IRB Form Funding Source Supplement - Fred Hutch



|[pic] |[pic] |Funding Source Supplement |

|Date: |      |IR File#: |      |Protocol #: |      |

|Principal Investigator: |      |

|Study Title: |      |

|Type of Funding Review: | New IRB Application Continuing Review Report (CRR) |

| | Modification - Adding new or updating funding source to existing IRB file |

The IRB is required under the Pre-2018 Requirements of the Common Rule to review federal grant applications and the human subjects research activity to be supported by them. Fred Hutch policy extends this review to all funding sources. All funding sources must be listed, including internal funding. If your Human Subjects research project will receive funding through a grant, contract, or any other external funding source, the funding source documents must be reviewed and approved by the IRB.

• At Initial IRB Review - complete the following grid for each individual funding source. For external funding, attach a copy of each grant, sub-award, contract, etc. so the IRB can compare the aims outlined in the funding document scope of work with the research protocol. For internal funding, a funding source document does not need to be submitted.

• At Continuing Reviews - complete the grid only, you do not need to re-submit a copy of previously submitted funding documents unless there has been a change to the funding source’s aims or scope or work. If you have a new or updated funding source at the time of CRR, check the new or updated box on the grid and, for external funding, attach a copy of the funding source documents along with a research modification form to add the new funding.

• For On-going studies - If you have a new or updated funding source outside the CRR cycle, submit a research modification form along with this funding source supplement; complete the grid below. Attach a copy of the new or updated funding source document(s) for external funding.

• If your funding source documents are over 200 pages (e.g., Program Project Grant), include only the cover page and the applicable sections of the funding source documents as they relate to this new IRB application or existing IRB file.

|Funding 1 | |

|Is this a new or updated funding source? | Yes No |

|Name of PI of Funding Source ( |      |

|Contact for Funding Source Questions ( |      |

|Title of Funding Source ( |      |

|Type of Funding (select one) ( | Government |

| |Private Foundation |

| | |

| |Non-Sponsored |

| |Pharmaceutical/Commercial Sponsor |

| | |

| |Other:       |

| | |

|Name of Funding Agency/Organization (e.g., NIH, CCSG) ( |      |

|For Sponsored funding, provide the grant number assigned by the funding agency. For Non-sponsored funding |      |

|provide the project ID from Fred Hutch Finance (this number must match the information provided to OSR on | |

|Finance Attachment B, [e.g., R01 CA123456; 206140]) ( | |

|Inclusive Dates of Support if known (if not known, send an e-mail to the IRO when your grant/contract is |From: |To: |

|awarded to update the file with dates of support) ( |      |      |

|What pages, in the attached grant or document describes the Human Subjects research activity relating to the |Pages: |

|new IRB application or existing IRB file ( |      |

|Is this a sub-award from another institution? ( | No |

| |Yes ( Prime award issued to:       |

If the study has more than one funding source, continue to page 2 to complete additional funding grids.

|Funding 2 | |

|Is this a new or updated funding source? | Yes No |

|Name of PI of Funding Source ( |      |

|Contact for Funding Source Questions( |      |

|Title of Funding Source ( |      |

|Type of Funding (select one) ( | Government |

| |Private Foundation |

| | |

| | |

| | |

| |Non-Sponsored |

| |Pharmaceutical/Commercial Sponsor |

| | |

| | |

| | |

| |Other:       |

| | |

| | |

| | |

|Name of Funding Agency/Organization (e.g., NIH, CCSG) ( |      |

|For Sponsored funding, provide the grant number assigned by the funding agency. For Non-sponsored funding |      |

|provide the project ID from Fred Hutch Finance (this number must match the information provided to OSR on | |

|Finance Attachment B, [e.g., R01 CA123456; 206140]) ( | |

|Inclusive Dates of Support if known (if not known, send an e-mail to the IRO when your grant/contract is |From: |To: |

|awarded to update the file with dates of support) ( |      |      |

|What pages, in the attached grant or document describes the Human Subjects research activity relating to the |Pages: |

|new IRB application or existing IRB file ( |      |

|Is this a sub-award from another institution? ( | No |

| |Yes ( Prime award issued to:       |

|Funding 3 | |

|Is this a new or updated funding source? | Yes No |

|Name of PI of Funding Source ( |      |

|Contact for Funding Source Questions ( |      |

|Title of Funding Source ( |      |

|Type of Funding (select one) ( | Government |

| |Private Foundation |

| | |

| | |

| | |

| |Non-Sponsored |

| |Pharmaceutical/Commercial Sponsor |

| | |

| | |

| | |

| |Other:       |

| | |

| | |

| | |

|Name of Funding Agency/Organization (e.g., NIH, CCSG) ( |      |

|For Sponsored funding, provide the grant number assigned by the funding agency. For Non-sponsored funding |      |

|provide the project ID from Fred Hutch Finance (this number must match the information provided to OSR on | |

|Finance Attachment B, [e.g., R01 CA123456; 206140]) ( | |

|Inclusive Dates of Support if known (if not known, send an e-mail to the IRO when your grant/contract is |From: |To: |

|awarded to update the file with dates of support) ( |      |      |

|What pages, in the attached grant or document describes the Human Subjects research activity relating to the |Pages: |

|new IRB application or existing IRB file ( |      |

|Is this a sub-award from another institution? ( | No |

| |Yes ( Prime award issued to:       |

If additional funding sources, unprotect the supplement form and copy/paste additional funding grids as needed

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