Tag Archives: SFI

March 2013

  • New Action Items section: Investigators can easily see what they need to do next in the new Action Items section on the FIDS Profile page. This section lists investigators’ pending disclosures and easily allows the creation of new ones.
  • SFI Updates: When an existing Significant Financial Interest (SFI) is updated or deleted, any related disclosure which has not yet reached the Review Complete or No Review Required status will reflect the changes.
    • The Institutional Official will review the most current SFI and disclosures which have deleted SFI.
    • A new section in the disclosure will display information about the deleted SFI.
  • Edit Disclosures: Investigators can now edit any disclosure that is not in Review Complete or No Review Required status. This means related research activities can be selected/deselected, and on disclosures for non-Public Health Service (PHS) sponsored eGC1s, and Center for Commercialization (C4C) and Human Subjects Division (HSD) activities, SFI can be selected or deselected.
  • FCOI displayed: The Institutional Official can check a box to indicate which SFI in a disclosure are financial conflicts of interest (FCOI). Investigators will be able to view but not change this indication.
  • Later review: The determination of whether a review is required for primary eGC1 disclosures with no SFI will occur as part of the Just in Time (JIT) process instead of when the disclosure is submitted.
  • New history section: Changes in status and SFI now display in a new History section on the Disclosure Summary page and on a page the Institutional Official views.
  • Concurrency: When multiple people are editing a disclosure, only the first person to save their changes will be able to save. Subsequent users will not be able to save their updates until the page is refreshed and displays the first person’s changes.
  • Review Statuses displayed: The Disclosures section on the Profile page will now display the Review Statuses of each disclosure: Review Required, Waiting for JIT, No Review Required, Duplicate, or Review Complete.
  • Related Sponsored Research Projects: By default, only the primary eGC1 will be selected in the Related Sponsored Research Projects section of a disclosure. You will have to manually select other eGC1s that are related to the disclosure.
I am a graduate student/postdoc funded on my own individual NIH F30/F31/F32/F33 award. Am I considered an investigator?

Yes, the SFI reporting requirements apply.

I am a graduate student/postdoc funded on my department’s PHS T32 training grant. Am I considered an investigator?

Yes, the SFI reporting requirements apply.

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This page displays when you click the Add new SFI link on the Disclose Significant Financial Interests page, or the entity name of an existing SFI to edit.

When adding new SFI, complete each of the sections on the page to provide all of the necessary details about your disclosure.

Significant Financial Interest (SFI)

Any of the following Financial Interests related to the Investigator’s Institutional Responsibilities:

  • For Publicly Traded Entities:

SFI exists if the value of any Compensation received during the twelve months preceding the date of disclosure and/or reasonably anticipated to be received in the twelve months following the date of disclosure, and the value of any Equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000.

  • For Non-Publicly Traded (Private) Entities:

SFI exists if any Equity is held, or if the value of any Compensation received from the entity in the twelve months preceding the date of disclosure and/or reasonably anticipated to be received in the twelve months following the date of disclosure, when aggregated, exceeds $5,000.

For more information, see SFI Disclosures by Investigators in GIM 10.

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As you are completing your disclosure, you will see one of three versions of the Disclose Significant Financial Interests page. Which version you see depends on whether you have previously disclosed any SFI and whether your sponsor (or originating sponsor) is a Public Health Service (PHS) one. A list of PHS Sponsors is available.

The Disclose Significant Financial Interests page appears when you select Complete Disclosure or Create New Disclosure in the Action Items section and then select an eGC1 or CoMotion/IRB activity.

No Existing SFI

If you have not yet entered any SFI, you will need to indicate whether you have any SFI to disclose.

Indicate SFI

  • If you do not have any SFI to disclose, just click Next to complete your disclosure.
  • If you do have SFI to disclose, when you click on Next, the SFI Entry page will display for you to fill in your information.

Existing SFI – Non-Public Health Service (PHS) Sponsor

If you have existing SFI and your sponsor is not a PHS one, you must answer the question: Does your SFI pertain to this research activity?

  • If you select No, then click Next, you will complete the disclosure. The disclosure will not include any of your existing SFI.
  •  If you select Yes, an additional question displays: Do you need to add new SFI or change existing SFI?

Does SFI pertain question

For this question, select No or Yes.

  • Selecting No displays the Next button so you can continue.
  • Selecting Yes displays a list of your current SFI, if any. You can then Add new SFI or click on the Entity Name of an existing SFI to edit it. When finished, click Next to continue.

SFI add or edit SFI list

Existing SFI – Public Health Service Sponsor

A disclosure for a Public Health Service (PHS) sponsor or originating sponsor automatically includes all of your existing SFI. So in this case, you just need to indicate if you want to add new or update existing SFI.

PHS need to add or edit SFI

  • If you select No and click Next, you will complete the disclosure.
  • If you select Yes, then the list of your existing SFI will display, allowing you to edit any existing SFI or add new ones.

PHS Update SFI

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You can make changes to your SFI while you are completing a disclosure, either for a specific eGC1, for unsponsored activities, or just to disclose your SFI updates.

To delete an SFI entry, you need to be on the Disclose Significant Financial Interests page. You can access that page:

  • By clicking on a Complete Disclosure button on the SFI Profile page, choosing I need to update my SFI, and clicking Next.
  • By clicking the Create New Disclosure button on the SFI Profile page, choosing I need to add new SFI or change existing SFI on the Disclosure Type page, and clicking Next.

On the list of your existing SFI on the Disclose Significant Financial Interests page, click the Name of Entity for the SFI you want to delete. The Significant Financial Interests page will display.

  • Click on the trash icon located in the top right corner.

SFI Entity with delete icon

A dialog box will display.

  • If you have included this SFI in a completed disclosure, you will need to provide an explanation for why you are deleting the SFI.
  • The history of the change to the SFI will appear in any disclosure that included the SFI. See the History section for more details.
  • Click the Delete button to complete the process.

Delete SFI explanation box

  • If you have not included this SFI in a completed disclosure, or if you do not have any PHS-sponsored eGC1 disclosure to which it has been automatically added, the dialog box will ask for a confirmation.
  • Select OK to delete the SFI.

screenshot of dialog box for deleting unused SFI

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Read the declaration.

To complete your disclosure, click the Submit Disclosure button. If you wish to cancel the disclosure, you can go back to the Profile Page using the breadcrumbs at the top of the page.

 

Declaration
By submitting this form, I affirm that the information I have provided is true and complete to the best of my knowledge, and I agree:

  • to provide any additional information, including further details of my financial interests, as requested by the Office of Research and, when applicable, the Office of the Vice Dean for Research, or their equivalent in my school/college
  • to cooperate in the development of an appropriate Management Plan as required by the Office of Research
  • to update this disclosure on an annual basis and to submit a disclosure of all new Financial Interests arising within 30 days of acquiring such interests
  • to comply with all terms and conditions contained in any Management Plan
  • to take reasonable measures to ensure that any of my Financial Interests that are less than a Significant Financial Interest do not adversely influence any Research or any person involved in any Research in which I participate as an Investigator or any Technology Transfer Transaction
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This section displays all of your current SFI and includes the details about the Entity and any declared Compensation, Equity, Intellectual Property, or Travel. You will see one of two versions depending on whether the sponsor and/or originating sponsor are PHS or not for the primary eGC1, or if the disclosure does not have a primary eGC1.

PHS-Sponsored Primary eGC1

PHS-funded investigators must disclose all Significant Financial Interests (SFI) related to their Institutional Duties, as defined by GIM 10. FIDS will automatically include all SFI in a disclosure for a PHS-funded eGC1.

SFI List for PHS sponsor

Non-PHS Sponsored Primary eGC1 or No Primary eGC1

If the primary eGC1 does not have a PHS sponsor, you should indicate only related SFI. Specifically, SFI related to research means that the SFI either impacts, or could appear to impact, the design, conduct, or reporting of any current or proposed sponsored research projects.

Click the checkbox to include an SFI, or use the Select All or Deselect All links.

SFI List for Non-PHS sponsor

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Use this section to complete a brief narrative, or description, outlining the connection between your research and your SFI.

Screenshot of narrative section in FIDS

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You can see all of your existing Significant Financial Interests (SFI) listed in this section. The following image shows an example list.

existing significant financial interests section

You can add, edit, or delete SFIs when you are creating a disclosure. Select Complete Disclosure or  Create New Disclosure in the Action Items section to start this process.

If you are an investigator for an eGC1 with a Public Health Service (PHS) sponsor, you must disclose all Significant Financial Interests (SFI) related to your Institutional Duties, as defined by GIM 10: Financial Conflict of Interest Policy. FIDS will automatically link all of your SFI to any PHS-funded eGC1 disclosures.  An eGC1 is PHS-sponsored if either the Sponsor or the Originating Sponsor is a PHS one. A list of PHS Sponsors is available.

If your eGC1’s sponsor is not PHS, you should only include those SFI related to the eGC1’s research. Specifically, SFI related to research means that the SFI either impacts, or could appear to impact, the design, conduct, or reporting of any current or proposed research projects.