was written consent from all embryo donors secured?

Select or enter value

III F4. Was written consent from the embryo donors obtained (or reconfirmed) at the time of donation?

Select or enter value

III F5. Was cash or payments-in-kind provide to oocyte, sperm, embryo or somatic cell donors?

Questions III F1- III F5): If you answered Yes to any of the five questions above, please provide documentation supporting the statement or information describing the process. If you answered No, 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 answered “Unknown," please coordinate with the Administrative Contact at your Institution to obtain the relevant information about the proposed hES cell line.

Select or enter value

III B. F2. Was written consent from the donors obtained (or reconfirmed) at the time of donation?

Select

III B. F3. Was cash or payment-in-kind provided to donors?

If you answered No to either question III B. F1 or F2 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 the 3 questions above, please coordinate with the Administrative Contact at your Institution to obtain the relevant information about the proposed hPS cell line.

Select

IV A. Do you propose to transplant hES cells, hPS cells, or their derivatives into laboratory animals in manner or into a species not approved under the current protocol.

In vivo Procedures Complete this section if this amendment requests the addition of in vivo use of hES cells, hPS cells, or their derivatives which was not listed in the originally approved ESCRO protocol. Such methods include injection of hPS cells into animal models to confirm pluripotency, cell growth or integration of hES/hPS-derived, differentiated cells in an animal model, etc.

Select

IV A1. If Yes, which type(s) of human cells do you propose to transplant?

Select

IV A1a. If cells were derived from hES and/or hPS cells, describe system or type:

IV A1b. If Other, describe:

IV A2. At what stage of development?

Select

IV A3. Describe the species:

IV A3a. 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:

Describe.

Whether you anticipate that a possible effect will be migration/function of the human cells in and describe below:

IV A3b1. The animal's brain/central nervous system:

Describe or answer as No.

IV A3b3 Other systems:

Describe or answer as No.

IV A3c. Whether human cells are anticipated to contribute to the germ line of the animal:

Describe or answer as No.

IV A4. Whether animals into which human cells have been introduced will be bred to produce offspring:

IV A5. If breeding of animals into which human cells have been introduced is not to occur, what steps will be taken to prevent breeding:

IV A6. 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.

Other Required Reviews:

Do the activities for which you are seeking approval under this amendment request require either amendment of approvals from other oversight committees and/or new review and approval from other oversight committees (Institutional Review Board- IRB, Institutional Animal Care and Use Committee- IACUC, Institutional Biosafety Committee (IBC)? Please complete the questions below:

V. A. IRB Review

Is IRB review required?

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V. A1. IRB Submitted (Date)

V. A2. IRB Protocol #

V. A3. IRB Protocol Approval Date

V. B. IACUC Review

Is IACUC review required?

Select

V B1. IACUC Submitted Date

V B2. IACUC Protocol #

V B3. IACUC Protocol Approval Date

V C. IBC Review

Is IBC review required?

Select or enter value

V C1. IBC Submitted Date

V C2. IBC Registration or Protocol Number

V C3. IBC Approval Date

V D. Financial Conflict of Interest Certification Date*

File Attachments

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ESCRO Submission

This submission is complete.

This submission is NOT complete - please return the form back to me.

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 amendment to the 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. 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. PLEASE TYPE YOUR NAME BELOW TO CERTIFY:

Principal Investigator Certification Date

Send me a copy of my responses

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