Tag Archives: Compliance

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

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.

add i r b dialog

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.

add i r b search results

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.

i r b study details

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.

add i r b manually dialog

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.

e g c 1 add irb table entry

The system adds reviewers to the approval flow when a preparer answers “Yes” to select compliance questions or to a compliance question in combination with other data.

The following table describes when a Compliance Reviewer is added, which individual or unit is added, and whether the Reviewer is an Approver or a Watcher.

Condition Reviewer Added Approver or Watcher
Environmental Health & Safety
EHS-1 – Biohazards selected EHS BioSafety Watcher
EHS-1 – Select Agents and Toxins selected EHS Select Agents Watcher
EHS-1 – Radioactive Materials selected EHS Radiation Watcher
EHS-1 -SCUBA Diving selected EHS Diving Watcher
EHS-1 – Chemical Thresholds selected EHS Fire Code Compliance Watcher
Animal Use
AU-1 = Yes AND the application is After-the-Fact (ATF)

OR

The application type is:

  • Transfer from Another Institution
  • Supplement and Extension
Animal Subjects Approver; see additional notes below
Data & Technology
D-2 = Yes: Is the project intended to assist a foreign country’s military or space activities? Export Control Watcher
D-4 = Yes: 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)? Export Control Watcher
Historical Security Question
SEC-4 = Yes (potentially involves access to classified national security information); only appears on older eGC1s Security Reviewer Approver

Additional Animal Use Notes

  • For an application with AU-1 = Yes, and an application type other than those listed above, the review is done “just-in-time”, when the sponsor notifies the PI that the proposal has a fundable score. Upon that notification, the PI or other application owner adds Animal Subjects to the Approval Graph as an ad hoc watcher. The system then sends an email notification to the Animal Subjects reviewers and gives them access to the application.
  • On the Non-Fiscal Compliance page, if a user chooses an existing Hoverboard protocol or enters a new protocol, and the protocol indicates that the Primate Center will be used, then the Department/Center Reviewer for the Primate Center (RSRCH:000105) is automatically added to the Approval Graph as an Approver.

When the Primate Center is involved due to an Animal Use protocol, a Primate Center compliance reviewer node is added to the approval flow. The reason is “Approver: Animal Use – Primate Center Involved.”

If the Washington National Primate Research Center (WaNPRC) needs to approve for personnel or as the Cost Center receiving funding, then approvals may be combined into a single node.

Cost Center Receiving Funding WaNPRC / Primate Center Personnel Primate Center Involved Approval Nodes and Reasons
WaNPRC Yes Yes
  • Primate Center, Reviewer
    • Approver: Animal Use – Primate Center Involved
  • Vice Provost-Research, Dean Reviewer
    • Approver: Personnel Selected Unit, Personnel Name, WANPRC
WaNPRC Yes No
  • WaNPRC, Dept Reviewer
    • Approver: Cost Center Receiving Funding
    • Approver: Personnel Selected Unit, Personnel Name, WANPRC
  • Vice Provost-Research, Dean Reviewer
    • Approver: Cost Center Receiving Funding
    • Approver: Personnel Selected Unit, Personnel Name, WANPRC
WaNPRC No Yes
  • Primate Center, Reviewer
    • Approver: Animal Use – Primate Center Involved
WaNPRC No No
  • WaNPRC, Dept Reviewer
    • Approver: Cost Center Receiving Funding
  • Vice Provost-Research, Dean Reviewer
    • Approver: Cost Center Receiving Funding
Not WaNPRC Yes Yes
  • Primate Center, Reviewer
    • Approver: Animal Use – Primate Center Involved
  • Vice Provost-Research, Dean Reviewer
    • Approver: Personnel Selected Unit, Personnel Name, WANPRC
Not WaNPRC Yes No
  • WaNPRC, Dept Reviewer
    • Approver: Personnel Selected Unit, Personnel Name, WANPRC
  • Vice Provost-Research, Dean Reviewer
    • Approver: Personnel Selected Unit, Personnel Name, WANPRC
Not WaNPRC No Yes
  • Primate Center, Reviewer
    • Approver: Animal Use – Primate Center Involved

 

August 2018 SAGE Maintenance Release

SAGE

Updated EH&S reviewer emails

Automated emails sent to eGC1 reviewers in Environmental Health & Safety have been updated to reference the new Non-Fiscal Compliance questions.

Originating Sponsor now required for eGC1s with flow-through funding

When the eGC1 indicates the presence of flow-through funding on the Details page, selection of an Originating Sponsor will now be required prior to completing the eGC1.

Minor updates, infrastructure, and bug fixes for Non-Fiscal Compliance

Following the 5/17 release of the Non-Fiscal Compliance page, a number of minor updates, infrastructure improvements, and bug fixes are included to stabilize that section going forward with completion of the SAGE Compliance Improvements project.

SPAERC

Assign NSF sponsored eGC1s to GCC in OSP upon completion

When the eGC1’s Sponsor or Originating Sponsor is the National Science Foundation, the OSP assignment will now default to the GCC role on the appropriate team.

Assign eGC1s with IPA/JPA/Staff Assignment SPA Type to GCC in OSP upon completion

When the eGC1’s Sponsored Program Activity Type is the IPA/JPA/Staff Assignment, the OSP assignment will now default to the GCC role on the appropriate team.

Auto-Generated Cover Letter now allows standard and fellowship opening on all eGC1s

The Application Cover Letter to Sponsor auto-generated documented in SPAERC now allows OSP to choose between “Standard” and “Fellowship” openings. Previously, this choice only displayed on eGC1s that included personnel with a role type of “Fellow.”

SPAERC background lightened for improved contrast/readability

The background color in SPAERC has been lightened to provide more contrast with the text to improve readability.

May 2018 Compliance Release 2

New Non-Fiscal Compliance page

The eGC1 Compliance Questions and Explanations pages have been replaced by a new page called Non-Fiscal Compliance. This consolidation provides a more streamlined experience for preparers and reviewers.

Updated questions reflect current institutional needs, with improved clarity in mind.  Links to supporting guidance have been added to assist preparers in understanding the policies and regulations behind each question. You can review the updated questions by visiting this page..

Design improvements make the page easier to navigate and gauge progress toward completion.

human subjects with H S 1 C answered yes

eGC1s that are in routing at the time of this release will display the old compliance questions that existed when the eGC1 was initially routed.

However, any eGC1 that is returned or withdrawn after the release will be reset with the new compliance questions. Answers to the previous questions will no longer display. Plan for additional time to re-complete that page in case a return or withdrawal is necessary.

Zipline and Hoverboard linked to eGC1

Human Subject (Zipline) and Animal Use (Hoverboard) protocols can now be linked to your eGC1. Searching by IRB Application Number or IACUC Protocol Number will allow you to pull in real-time information, reducing manual back-and-forth between systems and improving the accuracy of protocol details in SAGE.

animal use section with hoverboard protocol

Improved Collaboration

Send page link to PI, Reviewers

From any standard eGC1 page (excluding Grant Runner forms), the URL is now a direct link that you can copy and share with others who have access to that eGC1. This will be particularly useful when collaborating with the PI on completing the Non-Fiscal Compliance page.

direct U R L for e G C 1 page

Multi-User Editing (limited)

Currently, only one person can edit an eGC1 at a time. However, the Non-Fiscal Compliance page can now be edited, even while someone else is working in other areas of the eGC1. This will avoid situations where the PI could be blocked from contributing to the Non-Fiscal Compliance page while the administrator is currently editing other areas of the proposal.

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.

Applications

On the Non-Fiscal Compliance page, in the Data & Technology section, if you answer Yes to questions D-2 and/or D-4, the system will automatically add a hold for Export Control. The hold will be added when the eGC1 reaches In OSP status.

Funding Actions

When OSP creates a child Funding Action (FA) for an awarded eGC1, the system will automatically create compliance holds, if appropriate.

The system applies automatic holds to the FA based on the conditions in the following chart.

Compliance Hold Due to
Administrative Support Budget & Fiscal Compliance page: question F2 = Yes
F&A Budget & Fiscal Compliance page: question F1 = Yes
IRB Approval Non-Fiscal Compliance page: question HS-1 = Yes
Cost Share Budget & Fiscal Compliance page: question F3 = Yes
Fed Flow-Through Details page has an Originating Sponsor listed with a Sponsor Type of Federal Government
SFI/FCOI One or more investigators on the PI, Personnel, & Organizations page has an SFI value of Yes or Unknown
Export Control Non-Fiscal Compliance page: if Yes for any one of questions E-2, D-1, D-2, D-3, D-4.
IACUC Non-Fiscal Compliance page: question AU-1 = Yes
FCOI Training One or more investigators on the PI, Personnel, & Organizations page has either not done the sponsor-required FCOI training or the training has expired.

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

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

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”.

add protocol search results

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.

add protocol amendment question

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.

add external protocol list

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:

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

external protocol details

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

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

add protocol details

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.

protocol table entry example

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.

add new external institution 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.

new protocol

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.