• Tags
• Compliance
• eGC1

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 displays if HS-1 = Yes

HS-1A. 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 displays if HS-1 = Yes

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

HS-1C. 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

CRBB (Clinical Research Budget & Billing) 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 CRBB Coverage Analysis Checklist, Section II, 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 CRBB.
  • 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 CRBB at crbb@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

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 icons (pencil, trash can) 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

Use this section to indicate if and how specific types of information and technologies will be involved in the project so that reviewers can determine if special guidelines or restrictions apply. Contact exports@uw.edu for guidance on export control limitations related to sharing of data and technology. For information about the Washington Innovation Advantage Program (WIAP), visit the CoMotion site or contact osp@uw.edu with further questions.

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.

D-1. Does this project involve any of the following?

Answer: Check all that apply:

• Proprietary Information
• Export Controlled/Controlled Unclassified Information
• Classified Information
• Other Sensitive Information (Excludes personal or patient information)
• None of the above

You must make at least one selection. If “None of the above” is selected, the system will clear any other boxes that were checked.

D1-A displays if for D-1 you select any value other than “None of the above”

D-1A.  Will this information be shared with foreign nationals in the United States or abroad (including UW faculty, staff, or students)?

Answer: Yes or No

Note: U.S. Permanent Residents are not considered foreign nationals. The actual country of citizenship/residency of foreign nationals is not required at this time.

D1-B displays if for D-1 you select “Other Sensitive Information (Excludes personal or patient information)”

D1-B. Please describe the other sensitive information

D-2. Is this project intended to assist any foreign country’s military or space activities?

Answer: Yes or No

D-2A displays if D-2 = Yes

D-2A. Please describe.

D-3. As far as you know, will the sponsor require approval prior to foreign national participation or prior to publication of the research results of this project?

Answer: Yes or No

D-4. Will the project involve travel to or collaboration with a person or entity in a sanctioned country (e.g., Cuba, Iran, North Korea, Sudan, Syria)?

Answer: Yes or No

Question T-1 displays if the Sponsor Type and/or Originating Sponsor Type (as indicated on the Details page) is one of the following:

• Private Industry
• Private School, College, University
• Foreign Private Industry

T-1. Does the Sponsor wish to obtain an upfront commercial license to Project Intellectual Property (IP) based on the pricing under the Washington Innovation Advantage Program (WIAP)?

Answer: Yes, No, or Unknown

• Tags
• Compliance
• eGC1

Use this section to provide information about the use of vertebrate animals in the project to allow reviewers to determine compliance with UW and sponsor requirements. If you have questions regarding the use of Vertebrate Animals, please contact the Office of Animal Welfare.

Note: Hoverboard 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.

AU-1. Will the project involve the use of vertebrate animals?

Answer: Yes or No

A table for Animal Use Protocols and an Add Protocol button display if AU-1 = Yes

Note: If AU-1 = Yes, then you must include at least one protocol.

Add Protocol

You can add a protocol in three ways. Start by selecting Add Protocol. By default, the UW Protocol choice displays. Select the appropriate protocol type link from there.

Each type is explained below.

• UW Protocol (from Hoverboard)
• External Protocol
• New Protocol

UW Protocol

Use this to search Hoverboard and import your data. Start by entering at least 3 digits of your protocol number. The search will return any items that contain the digits you enter. Click in the results list to select the appropriate item.  The following image shows a results list after search for “234”.

When you select a protocol from the results list, the following data displays in the dialog window:

• Protocol Title
• Protocol PI
• Primate Center Involved – Yes or No
• Expiration Date

Select Next to continue the process. The dialog will display the question “Does the protocol require an amendment?”  Answer Yes or No.

Select Save to return to the Animal Use section.

Note: If the value for Primate Center Involved is Yes, the Primate Center will be added to the approval flow as an Approver.

The following image show the amendment question in the dialog window, with Yes selected.

External Protocol

Select this choice in the Add Protocol dialog to enter an External Protocol. Select the appropriate institution from the drop-down menu.

The choices are:

• Fred Hutchinson Cancer Research Center (FHCRC)
• VA Puget Sound Health Care System (VAPSHCS)
• Seattle Children’s Research Institute (SCRI)
• Benaroya Research Institute of Virginia Mason (BRI)
• Center for Infectious Disease Research (CIDR)
• Allen Institute
• Add a New Institute

The following image shows the initial screen with the drop-down menu expanded.

When you select one of the existing institutions from the menu, its details will display. These fields are

• Institution Assurance Number
• Institution Country
• Institution City

You can find more information about assurance numbers on these NIH web pages:

• Domestic Assurances: https://grants.nih.gov/grants/olaw/assurance/300index.htm
• International Assurances: https://grants.nih.gov/grants/olaw/assurance/500index.htm
• Foreign Assurances: https://grants.nih.gov/grants/olaw/assurance/500index.htm

The following image shows the details for Fred Hutchinson Cancer Center (FHCC).

Select Next to enter your Protocol Number and the Expiration Date.

The following image shows this step, with some example data entered.

Select Save to complete your entry.  You can save a partial entry. It must be complete prior to routing your application.

The following image shows the expanded table row from this entry on the compliance summary page.

Add a New Institution

If you select “Add a New Institution” from the External Protocol list, the dialog will display the following fields:

• Institution
• Assurance Number (optional)
• Institution Country

Add the appropriate information for these fields. Note that if you select any country other than the United States of America, you must also enter an Institution City.

The following image shows the first page of the dialog.

Select Next to display the section page of the dialog. Enter the Protocol Number and its Expiration Date.

Select Save to complete your entry.  You can save a partial entry. It must be complete prior to routing your application. The added information will display similarly to the existing external institution entries.

New Protocol

If you will be establishing a new protocol, select that option from the initial Add Protocol dialog box. You just need to answer yes or no to the question “Will the Primate Center be involved in the research?”

If you select Yes, the Primate Center will be added to the approval flow as an Approver.

The following image shows the New Protocol dialog with the Primate Center question.

• Tags
• Compliance
• eGC1

Use this section to indicate whether EH&S agents or activities are going to be used during the project. Responses to the EH&S section provide additional guidance on regulations and approvals needed to perform the work. Contact Environmental Health & Safety with questions.

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.

EHS-1. Will this project involve any of the following?

Answer: Check all that apply:

• Biohazards
• Select Agents and Toxins
• Radioactive Materials
• SCUBA Diving
• Chemical Thresholds (toxic, unstable, explosive)
• None of the Above

You must make at least one selection. If “None of the Above” is selected, the system will clear any other boxes that were checked.

Additional information will display when a box is selected.

• Biohazards: Biological Use Authorization from the UW Institutional Biosafety Committee is required as defined on the EH&S webpage. Please note that some categories of research require BUA prior to initiation. The BUA application submission deadlines are also posted on this website.
• Select Agents and Toxins: EH&S will work with the PI to obtain necessary federal clearances, approvals, and training. Documentation of due diligence is required for any transfer of Select Toxins in any amount. Some Select Agent and Select Toxin research is subject to review by the Dual Use Research of Concern (DURC) Institutional Review Entity (IRE). See the EH&S website for information about Select Agents and Select Toxins, Select Toxin Due Diligence, and DURC.
• Radioactive Materials: Approval of this application will be contingent on whether or not a Radiation Use Authorization (RUA), issued to the Principal Investigator (PI), sufficiently covers the proposed radioactive material work.
• SCUBA Diving: Anyone diving under the University of Washington’s auspices must have current certification as a University of Washington Scientific Diver and adhere to the standards set forth in the UW’s Diving Safety Manual. EH&S will contact you to assist in meeting Diving Safety Program requirements prior to diving. For more information, please see: https://www.ehs.washington.edu/research-lab/diving-safety-program
• Chemical Thresholds (toxic, unstable, explosive): EH&S will contact you for planning assistance as fire department requirements may not allow these quantities in your space or may require building modifications.