Tag Archives: Compliance

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The eGC1 Compliance Questions and Explanations pages have been replaced by a new page called Non-Fiscal Compliance.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However, any eGC1 that is returned or withdrawn after the release will be reset with the new compliance questions.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.

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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?

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.

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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
PHS Training One or more investigators on the PI, Personnel, & Organizations of a PHS-sponsored eGC1 has either not done the FCOI training or the training has expired.

 

 

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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

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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.

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
    • 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.

i r b table entry expanded

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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.

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 Research Center (FHCRC).

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

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

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Use this section 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 approval of this eGC-1 is required due to federal regulations. 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.
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Use this page to provide details related to non-fiscal compliance information. These details will

  • Identify special considerations in this application and bring them to the attention of reviewers
  • Provide information necessary for the UW approval process
  • Provide information that may help campus unit and central office approvers review your application quickly
  • Facilitate proposal review and central office review at time of award

There are five sections on this summary page and each is covered in more detail in its own article.

  • Human Subjects
  • Animal Use
  • Environmental Health & Safety
  • Equipment & Materials
  • Data & Technology

NOTE: If you are viewing an older application, you will see the questions you answered at that time, displayed in read-only mode and organized into the sections listed above.

On this summary page, select “Start Section” to open a section for data entry.

Once you have started a section, when you return to the summary page, you will see a link to Edit Section. In addition, an Expand + link will display on the right of the section. Select it to open the section and view the data in read-only mode. The link will change to Collapse – when the section is expanded.

This page also has Expand All and Collapse All links above the first section, on the right side of the page. Use the Expand All link to open all of the sections in read-only mode. Collapse All will close all of the sections.

In the following image, the second section, Animal Use, shows the Edit Section link. The third section, Environmental Health & Safety, shows a section in the expanded, read-only view.

non-fiscal compliance summary page

 

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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 Supplement: Table of F&A Rates and Base Types. A Primer on F&A Costs, GIM 13 Facilities and Administrative (F&A) Rates, can provide further detail. Guidelines for determining split rates when projects are conducted at two or more locations are found in GIM 13 Supplement: 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 committed (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.

October 2017 SAGE Compliance Release 1

As part of a larger effort to improve usability and content of the eGC1 Compliance page, this release makes a number of alterations to better focus the Compliance page on non-fiscal compliance questions. This was accomplished by either removing questions or relocating them to more intuitive sections of the eGC1.

There are more changes coming to the Compliance page in a later release that will build upon these enhancements.

Compliance Page Changes

Question Change
FG-1 Cost Share Relocated to Budget & Fiscal Compliance page
FG-2 Conducted off campus Replaced by Activity Locations section
FG-3 F&A at less than federally negotiated rate Relocated to Budget & Fiscal Compliance page
FG-4 New, rental or renovation Relocated to Activity Locations page
FG-5 Compensation for overtime Removed
FG-6 Deliverables Removed
FG-7 Administrative support Relocated to Budget and Fiscal Compliance page
FG-8 Interdisciplinary facilities Relocated to the PI, Personnel & Organizations page
FG-9 Review by other organization Relocated to the PI, Personnel & Organizations page
NG-1 Advancement assistance Removed
NG-3 Originating sponsor Relocated to the Details page with other sponsor information

New Activity Locations Page

A new page has been added to the eGC1 that centralizes details related to the location of research activities in a proposal.

This page includes relocated questions, as well as more detailed tracking on each location where UW work will take place. The sections on this page are:

Activity Locations

  • Includes identification of each location where UW research activities are taking place along with details helpful for budgeting and F&A rate determination.
  • The Location Search integrates with the UW’s space tracking system GeoSIMS, allowing you to partially enter a facility name, address or facility code and populate the eGC1 with the data for that location.
  • You can also manually enter locations not found in GeoSIMS.

Space Planning

  • Includes the “construction or renovation” question formerly on the Compliance page, along with approval details when answered ‘Yes’.

International Involvement

  • Includes the international involvement question and country identification formerly on the Details page. Country is now sourced from the more comprehensive international standard ISO 3166.

This new page introduces an updated, intuitive and more modern experience for SAGE. Based on feedback from users, we will be incrementally updating SAGE to new design standards with each new release.

Fiscal Compliance Combined with Budget

The existing FG-1, FG-3, and FG-7 compliance questions related to fiscal compliance have been relocated to the top of the Budget page (now rebranded “Budget & Fiscal Compliance”), along with the useful explanations when ‘Yes’ is selected.

Details Page Updates

The existing NG-3 “originating sponsor” compliance question has been relocated to the Details page directly below the Sponsor selection.

The international involvement question has been relocated to the Activity Locations page.

PI, Personnel, & Organizations Page Updates

The existing FG-8 Compliance question on interdisciplinary facilities, service centers, etc. has been relocated to the PI, Personnel, & Organizations page. In a previous release, the FG-9 “other organizational reviewers” question was relocated to this page as well. With these two changes, you can now better manage your eGC1 approvals in one location.

SAGE Toolbar Update

The “reset form” icon on the upper SAGE toolbar has been removed. Removal of this rarely used feature will allow the application design to progress to more modern standards.

SPAERC: Intellectual Property Questions Added to FA/PAC/NAA

A new question has been added to the FAs, PACs, and NAAs in SPAERC for OSP post-award administrators to indicate when an agreement includes an upfront exclusive commercial license or ownership over the project’s intellectual property. CoMotion will receive notification when these are marked YES in order to get a jump start on IP negotiation.

SPAERC: BUG FIX – Internal OSP Notes no longer display in SAGE Subawards “Latest Update”

An issue that was causing internal OSP notes for subawards to display in SAGE under “Latest Update” for requests in process has been resolved. The “Latest Update” will now only display the most recent status update and any accompanying comments to/from campus and OSP.