ESCRO Annual Progress Report

This is the Annual Progress Report on Human Embryo, Human Embryonic Stem Cell, Covered Human Pluripotent Stem Cell and Human Gamete Generating Research for Submission to the Tri-SCI ESCRO Committee. *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 Section X.

I A. Protocol Number*

I B. Project Title

I C. Original ESCRO Approval Date

I D. Is this a FINAL progress report?

Marking 'FINAL' means the ESCRO work has finished and any associated grant (if applicable) is closed.

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I E. Principal Investigator (PI) Name*

I F. PI Institutional Affiliation*

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I G. Approved Personnel #1

If there are multiple approved personnel: List each name (first name, last name, degree) below under (I G - I G3). If there are more than 4 approved personnel, please complete the additional personnel information using the excel template. This template is available on the Tri-SCI ESCRO website under the forms tab. Here is the direct link: http://www.trisci.org/forms/Personnel_List_for_hES_and_covered_hPS_Research_Protocol_TEMPLATE.xlsx. Attach the completed version under "File Attachments."

I G1. Approved Personnel #2

I G2. Approved Personnel #3

I G3. Approved Personnel #4

I H. New personnel added since original ESCRO approval or most recent annual report?

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I HA. Name of New Personnel Added

If the answer to the above question is Yes, please complete the questions below for each new person added to this protocol since the original approval or most recent progress report. If no new personnel were added, indicate N/A. If you have more than 4 personnel, please complete the excel template, available on the Tri-SCI ESCRO website under the forms tab. Here is the direct link: http://www.trisci.org/forms/Personnel_List_for_hES_and_covered_hPS_Research_Protocol_TEMPLATE.xlsx and attach the completed version under "File Attachments."

I Ha. Name of personnel added

I Hb. Title

Provide the Title of the new personnel.

I Hc. Institution

Provide the Institutional affiliation of the new personnel.

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I Hd. Department

New personnel's Department.

I Hd. New Personnel- Research Operating Procedures Training Completion Date

Indicate the training date of completion for the new personnel.

I Ia. Name of personnel added

I Ib. Title

I Ic. Institution

I Id. Department

I Id. Research Operating Procedures Training Completion Date

Provide the date of training completion for new personnel.

I Ja. Name of personnel added

I Jb. Title

I Jc. Institution

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I Jd. Department

I Je. Research Operating Procedures Training Completion Date

I Ka. Name of personnel added

I Kb. Title

I Kc. Institution

I Kd. Dept.

I Ke. Training Date

II A. Status of Project

Provide a brief summary of goals of the specific project approved by the ESCRO Committee that have been achieved since initiation or the last progress report. It is not necessary to repeat the stated goals from the original submission. The summary must be in lay language, e.g., in a way that would be useful for a public announcement or public relations purposes. Progress Reports that are not submitted in LAY language will be returned to the PI for revision.

II B. Modifications

Provide a brief description, in lay language, of any modifications (with dates of approval) to the original proposal that have been undertaken since the last annual report was filed. If None, so state.

III A. Have results from the project been published during the time covered by this report?

If "No," proceed to Section III.

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III A1. Citations of the publications.

Provide citation for the publication(s) that report on work undertaken as part of the protocol. Do not reference articles that are pending, but have no yet been published. If the publications are available online, provide the URLs. If the publications are not available online, attach a PDF copy of the article to this report under Section IX.

III B. Have materials developed under this protocol been made available to the research community during the time covered by this report?

If "No," skip to Section IV.

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III B1. Briefly describe what materials were made available:

IV. A. Addition of existing hES cells and/or existing hPS cells.

IV A1. Are there any new lines being used in this project that were not previously reported?

If no new cell lines were added since the last approval, indicate "No" and proceed to Section V.

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IV A2. All new cell lines that were not previously reported:

For all new cell lines that were not previously reported, please complete an excel spreadsheet and upload in the "File Attachments" section located at the bottom of this form. The excel templates for this section are available on the Tri-SCI ESCRO website under the forms tab. The direct links are: http://www.trisci.org/forms/Existing_hPS_Cell_Lines_TEMPLATE.xlsx http://www.trisci.org/forms/Existing_hES_Cell_Lines_TEMPLATE.xlsx You may also attach any supporting documents for non-registry/inventory lines in Section IX. Provide any information about the provenance of the cell line in the text box below. Please note, new cell lines derived as part of the approved work covered by this protocol should be reported in Section V.

IV E. Listed on NIH Registry?

For each existing hES cell line you propose to use, give the NIH Code(s) or Provider name/code, indicate whether the line is on the NIH Registry: https://grants.nih.gov/stem_cells/registry/current.htm or not.

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IV E1. Who is providing the line?

Provide the name of the company, institution or investigator that is providing the line.

IV F. Listed on Tri-SCI Inventory

Please also indicate whether the hES cell line is listed on the Tri-SCI hES Cell Inventory: http://www.trisci.org/inventory.pdf

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IV G. If not on original submission, provide start date for when use of the line was initiated.

If a cell line listed above is not listed on the NIH Registry or the Tri-SCI Inventory, please provide information about the provenance of the cell line.

New cell lines derived as part of the approved work covered by this protocol are to be reported in Section V.

V A. Derivation of new hES cells: Does your project include the aim to derive new hES cell lines?

Creation of genetically modified versions of previously derived hES cell lines need not be reported. If you answer NO, please skip to Section VI.

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V B. Have any new hES cell lines been derived during the time period covered by this report?

If the response for questions V.A. and V.B. are “No,” proceed to Section VI. If the response for question V.A. is yes, and the response for question V.B. is no, proceed to question V.C.

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V B1. Describe the newly derived lines and state the number of oocytes/embryos used in the process.

Description should include the name/identifier, unique characteristics, publications that reference the new line for newly derived lines.

V B2. Have new hES cell line been shared with other researchers and/or institutions?

If no, skip to question V.C.

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V B2a. What institutions have received the lines?

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IV B2c. Please explain why transfer of the new hES cell line(s) were not conducted in accordance with an approved MTA.

V C. If the project includes the intent to derive new hES cell lines, but none have been derived during the time period covered by this project, please indicate the reason below:

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V C1. If None of the Above, please explain:

VI A. Does your project include the intent to derive new hPS cell lines?

Creation of genetically modified versions of previously derived hPS cell lines need not be reported.

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VI B. Have any new hPS cell lines been derived during the time period covered by this report?

If the responses for questions VI.A. and VI.B are “No,” proceed to Section VII. If the response for question VI.A is yes, and the response for question VI.B. is no, proceed to VI.C

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VI B1. Describe the newly derived line(s).

(i.e., name/identifier, starting materials, derivation method, unique characteristics of the resulting hPS line and publications that reference the new line).

VI B2. Have the newly derived hPS cell line been shared with other researchers and/or institutions?

If No, proceed to Section VII.

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V B2a. What institutions have received the lines?

VI B2b. Were the transfers conducted in accordance with an approved material transfer agreement (MTA)?

If yes, proceed to Section VII.

VI B2c. Please explain why the transfers were not conducted in accordance with an approved material transfer agreement (MTA).

VI C. If the project includes the intent to derive new hPS cell lines, but none have been derived during the time period covered by this project, please indicate the reason below:

Please explain.

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VI C1. Other:

Please explain:

VII A. Does your project include the intent to generate human gametes?

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VII B. Were human gametes generated during the time period covered by this report?

If the response for questions VII.A. and VII.B. are “No,” proceed to Section VIII. If the response for question VII.A. is “Yes”, and the response for question VII.B. is “No”, proceed to question VII.C.

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VII B1. Have gametes generated under this protocol been shared with other researchers and/or institutions?

If no, skip to Section VIII.

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VII B1a. What institutions have received the gametes?

VII B1b. Were the transfer conducted in accordance with an approved material transfer agreement?

If "Yes," proceed to Section VIII.

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VII B1c. Please explain why the transfer of gametes was not conducted in accordance with an approved MTA.

VII C. if the project includes the intent to generate human gametes, but none were generated during the time period covered by this project, please indicate the reason below:

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VII C1. Other reason:

VIII A. During the period covered by this report, have there been any research-related adverse events, unforeseen incidents or significant protocol deviations?

If “No, proceed to question VIII.B.

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VIII A1. Provide copies of reports on the events submitted to your administration, other compliance committees (e.g., IRB, IACUC, IBC, RSC) and/or to the ESCRO Committtee.

Provide a description of any actions taken in response to the administrative or compliance committee review. Send the reports to your institution's ESCRO Administrator.

VIII B. Is the study under IRB oversight?

If "No," proceed to question VIII.C.

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VIII B1. Has the IRB-approved consent form for your research been amended since the original notification or last annual report?

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VIII C. Do you have current approval from the oversight compliance committees (IRB, IACUC, IBC, RSC) that were referenced on the Notification Form and on which ESCRO approval relied?

If “Yes,” proceed to Section IX.

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VIII C.1. Please identify the oversight committee(s) you do not have current approval from the reasons why approval(s) was not obtained:

XI. File Attachments

Please upload attachments in this section.

Drag and drop files here or

X. ESCRO Submission*

This submission is complete.

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

XI. Principal Investigator Certification

XI A. I certify that the information provided above is true and correct to the best of my knowledge. I certify that all work conducted under this protocol has been undertaken in compliance with the conditions of the Tri-SCI ESCRO approval of the protocol and with all applicable regulatory and institutional requirements.

PLEASE TYPE YOUR NAME BELOW TO CERTIFY:

XI B. Principal Investigator Certification Date

Send me a copy of my responses

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