Tag Archives: Disclosure

Change of Sponsor after Disclosure Completed

Issue: Primary disclosures for eGC1s with a PHS sponsor (either prime or originating) should include all of the investigator’s SFI.  However currently, if an investigator completes their primary disclosure before a PHS prime or originating sponsor is set on the parent eGC1 then the investigator’s SFI list on the disclosure does not update to show all.

Workaround: If the disclosure is editable, the investigator could update the SFI included.

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Once you complete a disclosure, the system assigns it a Review Status based on several factors.

A primary disclosure for an eGC1 initially has a status of Waiting for JIT, regardless of whether the disclosure includes SFI. The disclosure remains in this status until the appropriate time to review it. The disclosure’s status then changes to:

  • Review Required status if it has SFI, or
  • No Review Required, if it does not have SFI

The status change occurs when:

  • An After-the-Fact eGC1 reaches In OSP or Approved status, or
  • OSP creates a Funding Action for an eGC1 (other than After-the-Fact ones)

When you complete a disclosure for CoMotion, HSD/IRB, or just SFI, the system will assign a status.  If the disclosure has SFI, the status is Waiting for JIT; if no SFI, the status is No Review Required.

The Institutional Official will look at disclosures in Waiting for JIT status as needed. At the time of review, the disclosure status would change to:

  • Pending Answer if the Institutional Official has requested information about this disclosure from the investigator
  • Review Complete when the Institutional Official has completed their review of this disclosure
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The History section will display all changes made after the investigator completes the disclosure and before the review status becomes Review Complete or No Review Required. The information displayed includes the date and time of the change,  who generated the change, the type of change, and any notes. The two types of change are:

  • SFI change
    • The addition of new SFI
    • An update or deletion of an existing SFI
    • The selection or deselection of SFI on a non-PHS sponsored disclosure
  • Review Status change. When the Institutional Official changes the status, the change will display. The Review Statuses are
    • Review Required
    • Waiting for JIT
    • No Review Required
    • Duplicate
    • Review Complete

History will not display any additional SFI changes once the disclosure is 30 days past the completion of the review.

History section

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The Action Items section displays any pending disclosures that you need to complete and provides a button for creating new disclosures. The following image shows three pending disclosures, one for an eGC1, one for CoMotion, and one for Human Subjects.

Action Items section with pending disclosures

Pending Disclosures

A pending disclosure is a disclosure you need to complete. The system creates one when either an eGC1 owner or the system sends disclosure notification emails to the investigators. The eGC1 owner can click the Send Disclosure Notification button on the PI, Personnel, and Organizations page. If the owner routes the eGC1 to reviewers for approval without sending the notifications, the system will send them automatically. Also, when an investigator begins, but does not complete, a disclosure for Human Subjects Activity or a CoMotion Technology Transfer Agreement, the system creates a pending disclosure.

To complete a pending disclosure for a specific eGC1, CoMotion agreement, or Human Subjects Activity, click on the Complete Disclosure button to the right of the disclosure in the Action Items section.  Then make any necessary updates to your SFI and enter any other required information. The status of your completed disclosure for an eGC1 will display on its PI, Personnel, & Organizations page.

Create a New Disclosure

The Create New Disclosure button displays below the Action Items section, as shown in the following image.

action items no pending items

Click this button to start the process. The Disclosure Type page will display for you to select the appropriate type of disclosure. For more information see the Disclosure Types section.

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You may edit disclosures which do not have a Review Status of either Review Complete or No Review Required. In general, you will be able to add or remove Related Sponsored Research Projects and change the Narrative statement. Depending on the type of disclosure and the sponsor, you may be able to add or remove (de-select) SFI.

Edit a disclosure for a PHS-Sponsored eGC1

  1. In the Disclosures section at the bottom of the Profile page, click the relevant Disclosure ID.
  2. Click the Edit this Disclosure button at the bottom of the Disclosure page.
  3. The Disclose Significant Financial Interests page will display with the question: Do you need to add new SFI or change existing SFI?

add new SFI or change existing SFI?

  • Selecting Yes will display a list of your current SFI, if any. You can then Add new SFI or click on the Entity Name of an SFI to edit it. When finished, click Next to continue.
  • Selecting No will display the Next button so you can continue.
  1. The Complete Disclosure page will display.
    • You can update the items in the Related Sponsored Research Projects list; however, you cannot un-check the Primary eGC1.
    • You can update your narrative statement to reflect the changes you are making.
  2. Click Submit Disclosure to complete the editing process.

Edit a disclosure for a Non-PHS sponsored eGC1, CoMotion, or Human Subjects Division (HSD) activity

  1. In the Disclosures section at the bottom of the Profile page, click the relevant Disclosure ID.
  2. Click the Edit this Disclosure button at the bottom of the Disclosure page.
  3. The Disclose Significant Financial Interests page will display with the question: Do your SFI pertain to this research activity?
  • Selecting No and clicking Next will complete the disclosure. Any SFI originally included in your disclosure will have been deselected.
  • Selecting Yes will display an additional question.

Does SFI pertain question

  1. Do you need to add new SFI or change existing SFI?
    • Selecting No will display the Next button so you can continue.
    • Selecting Yes will display a list of your current SFI, if any. You can then Add new SFI or click on the Entity Name of an SFI to edit it. When finished, click Next to continue.
  2. The Complete Disclosure page will display.
    • You can update the items in the Related Sponsored Research Projects list; however, you cannot un-check a Primary eGC1.
    • You can update your narrative statement to reflect the changes you are making.
  3. Click Submit Disclosure to complete the editing process.

Note: If someone is reviewing your disclosure at the same time as you are editing it, only the first person to save his or her changes will be able to save. Subsequent users will not be able to save their updates until the page refreshes and displays the first person’s changes. You may have to re-enter your changes if this happens.

Can I edit my completed disclosure?

A completed disclosure can be edited, if it has not yet reached the review status of Review Complete or No Review Required. See the Edit a Disclosure section of the User Guide for more information.

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If this disclosure is for a CoMotion agreement or IRB approval, this section will appear on the page. The information you add will display in read-only mode.

CoMotion disclosure

Other Activities C4C

IRB disclosure

Other Activities for Human Subjects disclosure

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When you select Create New Disclosure at the bottom of the Action Items section on your Profile page, the Disclosure Type page displays. You can indicate what type of disclosure you need to create. The default choice is to create an eGC1 disclosure.

The system will display the eGC1 option only when you are an investigator on an eGC1 and you don’t yet have a pending disclosure for that application.

indicate disclosure purpose section, disclosure types

Based on your disclosure type choice, when you click Next you will be on either the

How will SFI disclosures be handled for PHS-funded projects which have “consultants” who are not UW faculty members? Does the PI need to obtain a temporary UW NetID for training and disclosures?

Most likely, consultants will not be considered investigators and will therefore not be affected.  If consultants (who are not UW employees) are investigators on a UW project, they will likely be contracted through their academic institution, rather than personally. The subawardee, whether through purchasing or a subcontract, will be required to have a compliant policy in order to get federal funding. To meet the mandatory training requirement, an investigator who is not UW personnel could take our training (via a sponsored UW NetID).

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This section displays your disclosure details, in read-only mode:

  • Disclosure Number: either the number of the primary eGC1, or “New”
  • Name
  • Academic Home Unit
  • Contact Phone
  • Email
  • Title
  • Date Disclosed is the date the disclosure is completed (today’s date)
  • Primary eGC1 for this Disclosure: either the number of the associated eGC1, or “(not available)”
  • Status is Disclosure Required for a disclosure associated to an eGC1, or “(not available)”

 Screenshot of Disclosure Details in FIDS