• Tags
• Compliance
• eGC1

• Human Subjects Questions
• Add IRB Application
• Search Zipline
• Enter Manually
• IRB Application Details

Use this section to provide information about human subject involvement and approvals for the project to help reviewers determine compliance with UW and sponsor requirements. Contact the Human Subjects Division with questions.

Note: Zipline data will be refreshed each time you view this page. 

As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.

Select Start Section to open the section initially, and then Edit Section to add or update existing data.

Human Subjects Questions:

HS-1:

Will the project involve interaction with Human Subjects, or identifiable data or specimens from human subjects?

Answer: Yes or No.  An answer is required.

HS-1A.

Note: HS-1A displays if HS-1 = Yes

Delayed Onset: Will IRB application submission be delayed until after award because you will (1) identify and develop new protocols that will be supported by the award or (2) complete other research described in the proposal that is necessary before the human subjects research can be fully planned.

Answer: Yes or No

HS-1B:

Note:HS-1B displays if HS-1 = Yes

IRB Approval Pending:  Will you need to submit a new IRB application, modify an existing IRB application, or are awaiting approval of a current IRB application for the human subject research in this project?

Answer: Yes or No

A table for IRB Application Details displays if HS-1 = Yes

Note: If HS-1 = Yes, and HS-1A = No (Delayed Onset), and HS-1B = No (IRB Approval Pending), then you must include at least one IRB application. See details below on how to add an IRB Application.

HS-1C:

Note:HS-1C displays if HS-1 = Yes AND Sponsored Program Activity Type (Details page) is “Clinical Trial – Federal Sponsors” or “Clinical Trial – Non-Federal Sponsors”

CRBB Involvement. Will the project involve use of UW Medicine clinical services or clinical space as a site of patient care, or include medical treatment of a patient by a UW Physicians provider?

Answer: Yes or No

UW CTO (UW Medicine Clinical Trials Office) Note: If any of the following statements apply to this proposed work, mark Yes, even if the research involves only usual patient care items or the study budget will not be charged.

• • Some of the proposed work will be conducted in a UW Medicine clinical setting. See Sites of Practice for a complete list of sites. Studies using Seattle Cancer Care Alliance locations should use the SRAMP access point when submitting to CTO.
  • The study involves one or more clinical procedures at one of these sites, such as use of a patient examination room, blood draws, imaging, clinical lab tests, administration of a research medication, or procedures.
  • Payment of physician professional fees for clinical services from a UW-affiliated or Northwest Hospital physician is required, separate from the salaried research personnel effort reflected in the budget.

Contact CTO at uwcto@uw.edu or 206-543-7774 for assistance.

HS-2

Stem Cells. Will this research involve the use and/or creation of human embryonic stem cells?

Answer: Yes or No. An answer is required.

Add IRB Application

Start by selecting Add IRB Application. A dialog box will open where you can choose how you enter your data.

• Search Zipline
• Enter manually
• IRB Application Details

Search Zipline

You can use the blue “X” in the upper, right-hand corner to close the dialog and return to the Human Subjects section without saving any data.

The following image shows the initial dialog box.

Enter all or part of the Zipline Application Number in the search box. The system will search for all applications that contain the entered numbers in the application number field. The results list will display below the search box, as shown in the following image.

Click on the appropriate study in the results list to select it. The study data will display in the dialog window, as shown in the following image.

Use the Save button in the lower, right-hand corner to add the study data, and return to the Human Subjects section.

Enter Manually

You have the option to add IRB Application information manually.  Select Enter Manually in the dialog, then add the requested information.

• Reviewing IRB Name
• IRB Application PI
• Reviewing IRB Application Number
• Approval Date
• Expire Date
• IRB Application Title

Select Save to return to the Human Subjects section.

Note: All of the fields are required prior to eGC1 completion.

The following image shows the manual entry screen.

IRB Application Details section

Your data will appear as an expandable row of a table in the IRB Application Details section of the page.

The table row shows the follow data fields:

• IRB Application Number
• Reviewing IRB Name
• IRB Application PI
• Approval Date
• Expiration Date

You can edit or delete it using the pencil or trash icons in the Actions column at the far right of the table row.

Use the chevron to the left of the row to expand the data shown. The additional data displayed includes:

• IRB Application Title
• Zipline Application Number
• Zipline Status
• Approved Funding Sources

The following image shows an expanded table entry.

• Tags
• Compliance
• eGC1

Use this section to provide information about tangible items involved in a project, such as equipment and biological materials. This information helps reviewers understand export control and budgetary implications as well as informing protections that need to be in place for any sharing of tangible items outside UW. Contact Equipment Inventory Office with specific questions about fabricating equipment, or email exports@uw.edu for guidance on export controls.

As with other eGC1 pages, you can partially complete your entries and save the eGC1. You must complete the required fields before you route your eGC1 for approval.

Select Start Section to open the section initially, and then Edit Section to add or update existing data.

E-1. Will equipment be fabricated by the UW on this project?

Answer: Yes or No

Note: if the fabrication is being performed entirely by a non-UW entity (that is, a subcontractor), answer “No”.

E-2. Will the project involve the export of hardware, equipment, specimens, goods, software or monies?  (excludes personal-use laptops)

Answer: Yes, No, or Unknown

Note: Answer “No” for personal-use laptops unless the laptop contains any military or space technical data, or if the only international transactions are for travel expenses.

E-2A displays if E-2 = Yes

E-2A. Describe the items/materials

Answer: enter a description

E-2B displays if E-2 = Yes

E-2B. Add one or more destination countries

Answer: search for by name, and select the appropriate countries

M-1. Will University-owned biological materials be provided to non-UW parties, including sponsor?

Answer: Yes or No

Note: Materials include (but are not limited to) cell lines, cultures, bacteria, nucleotides, proteins, transgenic animals, pharmaceuticals, or chemicals.

• Tags
• Compliance
• eGC1

You must answer each of the three fiscal compliance questions in this section of the eGC1 Budget & Fiscal Compliance page.

Question F1: Will F&A costs be reimbursed at less than a federally negotiated rate for the UW?

The F&A Cost Rate is determined by the location(s) where the research is performed and is charged as a percentage of total Direct Costs. Rates can be found in GIM 13: F&A Rate Table.  Guidelines for determining split rates when projects are conducted at two or more locations are found at GIM 13: Activity at Two or More Locations.

See also GCA’s page on Facilities & Administrative Costs.

If you answer Yes:

• Item F1a will display: Attach GIM 13 waiver in the Documents for OSP section of the attachments page, or provide documentation of sponsor F&A policy (e.g. RFP, application documents, or website URL)
• Use the text box to enter your documentation, or upload an attachment on the Attached Documents page.

Note: for RRF applications, the answer to this question must be No.

Question F2: Will administrative or clerical support be included in the budget as direct costs? (see GIM 23)

NIH grants do not allow administrative or clerical personnel costs unless they meet the criteria in GIM 23.

If you answer Yes:

• Explain how administrative or clerical personnel will be used in the proposed project, following the criteria in GIM 23 Appendix A (Examples of Direct Costs).  This must be appropriately justified in the sponsor application, following sponsor guidelines.

Question F3: Does this application commit funds for cost sharing or matching?

Cost Sharing, Matching or Continuation occurs when an application promises to deliver a support or service for which the research grant does not pay.

• Cost Sharing may be mandatory (required by sponsor) or voluntary (a contribution of effort or other costs offered by the Principal Investigator which the sponsor does not require as condition of the award).  Cost sharing occurs when an application commits allowable expenses (i.e., personnel, tuition, equipment or services) for which the research grant will not pay. You must charge these costs to an alternate source (UW or third party). You need to identify all sources and they must agree (via the eGC1 approval process) to commit the necessary funds. For more information, see the GCA Cost Sharing Overview page or GIM 21: Cost Share on Sponsored Programs.
• Matching funds occur when proposal funding is contingent on a unit’s agreement to commit a matching amount of funding ($) to a project. Matching funds may come in the form of a gift or a grant.
• Continuation funding takes three forms:
  • (a) it provides funding from a secondary source for ongoing support of a project after the original funding is depleted
  • (b) continuation funds may also be granted if the project is unable to be completed by the original time line and the sponsor has agreed to provide supplemental funding to see the project through to completion
  • (c) continuation funding also occurs when a portion of the original funding commitment is continued and the remaining budget must be found in grant money.

If you answer Yes:

• Identify whether you are including cost sharing, matching or program continuation.
• Provide a brief explanation in the text box and attach the completed Addendum form on the Attached Documents page. (On the Addendum, complete all fields including faculty effort, budget number and third party contribution.)
• Indicate the cost sharing amounts and sources in the Personnel section of the eGC1’s Cost Sharing page.